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Background: GP2 is a biologic nine amino acid peptide of the HER2/neu protein delivered in combination with Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) that stimulates an immune response targeting HER2/neu expressing cancers, the combination known as GLSI-100. In a prospective, randomized, single-blinded, placebo-controlled, multicenter Phase IIb study, no recurrences were observed in the HER2+ population after 5 years of follow-up, if the patient was treated with GLSI-100, survived and was followed for more than 6 months (p = 0.0338). Immunotherapy elicited a potent response measured by skin tests and immunological assays. Of the 146 patients that have been treated with GLSI-100 over 4 clinical trials, GLSI-100 was well-tolerated and no serious adverse events were observed considered related to the immunotherapy. Method: This Phase III trial is a prospective, randomized, double-blinded, multi-center study. After 1 year of trastuzumab-based therapy, 6 intradermal injections of GLSI-100 or placebo will be administered over the first 6 months and 5 subsequent boosters will be administered over the next 2.5 years for a total of 11 injections over 3 years. The participant duration of the trial will be 3 years treatment plus 1 additional year follow-up for a total of 4 years following the first year of treatment with trastuzumab-based therapy. Patients will be stratified based on residual disease status at surgery, hormone receptor status and region. Study Size – Interim Analysis: Approximately 498 patients will be enrolled. To detect a hazard ratio of 0.3 in invasive breast cancer free survival (IBCFS), 28 events will be required. An interim analysis for superiority and futility will be conducted when at least 14 events have occurred. This sample size provides 80% power if the annual rate of events in placebo patients is 2.4% or greater. Up to 100 non-HLA-A*02 subjects will be enrolled in an open-label arm. Eligibility Criteria: The patient population is defined by these key eligibility criteria: 1. HER2/neu positive and HLA-A*02 2. Residual disease or High risk pCR (Stage III at presentation) post neo-adjuvant therapy 3. Exclude Stage IV 4. Completed at least 90% of planned trastuzumab-based therapy Trial Objectives: 1. To determine if GP2 therapy increases IBCFS 2. To assess the safety profile of GP2 3. To monitor immunologic responses to treatment and assess relationship to efficacy and safety Contact information: Snehal Patel Greenwich LifeSciences, Inc. Stafford, TX Email: snehal.patel@greenwichlifesciences.com Website: greenwichlifesciences.com Funding: This trial is supported by Greenwich LifeSciences. Citation Format: Snehal Patel, Jaye Thompson, Mira Patel, F. Joseph Daugherty, C. Kent Osborne, Mothaffar Rimawi. Phase III study to evaluate the efficacy and safety of GLSI-100 (GP2 + GM-CSF) in breast cancer patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 therapy, Flamingo-01 [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT2-10-06.

Climate Smart Agriculture interventions have emerged to address the challenges in the agriculture sector caused by climate-induced disasters and stresses. For the present investigation data were collected from all the seven districts of the South Gujarat region, the overall sample size comprises of 280 young farmers. The results showed that the majority of the young farmers had adequate to best knowledge about CSA interventions. Further, results showed that the annual income, risk preference and leadership ability were found positively and significantly related to the knowledge of young farmers about CSA interventions at a 1 percent level of significance. While, education, mass media exposure, extension contact, scientific orientation, awareness on climate change, innovativeness, risk orientation and decision making ability were found positively and significantly related with the knowledge of young farmers about CSA interventions at a 5 percent level of significance. Furthermore, the land holding was found negatively and non-significantly related with the knowledge of young farmers about CSA interventions.

In this research, a Lantana camara seed extract was employed for easily and sustainably synthesis of silver nanocomposites. Aqueous silver ions reduced when exposed to seed extract, which led to the biogenesis of silver nanoparticles. The reduced silver nanoparticles were examined utilizing a multiple of methods, including transmission electron microscopy, X-ray diffraction, and Fourier transform infrared spectroscopy analysis. Absorption peak at 415 nm in the UV-vis absorption spectral analysis of the synthesized silver nanoparticles provided evidence that silver nanoparticles had formed. The FCC crystalline structure of the produced L. camara leaf extract silver nanoparticles is revealed by X-ray diffraction spectra analysis. The development of Gram-positive Pseudomonas aeruginosa and Gram-negative Staphylococcus aureus bacteria is repressed by green synthetic silver nanoparticles made from L. camara seed extract. The antibacterial activity that has been observed may have significant uses in biology, pharmacy, and economics.

Cancer is the primary cause of death worldwide, accounting for almost 10 million deaths. The most prevalent are lung, breast, colorectal, and skin cancer. Cancer does not obey the cell cycle which can lead to the formation of tumors. The biogenic amine histamine is synthesized by histidine. Increased amounts of histamine have been linked to the regulation of several tumors. The histamine receptors (H1, H2, H3, and H4) are distributed throughout the skin, where H1 and H2 are the primary targets for drug therapy. Repurposing of the current antihistamine drugs can be cost-effective, safe medications and allied with lesser adverse effects. Researchers examined Six H1-antihistamines (Cetirizine, clemastine, desloratadine, loratadine, ebastine, and fexofenadine) in a nationwide wide cohort study of all Swedish patients with ten types of immunogenic (melanoma, bladder cancer, kidney, prostate, lung, pancreatic, colorectal, breast cancer, and Hodgkin lymphoma) and six non-immunogenic (thyroid cancer, liver, ovarian, brain cancer and lymphoma) tumors. The study shows that Desloratadine and loratadine upsurge the survival rate for many tumors by inhibiting the growth of tumors and promoting apoptotic cell death. The other H1 receptor antagonist Cloperastine knockdown FGF13 expression which is responsible for anticancer agent cisplatin-resistance and selectively kills HeLa cisR cells. Some findings believe H1 receptor antagonists should be investigated in randomized clinical trials for immunogenic tumors. These drugs can be a curative therapy for several tumors including that prognosis with limited treatment options.

BACKGROUND: Follicular thyroid carcinoma (FTC) and Hurthle cell carcinoma (HCC) are rare and aggressive thyroid cancers with limited published data comparing their outcomes or regarding their subtypes. The aim of this study was to describe clinicopathological features and compare clinical outcomes of patients with FTC and HCC based on the 2017 World Health Organization definition and extent of vascular invasion (VI). METHODS: We retrospectively studied 190 patients with HCC and FTC primarily treated with surgery at Memorial Sloan Kettering Cancer Center between 1986 and 2015. Patients were classified as minimally invasive (MI), encapsulated angioinvasive with focal VI (EA-FVI), encapsulated angioinvasive with extensive VI (EA-EVI), and as widely invasive (WI). To compare clinical outcomes, patients were grouped as follows: group 1 = FTC-MI and FTC EA-FVI, group 2 = FTC EA-EVI and FTC-WI, group 3 = HCC-MI and HCC EA-FVI, group 4 = HCC EA-EVI and HCC-WI. Outcomes of interest were overall survival (OS), disease-specific survival (DSS), recurrence-free survival (RFS), locoregional recurrence-free survival (LRRFS), and distant recurrence-free survival (DRFS). Outcomes were determined using the Kaplan–Meier method and compared with log-rank test. RESULTS: Patients with HCC (n = 111) were more likely to be older than 55 years old (59% vs. 27%, p

To study the effect of SARS-CoV-2 Infection on maternal, fetal and neonatal outcomes. A retrospective cohort study was undertaken in a tertiary Covid Care Centre (CCC), Ahmedabad, Gujarat, India. The study was conducted from 1st April 2021 to 30th June 2021. A total of 22 symptomatic antenatal patients diagnosed with SARS-CoV-2 by RT-PCR method were included. The mean age of the mothers was 30.2 ± 4.0 years and the mean gestational age was 29.7 ± 9.1 weeks. Six (27.3%) patients required intensive care unit (ICU) admission. 63.7% of the subjects required respiratory support i.e. 40.9% with nasal oxygen therapy and 22.7% with invasive ventilation. Six Intrauterine fetal death were also recorded. Only two neonates (born at 37 and 38 weeks of gestation, respectively) both with low Apgar scores at 1st minute & 5th minute experienced respiratory distress and required neonatal ICU (NICU) admission. Among them, only one neonatal death was recorded because of the diffuse exudative lesions & lung whiteout. The current study had the maternal mortality rate of 13.6% (3/22) owing to various medical complications with two of them succumbing to multiple organ failure with Disseminated intravascular coagulation (DIC) & one patient to sepsis with DIC. The clinical course of COVID‐19 during pregnancy appears to be unique to each patient, with a higher incidence of DIC and multiorgan failure. Hence, a multidisciplinary team approach is vital in individualising the timing, mode for delivery, and course of management in these patients.

A UV-visible spectrophotometric method for quantifying tacrolimus in nanoparticles has been developed and validated, and it is accurate, simple, reproducible, and affordable. For drug analysis, optimal conditions have been identified. 291 nm was discovered to be the maximum wavelength (max). In the range of 0.2-1.8 mg/ml, the response was linear (r2 = 0.9989). The intra- and inter-day relative standard deviations for precision studies were found to be less than 2%, indicating that the procedure is precise.

Niosomes are vesicles, which are formulated by hydrating the mixture of cholesterol, non-ionic surfactant and other biodegradable lipids. Niosomes increase the drug activity as compare to their conventional dosage form of a drug. Niosomes can be used as carrier of amphiphilic and lipophilic drugs. Niosomes may overcome the issues related to instability, fast degradation, low bioavailability, and insolubility of medications. The structure of niosomes either multilamellar or unilamellar, is depends on the method of formulation. Niosomes contain very efficient drug delivery potential for site-specific delivery of anti-cancer, anti-infective agents, etc. Niosomes are stable as well as cost effective carriers as compared with other drug formulations. Niosomes also have various applications in parental drug delivery system, topical drug delivery system, oral drug delivery system and novel drug delivery system such as targeted drug delivery system and controlled drug release system.

Background Anosmia/hyposmia affects 13.3 million people in the U.S. alone according to the recent U.S. National Health and Nutrition Examination Survey (NHANES). Hundreds of thousands more people with persistent olfactory dysfunction will be added to this number due to the COVID-19 pandemic. Patients with loss-of-function mutations in SCN9A, the gene encoding NaV1.7, experience anosmia in addition to congenital insensitivity to pain. Tsp1a is a recently discovered peptide that inhibits NaV1.7 with high potency and selectivity. In this study, we examined whether a fluorescently tagged version of Tsp1a could be used to visualize normal and damaged mouse olfactory nerves. Methods Athymic nude mice were intravenously injected with Tsp1a-IR800. As a control, mice were injected with PBS only, and as a blocking control were injected with combination of Tsp1a and Tsp1a-IR800. All mice were imaged in-vivo and epifluorescence images were acquired using an IVIS Spectrum animal imaging system. Semiquantitative analysis of the Tsp1a-IR800 signal was conducted by measuring the average radiant efficiency in the region of the olfactory epithelium/bulb (ROEB). Methimazole was used to chemically ablate the olfactory epithelium. We performed a food buried test to correlate the level of anosmia with the level of radiance efficiency. Results The area of olfactory epithelium/bulb was clearly visible in epifluorescence in-vivo images of mice receiving the imaging agent. The radiant efficiency was significantly less in both mice injected with PBS and in mice injected with the blocking formulation. The mice after olfactory ablation had a significantly reduced radiant efficiency compared with normal mice. Moreover, there was a statistically significant and inverse correlation between the time required for the mouse to find buried food and the radiant efficiency. We also performed immunohistochemistry using NaV1.7 antibody. Mice after olfactory ablation as well as COVID-19-infected mice had significantly lower expression of NaV1.7 on the level of olfactory epithelium/bulb. Conclusion We show that the fluorescent imaging of mouse olfactory epithelium/bulb is possible, suggesting that labeled Tsp1a tracers may serve as the first objective diagnostic tool of smell disorders, including those caused by COVID-19.

Rural markets have suddenly come into lime light after most of the urban markets are being saturated by products. Health care in rural areas of India is not well developed when compared to their urban counterpart. Though government had started many initiatives to drive the health of rural Indians, still the awareness related to various health problems and their necessary treatment is at a very nascent stage in rural India. The decision regarding consultation of doctors in case of suffering from common diseases like cold, cough, etc comes from a variety of sources and hence the perceptions and attitudes of rural people must be studied regarding medical treatment in case of common diseases. The present study will also help to marketers of medicines and doctors to address the issues properly. The present study investigated the perceptions and attitudes of rural people of selected villages of Mehmdavad district towards medical treatments. A sample of 100 people living in rural areas of Mehmdavad was selected and a structured questionnaire was administered with them. Chi square and ANOVA test were used to check the influence of current state of suffering from common diseases and their perceptions and attitudes towards medical treatment. The study find out that recent suffering from common diseases do have effect on perceptions and attitudes of rural people with reference to medical treatment.

Serum albumin, often referred to simply as albumin, is a globular protein that in humans is encoded by the ALB gene. Albumin is a multifaceted, highly soluble, stable, nontoxic, non-poisonous, biocompatible and biodegradable plasma protein. Albumin has been widely studied as a protein carrier for drug delivery. Because of its versatile nature, it can also be used for the delivery of the hormones, metals and fatty acids by binding to its specific binding sites. Various studies revealed that albumin can be used to increase the circulating half-life and bioavailability of drug molecules which are smaller than the renal filtration threshold and are rapidly lost from the circulation leading to limiting therapeutic potential. This review article presents advantages, disadvantages, functions, importance, different nanoparticles that can be crowned with an albumin and the special features of albumin as a drug carrier, and how the understanding of these features is currently being employed to optimize the circulatory half-life albumin.

Central nervous system (CNS) disorder is the world’s leading cause of disability and account of more hospitalizations. Central nervous system disorders are a group of neurological disorder that affect the structure or function of the brain or spinal cord. Depression (major depressive disorder or clinical depression) is a common but serious mood disorder. It causes severe symptoms that affect how you feel, think, and handle daily activities, such as sleeping, eating, or working. The aim of treatment is release of neurotrophic proteins in the brain that can help to rebuild the hippocampus that has been reduced due to depression and to optimize patients’ physical, psychological and social functioning. This review presents a brief summary on psychological implications of living with depression, pathogenesis, diagnosis, causes, sign and symptoms and treatments associated with depression.

Although infections are a significant potential complication among patients undergoing left ventricular assist device (LVAD) implantation, standardized surgical infection prophylaxis (SIP) regimens are not well defined. At Montefiore Medical Center, a 4-drug SIP regimen containing fluconazole, ciprofloxacin, rifampin, and vancomycin was previously utilized. In January 2020, the antimicrobial stewardship program implemented a 2-drug SIP regimen of vancomycin and cefazolin to limit exposure to broad-spectrum antibiotics. This study evaluated LVAD-associated infection rates prior to and following the SIP revision.A retrospective review of patients who underwent LVAD implantation from 1/2018 to 4/2021 was performed. Infections were classified using the International Society for Heart and Lung Transplantation definitions. Infection rates at 2 weeks, 30 days, and 90 days post-implantation in the 4-drug SIP regimen (1/2018-12/2019) and the 2-drug SIP regimen (1/2020 to 4/2021) were compared.A total of 71 patients were included. The number of patients with LVAD-associated infections (including surgical site infections) was not significantly different in either SIP group at 2 weeks (9% vs. 4%, p = .64), 30 days (9% vs. 11%, p = .99), or 90 days (19% vs. 14%, p = .75). There was no statistically significant difference in 30 or 90-day mortality. LVAD-associated gram-negative (7% vs. 7%; p .99) and fungal (5% vs. 0%; p = .51) infections were uncommon. The most common organism isolated was Staphylococcus aureus, and the most common type of infection was pneumonia in both SIP groups.No significant difference in LVAD-associated infections or infection-related mortality was observed with de-escalation of perioperative antibiotics. Additional studies with larger sample sizes are needed to endorse the findings of this study.

The present research work attempted to improve the oral bioavailability of the antiviral drug Efavirenz (EFV) using a pharmaceutical cocrystallization technique. EFV comes under BCS-II and has extremely low water solubility, and results in low oral bioavailability. EFV and nicotinamide (NICO) were selected in a (1:1) stoichiometric ratio and efavirenz nicotinamide cocrystal (ENCOC) was prepared through the liquid-assisted grinding method (LAG). The confirmation of the formation of a new solid phase was done through spectroscopic techniques like Fourier transmission infrared (FTIR), Raman, and

Nanobiotechnology is a fast expanding scientific field with potential applications in life sciences and human health care. Silver is a precious metal that occurs naturally, most commonly as a mineral or in combination with other elements. Aqueous T. grandis plant seed extract was utilized in the current investigation as a reducing and capping agent in the biogenesis of silver nanoparticles. Nanoparticles were examined using different techniques like UV-visible spectral analysis, Fourier transform infrared spectra technique, X-ray diffraction technique, and transmission electron microscopy technique. The peak at 429 nm of the surface plasmon resonance by using UV-visible spectra, confirmed the synthesis of nanoparticles. Utilizing Fourier transforms infrared spectral analysis, the explicit functional groups that reduced silver nitrate to create silver nanoparticles in seed extract were found. X-ray diffraction analytical technique was utilized to found the crystalline nature and Face-centered cubic (FCC) configuration of green synthesized silver nanoparticles. Silver nanoparticles with sizes ranging from 32 to 62 nm are visible in images taken using transmission electron microscopy. Using disc diffusion technique, the generated silver nanoparticles showed remarkable antibacterial activity against selected organism, Escherichia coli, Bacillus subtilis, Staphylococcus aureus, and Pseudomonas aeruginosa. AgNPs demonstrated broad spectrum antibacterial action as a result at lower concentrations, and they may provide an effective therapeutic alternative in the future like, development of new antibacterial drugs. This research identified a quick and eco-friendly green synthetic method for producing stable silver nanoparticles. HIGHLIGHTS Preparation of synthesis from selected traditional medicinal plant Tectona grandis Bio synthesis and characterization of silver nanoparticles synthesized using Tectona grandis Seed extract and evaluate its antibacterial activity against selected pathogens The present study established a rapid, economical cheap way of synthesizing silver nanoparticles Synthesized plant mediated nanoparticles can be used against human pathogens acts as antimicrobial drug and have more medicinal applications GRAPHICAL ABSTRACT

Accurate identification at an early stage of infection is critical for effective care of any infectious disease. The “coronavirus disease 2019 (COVID-19)” outbreak, caused by the virus “Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)”, corresponds to the current and global pandemic, characterized by several developing variants, many of which are classified as variants of concern (VOCs) by the “World Health Organization (WHO, Geneva, Switzerland)”. The primary diagnosis of infection is made using either the molecular technique of RT-PCR, which detects parts of the viral genome’s RNA, or immunodiagnostic procedures, which identify viral proteins or antibodies generated by the host. As the demand for the RT-PCR test grew fast, several inexperienced producers joined the market with innovative kits, and an increasing number of laboratories joined the diagnostic field, rendering the test results increasingly prone to mistakes. It is difficult to determine how the outcomes of one unnoticed result could influence decisions about patient quarantine and social isolation, particularly when the patients themselves are health care providers. The development of point-of-care testing helps in the rapid in-field diagnosis of the disease, and such testing can also be used as a bedside monitor for mapping the progression of the disease in critical patients. In this review, we have provided the readers with available molecular diagnostic techniques and their pitfalls in detecting emerging VOCs of SARS-CoV-2, and lastly, we have discussed AI-ML- and nanotechnology-based smart diagnostic techniques for SARS-CoV-2 detection.

Epidemiology of the US coronavirus disease 2019 (COVID-19) outbreak focuses on individuals’ biology and behaviors, despite centrality of occupational environments in the viral spread. This demonstrates collusion between epidemiology and racial capitalism because it obscures structural influences, absolving industries of responsibility for worker safety. In an empirical example, we analyzed economic implications of race-based metrics widely used in occupational epidemiology. In the United States, White adults have better average lung function and worse hearing than Black adults. Impaired lung function and impaired hearing are both criteria for workers’ compensation claims, which are ultimately paid by industry. Compensation for respiratory injury is determined using a race-specific algorithm. For hearing, there is no race adjustment. Selective use of race-specific algorithms for workers’ compensation reduces industries’ liability for worker health, illustrating racial capitalism operating within public health. Widespread and unexamined belief in inherent physiological inferiority of Black Americans perpetuates systems that limit industry payouts for workplace injuries. We see a parallel in the epidemiology of COVID-19 disparities. We tell stories of industries implicated in the outbreak and review how they exemplify racial capitalism. We call on public health professionals to critically evaluate who is served and neglected by data analysis and to center structural determinants of health in etiological evaluation.