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Item High-Dose vs. Low-Dose Dexamethasone in Patients With COVID-19: A Cohort Study in Rural Central America(Ainosco Press, 2023) Montalvan-Sanchez, Eleazar; Chambergo-Michilot, Diego; Rodriguez-Murillo, Aida A.; Brooks, Alexandra E.; Palacios-Argenal, Dairy; Rivera-Pineda, Shery; Ordonez-Montes, Jose; Estevez-Ramirez, Rosa; Riva-Moscoso, Adrian; Norwood, Dalton A.; Calderon-Rodriguez, Alex; Pineda-SanMartin, Elizabeth; Giron, Roberto; Rivera-Corrales, Luis; Carcamo-Murillo, Balduino; Garner, Orlando; Medicine, School of MedicineTo compare the clinical outcomes of a low dose dexamethasone strategy vs. a high-dose dexamethasone strategy in hypoxemic COVID-19 patients. A retrospective observational study comparing low-dose (8 mg) and high-dose dexamethasone (24 mg) of COVID-19 patients admitted from September 1, 2020 to October 31, 2020 in a hospital in Honduras. We included 81 patients with confirmed COVID-19 who required oxygen therapy. The mean age was similar between groups (57.49 vs. 56.95 years). There were more male patients in the group of 24 mg ( p = 0.01). Besides, patients on the 24 mg dose had more prevalence of hypertension ( p = 0.052). More patients in the 24 mg group had a higher rate of invasive mechanical ventilation (15.00% vs. 2.56%, p = 0.058). When evaluating the association between the high dose group and outcomes, we find no significant association with mortality, nosocomial infections, high flow mask, invasive mechanical ventilation, or the need for vasopressors. We find no significant differences in the Kaplan–Meier analysis regarding the survival (log-rank p -value = 0.315). We did not find significant differences between the use of 24 mg and 8 mg of dexamethasone in hypoxemic COVID-19 patients.Item Pattern of self-reported adverse events related to COVID-19 vaccines in Saudi Arabia: A nationwide study(Frontiers Media, 2023-02-23) Alkhalifah, Joud Mohammed; Al Seraihi, Ahad; Al-Tawfiq, Jaffar A.; Alshehri, Badr Fadhel; Alhaluli, Alhanouf Hani; Alsulais, Naif Mansour; Alessa, Mohammed Mesfer; Seddiq, Waleed; Aljeri, Thamer; Qahtani, Mohammad Hassan; Barry, Mazin; Al-Otaiby, Maram; Medicine, School of MedicineBackground: Vaccination against coronavirus disease 2019 (COVID-19) is the most effective way to end the pandemic. Any development of adverse events (AEs) from various vaccines should be reported. We therefore aimed to explore major and minor AEs among vaccinated individuals in Saudi Arabia. Methods: This is a nationwide report based on the Saudi Arabian Ministry of Health (MOH) registry. It included those who received COVID-19 vaccines from 17th December 2020 to 31st December 2021. The study included spontaneous self-reported adverse effects to COVID-19 vaccines where the study participants used a governmental mobile app (Sehhaty) to report their AEs following vaccination using a checklist option that included a selection of side-effects. The primary outcome was to determine AEs reported within 14 days of vaccination which included injection site itching, pain, reaction, redness, swelling, anxiety, dizziness, fever, headache, hoarseness, itchiness, loss of consciousness, nausea, heartburn, sleep disruption, fatigue, seizures, anaphylaxis, shortness of breath, wheezing, swelling of lips, face, and throat, loss of consciousness, and admissions into the intensive care unit (ICU). Results: The study included a total number of 28,031 individuals who reported 71,480 adverse events (AEs); which were further classified into minor and major adverse events including ICU admissions post vaccination. Of the reported AEs, 38,309 (53. 6%) side-effects were reported following Pfizer-BioNTech, 32,223 (45%) following Oxford-AstraZeneca, and 948 (1.3%) following Moderna. The following reported AEs were statistically significant between the different vaccine types: shortness of breath\difficulty of breathing, dizziness, fever above 39°C, headache, hoarseness, injection site reactions, itchiness, nausea, sleep disruption, fatigue, wheezing, swelling of lips/face and\or throat, and loss of consciousness (p-value < 0.05). Fever and seizure were the only statistically significant AEs amongst the number of vaccine doses received (p-value < 0.05). Ten ICU admissions were reported in the 14 days observation period post-COVID-19 vaccination with the following diagnoses: acute myocardial infarction, pneumonia, atherosclerosis, acute respiratory failure, intracranial hemorrhage, grand mal seizure, Guillain-Barré syndrome, abnormal blood gas levels, and septic shock. Conclusion: This study demonstrated that the most prevalent SARS-CoV-2 vaccine side-effects among adults in Saudi Arabia were mild in nature. This information will help reduce vaccine hesitancy and encourage further mass vaccination to combat the COVID-19 pandemic, especially as booster doses are now available. Further studies are warranted to obtain a better understanding of the association between risk factors and the experiencing of side-effects post vaccination.Item PROspective Evaluation of Chronic Pancreatitis for EpidEmiologic and Translational StuDies: Rationale and Study Design for PROCEED From the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer(Wolters Kluwer, 2018-11) Yadav, Dhiraj; Park, Walter G.; Fogel, Evan L.; Li, Liang; Chari, Suresh T.; Feng, Ziding; Fisher, William E.; Forsmark, Christopher E.; Jeon, Christie Y.; Habtezion, Aida; Hart, Phil A.; Hughes, Steven J.; Othman, Mohamed O.; Rinaudo, Jo Ann; Pandol, Stephen J.; Tirkes, Temel; Serrano, Jose; Srivastava, Sudhir; Van Den Eeden, Stephen K.; Whitcomb, David C.; Topazian, Mark; Conwell, Darwin L.; Medicine, School of MedicineProspective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies (PROCEED) is the first prospective, observational cohort study of chronic pancreatitis (CP) in the United States. The primary goals of PROCEED are to define disease progression, test the predictive capability of candidate biomarkers, and develop a platform to conduct translational and mechanistic studies in CP. Using objective and consensus-driven criteria, PROCEED will enroll adults at different stages of CP-controls, suspected CP, and definite CP. In addition to collecting detailed information using structured case report forms and protocol-mandated evaluations at baseline and during follow-up, PROCEED will establish a linked biorepository of blood, urine, saliva, stool, pancreatic fluid, and pancreatic tissue. Enrollment for PROCEED began in June 2017. As of July 1, 2018, nine clinical centers of the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer are enrolling, and 350 subjects have completed baseline evaluation. In conclusion, PROCEED will provide the most accurate and reliable estimates to date on progression of CP. The established cohort and biorepository will facilitate numerous analyses, leading to new strategies for diagnosis, methods to monitor disease progression, and treatment of CP.Item The Heart and Cannabis (THC) Cohort: Differences in Baseline Health and Behaviors by Cannabis Use(Springer, 2022) Keyhani, Salomeh; Cohen, Beth E.; Vali, Marzieh; Hoggatt, Katherine J.; Bravata, Dawn M.; Austin, Peter C.; Lum, Emily; Hasin, Deborah S.; Grunfeld, Carl; Shlipak, Michael G.; Medicine, School of MedicineBackground: Evidence on the cardiovascular health effects of cannabis use is limited. We designed a prospective cohort study of older Veterans (66 to 68 years) with coronary artery disease (CAD) to understand the cardiovascular consequences of cannabis use. We describe the cohort construction, baseline characteristics, and health behaviors that were associated with smoking cannabis. Objective: To understand the cardiovascular consequences of cannabis use. Design: We designed a prospective cohort study of older Veterans (66 to 68 years) with CAD. Participants: A total of 1,015 current cannabis smokers and 3,270 non-cannabis smokers with CAD. Main measures: Using logistic regression, we examined the association of baseline variables with smoking cannabis in the past 30 days. Results: The current cannabis smokers and non-current smokers were predominantly male (97.2% vs 97.1%, p=0.96). Characteristics associated with recent cannabis use in multivariable analyses included lack of a high school education (odds ratio [OR] 2.15, 95% confidence interval [CI]: 1.10 to 4.19), financial difficulty (OR 1.47, 95% CI: 1.02 to 2.11), tobacco use (OR 3.02, 95% CI: 1.66 to 5.48), current drug use (OR 2.82, 95% CI: 1.06 to 7.46), and prior drug use (OR 2.84, 95% CI: 2.11 to 3.82). In contrast, compared to individuals with 0 to 1 comorbid conditions, those with 5 chronic conditions or more (OR 0.43, 95% CI: 0.27 to 0.70) were less likely to smoke cannabis. Conclusions: In this older high-risk cohort, smoking cannabis was associated with higher social and behavioral risk, but with fewer chronic health conditions.