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FDA Approval of the Eversense 365 Continuous Glucose Monitoring System: A New Era in Long-Term Glucose Monitoring
No full textEversense 365 is an implantable continuous glucose monitoring (CGM) system designed to provide accurate glucose measurements for up to 365 days. Current clinical guidelines recommend CGM use for patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM), with evidence demonstrating benefit in patients with T2DM regardless of concurrent insulin use. Healthcare providers play a key role in patient education and are well-positioned to support the adoption of long-term CGM technologies, including Eversense 365. The safety and efficacy of the 365-day CGM have been evaluated across a series of clinical trials, which demonstrate clinically meaningful improvements in glucose monitoring and diabetes mellitus (DM) management. Together, these findings support the Eversense 365 CGM as a valuable long-term CGM option for appropriate patients
Impact of Apitegromab on Motor Function in Spinal Muscular Atrophy
No full textSpinal muscular atrophy (SMA) is an inherited neuromuscular disorder characterized by the progressive loss of alpha motor neurons in the anterior horn of the spinal cord, leading to muscle weakness, atrophy, and impaired motor function.1 SMA remains an extensive and difficult-to-treat condition, with only three disease-modifying therapies currently available to patients. A new investigational agent with a unique mechanism of action, apitegromab (SRK-015), has shown promising results in recent clinical trials. The safety and efficacy of apitegromab in patients with SMA have been explored in several clinical trials, with the TOPAZ and SAPPHIRE studies being the most notable. This review summarizes the pathology, diagnostic considerations, and clinical subtypes of SMA, and evaluates the mechanism, clinical evidence, and emerging therapeutic role of apitegromab in the modern treatment landscape
FDA Policy Shift on Clinical Efficacy Study Requirements for Monoclonal Antibody Biosimilars
No full textBiologic products are widely used in the treatment of various disease states, including rheumatoid arthritis, inflammatory bowel disease, cancers, and genetic diseases. These products are derived from proteins and genes produced by living organisms and are subsequently used to treat specific disease states. Due to the complexity of biological products, the costs of research and production are high. Currently, the United States approval pathway requires extensive testing for biologics to be designated as biosimilars, meaning there are no clinically meaningful differences in safety or purity of their active components. These required tests can be redundant, as biosimilars are developed using the same reference product, unnecessarily increasing development costs and delaying patient access. As a result, the Food and Drug Administration (FDA) has decided to follow the European Medicines Agency (EMA) by progressively adopting drug function and chemical property tests in place of additional clinical efficacy studies (CESs). Waiving CESs can make the biosimilar approval process more efficient, ethical, and affordable while improving patient access without compromising safety or efficacy. The risks and benefits of waiving CESs need to be carefully considered, and patients and providers need to be appropriately informed of biosimilar interchangeability. By increasing prescribers’ familiarity with biosimilars, patients can be treated more promptly and receive higher-quality care at a more affordable cost
Poor Birth Outcomes Related to Cannabis Use in Pregnancy
Full text linkPregnancy, a period of dynamic physiological changes, necessitates careful consideration of external influences on maternal and fetal health. Despite increasing legalization and prevalence, the impact of cannabis use during gestation remains a topic of significant concern and investigation.
Recent studies have shed light on the consequences of in utero cannabis exposure, encompassing both fetal and maternal outcomes. Notably, several studies have identified associations between cannabis exposure during pregnancy and adverse fetal outcomes, including small-for-gestational-age birth, altered neurodevelopment, preterm birth, and increased risk of neonatal morbidity. Evidence to date underscores the urgent need for education, intervention, and regulatory oversight regarding cannabis use during pregnancy.
The role of pharmacists in mitigating the risks associated with cannabis use during pregnancy is paramount for the safety of the mother and fetus. Pharmacists are positioned to provide patient-centered care and can play a pivotal role in optimizing maternal and fetal health outcomes. By adhering to comprehensive medication management principles and leveraging their expertise in pharmacotherapeutics, pharmacists can help ensure the safe and appropriate use of medications during pregnancy, including the avoidance of cannabis
Effects of pretreatment with the CB1 receptor agonist (WIN 55212) on cocaine-induced behavioral effects in male and female mice
No full textCocaine is an illicit substance that is widely abused in the Unites States. Over the last few years, cannabis and products utilizing cannabis are being legalized across the United States. This has led to their increasing use. Cannabis and products utilizing cannabis activate CB1 receptors in the brain, which can have several behavioral effects. More recently sex-dependent differences in the role of CB1 receptors have been reported. However, the effects of CB1 receptor activation in adult male and female mice on the rewarding and psychomotor effects of cocaine have not been systematically evaluated. This study aimed to address this gap in knowledge. Adult (12-18 weeks old) male and female mice (C57BL6) were used for the study. Cocaine-induced locomotor activity and rewarding effects were assessed at two doses of cocaine (5 and 15 mg/kg). The rewarding effects of cocaine were assessed using the conditioned place preference test (CPP). CB1 receptors were activated using CB1 agonist WIN 55212-2 (3 mg/kg). Data in this project is currently being collected and analyzed. We hypothesize that activation of CB1 receptors will have differential effects on cocaine-induced behavioral effects in male and female mice
Can You Spot the Difference? Impact of Distractor Type and Intensity On Number Of Differences Identified in a Spot-The-Difference Task
No full textEveryday, individuals are faced with tasks that require sustained visual attention. However, distractions are also a part of daily life, and with the increase in technology use came an increase in distractions that may affect concentration and performance on visual tasks. Previous research has examined how task-unrelated visual and auditory stimuli, presented at different intensities, impact functions of learning and memory. However, little research exists on how such distractions might impact an ongoing attention-demanding visual task. The present study used a 2x2 between-subjects design to test the impact of both visual and auditory distractors, presented at either a high or low intensity, on performance during a spot-the-difference task. 110 college students with a mean age of 19 were randomly assigned to one of the four conditions. The number of correct differences participants identified out of 24 on a spot-the-difference task was recorded. A significant effect of distractor type was found (p \u3c .05), with visual distractors leading to significantly fewer differences identified during the spot-the-difference task than auditory distractors. This suggests that task-unrelated visual material is more distracting during an ongoing visual task than auditory material. Removing these external stimuli could potentially increase academic performance in students who complete tasks with unrelated visual and auditory stimuli present
Breaking Hardware Security: The Chip Whisperer
No full textDetailing how the Chip Whisperer technology can be used to break hardware encryption and exploring how to use the Chip Whisperer as a way for future students to learn during lab
Patient Satisfaction and Nutrition Understanding
No full textProblem: Patients in the hospital are given a standardized menus with food options that may not promote optimal health and healing. Many hospitalized patients are on specific diets related to their medical conditions. When patients on these specific diets try to order meals outside the bounds of their dietary guidelines, they are told “no” without being told why or what they can have.
Aim: The aim of this study is to measure patient satisfaction regarding their meals when they receive a general menu as compared to patients who are given specific menus and nutrition education catered to their medical problems.
Methods: This will be a quasi-experimental single blind design. Patients will be randomly assigned into the control group (patients given the general menu) and the intervention group (patients given a menu related to their specific medical condition and nutritional support). At the end of their hospital stay, all patients will complete a survey measuring satisfaction and nutritional knowledge.
Conclusion: It is expected that patients who had the menus related to their specific medical condition will have higher satisfaction with their meals. Additionally, because of the intervention group received additional nutritional support, they will have a greater understanding of their nutritional needs. This will lead to increased patient compliance with these diets and improved health outcomes
Impact of Compression Sock Use on Lower Extremity Health Among Nurses Working 12-Hour Shifts: A 6-Month Study
No full textProblem Nurses working 12-hour shifts face increased risks of lower extremity issues like varicose veins, chronic pain, and swelling due to prolonged standing and walking. These conditions can impact physical health, job satisfaction, and well-being. Although compression therapy is known to improve circulation and alleviate such symptoms, its long-term effectiveness remains unclear.
Purpose This research aims to determine if wearing compression socks during 12-hour shifts reduces lower extremity issues like varicose veins, pain, and swelling in nurses over six months, and whether it improves their long-term health and comfort.
Methods The research employs a longitudinal, experimental design with two groups: an experimental group that wears compression socks and a control group that does not. The study evaluates whether compression socks can alleviate symptoms such as varicose veins, pain, and swelling, while also improving job satisfaction and overall well-being.
Conclusion Wearing compression socks during 12-hour shifts reduces lower extremity issues in nurses. Participants in previous research reported high adherence and positive feedback on comfort and effectiveness. Wearing compression socks improves physical health, job satisfaction, and well-being, making compression socks a recommended practice for nurses. Its cost-effectiveness offers healthcare facilities a practical solution to improve nurse health and reduce absenteeism. Further research is needed to explore long-term effects and broader applications
The Search for Common Ground: Analyzing Language Commonly Used For Individuals with Intellectual and Developmental Disabilities
No full textRespect and acceptance of individuals within a society can start simply from the language used to refer to them, especially those with intellectual and developmental disabilities (IDD). With debates of researchers and professors using either identity-first language (IFL) or person-first language (PFL) within their teachings and findings, no consistent standard for usage has emerged and not much has been said on what is generally being used. Using an exploratory survey, this research explores the language used on a college campus when referring to individuals with IDD. Variations of IFL, PFL, and slang (or outdated language) were analyzed in terms of the communities’ preference and frequency of use. Staff and faculty on campus, in addition to current students, were invited to participate in the survey and differences between the two groups were examined. Additionally, comparisons in usage between those who identified as being disabled and those who are not were made