• A Microparticulate Vaccine Microneedle patch for pain-free Immunization against Coronavirus Disease

      Vijayanand, Sharon; Patil, Smital R.; Joshi, Devyani; D'Souza, Martin J. (2021)
      Microneedle (MN) patches for vaccine delivery is an effective immunization strategy suitable for mass immunization. Here, we test the level of immunity provided by a microparticulate (MP) heat-inactivated coronavirus vaccine when administered via the skin as pain-free dissolving MN patches. The vaccine formulation utilizes an MP matrix that provides protection of the antigen and improved antigen uptake by antigen-presenting cells (APCs). The microparticles (MPs) were formulated using a double emulsion method, lyophilized, characterized, and assessed for their in vitro immunogenicity. The in vivo efficacy of the MP vaccine was tested in mice. The immunization was done in 3 doses. ELISA was done to assess the IgG level in mice sera. The animals were sacrificed at week 10 and their organs were harvested for further analysis and expression of immune markers. The results show that the MPs were less than 1 microns in size and the MP vaccine induced a strong innate immune response in vitro. Serum analysis showed higher IgG levels of the vaccine groups. The vaccine groups showed a higher expression of antigen-presenting molecules. Based on the results, we summarize that the MP vaccine can produce an effective immune response when administered as an MN patch via the skin. Moreover, MN patches allow self-administration, which greatly increases patient compliance in addition to decreasing the need for trained pharmacists for immunization.
    • A Novel Diagnostic Method for Detection and Quantitation of Paralytic Shellfish Poisoning in Humans

      Vakkalanka, Mani Deepika; Knaack, Jennifer S.; Strom, Grady J. (2021)
      Paralytic shellfish toxins(PSTs) are potent neurotoxins which bind to the voltage gated sodium channels and prevent the conduction of action potentials leading to respiratory paralysis and death. Gonyautoxins(GTXs) 1,2,3,4 are the most potent PSTs and testing them in human matrices is the best approach to quantify the exposures. Here, we describe a solid phase extraction method for extracting GTXs from human plasma using HILIC HPLC-MS/MS analysis. Pooled plasmas were spiked with GTXs and extracted using strong cationic exchange cartridges. These cartridges were conditioned with methanol and acetate buffer and eluted with 5% ammonium hydroxide in methanol. Calibrants were prepared at the following concentration ranges: GTX1 8.13-517.66 ng/mL, GTX2 6.98-473.25 ng/mL, GTX3 2.96-200.68 ng/mL and GTX4 2.56-162.91 ng/mL. Eight plasma specimens were spiked with toxin at a concentration of 173.85ng/ml. All the samples were extracted and injected onto HPLC-MS/MS for analysis. The developed method was validated according to FDA guidance for bioanalytical method validation. The method showed good percent accuracies for all the toxins: GTX1 95-104%, GTX2 92-114%, GTX3 92-117%, GTX4 92-107%. Precision ranged from 3.5 to 10.9% for GTX1, 3.03 to 11.25% for GTX2, 3.01 to 12.72 for GTX3 and 2.08 to 10.49 for GTX4. Recovery of GTXs from specimen plasmas were between 83.27% to 110.55%. We have successfully developed a fast and simple diagnostic method accessible to common clinical laboratories.
    • A Prophylactic Gonorrhea Vaccine: Evaluation of In vivo Immune Response

      Bagwe, Priyal; Bajaj, Lotika; Gala, Rikhav; Zughaier, Susu; D'Souza, Martin (2021)
      Neisseria gonorrhoeae is the bacteria causing gonorrhea and has gradually developed antimicrobial resistance. Currently, there is no vaccine for gonorrhea. This study aims to investigate the immunogenicity of novel whole-cell inactivated gonococcal microparticulate vaccine formulation loaded in dissolving microneedles for skin delivery. The efficacy of vaccine formulation was assessed in vivo using female mice. The mice were immunized with a prime dose at week 0 followed by two boosters at weeks 2 and 4. Enzyme linked immunosorbent assay (ELISA) was used to measure immunoglobulin levels in collected mice sera. Formalin-fixed gonococci were intact as observed by SEM. The average length of microneedles as observed by SEM was 350 �m. ELISA demonstrated significantly higher serum immunoglobulin levels in groups receiving adjuvanted gonorrhea particulate vaccine when compared to untreated group (p<0.001). The particulate vaccine allows better uptake of antigen facilitated by the APCs causing improved antigen presentation and subsequent immune response by activation of T cells. Skin delivery of the inactivated whole-cell gonococcal microparticulate vaccine formulation loaded in dissolving microneedles is therefore an effective strategy.
    • Administration of a microparticulate Zika vaccine using dissolving microneedle patches

      Kale, Akanksha; D'Souza, Martin (2021)
      Zika is an infectious disease transmitted to humans through mosquito bites. It can lead to Guillain-Barré Syndrome. If transferred from mother to fetus, Zika can cause microcephaly. However, there is no approved treatment or vaccine available for Zika. Hence, we aim to develop a microparticulate vaccine for Zika and to investigate transdermal route for administration using microneedle patches to provide pain-free and needle-free immunization. PLGA microparticles (MP) encapsulating antigen (Zika PRVABC59) and adjuvants were formulated using double emulsion solvent evaporation. The size and zeta potential of MP were 573.4±10.18nm and -22.6±0.503mV. The encapsulation efficiency was 55-70%. Scanning electron microscopy showed that the MP were spherical. SDS-PAGE confirmed that the process did not affect antigen integrity. In vitro release study showed sustained release of antigen. MP were immunogenic and non-cytotoxic in vitro in dendritic cells. Subsequently, the vaccine MP with or without adjuvant MP were either injected IM or using microneedle patches via transdermal route to mice. Mice immunized with particulate vaccine produced significantly higher IgG, IgG1 and IgG2a antibody titers than the control group a robust humoral response as well as a balanced Th1/Th2 response. Antibody titers after transdermal immunization were comparable with titers after intramuscular immunization. Thus, this study established the feasibility of transdermal microneedle-based vaccine for Zika.
    • Analyzing propensity of hospital readmissions of diabetic customers to reduce medical expenditure

      Bandi, Ravi; Pokhriyal, Shitanshu; Khan, Shakeel A. (2021)
      Background: A large portion of hospital inpatient management expenditure is due to high readmission rates. Diabetes is one of the leading causes of re admissions for chronically ill patients. Analyzing readmission patterns helps proactively manage and reduce readmission, thus resulting in reduced medical expenditure. Objective of the study is to find factors that lead to readmission of Diabetic patients and identify key influencers impacting readmission rates. Study Design Methods: The data originated from Cerner EMR systems with instances for over 70,000 patients and has information on Inpatient admission, diabetes type, length of stay, Lab tests performed, and medications administered across 130 US hospitals We used Logistic Regression, Na�ve Bayes and Classification tree methods and Data visualization by using key influencers to identify the key factors. Results & Findings: Using the above data mining and visualization techniques, the study had key findings as below: - Outpatient Diabetics above age 40 with HBA1c level more than 8 are more likely to readmit. - Inpatient diabetic patients with higher number of prescribed medications and number of procedures are less likely to get readmitted. - Serum level analysis shows that with High glucose serum levels, the readmission rates are higher. - Higher HbA1c in patients has a direct relationship with re admissions. - Lab Procedures show high correlation with medications, diagnosis, and time in Hospital.
    • Assessing Expression and Function of Serotonin Receptors and Transporter in Fmr1 Knockout Mice

      Saraf, Tanishka Satyajit; Chen, Yiming; Armstrong, Jessica; Prophitt, Jennifer; Canal, Clinton (2021)
      The serotonin receptors (5-HTRs) and transporter (SERT) modulate excitation-inhibition altered in autism and its leading monogenic cause, fragile X syndrome (FXS). Here, we assessed their expression and function in adult Fmr1 knockout (KO) mice, a model of FXS, compared to wild type (WT) mice. We performed autoradiography on brain sections using [3H]5-CT for 5-HT1ARs, [3H]Ketanserin for 5-HT2ARs, [3H]Mesulergine for 5-HT2CRs, [3H]Citalopram for SERT. Regions of interest were analyzed using ImageJ. Saturation binding assay was performed for 5-HT1ARs with [3H]5-CT. Behavioral effects of 1,2mg/kg (R)-8-OH-DPAT, 1 mg/kg (�)-DOI, 1,3,10mg/kg lorcaserin and 10mg/kg escitalopram were used to probe in vivo functional activity of 5-HT1A, 5-HT2A, 5-HT2CRs, and SERT, respectively. KO males have higher 5-HT1AR expression in lateral septum and frontal cortex, lower 5-HT2AR expression in isocortex layer V and lower 5-HT2CR expression in anterior olfactory nucleus and nucleus accumbens, than WT males. Saturation binding analysis confirmed the increased 5-HT1AR expression. WT and KO males had lower 5-HT2CR expression in choroid plexus and caudate putamen than females. KO mice showed more pronounced responses to (R)-8-OH-DPAT, decreased DOI-elicited head twitches, and similar lorcaserin-induced hypolocomotion compared to WT mice. SERT expression and function are being evaluated. This shows perturbations in key 5-HTRs in Fmr1 KO mice, suggesting dysfunctions in the central 5-HT system in FXS.
    • Assessment of a Best Practice Alert in Managing Patients on Anticoagulation

      Olocha, Queen O.; Patel, Sweta; Elliott, Jennifer (2021)
      Estimated 900,000 patients in the United States and nearly 1 million patients worldwide have Venous Thromboembolism (VTE). Untreated VTE can lead to long-term morbidity and mortality with an increased risk of stroke, heart failure, and death. The use of Best Practice Alerts (BPAs) to encourage prophylaxis will reduce the frequency of VTE among high-risk hospitalized patients as well as educating medical clinicians and adhering to guidelines. BPAs are clinical support tools accessible through EHR to alert the clinicians about a particular element of a patient's care, such as improper dosing, platelet counts, high serum creatinine, infections, blood transfusions, or overuse of testing. The usage of BPAs integrated with the EHR can bring attention to clinicians when prescribing anticoagulants to non-indicated patients and better educate physicians. Single-center, retrospective, chart review study assessed eligible adult patients who were prescribed anticoagulants for VTE prophylaxis. Eligible adult patients were 18 years old and older and were at increased risk for venous thromboembolism. The following were determined: the accuracy of the BPAs firing related to VTE prophylaxis and the providers' acceptance of BPA recommendation. A VTE prophylaxis report was processed through EPIC� at Grady Memorial Hospital between July 27, 2019 � August 26, 2019. One hundred patients were identified, and 207 BPAs were fired during this period. Electronic orders were searched for VTE prophylaxis and mechanical prophylactic measures, including sequential compression devices. Patient notes were screened for past/present medical history, accidents, providers, surgeries/procedures, length of stay, or social history. A list of active and discontinued medications was also screened for the presence of prophylactic pharmacologic measures, including UFH/Lovenox, aspirin, DOACs, or Warfarin. One hundred patients identified and 207 BPAs. The number of BPAs was fired per unique patient weekly and by floor unit. The firing of the BPAs related to VTE prophylaxis was 94.5% accuracy for 36 patients. The provider could not prescribe each unique patient with anticoagulation therapy due to having PCI, dementia, or timing when the BPA fired. During the study period, BPA was accurately fired and assessed. The assessment showed that VTE prophylaxis was not needed due to a specific event that the patient may have had. This specific BPA improved the appropriate management of anticoagulation for VTE prophylaxis in patients.
    • COVID-19 Subunit Vaccine: A novel microparticulate microneedle vaccine using spike S1 protein

      Patil, Smital Rajan; Vijayanand, Sharon; Joshi, Devyani; Gomes, Keegan Braz; Menon, Ipshita, J; D'Souza, Martin J. (2021)
      COVID-19 has affected around 118 million people and caused more than 2 million deaths worldwide. Currently, the Food Drug Administration (FDA) authorized vaccines such as Pfizer for COVID-19 require cold chain storage, thus their availability in developing countries is challenging. Microparticles (MPs) are suitable delivery vehicles for vaccine antigens as they are better taken up by antigen-presenting cells, and they eliminate the need for cold chain storage. The spike S1 protein is a suitable antigen candidate due to its ability to produce a robust immune response. For this study, the spike protein was loaded into poly (lactic-co-glycolic acid) (PLGA) MPs and then incorporated into dissolving microneedles, a promising delivery system for large molecules such as proteins. The microparticles were characterized and assessed for innate and adaptive immune response in vitro. The vaccine particles induced a significantly higher nitrite production in mammalian cells compared to control groups. They also exhibited significantly higher expression of antigen-presenting molecules: major histocompatibility complex (MHC) I, CD80, MHC II, and CD40 on the surface of the dendritic cells. This formulated vaccine thus shows high immunogenicity in vitro and has the potential to produce a robust immune response in a murine model, conferring long-lasting protection against coronavirus. This has the potential to be a promising vaccine in the ongoing COVID-19 pandemic the world is facing currently.
    • Coworker Support Amplifies Reactions to the COVID-19 Pandemic for Working Parents

      Donnelly, Lilah; O'Brien, Kimberly; Shepard, Agnieszka (2021)
      The COVID-19 pandemic directly threatened our health and safety, while contradictory scientific and media reports generated uncertainty. Employees likely relied on their coworkers for emotional support and to make sense of the confusion. In this study, we evaluate the role of coworker support, which has been shown in the past to have either ameliorative (as a resource) or exacerbating (as social information) results. We use data, collected from a heterogeneous sample of working parents in May of 2020 (when most states were getting ready to lift their stay-at-home orders), to illustrate the path from resilient personal resources (measured as optimism, generalized self-efficacy, and internal locus of control) to fear of COVID-19 to workplace outcomes in a multiphasic study design. Employees with more optimism, generalized self-efficacy, and internal locus of control reported less fear of COVID-19, and in turn, less decrement to their workplace outcomes. This mediation is moderated by coworker support, such that the indirect effect is amplified by coworker support. This is consistent with previous research, which shows that coworker support can unintentionally corroborate and amplify employee stress perceptions. We therefore recommend that, when faced with significant adversity, organizations provide communication training oriented toward increasing positive coworker interactions and guiding social information.
    • Direct regulation of cerebral artery contractility by simvastatin and rosuvastatin

      Zerin, Farzana; Pandey, A.; Hasan, A.; Menon, S.; Hasan, R. (2021)
      Statins are amongst the most widely prescribed drugs in the world with a range of vascular effects that have been primarily attributed to the inhibition of cholesterol and mevalonate biosynthesis, and the inhibition of mevalonate-dependent Rho/ROCK signaling upon long-term treatment. However, no studies have investigated the direct effects of acute statin application on fresh isolated resistance cerebral arteries using therapeutic concentrations of statins. Here, we examined acute vascular effects of therapeutically relevant concentrations of statins on male and female Sprague Dawley rat cerebral arteries and underlying molecular mechanisms using pressurized arterial myography as well as Ca2+ fluorescence and diameter measurement. Our data showed that the application of 1nM rosuvastatin and simvastatin constricted cerebral arteries within 2-3 minutes of drug application. The removal of extracellular Ca2+ with EGTA or the application of nimodipine, a selective blocker of smooth muscle cell voltage-gated Ca2+ channel, CaV1.2, each abolished cerebral artery vasoconstriction by statins, indicating that the Ca2+ entry through CaV1.2 plays a critical role here. Since Ca2+ entry into smooth muscle cells induces Ca2+ release from intracellular Ca2+ stores such as sarcoplasmic reticulum and endoplasmic reticulum. Altogether, our data suggests that smooth muscle cell CaV1.2 opening and Ca2+ influx is the primary mechanism underlying statin-induced constriction of cerebral arteries.
    • Effect of barrier integrity on topical/transdermal delivery of diclofenac sodium via iontophoresis

      Dandekar, Amruta; Kale, Madhura S.; Mahadevabharath, R. Somayaji; Garimella, Harsha T.; Banga, Ajay K. (2021)
      Introduction: Application of a drug product on compromised skin may result in altered drug delivery leading to potential systemic toxicity. In this study, we investigated the effect of barrier integrity on the topical and transdermal delivery of brand: generic pair of diclofenac sodium (model anti-inflammatory drug) via iontophoresis. Methods: In vitro drug permeation studies were performed on normal and compromised skin using vertical Franz diffusion cells. A compromised skin model was created using ten tape strips on dermatomed human skin. We compared marketed brand and generic formulations of diclofenac sodium (Voltaren� and 1% diclofenac sodium topical gel by Amneal) via cathodal iontophoresis (0.5 mA/cm2; 2h followed by passive delivery till 6h) using 700 �L of formulation. Results/Conclusion: No significant difference observed between brand and generic formulations for delivery of diclofenac sodium via normal (149.78�18.43�g/cm2(brand);145.53�12.61�g/cm2(generic)) and compromised skin (233.13�8.32 �g/cm2(brand); 242.07�11.17 �g/cm2(generic)). The total delivery of diclofenac was significantly higher for the brand-generic pair into and across compromised skin as compared to normal skin indicating the effect of barrier integrity on delivery of diclofenac sodium. However, there was no significant difference in skin delivery of diclofenac sodium for normal (94.18�15.08 �g/cm2 (brand); 76.97�14.15 �g/cm2 (generic)) and compromised skin (76.74�8.75 �g/cm2 (brand); 72.36�5.18 �g/cm2 (generic)).
    • Evaluating and comparing release profiles of four different non-prescription niacin formulations

      Shah, Sarthak; Uddin, Mohammad N. (2021)
      Niacin, nicotinic acid or vitamin B3 is critical portion of a balanced nutritional diet. None of the niacin's dissolution profiles were evaluated and compared in literature. Niacin, a supplement, is not subjected to Federal Drug Administration (FDA) monitoring. The study compared several different formulations such as immediate release (IR) powder, IR tablet, timed release (TR) capsule, extended release (ER) capsule, and controlled release (CR) tablet to validate the claims for each formulation provided by the manufacturer. In our in vitro study, dissolution apparatus was used. Two different media were prepared, simulated gastric fluid (SGF) at pH 1 and simulated intestinal fluid (SIF) at pH 7. UV/VIS Spectrophotometry for analysis was used. In IR form, maximum concentration was 80% concentration of the label's claim. In ER, in pH 7, drug remained constant at about 50% niacin concentration over 24-hour period. In TR, in both pH conditions, the maximal niacin release concentration was about 65-70%. In Slo-Niacin tablets, release rates were consistent in both pH 1 and pH 7. Our findings illustrate that the four release forms (IR, ER, TR, CR) and their modified drug formulations are aligned with their release definitions. Further research is encouraged and should evaluate other non-FDA formulations.
    • Evaluation of Hypoglycemia Causes and Treatment at a Community Hospital

      Carbone, Kristina; Murphy, Sarah (2021)
      Hypoglycemia is defined as dangerously low blood glucose levels of less than 70 mg/dL where action, such as administration of glucose, is required to raise the blood glucose levels to the target range. This review seeks to analyze hypoglycemic episodes to determine the cause of hypoglycemia, assess treatment, and identify areas for improvement to enhance patient outcomes and prevent hypoglycemia. This is a retrospective chart review of patients who experienced a hypoglycemic event during their stay between 1/2020 to 12/2020. Patients who experienced a blood glucose level less than 70 mg/dL were identified and randomly selected for review. Patients under 18 years of age and obstetrical patients were excluded. 120 patients were reviewed, with a median blood glucose of 59 mg/dL. 19.2% of patients experienced a severe blood glucose less than 50 mg/dL. Basal insulin was the most common cause of hypoglycemia along with low feeding status. Average time between last basal insulin dose and hypoglycemia was approximately 10 hours with a majority of basal insulin given in the evening and hypoglycemia occurring in the morning. 95.8% of patients had the institutional standard hypoglycemic treatment protocol orders available for use prior to the hypoglycemic event, and 62.5% of patients were treated per protocol. The treatment protocol should always be used to treat hypoglycemia to ensure standardization, and education to nurses on how to use the protocol appropriately is necessary.
    • FoxM1 upregulation correlates with worse recurrence-free survival in breast cancer

      Nguyen, Tro; Nahta, Rita (2021)
      Breast cancer is the second most deadly malignancy among women in the US. Breast cancers harbor intrinsic heterogeneity, allowing stratification into molecular subtypes. Basal-like breast cancer (BLBC) is an aggressive subtype with a high rate of metastasis and poor overall survival. Due to poor understanding of the molecular drivers, few therapeutic options exist for BLBC. Studies suggest that the forkhead box M1 (FoxM1) transcription factor is upregulated in breast cancer. However, the clinical implications of FoxM1 upregulation, including in BLBC, remain unclear. The aims of this study were to (1) compare FoxM1 expression in breast cancer vs normal breast, and (2) correlate FoxM1 expression with clinical outcome using publicly accessible databases. First, we searched breast cancer datasets in Oncomine using FoxM1 as a query term. FoxM1 expression was significantly (p<0.001) higher in invasive ductal breast carcinoma vs normal breast. Next, we searched the KM Plotter breast cancer database using FoxM1 as a query. Among 4,929 patients with breast cancer, median recurrence-free survival (RFS) was significantly (p<0.001) lower in patients with high (upper quartile, 34.13 months) vs low (upper quartile, 80 months) FoxM1 expression. A sub-analysis for BLBC (n=846) demonstrated that median RFS did not significantly (p<0.053) differ in patients with high (upper quartile, 25.2 months) vs low (upper quartile, 26 months) FoxM1. These results suggest that FoxM1 is upregulated in breast cancer in association with worse clinical outcome. Future studies will examine the mechanisms through which FoxM1 is upregulated and strategies for targeting FoxM1 in breast cancer.
    • Gut microbiota-derived short chain fatty acids stimulate mesenteric artery vasodilation

      Menon, Sreelakshmi Nandakumar; Zerin, Farzana; Pandey, Ajay K.; Rahman, Taufiq; Hasan, Raquibul (2021)
      Authors: SN Menon, F Zerin, AK Pandey, T Rahman, and R Hasan Accumulating evidence suggests that gut microbiota-derived short-chain fatty acids (SCFA's) such as acetate, propionate and butyrate have beneficial effects on the cardiovascular system. However, whether these SCFAs can directly influence arterial contractility remains unclear. Here, we sought to examine the effects of sodium acetate and propionate on the contractility of resistance mesenteric arteries from Sprague Dawley rats, and characterize their mechanism of action. Our pressurized artery myography data showed that both acetate and propionate produced a concentration-dependent vasodilation in mesenteric arteries. Our data also showed that co-application of L-NNA, a selective inhibitor of endothelial nitric oxide synthase (eNOS), with acetate caused 35% reversal of acetate-evoked vasodilation, suggesting that additional vasodilatory mechanisms, including those of smooth muscle origin may be involved. On the other hand, co-application of L-NNA with propionate caused no reversal of sodium propionate-evoked vasodilation, precluding the role of endothelial nitric oxide production. Altogether, our data unveils a novel role for SCFA's in producing direct systemic mesenteric artery vasodilation, which is likely to be mediated by both endothelium- and smooth muscle-specific vasodilatory signaling. Future studies will be focused on dissecting the detailed mechanisms for SCFA-induced mesenteric artery vasodilation, and its relevance for systemic blood pressure regulation.
    • Microparticulate vaccine for transdermal measles immunization

      Joshi, Devyani; Gala, Rikhav; Uddin, Mohammad N.; D'Souza, Martin J. (2021)
      Measles is a major global cause of death. Since children are primary targets for vaccine, we aimed at delivering the vaccine via needle-free transdermal route. Vaccine microparticles were formulated using Buchi spray dryer B-290. The induction of immune response by the microparticles was confirmed by Griess's assay. Expression of antigen-presenting molecules, MHC I, MHC II, and co-stimulatory molecules CD80, CD40 was assessed using flow cytometry. Cytotoxicity of microparticles was assessed by MTT assay. In vivo efficacy of was studied in the mouse model. For transdermal immunization, P.L.E.A.S.E. ablative laser was used. It creates micropores of defined size on the skin for transdermal immunization. The animals were administered with a prime and a booster dose. The serum was collected, and IgG and IgM antibody titers were measured. Microparticulate vaccine showed significantly higher release of nitric oxide compared to the blank microparticles. It resulted in significantly higher cell-surface expression of MHC I, MHC II, CD80 and CD40. The vaccine and adjuvant microparticles were non-cytotoxic. The in vivo studies demonstrated elevated humoral immune responses in the mice receiving vaccine and adjuvant microparticles via both, subcutaneous and transdermal routes. The microparticles augment the immunogenic properties of vaccine. Transdermal administration produced comparable results as of the subcutaneous administration indicating the potential of the transdermal vaccination.
    • Perceptions, Attitudes, and Beliefs of Young, Underrepresented Minorities in Clinical Trials

      Ross, Allison; Wong, U.; Nguyen, J. (2021)
      Introduction:This study is designed to ask Millennials (1981-1996) and early Generation Zers (1997-2002) about their perceptions of clinical trials. This will provide insight to identify reasons for the lack of diversity in age, ethnicity, and background for the advancement of future medicine. Methods:The data provided evaluated Millennials and Generation Zers using a survey. Participants were recruited via convenience sampling. Questions included personal demographics, knowledge of clinical trials, willingness to participate in clinical trials. Results:A chi-square test was performed to examine potential associations between individual demographics and responses(N=172, Minority=126, Male=37.7%). For the likelihood of participating in vaccine-focused clinical trials, 62.4% of the respondents reported that it would be unlikely for them to participate in a study; 76.9% Millennials versus Gen Z (N=125, p=0.009). When analyzing gender, women were found to be 69.5% more likely than men to deny participating in a clinical trial for vaccines (N=81, p=0.0005). Discussion:In regard to participating in a clinical trial with a focus on vaccinations, Millennials were less likely to indicate participation than Gen Zers. Between both generations, females were most opposed to the concept. Increased representation in gender and minority-based ethnicity (significantly in the Hispanic and/or Asian community) will allow more comprehensive insight for future implementation and analysis.
    • Spaciotemporal analysis of COVID-19 to study impact of mobility on infection rate

      Hamza, Syed Ali; Bukhari, Syeda Sydra; Chandio, Sara Khan; Khan, Shakeel (2021)
      Background: COVID-19’s asymptomatic nature in some people makes it undetectable in initial days of contact and results in spread of the infection. Some countries have contained its spread, whereas some are still experiencing increasing cases. This study includes spaciotemporal analysis of COVID-19 and mobility data to provide insights in how the infection spreads while comparing the public mobility between the best and worst performing countries. Study Design/Method: The data about cases, recoveries, and deaths from Jan ’20 to Feb ’21 from John Hopkins-CSE is integrated with mobility data from Google. It is then analyzed at global level with further drilldowns into continent, countries, and states in US. Study includes comparative analysis between US and New Zealand to show which mobility parameters influenced the spread. Locations such as transit stations, retail, grocery, workspaces, residential areas, and parks were studied to find their impact. Findings: The analysis indicates that there was a short-term drop in mobility around workplaces, retail and grocery stores, and transit stores in United States along with a spike in the mobility across parks during the initial period. On the other hand, mobility has been under control in New Zealand. The study highlights that the areas with higher public activity shows higher infection rate, thus controlling the public movement around retail and grocery places has positive influence than complete shutdown of the workplaces.
    • Topical and Transdermal Iontophoretic Delivery of Methotrexate in Healthy and Psoriatic Human Skin

      Vora, Deepal; Somayaji, Mahadevabharath R.; German, Carrie; Banga, Ajay K. (2021)
      Psoriasis is a condition of the skin which involves scales, dry patches, and inflammation. Methotrexate (logP: -0.236, MW: 454.44 g/mol) is administered orally or intravenously to treat psoriasis. The first pass metabolism and systemic side effects associated can be avoided by transdermal delivery. We investigated the iontophoretic delivery of methotrexate using healthy and psoriatic human skin to understand the effect of skin�s disease condition on topical and transdermal delivery. In vitro permeation testing using vertical Franz diffusion cell were conducted. Cathodal iontophoresis (0.5 mA/sq.cm for 4 h) delivered a significantly higher total amount of methotrexate into the skin and receptor when compared to that delivered by passive diffusion and anodal iontophoresis. A current density of 0.2 mA/sq.cm using cathodal iontophoresis and 10mg/mL donor concentration was optimized to obtain the target delivery through healthy human skin. There was no significant difference in receptor delivery for psoriatic skin as compared to healthy skin, while significantly higher methotrexate delivery in skin was observed for psoriatic skin as compared to healthy skin. Thus, cathodal iontophoresis delivered a significantly higher total amount of methotrexate as compared to passive diffusion and anodal iontophoresis. Significantly higher delivery in skin and hence significantly higher total delivery was observed for psoriatic skin as compared to healthy skin.