[Impact of the COVID-19 pandemic on the Colombian population according to mitigation measures. Preliminary data from epidemiological models for the period March 18 to April 18, 2020]. / Proyecciones de impacto de la pandemia COVID-19 en la población colombiana, según medidas de mitigación. Datos preliminares de modelos epidemiológicos para el periodo del 18 de marzo al 18 de abril de 2020.

INTRODUCTION: First case of COVID-19 in Colombia was diagnosed on March 6th. Two weeks later, cases have rapidly increased, leading the government to establish some mitigation measures. OBJECTIVES: The first objective is to estimate and model the number of cases, use of hospital resources and mortality by using different R0 scenarios in a 1-month scenario (from March 18 to April 18, 2020), based on the different isolation measures applied. This work also aims to model, without establishing a time horizon, the same outcomes given the assumption that eventually 70% of the population will be infected. MATERIALS AND METHODS: Data on the number of confirmed cases in the country as of March 18, 2020 (n=93) were taken as the basis for the achievement of the first objective. An initial transmission rate of R0= 2.5 and a factor of 27 for undetected infections per each confirmed case were taken as assumptions for the model. The proportion of patients who may need intensive care or other in-hospital care was based on data from the Imperial College of London. On the other hand, an age-specific mortality rate provided by the Instituto Superiore di Sanità in Italy was used for the second objective. RESULTS: Based on the 93 cases reported as of March 18, if no mitigation measures were applied, by April 18, the country would have 613 037 cases. Mitigation measures that reduce R0 by 10% generate a 50% reduction in the number of cases. However, despite halving the number of cases, there would still be a shortfall in the number of beds required and only one in two patients would have access to this resource. CONCLUSION: This model found that the mitigation measures implemented to date by the Colombian government and analyzed in this article are based on sufficient evidence and will help to slow the spread of SARS-CoV-2 in Colombia. Although a time horizon of one month was used for this model, it is plausible to believe that, if the current measures are sustained, the mitigation effect will also be sustained over time.

[Impact of mitigation measures on the COVID-19 pandemic in Chile: preliminary data for the period April 14 to May 14]. / Impacto de diferentes medidas de mitigación en el curso de la pandemia de COVID-19 en Chile: proyección preliminar para el período del 14 de abril al 14 de mayo.

OBJETIVE: To model disease progression, healthcare demand and case fatality rate attributed to COVID-19 pandemic that may occur in Chile in 1-month time, by simulating different scenarios according to diverse mitigation measures hypothetically implemented. Furthermore, we aimed to estimate the same outcomes assuming that 70% of the population will be infected by SARS-CoV-2, with no time limit assumption. METHODS: We based on the number of confirmed COVID-19 cases in Chile up to April 14th 2020 (8 273 cases and 94 deaths). For the simulated scenarios we assumed basic reproduction numbers ranging from R0=2.5 to R0=1.5. The estimation of the number of patients that would require intensive care and the age-specific case fatality rate were based on data provided by the Imperial College of London and the Instituto Superiore di Sanità en Italia. RESULTS: If no mitigation measures were applied (R0=2.5), by May 25, Chile would have 2 019 775 cases and 15 068 deaths. If mitigations measures were implemented to decrease R0 to 1.5 (early detection of cases, quarantine, social distancing of elderly), the number of cases and deaths would importantly decrease. Nonetheless, the demand for in-hospital care including intensive care would exceed the available resources. Our age-specific analysis showed that population over 60 years are at higher risk of needing intensive care and death. CONCLUSION: Our evidence supports the mitigation measures implemented by the Chilean government. Nevertheless, more stringent measures are needed to prevent the health care system's collapse due to shortfall of resources to confront the COVID-19 pandemic.

Risk of Major Malformations Following First-Trimester Exposure to Olanzapine: Preliminary Data From the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications.

PURPOSE/BACKGROUND: Since its US Food and Drug Administration approval in 1996, olanzapine has been one of the most commonly prescribed atypical antipsychotics, making a better understanding of its reproductive safety profile critical. The goal of the current analysis was to determine the risk of major malformations among infants exposed to olanzapine during pregnancy compared with a group of nonexposed infants. METHODS/PROCEDURES: The National Pregnancy Registry for Psychiatric Medications is a prospective pharmacovigilance program in which pregnant women are enrolled and interviewed during pregnancy and the postpartum period. Labor and delivery and pediatric medical records were screened for evidence of major malformations followed by adjudication by a dysmorphologist blinded to medication exposure. Infants with first-trimester exposure to olanzapine were compared with controls without second-generation antipsychotic exposure. FINDINGS/RESULTS: As of April 18, 2022, 2619 women have enrolled in the study. At the time of data extraction, 49 olanzapine-exposed infants and 1156 infants in the comparison group were eligible for these analyses. There were no major malformations associated with olanzapine exposure in the first trimester. The absolute risk for major malformations in the exposure group was 0.00% (95% confidence interval, 0.00-7.25) for olanzapine compared with 1.64% (95% confidence interval, 0.99-2.55) in the control group. IMPLICATIONS/CONCLUSIONS: In this prospective cohort, no major malformations were associated with olanzapine exposure during the first trimester. Although these data are preliminary and cannot rule out more modest effects, they are nonetheless important, adding to the growing reproductive safety data for olanzapine.

Does Compliance or Cost Regulate Effectiveness of Notched Sound Therapy Phone Applications for Tinnitus Relief? Preliminary Data of a Prospective Randomized Control Trial.

OBJECTIVE: The objective of this study is to evaluate compliance with and effectiveness of notched sound therapy (NST) administered through a mobile application in improving symptoms of patients experiencing chronic tinnitus. STUDY DESIGN: A prospective randomized control trial was done. SETTING: The study was done at a tertiary referral center. PATIENTS: Adult patients with tinnitus were monitored. INTERVENTIONS: Patients were randomized at enrollment to either the NST or a standard of care (SOC) group. NST arm included, in addition to SOC, a free subscription to NST mobile application, whereas the SOC arm included NST at subscription cost. MAIN OUTCOME MEASURES: The main outcome measures were continued enrollment in study, compliance with the therapy, frequency and duration of therapy use, and change from the baseline in the Tinnitus Handicap Inventory (THI). RESULTS: Patients in the NST group were 2.25 times more likely to use the NST application for 3 months postenrollment. Only 33% of users in the NST group listened for the prescribed 2 h/d compared with 0% of users in the SOC group. There was a clinically relevant mean decrease in THI from a baseline of 13.5 in the NST group (p = 0.09) and of 14.8 in the SOC group (p = 0.02). There was a positive correlation between initial THI and decrease in THI after 3 months (p = 0.001). CONCLUSIONS: Monitoring tinnitus for 3 months leads to a decrease in subjective symptoms regardless of NST use. Patients who received a free subscription to the application were more likely to continue with therapy, but very few patients were able to comply with 2 hours of listening time per day.

Preliminary data on oxytocin modulation of neural reactivity in women to emotional stimuli of children depending on childhood emotional neglect.

Sensitivity for rewarding cues and distress signals from children is fundamental to human caregiving and modulated by the neuropeptide oxytocin. In a functional magnetic resonance imaging study, we investigated whether oxytocin regulates neural responses to reward or distress cues form children. In a placebo-controlled, within-subject design, we measured neural responses to positive, negative, and neutral cues from children in 22 healthy female subjects who received oxytocin (24 IU) versus placebo. Further, based on current literature, we hypothesized that oxytocin effects are modulated by experiences of childhood trauma. The task elicited valence-specific effects-positive images activated the ventromedial prefrontal cortex, left anterior cingulate cortex, and right putamen, and images of children in distress activated the bilateral amygdala, hippocampus, and right medial superior frontal cortex. The effects of oxytocin depended on subjective reports of childhood emotional neglect. Self-reported neglect interacted with oxytocin administration in the amygdala, hippocampus, and prefrontal areas. In individuals with higher scores of emotional neglect, oxytocin increased neural reactivity of limbic structures to positive and neutral images. Our findings need replication in larger samples and can therefore be considered preliminary but are in line with the recent literature on the modulating effect of childhood adversity on the sensitivity to oxytocin administration.

Relationship between Nutritional Status, Food Consumption and Sarcopenia in Post-Stroke Rehabilitation: Preliminary Data.

After a stroke, patients can suffer from sarcopenia, which can affect recovery. This could be closely related to an impairment in nutritional status. In this preliminary analysis of a longitudinal prospective study, we screened 110 subjects admitted to our rehabilitation center after a stroke. We then enrolled 61 patients, who underwent a 6-week course of rehabilitation treatment. We identified a group of 18 sarcopenic patients (SG), according to the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), by evaluating muscle strength with the handgrip test, and muscle mass with bioelectrical impedance analysis (BIA). With respect to the non-sarcopenic group (NSG), the SG at admission (T0) had worse muscle quality, according to the BIA-derived phase angle, and a lower score of MNA®-SF. In contrast to the NSG, the SG also exhibited lower values for both BMI and the Geriatric Nutritional Risk Index (GNRI) at T0 and T1. Moreover, 33% of the SG had a major risk of nutrition-related complications (GNRI at T0 < 92) and discarded on average more food during the six weeks of rehabilitation (about one-third of the average daily plate waste). Of note is the fact that the Barthel Index's change from baseline indicated that the SG had a worse functional recovery than the NGS. These results suggest that an accurate diagnosis of sarcopenia, along with a proper evaluation of the nutritional status on admission to rehabilitation centers, appears strictly necessary to design individual, targeted physical and nutritional intervention for post-stroke patients, to improve their ability outcomes.

The Impact of the COVID-19 Pandemic on Women's Perinatal Mental Health: Preliminary Data on the Risk of Perinatal Depression/Anxiety from a National Survey in Italy.

Increasing evidence suggests that during the COVID-19 pandemic, anxiety and depression during the perinatal period increased. The aim of the study is to estimate the prevalence of risk for both maternal depression and anxiety among women attending 18 healthcare centres in Italy during the SARS-COV-2 pandemic and to investigate the psychosocial risks and protective factors associated. It was divided into a retrospective phase (2019, 2020, and the first nine months of 2021) and a prospective phase (which began in November 2021 and it is still ongoing), which screened 12,479 and 2349 women, respectively, for a total of 14,828 women in the perinatal period. To evaluate the risk of anxiety and depression, the General Anxiety Disorder-7 (GAD-7), the Edinburgh Postnatal Depression Scale (EPDS), and an ad hoc form were used to collect sociodemographic variables. In the prospective study, the average age of the women is 31 (range 18-52) years. Results showed that the percentage of women who had EPDS score ≥9 increased from 11.6% in 2019 to 25.5% in the period ranging from November 2021 to April 2022. In logistic regression models, the variables associated with the risk of depression at a level ≤0.01 include having economic problems (OR 2.16) and not being able to rely on support from relatives or friends (OR 2.36). Having the professional status of the housewife is a lower risk (OR 0.52). Those associated with the risk of anxiety include being Italian (OR 2.97), having an education below secondary school level (OR 0.47), having some or many economic problems (OR 2.87), being unable to rely on support from relatives or friends (OR 2.48), and not having attended an antenatal course (OR 1.41). The data from this survey could be useful to determine the impact of the SARS-COV-2 pandemic on women and to establish a screening program with common and uniformly applied criteria which are consistent with national and international women's mental health programs.

Pertussis, diphtheria, and tetanus antibodies seroprevalence in pregnant women and neonates, as a preliminary data for introduction of preconception or prenatal DTaP vaccination among Japanese society.

An increasing number of countries have been introducing acellular pertussis vaccination during pregnancy for the prevention of neonatal pertussis. In response to the fact that infantile pertussis cases of 0-5 months age groups remained unchanged despite the universal vaccination program, prenatal pertussis vaccination has been a rising issue in Japan. Hence, we investigated the seroprevalence of pertussis, diphtheria, and tetanus antibodies in Japanese pregnant women and neonates, and evaluated the necessity of diphtheria-tetanus-acellular pertussis (DTaP) vaccination during the preconception or prenatal period. Maternal PT-IgG (EIA) and FHA-IgG (EIA) for the first trimester, within 1 week after delivery, and cord blood were collected, along with colostrum pertussis-IgA (ELISA), diphtheria-IgG (EIA), tetanus-IgG (EIA), and blood samples from the first trimester. The maternal seroprevalence of PT-IgG and FHA-IgG was 69 % and 75 %, respectively. All tested participants were positive for diphtheria-IgG and tetanus-IgG (100 %). First trimester PT-IgG/FHA-IgG antibody titers were significantly associated with cord blood PT-IgG/FHA-IgG titers (P < 0.001). We found that pertussis seroprevalence among pregnant Japanese women was approximately 70 %. The antibody seropositivity rate of pertussis was lower than that of diphtheria and tetanus. Fetal acquired passive immunity against pertussis is higher when the level of maternal antibody in the first trimester is sufficient. At least 30 % of study population did not reach to the threshold value to provide sufficient pertussis immunity for the neonates and themselves. The acellular pertussis vaccine (DTaP) approved in Japan lacks safety information for pregnancy, hence, a solution for prompt administration of prenatal acellular pertussis vaccination might be introducing DTaP in the preconception period.

Transcatheter closure of congenital ventricular septal defects using the Amplatzer Duct Occluder II device: preliminary data from a Tunisian monocentric study.

INTRODUCTION: Percutaneous closure of congenital ventricular septal defects (VSDs) represents a promising alternative to surgery with lower rate of complications and shorter hospital stay. Its main limitation is the choice of the appropriate device for each type of defect. AIM: To report the experience of the service of cardiology (Sahloul hospital, Sousse, Tunisia) in percutaneous closure of congenital VSDs with Amplatzer Duct Occluder II (ADOII). METHODS: This was a retrospective, monocentric study, conducted from January 2013 to December 2017. The study included patients treated by percutaneous closure of congenital VSDs with the ADOII device. RESULTS: Twelve patients (6 boys; 6 girls) were included. The mean±SD of patients' age and weight were 65±41 months and 23±10 kg, respectively. VSDs were peri-membranous (n=9) and muscular (n=3), and defects were restrictive (n=11) and non-restrictive (n=1). The mean (minimum-maximum) size of VSDs was 4.72 (3-6) mm. Eleven ADOII prostheses were successfully implanted. One failure procedure was noted with migration of the device into the pulmonary artery. A second child with perimembranous defect developed transient atrioventricular block. No deaths occurred. CONCLUSION: The present early experience shows that percutaneous closure with ADOII device of perimembranous and trabecular VSDs is safe and effective.

Dolutegravir Plus Lamivudine Dual-Drug Regimen in Treatment-Naive HIV-1-Infected Patients With High-Level Viral Load: Preliminary Data From the Real World.

BACKGROUND: Some inpatients with HIV-RNA ≥500,000 copies/mL in China need to use 2-drug regimen for some reasons, although limited data are available for dolutegravir plus lamivudine (3TC) in those patients with ultra-high viral loads. METHODS: We conducted a single-center retrospective-prospective study in China and enrolled 42 ART-naive HIV-infected inpatients who use a once-daily 2-drug regimen because of various reasons (drug interaction, renal impairment, age, and other related comorbidities).They were divided into 2 groups, low viral load group (baseline viral load <500,000 copies/mL, n = 20) and high viral load group (baseline viral load ≥500,000 copies/mL, n = 22). All patients were followed up for 48 weeks. RESULTS: The median of baseline viral load was 5.74 log10 copies/mL and CD4+ T-cell count was 59 cells/µL. At week 48, there was no significant difference (P = 0.598) in proportions of participants with HIV-1 RNA <50 copies/mL [90%, 95% confidence interval (CI) (75.6% to 104.4%) in low viral load groups vs 95.5%, 95% CI (86.0% to 104.9%) in high viral load groups]. No differences were found in mean increase of CD4+ T-cell count from baseline between 2 groups (218 ± 122 vs 265 ± 127 cells/µL, P = 0.245). There is no grade 3 or higher treatment-related adverse events and none discontinued treatment because of adverse events. CONCLUSIONS: The results of our study in real world support dolutegravir + 3TC dual regimen as a promising therapy option for treatment-naive HIV-infected patient with baseline viral load ≥500,000 copies/mL.

Gamma glutamyl transferases in association with cardiovascular risk scores in non-diabetic hypertensive Cameroonians: preliminary data from HYRICCA study.

OBJECTIVE: The usefulness of gamma glutamyl transferase (GGT) as biomarker of cardiovascular risk (CVR) remains unexplored in sub-Saharan Africans. To evaluate their relevance on CVR assessment in non-diabetic hypertensive Cameroonians. This was a prospective cross-sectional study on non-diabetic hypertensive adults aged 57.7 ± 10 years (62% female), without evidence of acute or chronic liver disease, in which we assessed GGT levels and correlates it with validated CVR biomarkers, CVR scores (WHO risk score, Framingham 2008, ASCVD 2013, EuroSCORE 2003, and Reynolds score), and plasma atherogenic index (PAI). RESULTS: We found a positive but weak association between GGT and PAI on linear regression [0.004 (0.001; 0.007); p = 0.021], which was dependent of triglycerides levels (r = 0.17; p = 0.03). We did not find a significant association between GGT levels and the results of the CVR scores studied; Although being related to atherogenic risk, as reported in literature in non-sub-Saharan Africans, GGTs would be of little value for CVR assessment in our population.

Birth weight distribution in Golden and Labrador retriever dogs: A similar morphotype with a different trend. Preliminary data.

Birth weight (bW) is considered an indicator of neonatal maturity and a predictor of neonatal mortality. According to its importance, many efforts have been made so far to identify physiological body weight ranges at birth. Due to the high heterogeneity among breeds, optimal bW is difficult to define in dogs. The aim of this study was to carefully analyze the shape and pattern of the bW distribution in dogs. Furthermore, the role of breed on bW determination was specifically investigated in relation to maternal (age, weight, height, diet, season, litter size) and neonatal (sex, malformations, assistance at birth) aspects. For these purposes two canine breeds with very similar phenotypic characteristics, Golden and Labrador retrievers, were selected. An accurate statistical model to explore bW distribution and compare it between Goldens and Labradors was developed. At birth most of the Golden and Labrador pups (estimated 95th percentile) weighed up to 630 g and 500 g, respectively. The estimated 5th percentile of bW distributions was 295 g in Golden and 290 g in Labrador pups. These lowest values could be indicative cut-offs of underweight pups. The probability of neonatal mortality within 1 week of life decreased with increasing bW (P = 0.031) and was higher in Golden than Labrador pups even though this difference was not significant. In conclusion, our results suggest that genetics have a relevant influence on the determination of birth weight which is confirmed to be closely associated with neonatal mortality.

MPN-375 BET Inhibitor Pelabresib (CPI-0610) Combined With Ruxolitinib in Patients With Myelofibrosis - JAK Inhibitor-Naïe or With Suboptimal Response to Ruxolitinib - Preliminary Data From the MANIFEST Study.

CONTEXT: Myelofibrosis is characterized by splenomegaly, symptoms, cytopenias, and bone marrow (BM) fibrosis. Pelabresib is an investigational, oral, small-molecule BET inhibitor designed to selectively inhibit the BD1 and BD2 bromodomains of BET proteins. OBJECTIVE: Evaluation of pelabresib combined with ruxolitinib in patients with myelofibrosis. DESIGN: In Arm 3 of the Phase 2 MANIFEST study (NCT02158858), JAKi-naïve myelofibrosis patients are treated with pelabresib combined with ruxolitinib. In Arm 2, myelofibrosis patients with suboptimal response to ruxolitinib are treated with pelabresib as 'add-on' to ruxolitinib (Arm 2A: transfusion-dependent [TD]; Arm 2B: non-TD). The primary endpoints are ≥35% spleen volume reduction (SVR35) at Week 24 for Arms 3 and 2B and TD to transfusion independence (TI) in Arm 2A. The key secondary endpoint is ≥50% total symptom score reduction (TSS50) at Week 24; in Arm 2A, SVR35 is an additional key secondary endpoint. BM biopsies to assess BM fibrosis and safety data are also evaluated. RESULTS: As of September 2021, at Week 24 in Arm 3 (N=84), 68% (57/84) of patients achieved SVR35 (median change: -50%), and 56% (46/82) of patients achieved TSS50 (median change: -59%). At Week 24 in Arm 2 (N=86), 20% (16/81; 17% in Arm 2A and 26% in Arm 2B) of patients achieved SVR35 (median change: -18%), and 37% (30/81) of patients achieved TSS50 (median change: -47%). In Arm 2A, the TD to TI rate was 16% (6/38). At Week 24, BM fibrosis improvement ≥ 1 grade was achieved in 28% (16/57) and 26% (12/47) of patients in Arms 3 and 2, respectively. Hematologic treatment-emergent adverse events (TEAEs) included thrombocytopenia, in 52% (≥Grade 3: 12%) and 52% (≥Grade 3: 33%) of patients, and anemia, in 42% (≥Grade 3: 35%) and 27% (≥Grade 3: 19%) of patients in Arms 3 and 2, respectively. Low-grade gastrointestinal TEAEs and respiratory infections were observed but rarely resulted in discontinuation. CONCLUSIONS: In ruxolitinib treatment-naïve and previously treated patients with myelofibrosis, pelabresib combined with ruxolitinib resulted in splenic and symptom responses and BM fibrosis improvement and was generally well tolerated. The Phase 3 MANIFEST-2 study is evaluating pelabresib combined with ruxolitinib in JAKi treatment-naïve patients with myelofibrosis (NCT04603495).

Cardiovascular Disease Risk in a Cohort of Virologically Suppressed People Living with HIV Switching to Doravirine: Preliminary Data from the Real Life.

Aim of this study is to assess the impact of doravirine (DOR)-based regimens on cardiovascular risk in treatment-experienced people living with HIV (PLWHIV). We retrospectively analyzed a cohort of 40 treatment-experienced PLWHIV switching to a DOR-based three-drug regimen, evaluating 10-year risk of manifesting clinical cardiovascular diseases (CD) through the Framingham Risk Score at baseline, 12, and 24 weeks of follow-up. At baseline, median predicted 10-year risk of cardiovascular disease (10Y-CD) was 8.0% (interquartile range 4.0-13.0). After 12 weeks, we observed a significant reduction in 10Y-CD (mean decrease -2.21, p = .012); similarly, we observed a nonsignificant reduction at week 24 (p = .336). Regarding metabolic parameters, after 24 weeks we observed a significant reduction in total cholesterol (median change -8.8 mg/dL, p = .018), low-density lipoprotein cholesterol (median -9.5 mg/dL, p = .007), and triglycerides (median -19.8 mg/dL, p < .001). Our results show a favorable metabolic impact of DOR-based regimens along with a promising reduction in 10-year risk of cardiovascular disease.

A survey of the clinical practice followed by Korean medicine doctors for scoliosis: Preliminary data for clinical practice guidelines.

Scoliosis is a spinal disease in which the Cobb angle is >10°. Scoliosis treatment can be surgical or conservative, and clinical practice guidelines (CPGs) for conservative treatments have been updated since 2006. There have been several articles regarding the efficacy and safety of Korean medicine (KM) in treating scoliosis, but there are no CPGs. Our study investigated the current clinical practice using a survey for the future establishment of KM-CPGs. The survey mainly comprised clinical practice status, diagnosis, treatment, progress and prognosis, and perception of KM on scoliosis, with reference to existing surveys of other musculoskeletal disorders and scoliosis-related articles. A web-based survey was conducted from February 16, 2021 to February 28, 2021. We found that 60% of KM doctors (KMDs) respondents treated patients with scoliosis, and they valued radiographical measurements and scoliosis-related factors in the diagnosis. KMDs used multiple KM treatments, including acupuncture, Chuna, cupping, pharmacopuncture, and herbal medicine, and they emphasized the importance of KM more in nonstructural scoliosis than in structural scoliosis. Although the perception of the prognosis of scoliosis was in agreement with that suggested by previous guidelines, KMDs showed outstanding focus on reduction of symptoms of scoliosis and improvement of quality of life. Despite some limitations, including low participation and the need for consulting other medical practitioners, our study may be helpful for the development of KM-CPGs because it is the first to analyze the perceptions of KMDs on scoliosis and to collect preliminary data that are of significance for preparing clinical guidelines.

Exploring the brain metabolic correlates of process-specific CSF biomarkers in patients with MCI due to Alzheimer's disease: preliminary data.

We explored the brain metabolism correlates of emergent cerebrospinal fluid (CSF) biomarkers in a group of 26 patients with prodromal Alzheimer's disease (AD). Distinct volumes of interest (VOIs) expressed the sites of correlation between CSF biomarkers and brain metabolism as determined on [18F]FDG-PET images, as well as of significant hypometabolism in patients compared to healthy controls. Neurogranin- and α-synuclein-VOIs included left precuneus and/or posterior cingulate cortex (PC and/or PCC) and partially overlapped hypometabolism at those sites. ß-synuclein- and neurofilament light chain (NfL)-VOIs regarded either left or right lateral temporal areas, respectively, with partial overlap with hypometabolism only for the ß-synuclein-VOI, whereas the NfL-VOI did not include hypometabolic regions. We speculate that CSF neurogranin and α-synuclein express an already established hippocampal damage leading to PC and/or PCC deafferentation and hypometabolism. ß-synuclein may represent the progression of synaptopathy in the temporal lobe, while NfL the axonal injury in right temporal regions where neuronal loss is not yet evident.

Conservative management of posterior tracheal wall injury by endoscopic stent placement in children: Preliminary data of three cases.

The management of tracheal wall lacerations is debated. Current treatments are mainly derived by the experience on adults and include conservative or surgical treatments depending on the clinical condition of the patient. We report our preliminary data with removable tracheal stents in 3 children with tracheal tears and respiratory failure. If performed in specialized centers with appropriate endoscopic and clinical follow-up, airway stents can be considered a valid and safe conservative treatment for tracheal tears and an alternative to intubation or tracheostomy. Further studies are needed to compare different therapeutic options and better define the management and duration of stent treatment.

An Argentinean cohort of patients with rheumatic and immune-mediated diseases vaccinated for SARS-CoV-2: the SAR-CoVAC Registry-protocol and preliminary data.

BACKGROUND/OBJECTIVE: To evaluate the efficacy and safety of SARS-CoV-2 vaccine in patients with rheumatic and immune-mediated inflammatory diseases (IMIDs) in Argentina: the SAR-CoVAC registry. METHODS: SAR-CoVAC is a national, multicenter, and observational registry. Adult patients with rheumatic or IMIDs vaccinated for SARS-CoV-2 were consecutively included between June 1 and September 17, 2021. Sociodemographic data, comorbidities, underlying rheumatic or IMIDs, treatments received, their modification prior to vaccination, and history of SARS-CoV-2 infection were recorded. In addition, date and place of vaccination, type of vaccine applied, scheme, adverse events (AE), disease flares, and new immune-mediated manifestations related to the vaccine were analyzed. RESULTS: A total of 1234 patients were included, 79% were female, with a mean age of 57.8 (SD 14.1) years. The most frequent diseases were rheumatoid arthritis (41.2%), osteoarthritis (14.5%), psoriasis (12.7%), and spondyloarthritis (12.3%). Most of them were in remission (28.5%) or low disease activity (41.4%). At the time of vaccination, 21% were receiving glucocorticoid treatment, 35.7% methotrexate, 29.7% biological (b) disease modifying anti-rheumatic drugs (DMARD), and 5.4% JAK inhibitors. In total, 16.9% had SARS-CoV-2 infection before the first vaccine dose. Most patients (51.1%) received Gam-COVID-Vac as the first vaccine dose, followed by ChAdOx1 nCoV-19 (32.8%) and BBIBP-CorV (14.5%). Half of them (48.8%) were fully vaccinated with 2 doses; 12.5% received combined schemes, being the most frequent Gam-COVID-Vac/mRAN-1273. The median time between doses was 51 days (IQR 53). After the first dose, 25.9% of the patients reported at least one AE and 15.9% after the second, being flu-like syndrome and local hypersensitivity the most frequent manifestations. There was one case of anaphylaxis. Regarding efficacy, 63 events of SARS-CoV-2 infection were reported after vaccination, 19% occurred during the first 14 days post-vaccination, 57.1% after the first dose, and 23.8% after the second. Most cases (85.9%) were asymptomatic or mild and 2 died due to COVID-19. CONCLUSIONS: In this national cohort of patients, the most common vaccines used were Gam-COVID-Vac and ChAdOx1 nCoV-19. A quarter of the patients presented an AE and 5.1% presented SARS-CoV-2 infection after vaccination, in most cases mild. STUDY REGISTRATION: This study has been registered in ClinicalTrials.gov under the number: NCT04845997. Key Points • This study shows real-world data about efficacy and safety of SARS-CoV-2 vaccination in patients with rheumatic and immune-mediated inflammatory diseases. Interestingly, different types of vaccines were used including vector-based, mRNA, and inactivated vaccines, and mixed regimens were enabled. • A quarter of the patients presented an adverse event. The incidence of adverse events was significantly higher in those receiving mRAN-1273 and ChAdOx1 nCoV-19. • In this cohort, 5.1% presented SARS-CoV-2 infection after vaccination, in most cases mild.