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The New England Journal of Medicine Jan 2023The effects of empagliflozin in patients with chronic kidney disease who are at risk for disease progression are not well understood. The EMPA-KIDNEY trial was designed... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The effects of empagliflozin in patients with chronic kidney disease who are at risk for disease progression are not well understood. The EMPA-KIDNEY trial was designed to assess the effects of treatment with empagliflozin in a broad range of such patients.
METHODS
We enrolled patients with chronic kidney disease who had an estimated glomerular filtration rate (eGFR) of at least 20 but less than 45 ml per minute per 1.73 m of body-surface area, or who had an eGFR of at least 45 but less than 90 ml per minute per 1.73 m with a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of at least 200. Patients were randomly assigned to receive empagliflozin (10 mg once daily) or matching placebo. The primary outcome was a composite of progression of kidney disease (defined as end-stage kidney disease, a sustained decrease in eGFR to <10 ml per minute per 1.73 m, a sustained decrease in eGFR of ā„40% from baseline, or death from renal causes) or death from cardiovascular causes.
RESULTS
A total of 6609 patients underwent randomization. During a median of 2.0 years of follow-up, progression of kidney disease or death from cardiovascular causes occurred in 432 of 3304 patients (13.1%) in the empagliflozin group and in 558 of 3305 patients (16.9%) in the placebo group (hazard ratio, 0.72; 95% confidence interval [CI], 0.64 to 0.82; P<0.001). Results were consistent among patients with or without diabetes and across subgroups defined according to eGFR ranges. The rate of hospitalization from any cause was lower in the empagliflozin group than in the placebo group (hazard ratio, 0.86; 95% CI, 0.78 to 0.95; Pā=ā0.003), but there were no significant between-group differences with respect to the composite outcome of hospitalization for heart failure or death from cardiovascular causes (which occurred in 4.0% in the empagliflozin group and 4.6% in the placebo group) or death from any cause (in 4.5% and 5.1%, respectively). The rates of serious adverse events were similar in the two groups.
CONCLUSIONS
Among a wide range of patients with chronic kidney disease who were at risk for disease progression, empagliflozin therapy led to a lower risk of progression of kidney disease or death from cardiovascular causes than placebo. (Funded by Boehringer Ingelheim and others; EMPA-KIDNEY ClinicalTrials.gov number, NCT03594110; EudraCT number, 2017-002971-24.).
Topics: Humans; Benzhydryl Compounds; Cardiovascular Diseases; Creatinine; Diabetes Mellitus, Type 2; Disease Progression; Glomerular Filtration Rate; Kidney; Renal Insufficiency, Chronic; Sodium-Glucose Transporter 2 Inhibitors
PubMed: 36331190
DOI: 10.1056/NEJMoa2204233 -
Journal of Bioethical Inquiry Jun 2023The recently passed Privacy Legislation Amendment (Enforcement and Other Measures) Act 2022 (Cth) introduced important changes to the Australian Privacy Act 1988 (Cth)... (Review)
Review
The recently passed Privacy Legislation Amendment (Enforcement and Other Measures) Act 2022 (Cth) introduced important changes to the Australian Privacy Act 1988 (Cth) which increase penalties for serious and repeated interferences with privacy and strengthen the investigative and enforcement powers of the Information Commissioner. The amendments were made subsequent to a number of high profile data breaches and represent the first set of changes to the Privacy Act following the review of the Act commenced by the Attorney-General in October 2020. The submissions made to the review emphasized the need for more effective enforcement mechanisms to increase individuals' control over their personal information and as a form of deterrence. This article reviews the recent amendments to the Privacy Act and explains their effect. It comments upon the relevance of the amendments for health and medical data and other data collected in the context of healthcare, and refers to the Attorney-General's Department's review of the Privacy Act regarding other proposals relating to enforcement which have not as yet been put into effect in legislation.
Topics: Humans; Privacy; Australia; Personally Identifiable Information; Confidentiality
PubMed: 37432509
DOI: 10.1007/s11673-023-10249-4 -
History and Philosophy of the Life... Jan 2021Many governments have seen digital health technologies as promising tools to tackle the current COVID-19 pandemic. A much-talked example in this context involves the...
Many governments have seen digital health technologies as promising tools to tackle the current COVID-19 pandemic. A much-talked example in this context involves the recent deluge of digital contact tracing apps (DCT) aimed at detecting Covid-19 exposure. In this short contribution we look at the bio-political justification of this phenomenon and reflect on whether DCT apps constitute, as it is often argued, a serious potential breach of our right to privacy. Despite praising efforts attempting to develop legal and ethical frameworks for DCT apps' usage; we argue that such endeavours are not sufficient to tackle the more fundamental problem of mass surveillance, which will remain largely unaddressed unless we deal with the biopolitical arguments presented and resort to a technical and structural defence.
Topics: COVID-19; Contact Tracing; Freedom; Humans; Pandemics; Philosophy; Privacy
PubMed: 33417016
DOI: 10.1007/s40656-020-00354-7 -
Frontiers in Digital Health 2022Healthcare is facing a growing threat of cyberattacks. Myriad data sources illustrate the same trends that healthcare is one of the industries with the highest risk of... (Review)
Review
BACKGROUND
Healthcare is facing a growing threat of cyberattacks. Myriad data sources illustrate the same trends that healthcare is one of the industries with the highest risk of cyber infiltration and is seeing a surge in security incidents within just a few years. The circumstances thus begged the question: are US hospitals prepared for the risks that accompany clinical medicine in cyberspace?
OBJECTIVE
The study aimed to identify the major topics and concerns present in today's hospital cybersecurity field, intended for non-cyber professionals working in hospital settings.
METHODS
structured literature searches of the National Institutes of Health's and Tel Aviv University's databases, 35 journal articles were identified to form the core of the study. Databases were chosen for accessibility and academic rigor. Eighty-seven additional sources were examined to supplement the findings.
RESULTS
The review revealed a basic landscape of hospital cybersecurity, including primary reasons hospitals are frequent targets, top attack methods, and consequences hospitals face following attacks. Cyber technologies common in healthcare and their risks were examined, including medical devices, telemedicine software, and electronic data. By infiltrating any of these components of clinical care, attackers can access mounds of information and manipulate, steal, ransom, or otherwise compromise the records, or can use the access to catapult themselves to deeper parts of a hospital's network. Issues that can increase healthcare cyber risks, like interoperability and constant accessibility, were also identified. Finally, strategies that hospitals tend to employ to combat these risks, including technical, financial, and regulatory, were explored and found to be weak. There exist serious vulnerabilities within hospitals' technologies that many hospitals presently fail to address. The COVID-19 pandemic was used to further illustrate this issue.
CONCLUSIONS
Comparison of the risks, strategies, and gaps revealed that many US hospitals are unprepared for cyberattacks. Efforts are largely misdirected, with external-often governmental-efforts negligible. Policy changes, e.g., training employees in cyber protocols, adding advanced technical protections, and collaborating with several experts, are necessary. Overall, hospitals must recognize that, in cyber incidents, the real victims are the patients. They are at risk physically and digitally when medical devices or treatments are compromised.
PubMed: 36033634
DOI: 10.3389/fdgth.2022.862221 -
Journal of Medical Virology Apr 2022Young age, female sex, absence of comorbidities, and prior infection or vaccination are known epidemiological barriers for contracting the new infection and/or increased... (Review)
Review
Young age, female sex, absence of comorbidities, and prior infection or vaccination are known epidemiological barriers for contracting the new infection and/or increased disease severity. Demographic trends from the recent coronavirus disease 2019 waves, which are believed to be driven by newer severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants, indicate that the aforementioned epidemiological barriers are being breached and a larger number of younger and healthy individuals are developing severe disease. The new SARS-CoV-2 variants have key mutations that can induce significant changes in the virus-host interactions. Recent studies report that, some of these mutations, singly or in a group, enhance key mechanisms, such as binding of the receptor-binding domain (RBD) of the viral spike protein with the angiotensin-converting enzyme 2 (ACE2) receptor in the host-cells, increase the glycosylation of spike protein at the antigenic sites, and enhance the proteolytic cleavage of the spike protein, thus leading to improved host-cell entry and the replication of the virus. The putative changes in the virus-host interactions imparted by the mutations in the RBD sequence can potentially be the reason behind the breach of the observed epidemiological barriers. Susceptibility for contracting SARS-CoV-2 infection and the disease outcomes are known to be influenced by host-cell expressions of ACE2 and other proteases. The new variants can act more efficiently, and even with the lesser availability of the viral entry-receptor and the associated proteases, can have more efficient host-cell entry and greater replication resulting in high viral loads and prolonged viral shedding, widespread tissue-injury, and severe inflammation leading to increased transmissibility and lethality. Furthermore, the accumulating evidence shows that multiple new variants have reduced neutralization by both, natural and vaccine-acquired antibodies, indicating that repeated and vaccine breakthrough infections may arise as serious health concerns in the ongoing pandemic.
Topics: COVID-19; Disease Susceptibility; Host-Pathogen Interactions; Humans; Immune Evasion; Mutation; SARS-CoV-2; Spike Glycoprotein, Coronavirus; Virus Internalization; Virus Replication
PubMed: 34811761
DOI: 10.1002/jmv.27467 -
The Cochrane Database of Systematic... Mar 2020Reason for withdrawal: Serious breach of Cochrane's conflict of interest policy. A ruling by Cochrane's Funding Arbiters that a Cochrane Review has seriously breached... (Review)
Review
Reason for withdrawal: Serious breach of Cochrane's conflict of interest policy. A ruling by Cochrane's Funding Arbiters that a Cochrane Review has seriously breached Cochrane's conflict of interest policy.
PubMed: 32212387
DOI: 10.1002/14651858.CD012271.pub3 -
Saudi Journal of Biological Sciences Jan 2022Besides its impacts on governance, economics, human culture, geostrategic partnership and environment, globalization greatly exerted control over science and security... (Review)
Review
Besides its impacts on governance, economics, human culture, geostrategic partnership and environment, globalization greatly exerted control over science and security policies. Biosecurity is the critical job of efforts, policy and preparation to protect health of human, animal and environmental against any biological threats. With the transition into a global village, the possibility of biosecurity breaches has significantly increased. The COVID-19 pandemic is an example of an infringement on biosecurity that has posed a serious threat to the world. Since the first report on the recognition of COVID-19, a number of governments have taken preventive measures, like; lockdown, screening and early detection of suspected and implementing the required response to protect the loss of life and economy. Unfortunately, some of these measures have only recently been taken in some countries, which have contributed significantly to an increased morbidity and loss of life on a daily basis. In this article, the biological risks affecting human, animal and environmental conditions, biosafety violations and preventive measures have been discussed in order to reduce the outbreak and impacts of a pandemic like COVID-19.
PubMed: 34483699
DOI: 10.1016/j.sjbs.2021.08.060 -
Cureus Feb 2023The sphenoethmoidal meningocele is a herniation of the meninges through a communication of the skull base with an aeric cavity. It means the presence of an...
The sphenoethmoidal meningocele is a herniation of the meninges through a communication of the skull base with an aeric cavity. It means the presence of an osteomeningeal breach, which is manifested by cerebrospinal rhinorrhea and nasal obstruction. iIs diagnosis is based on a very specific radiological assessment and biology allows the dosage of certain substances to confirm the nature of the cerebrospinal fluid, such as beta-2-transferrin, Once the breach has been found, the endoscopic route exclusively allows the pathology to be treated and the defect to be reconstructed using different materials before the occurrence of serious complications such as meningitis.
PubMed: 36938298
DOI: 10.7759/cureus.35022 -
Responding to chemical weapons violations in Syria: legal, health, and humanitarian recommendations.Conflict and Health 2018The repeated use of prohibited chemical weapons in the Syrian conflict poses serious health, humanitarian, and security threats to civilians, healthcare personnel, and... (Review)
Review
BACKGROUND
The repeated use of prohibited chemical weapons in the Syrian conflict poses serious health, humanitarian, and security threats to civilians, healthcare personnel, and first responders. Moreover, the use of chemical weapons constitutes a clear and egregious violation of international law-likely amounting to a war crime-for which continued impunity is setting a dangerous precedent in relation to current and future conflicts. This debate article calls upon concerned states, organizations, and individuals to respond urgently and unequivocally to this serious breach of international legal and humanitarian norms.
MAIN BODY
Based on health, humanitarian, and legal findings, this article calls for concrete action to: 1) reduce the risk of chemical weapons being used in current and future conflicts; 2) review and support the preparedness equipment and antidote supplies of first responders, humanitarian organizations, and military forces operating in Syria; 3) support international mechanisms for monitoring and enforcing the prohibition on chemical weapons, including through criminal accountability; 4) support civilian victims of chemical weapons attacks, including refugees; and 5) re-commit to the complete elimination of chemical weapons in compliance with the (1993), a comprehensive treaty that bans chemical weapons and requires their complete destruction.
CONCLUSION
All involved states and organizations should take urgent steps to ensure the protection of the most vulnerable victims of conflict, including victims of chemical weapons attacks in Syria, and to reinforce international law in the face of such serious violations.
PubMed: 29479374
DOI: 10.1186/s13031-018-0143-3