A Novel Ultrasound-based Measure of the Liver among Diabetes Mellitus Type II Patients

Diabetes mellitus type II (DM II) or adult onset diabetes is due to the inefficient use of insulin, which affects various organs and tissues. Patients with DM II are at risk of suffering non-alcoholic fatty liver disease (NAFLD) that can later develop into more life threating forms such as hepatomegaly, cirrhosis or liver cancer. Following the logic of the non-inferiority trial test, we aim to establish a more accurate anatomical measure of the right liver lobe (RLL) to facilitate close monitoring of liver size with ultrasound (US). We hypothesize that US is not unacceptably worse than computed tomography (CT) or magnetic resonance imaging (MRI) to accurately and reliably measure the size of the RLL when the measure is taken in the midaxillary line and craniocaudal plane (MAL-CC). Therefore, the objective of this study is to conduct a non-inferiority trial to test our novel MAL-CC measure. To meet this aim, US measure of the RLL was taken from DM II (n=7) and non-DM II (n=5) patients, whom were recruited from 2 endocrinology clinics at SoM-UPR. Preliminary data shows that MAL-CC measure of the RLL from non-DM II patients is 13.99 + 2.53 cm whereas the same measurement among DM II patients is 15.25 + 3.25 cm (Mann-Whitney U test, p= 0.42). It is concluded that there is a non-significant trend for large RLL sizes among DM II patients. Future work aims to increase sample size and to validate our novel measurement with MRI

Thermodynamic Parameters of Adsorption from Systems Activated Carbon Chlordiazepoxide and Activated Carbon-Diazepam Parámetros termodinámicos de adsorción de los sistemas carbón activado-clordiazepóxido y carbón activado-diazepam

Resumen Se estudian los parámetros termodinámicos de la adsorción de clordiazepóxido y diazepam en seis carbonos activados: Norit B, BDH, Merck, Panreac, M1 y M, en fluido gástrico simulado. Los materiales se caracterizan por: FTIR, pHzpc y adsorción de N 2 a 77 K. La porosidad fue interpretada por las ecuaciones de Dubinin-Radushkevich y BET. Los resultados muestran la relación entre el aumento de la temperatura, las características de cada adsorbente y el comportamiento de estos fármacos. Los valores positivos de todas las entalpías isostéricas de adsorción determinadas a partir de la pendiente de Van 't Hoff (R 2 > 97), indican la naturaleza endotérmica del proceso de adsorción, así como la ∆G < 0 con el incremento de la temperatura. La ∆G < 0 en todos los casos explica el carácter espontáneo del proceso de adsorción. Los valores positivos ∆S dejan claramente que la aleatoriedad se incrementó en la interfaz sólido-solución durante el proceso de adsorción. Palabras clave: carbón activado, adsorción, parámetros termodinámicos. Abstract It is study the thermodynamic parameters of chlordiazepoxide and diazepam drugs adsorbed onto six activated carbons: Norit B, BDH, Merck, Panreac, M1 and M, from simulated gastric fluid at pH 1,2 for 4 h were characterized by FTIR, pH zpc, and adsorption of N 2 to 77 K. The results of porosity were interpreted with the Dubinin-Radushkevich's models and BET' equation. By UV visible spectra residual drugs were monitored. The results show relationship between: increased of temperature, the characteristics of each adsorbent and the behavior of these drugs in acid solution. The positive values of all the isosteric adsorption enthalpies determined from the slope Van't Hoff plot (R 2 > 97), indicate the nature endothermic process of adsorption. The ∆G<0 in all cases explained the spontaneous character of the adsorption process and the positive values of ∆S state clearly that the randomness increased at the solidsolution interface during adsorption process

Outcomes of Early Versus Late Tracheostomy in Patients With COVID-19: A Multinational Cohort Study

Objectives:. Timing of tracheostomy in patients with COVID-19 has attracted substantial attention. Initial guidelines recommended delaying or avoiding tracheostomy due to the potential for particle aerosolization and theoretical risk to providers. However, early tracheostomy could improve patient outcomes and alleviate resource shortages. This study compares outcomes in a diverse population of hospitalized COVID-19 patients who underwent tracheostomy either “early” (within 14 d of intubation) or “late” (more than 14 d after intubation). Design:. International multi-institute retrospective cohort study. Setting:. Thirteen hospitals in Bolivia, Brazil, Spain, and the United States. Patients:. Hospitalized patients with COVID-19 undergoing early or late tracheostomy between March 1, 2020, and March 31, 2021. Interventions:. Not applicable. Measurements and Main Results:. A total of 549 patients from 13 hospitals in four countries were included in the final analysis. Multivariable regression analysis showed that early tracheostomy was associated with a 12-day decrease in time on mechanical ventilation (95% CI, −16 to −8; p < 0.001). Further, ICU and hospital lengths of stay in patients undergoing early tracheostomy were 15 days (95% CI, −23 to −9 d; p < 0.001) and 22 days (95% CI, −31 to −12 d) shorter, respectively. In contrast, early tracheostomy patients experienced lower risk-adjusted survival at 30-day post-admission (hazard ratio, 3.0; 95% CI, 1.8−5.2). Differences in 90-day post-admission survival were not identified. Conclusions:. COVID-19 patients undergoing tracheostomy within 14 days of intubation have reduced ventilator dependence as well as reduced lengths of stay. However, early tracheostomy patients experienced lower 30-day survival. Future efforts should identify patients most likely to benefit from early tracheostomy while accounting for location-specific capacity

Aeroallergen immunotherapy associated with reduced risk of severe COVID-19 in 1095 allergic patients

Introduction: Allergen immunotherapy (AIT) brings along changes in the immune system, restoring dendritic cell function, reducing T2 inflammation and augmenting the regulatory cell activation. Coronavirus disease (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections, interferes with the immune system causing immune suppression during the first phase and over-activation in more advanced disease. We decided to explore the interaction of both in a real-world observational trial. Methods: We registered COVID-19 outcomes in patients with allergic disorders in Latin America, treated with and without AIT. The registry was conducted during the first 1.3 years of the pandemic, with most of the data collected before COVID-19 vaccination was concluded in most countries. Data collection was anonymous via a web-based instrument. Ten countries participated. Results: 630/1095 (57.6%) of the included patients received AIT. Compared to patients without AIT, those treated with AIT had a reduced risk ratio (RR) for COVID-19 lower respiratory symptoms (RR 0.78, 95% CI: 0.6703–0.9024; p = 0.001662) and need for oxygen therapy (RR 0.65, 95% CI: 0.4217–0.9992; p = 0.048). In adherent patients on maintenance sublingual immunotherapy/subcutaneous immunotherapy (SLIT/SCIT) the RR reduction was larger [RR = 0.6136 (95% CI 0.4623–0.8143; p < 0.001) and RR: 0.3495 (95% CI 0.1822–0.6701; p < 0.005), respectively]. SLIT was slightly more effective (NS). We excluded age, comorbidities, level of health care attendance, and type of allergic disorder as confounders, although asthma was related to a higher frequency of severe disease. When analyzing patients with allergic asthma (n = 503) the RR reduction favoring AIT was more pronounced with 30% for lower respiratory symptoms or worse (RR 0.6914, 95% CI 0.5264 to 0.9081, p = 0.0087) and 51% for need of oxygen therapy or worse (RR 0.4868, 95% CI 0.2829–0.8376, p = 0.0082). Among severe allergic patients treated with biologics (n = 24) only 2/24 needed oxygen therapy. There were no critical cases among them. Conclusion: In our registry AIT was associated with reduced COVID-19 severity

Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial

Background: Sparsentan is a novel, non-immunosuppressive, single-molecule, dual endothelin and angiotensin receptor antagonist being examined in an ongoing phase 3 trial in adults with IgA nephropathy. We report the prespecified interim analysis of the primary proteinuria efficacy endpoint, and safety. Methods: PROTECT is an international, randomised, double-blind, active-controlled study, being conducted in 134 clinical practice sites in 18 countries. The study examines sparsentan versus irbesartan in adults (aged ≥18 years) with biopsy-proven IgA nephropathy and proteinuria of 1·0 g/day or higher despite maximised renin-angiotensin system inhibitor treatment for at least 12 weeks. Participants were randomly assigned in a 1:1 ratio to receive sparsentan 400 mg once daily or irbesartan 300 mg once daily, stratified by estimated glomerular filtration rate at screening (30 to 1·75 g/day). The primary efficacy endpoint was change from baseline to week 36 in urine protein-creatinine ratio based on a 24-h urine sample, assessed using mixed model repeated measures. Treatment-emergent adverse events (TEAEs) were safety endpoints. All endpoints were examined in all participants who received at least one dose of randomised treatment. The study is ongoing and is registered with ClinicalTrials.gov, NCT03762850. Findings: Between Dec 20, 2018, and May 26, 2021, 404 participants were randomly assigned to sparsentan (n=202) or irbesartan (n=202) and received treatment. At week 36, the geometric least squares mean percent change from baseline in urine protein-creatinine ratio was statistically significantly greater in the sparsentan group (-49·8%) than the irbesartan group (-15·1%), resulting in a between-group relative reduction of 41% (least squares mean ratio=0·59; 95% CI 0·51-0·69; p<0·0001). TEAEs with sparsentan were similar to irbesartan. There were no cases of severe oedema, heart failure, hepatotoxicity, or oedema-related discontinuations. Bodyweight changes from baseline were not different between the sparsentan and irbesartan groups. Interpretation: Once-daily treatment with sparsentan produced meaningful reduction in proteinuria compared with irbesartan in adults with IgA nephropathy. Safety of sparsentan was similar to irbesartan. Future analyses after completion of the 2-year double-blind period will show whether these beneficial effects translate into a long-term nephroprotective potential of sparsentan. Funding: Travere Therapeutics