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2.
Gastroenterology ; 162(7):S-596, 2022.
Article in English | EMBASE | ID: covidwho-1967340

ABSTRACT

Background: While vaccines against COVID-19 are effective in healthy individuals, we reported significantly lower serologic responses to BNT162b2 in patients with inflammatory bowel diseases (IBD) treated with anti-tumor necrosis factor (TNF) α agents. As this was apparent already 4 weeks post vaccination, vaccine longevity is concerning. Aim: to assess long-term serologic responses to BNT162b2 in patients with IBD stratified according to medical treatment. Methods: A prospective, observational multi-center Israeli study. Patients with IBD (anti-TNFα treated versus non-anti-TNFα treated) and healthy controls (HC) were followed from before the 1st BNT162b2 dose until 6 months after vaccination. COVID-19 spike (S) and nucleocapsid (N) antibodies (Abs) concentrations were analyzed by ELISA, followed by neutralization studies. Specific anti-receptor binding domain (RBD) memory Bcells response, serologic responses against variants of concern (VOCs), Beta, Gamma and Delta, immunoglobulin levels and lymphocyte cell subsets were evaluated as well. Safety was assessed using questionnaires, clinical and laboratory data. Results: Of 193 subjects, 130 had IBD (45 and 85 in the anti-TNFa and non-anti-TNFα groups, respectively), 63 HC. Serologic response assessed 176 (median) days (IQR 166-186) and compared to 4 weeks after 1st dose significantly declined in all three groups, but was lowest in the anti- TNFα group: 6 months anti-S Abs titer geometric means: 193 (95%CI: 128-292), 703 (520- 951), and 1253 (1023-1534) in anti-TNFα, non- anti-TNFα and HC groups, respectively, p<0.001, Figure 1. This was further supported by neutralization and inhibition studies. Importantly, significantly decreased memory B-cell response towards RBD was detected only in the anti-TNFα group, with the most significant reduction in response to Beta VOC (p<0.0008 and p<0.0001, vs. non-anti-TNFα and HC, respectively). Older age was an additional predictor of lower serologic response. Immunoglobulin levels and lymphocyte cell subsets were comparable between the study groups. Infection rate reflected by anti-N Abs was ~1% in all groups. Safety was comparable in all groups. Conclusion: The 6-months serologic response to BNT162b2 vaccine, evaluated prospectively, decreased in all subjects, most prominently in patients with IBD treated with anti-TNFα. Importantly, the latter also had the sharpest decline in serologies, the lowest functional activity and lowest RBD specific memory B-cells. Older age is an additional predictor of decreased serologic response. Altogether, waning of COVID-19 serologic and functional response over 6 months, specifically in patients with IBD treated with anti-TNFα, supports the need for an early third vaccine dose. (Figure Presented)

3.
Implementation Science ; 17(SUPPL 1):1, 2022.
Article in English | Web of Science | ID: covidwho-1894010
5.
Journal of Urology ; 207(SUPPL 5):e3, 2022.
Article in English | EMBASE | ID: covidwho-1886477

ABSTRACT

INTRODUCTION AND OBJECTIVE: BPH affects tens of millions of men across the world. Most procedures require either general or regional anesthesia or a transurethral approach. Herein, we present the 3 & 6 months results of NCT04760483 is a phase I prospective, single center, interventional pilot study evaluating transperineal laser ablation (TPLA) of BPH tissues, carried in Office setting under local anesthesia. A detailed step by step video depiction of this procedure is available at the AUA video library. The objectives call for safety, feasibility, and impact in pertinent outcomes measures, such as Uroflowmetry, IPSS, Hematuria, Erectile function, and ejaculation METHODS: The study contemplated accrual of 20 men between 50 and 80 years with prostate volumes between 30 and 120 cc, IPSS scores >9, peak flows between 5 and 15 cc/s and void residuals under <250 ml. Any patient neurological conditions, history of any surgical intervention or urinary retention were excluded. IPSS assessments, Flow studies and prostate volume measures were conducted at 3 months. Herein we present the results. Bayesian analysis for continuous measurements were performed and non-parametric differences were evaluated using chi2 tests. RESULTS: Patients enrolled between December 2020 and February of 2021. The median (IQR) for age and BMI was 68 (58,73) and 29 (27,31), respectively. These parameters for room time, ablation time, watts and total joules were 29 (23,32), 9 minutes (7,12), 6 (5,7) watts and 3,400 (2,600, 3600) joules, respectively. 8(40%) were discharged with a Foley due to elevated residuals. 16 patients had erections and ejaculations before and 3 months after TPLA. 17/20 (85%) had significant improvement in their urinary profile after TPLA (See TABLE for details). One of the initial responders suffered from COVID- 19 infection and developed a CVA that hindered his urinary function. CONCLUSIONS: TPLA in the office setting is feasible and safe. Three month outcomes showed subjective and objective sustained improvement in over 80% of patients for at least 6 months. Furthermore, erections or ejaculations were not affected. This novel and promising approach demands further evaluation in phase II-III trials. (Figure Presented).

6.
Tijdschrift voor Psychiatrie ; 63(7):499-508, 2021.
Article in Dutch | APA PsycInfo | ID: covidwho-1813095

ABSTRACT

Background: The Clozapine Plus Working Group is frequently consulted for advice on measures in case of infection with SARS-CoV-2 and on vaccination against COVID-19 in patients receiving clozapine. Aim: Inform about risks of infection with SARS-CoV-2 in patients with severe mental illness (SMI), patients with schizophrenia spectrum disorders (SSD), and patients treated with clozapine. Advise on monitoring of clozapine plasma levels and white blood cell count and differential in COVID-19 and after vaccination, as well as measures to be taken. Method: Literature research and case studies. Results: SMI patients and in particular SSD patients have an increased risk of infection with SARS-CoV-2 with more hospitalizations and higher mortality than non-psychiatric patients. Patients using clozapine may be at greater risk of infection. SARS-CoV-2 infection may cause a dangerous increase of clozapine plasma levels and generally mild and short-term granulocytopenia and lymphocytopenia, which are usually not a result of clozapine treatment. Conclusion: In case of COVID-19 extra alertness is required in patients with SMI and especially SSD. In clozapine users, in case of COVID-19, reduction in dose by half to three quarters of the original dose is recommended. When patients develop granulocytopenia, SARS-CoV-2 should be considered as the cause and not immediately clozapine. SMI patients and clozapine users in particular belong to a high risk group with a medical indication for early vaccination. (PsycInfo Database Record (c) 2022 APA, all rights reserved) (Dutch) Achtergrond: De Clozapine Plus Werkgroep wordt veelvuldig advies gevraagd over maatregelen bij infectie met SARS-CoV-2 en over vaccinatie tegen COVID-19 bij patienten die clozapine gebruiken. Doel: Informeren over risico's van infectie met SARS-CoV-2 bij patienten met een ernstige psychiatrische aandoening (EPA), schizofreniespectrumstoornis (SSS) en bij patienten die clozapine gebruiken. Adviseren over controle van de clozapineplasmaspiegel en leukocyten met differentiatie bij COVID-19 en na vaccinatie, en over te nemen maatregelen. Method: Literatuuronderzoek en casuistiek. Resultaten: Patienten met EPA en in het bijzonder met SSS hebben een verhoogd risico op infectie met SARS-CoV-2 met meer ziekenhuisopnames en hogere sterfte dan niet-psychiatrische patienten. Patienten met clozapine hebben mogelijk nog meer kans op besmetting. Bij een SARS-CoV-2-infectie kan de clozapineplasmaspiegel gevaarlijk stijgen en kunnen meestal lichte en kortstondige granulocytopenie en lymfocytopenie optreden, die doorgaans geen gevolg van behandeling met clozapine zijn. Conclusie: Bij COVID-19 is extra alertheid geboden bij mensen met EPA en vooral SSS. Bij clozapinegebruikers is bij COVID- 19 dosisverlaging met de helft tot driekwart van de oorspronkelijke dosering aangewezen. Bij granulocytopenie moet men aan SARS-CoV-2 als oorzaak denken en niet meteen clozapine als veroorzaker aanmerken. Patienten met EPA en zeker clozapinegebruikers behoren tot een risicogroep met een medische indicatie voor versnelde vaccinatie. (PsycInfo Database Record (c) 2022 APA, all rights reserved)

7.
Non-conventional in English | National Technical Information Service, Grey literature | ID: grc-753552

ABSTRACT

Our goal is to perform clinical trials in PDA patients testing strategies to modulate the microbiome to enhance the efficacy for immunotherapy. However, the optimal regimen has not been defined. We will perform experiments in mouse PDA models and in human organotypic systems which are designed to define the most efficacious microbiome modulatory regimens - either antibiotics or probiotics - to combine with immunotherapy. In Aim 1 we will test the immune-activating and tumor-protective effects of specific antibiotic and probiotic regimens in mouse models of PDA and an innovative microfluidic-based organotypic model derived from freshly resected human PDA. In Aim 2 we will determine the regimen that most effectively synergizes with immunotherapy. Aim 3 will encompass the first clinical trial in PDA targeting the microbiome as a strategy to enable immunotherapeutic efficacy. Collectively, these Aims will lead to a new treatment paradigm for PDA patients that targets the microbiome.

8.
Journal of Crohn's and Colitis ; 16:i337-i338, 2022.
Article in English | EMBASE | ID: covidwho-1722324

ABSTRACT

Background: While vaccines against COVID-19 are effective in healthy individuals, we reported significantly lower serologic responses to BNT162b2 in patients with inflammatory bowel diseases (IBD) treated with anti-tumor necrosis factor (TNF) α agents. As this was apparent already, 4 weeks post vaccination, vaccine longevity is concerning. Aim: to assess long-term serologic responses to BNT162b2 in patients with IBD stratified according to medical treatment. Methods: A prospective, observational multi-center Israeli study. Patients with IBD (anti-TNFα treated versus non-anti-TNFα treated) and healthy controls (HC) were followed from before the, 1st BNT162b2 dose until, 6 months after vaccination. COVID-19 spike (S) and nucleocapsid (N) antibodies (Abs) concentrations were analyzed by ELISA, followed by neutralization studies. Specific anti-receptor binding domain (RBD) memory B-cells response, serologic responses against variants of concern (VOCs), Beta, Gamma and Delta, immunoglobulin levels and lymphocyte cell subsets were evaluated as well. Safety was assessed using questionnaires, clinical and laboratory data. Results: Of, 193 subjects, 130 had IBD (45 and, 85 in the anti-TNFα and non-anti-TNFα groups, respectively), 63 HC. Serologic response assessed, 176 (median) days (IQR, 166-186) and compared to, 4 weeks after, 1st dose significantly declined in all three groups, but was lowest in the anti- TNFα group:, 6 months anti-S Abs titer geometric means:, 193 (95%CI:, 128-292), 703 (520-951), and, 1253 (1023-1534) in anti-TNFα, nonanti- TNFα and HC groups, respectively, p<0.001, Figure, 1. This was further supported by neutralization and inhibition studies. Importantly, significantly decreased memory B-cell response towards RBD was detected only in the anti-TNFα group, with the most significant reduction in response to Beta VOC (p<0.0008 and p<0.0001, vs. non-anti-TNFα and HC, respectively). Older age was an additional predictor of lower serologic response. Immunoglobulin levels and lymphocyte cell subsets were comparable between the study groups. Infection rate reflected by anti-N Abs was ∼1% in all groups. Safety was comparable in all groups. Conclusion: The, 6-months serologic response to BNT162b2 vaccine, evaluated prospectively, decreased in all subjects, most prominently in patients with IBD treated with anti-TNFα. Importantly, the latter also had the sharpest decline in serologies, the lowest functional activity and lowest RBD specific memory B-cells. Older age is an additional predictor of decreased serologic response. Altogether, waning of COVID- 19 serologic and functional response over, 6 months, specifically in patients with IBD treated with anti-TNFα, supports the need for an early third vaccine dose. (Figure Presented).

9.
Journal of Medical Devices, Transactions of the ASME ; 16(1), 2022.
Article in English | Scopus | ID: covidwho-1708439

ABSTRACT

Helmet continuous positive applied pressure is a form of noninvasive ventilation (NIV) that has been used to provide respiratory support to COVID-19 patients. Helmet NIV is low-cost, readily available, provides viral filters between the patient and clinician, and may reduce the need for invasive ventilation. Its widespread adoption has been limited, however, by the lack of a respiratory monitoring system needed to address known safety vulnerabilities and to monitor patients. To address these safety and clinical needs, we developed an inexpensive respiratory monitoring system based on readily available components suitable for local manufacture. Open-source design and manufacturing documents are provided. The monitoring system comprises flow, pressure, and CO2 sensors on the expiratory path of the helmet circuit and a central remote station to monitor up to 20 patients. The system is validated in bench tests, in human-subject tests on healthy volunteers, and in experiments that compare respiratory features obtained at the expiratory path to simultaneous ground-truth measurements from proximal sensors. Measurements of flow and pressure at the expiratory path are shown to deviate at high flow rates, and the tidal volumes reported via the expiratory path are systematically underestimated. Helmet monitoring systems exhibit high-flow rate, nonlinear effects from flow and helmet dynamics. These deviations are found to be within a reasonable margin and should, in principle, allow for calibration, correction, and deployment of clinically accurate derived quantities. Copyright © 2022 by ASME.

10.
Neuropsychiatrie de l'Enfance et de l'Adolescence ; 2022.
Article in English, French | Scopus | ID: covidwho-1699082

ABSTRACT

Diagnosing depression during adolescence is complex due to the variety of manifestations encountered. Besides, depression is a common comorbidity in autism spectrum disorders and can be difficult to diagnose. We report here the case of a 17-year-old adolescent hospitalized for major hetero-aggressive behavior in a context of melancholic depression. We present the multidisciplinary care provided: psychotherapeutic, medication, family, and body packing. The case of this patient was complex due to multiple “internal” constraints linked to comorbidities (autism spectrum disorder, coordination impairment, attention disorder, sluggish cognitive tempo), as well as “external” constraints (complicated family context, worsening of disorders coinciding with the start of the SARS-cov-19 epidemic and the closure of the day hospital supporting him). These factors raised important questions in the choice of treatments for this patient, required several months of hospitalization and opened a discussion around differential diagnoses. © 2022 Elsevier Masson SAS

11.
Neuropsychiatrie de l'Enfance et de l'Adolescence ; 2022.
Article in French | ScienceDirect | ID: covidwho-1693069

ABSTRACT

Résumé Le diagnostic de dépression à l’adolescence est complexe du fait de la diversité des manifestations rencontrées. Par ailleurs, la dépression est une comorbidité fréquente dans les troubles du spectre autistique et elle peut poser des difficultés diagnostiques. Nous résumons ici la prise en charge multidisciplinaire (psychothérapeutique, médicamenteuse, familiale, et corporelle par enveloppement) d’un adolescent de 17 ans hospitalisé pour troubles de comportement à type d’hétéro-agressivité majeure dans un contexte de dépression mélancolique. La prise en charge a été complexe du fait de multiples contraintes « internes » liées à des comorbidités (trouble du spectre autistique, trouble de coordination motrice, trouble de l’attention, et lenteur de traitement cognitif), ainsi que des contraintes « externes » (contexte familial compliqué, aggravation des troubles coïncidant avec le début de l’épidémie de SARS-cov-19 et la fermeture de l’hôpital de jour le prenant en charge). L’ensemble de ces facteurs ont entraîné des questionnements importants dans le choix des traitements pour ce patient, ont nécessité plusieurs mois d’hospitalisation et ouvert une discussion autour des diagnostics différentiels. Diagnosing depression during adolescence is complex due to the variety of manifestations encountered. Besides, depression is a common comorbidity in autism spectrum disorders and can be difficult to diagnose. We report here the case of a 17-year-old adolescent hospitalized for major hetero-aggressive behavior in a context of melancholic depression. We present the multidisciplinary care provided: psychotherapeutic, medication, family, and body packing. The case of this patient was complex due to multiple “internal” constraints linked to comorbidities (autism spectrum disorder, coordination impairment, attention disorder, sluggish cognitive tempo), as well as “external” constraints (complicated family context, worsening of disorders coinciding with the start of the SARS-cov-19 epidemic and the closure of the day hospital supporting him). These factors raised important questions in the choice of treatments for this patient, required several months of hospitalization and opened a discussion around differential diagnoses.

12.
Surviving Lockdown: Human Nature in Social Isolation ; : 1-120, 2020.
Article in English | Scopus | ID: covidwho-1512909

ABSTRACT

2020 has been the year of the virus, and it will not be a mere footnote in history. This book reflects on the unprecedented changes to our lives and the impact on our behaviour as we lived through social isolation during the global COVID-19 pandemic. From sociable creatures of habit, we were forced into a period of uncertainty, restriction and risk, physically separated from families and friends. Packed with guidance and coping strategies for lockdown, this book, authored by top psychologist David Cohen, explores the impact of this widespread quarantine on our relationships, our children, our mental health and our daily lives. Benedictine monks, hermit popes, Dorothy Sayers, Daniel Defoe (who made the isolated Robinson Crusoe a hero), Sigmund Freud and a rabbi’s angry dog are all among the cast of characters as we are taken on a whistle-stop tour through plagues in history and brain science, to the importance of introspection and how to make meaning from lockdown. In his trademark entertaining style, Cohen examines the psychology behind our behaviour during this unusual time to discover what we can learn about human nature, what lessons we can learn for the future – and whether we will apply them. © 2021 David Cohen.

14.
American Journal of Transplantation ; 21(SUPPL 4):855-856, 2021.
Article in English | EMBASE | ID: covidwho-1494492

ABSTRACT

Purpose: COVID-19 has been reported as a cause of kidney injury and data from published native kidney biopsy results demonstrate a variety of causes. To our knowledge, there are no published series looking specifically at kidney allograft biopsy findings in patients with COVID-19. Methods: We identified 10 kidney transplant recipients who underwent allograft biopsy within one month after infection with SARS-CoV-2 virus. We collected data regarding patients' clinical characteristics, transplant history, COVID-19 illness, and histology and immunohistochemistry findings of the kidney allograft biopsies. Results: Patients had a median age of 50.3 years, and four of the patients were female. Demographics included four Hispanics, three Whites, two Blacks, and one unidentified. All patients had co-morbidities, including hypertension in eight and diabetes in three. Cause of allograft biopsy was acute kidney injury (n=9), proteinuria (n=2), and nephrectomy after allograft failure (n=1). 6/10 had developed COVID pneumonia, and two of those required mechanical ventilation.On analysis of histology results, three had severe acute rejection (two with acute T cell rejection - grades 2A and 2B, and one with a mixed rejection), two revealed podocytopathy (one with collapsing glomerulopathy and one with recurrent lupus podocytopathy), one showed cortical necrosis, one had chronic thrombotic microangiopathy/transplant glomerulopathy, one had acute tubular injury, and two showed no specific histologic abnormalities. Immunohistochemical staining for SARS-N-Capsid was negative in 5/5 biopsies where performed.Follow up data including serum creatinine levels was available for 8/10 patients. Of these, only two demonstrated an improvement in kidney function back to baseline. No deaths were reported in the studied population. Conclusions: This series of kidney transplant recipients who underwent allograft biopsy after COVID-19 illness demonstrates a wide variety of causes of kidney allograft dysfunction, the most common of which was rejection. Similar to the cases of native kidney dysfunction, we found no evidence of direct viral invasion.

15.
Colorectal Disease ; 23(SUPPL 1):35, 2021.
Article in English | EMBASE | ID: covidwho-1457756

ABSTRACT

Purpose: The number of target colorectal cancer [TCC] referrals continues to rise, particularly in the elderly and frail population. Here we evaluate the outcome of patients over 80 seen in clinic not qualifying for our Straight To Test (STT) scheme. We aim to propose an alternative, cost-effective pathway for these vulnerable patients in a Covid-19 era. Method: A retrospective observational study of 267 >80-year- old patients referred to the STT service over a 3 month period. Data on demographics, investigations and outcome was taken from the electronic patient record system and analysed. Results: Of the 171 patients having a face-to- face appointment;90% had a CT (including virtual colonoscopy) requested as deemed unfit for bowel prep/endoscopy. Comparing patients only having a CT with those having more invasive investigations, they were older and frailer (WHO performance score of >2) (P = 0.0017∗ and 0.005∗ ∗) but there was no difference in discharge frequency (P = 0.45∗ ∗) and identification of Lower GI or other malignancy (P = 0.48 and 0.63∗ ∗). Conclusion: Selection of patients based on their age and frailty to go directly to CT is a safe and effective strategy in TCC referrals processed by a STT service without comprising outcome. This process may lead to higher patient satisfaction as well as fulfilling current Clinical Practice Groups' key performance indicators.

16.
Tijdschrift voor Psychiatrie ; 63(7):499-508, 2021.
Article in Dutch | MEDLINE | ID: covidwho-1408029

ABSTRACT

BACKGROUND: The Clozapine Plus Working Group is frequently consulted for advice on measures in case of infection with SARSCoV-2 and on vaccination against COVID-19 in patients receiving clozapine. AIM: Inform about risks of infection with SARS-CoV-2 in patients with severe mental illness (SMI), patients with schizophrenia spectrum disorders (SSD), and patients treated with clozapine. Advise on monitoring of clozapine plasma levels and white blood cell count and differential in COVID-19 and after vaccination, as well as measures to be taken.

17.
Perspectives on Politics ; 2021.
Article in English | Scopus | ID: covidwho-1402009

ABSTRACT

Vast disparities between and within American states' responses to the COVID-19 pandemic have evoked renewed attention to whether greater centralization might enhance investments in subnational capacity and remedy subnational inequalities or instead erode subnational organizational capacity. Developments in American public education (1997-2015) offer perspective on this puzzle, which we examine by applying interrupted time series analysis to a novel dataset to assess the implications of centralization on subnational investments in administrative and technical capacity, two dimensions of organizational capacity. We find simultaneous subnational erosion in administrative capacity and growth in technical capacity following centralization, both of which appear concentrated in low-poverty areas despite centralization's explicit antipoverty purposes. Public education reforms highlight both the challenge of dismantling subnational inequality through centralization and the need for future research on policy designs that enable centralization to yield subnational capacity that is able to remedy inequality. © The Author(s), 2021. Published by Cambridge University Press on behalf of the American Political Science Association.

18.
Bjog-an International Journal of Obstetrics and Gynaecology ; 128(8):E35-E36, 2021.
Article in English | Web of Science | ID: covidwho-1282915
19.
Progr. Biomed. Opt. Imaging Proc. SPIE ; 11596, 2021.
Article in English | Scopus | ID: covidwho-1175124
20.
Harefuah ; 160(3):139-143, 2021.
Article in Hebrew | MEDLINE | ID: covidwho-1144004

ABSTRACT

INTRODUCTION: Israel is currently struggling with the Coronavirus Disease (COVID-19) caused by SARS CoV-2. Transmission is increasing, with higher morbidity and mortality among populations at risk. Over-representation of blood type A was reported in COVID-19 patients with increased respiratory failure, while blood type O seems to have a protective effect. This may be caused by interference of anti-A antibodies in viral binding to the ACE receptor, different neutralization antibodies potency or variations in the stability of von Willebrand factor (VWF) multimers in different blood types. Since transfusion of convalescent COVID19 Plasma (CCP) is an accepted therapeutic modality, the Ministry of Health initiated a national project whereby CCP is collected by Magen David Adom (MDA) Blood Services using apheresis procedures and transfusions are approved by an experts committee, as part of the clinical trial or as compassionate treatment. Preliminary analysis of 49/170 patients treated so far shows improvement in 49%, with important relations with the anti-SARS-CoV-2 IgG antibodies level in the transfused plasma. Anti-SARS-CoV-2 antibodies were found in 83% of 1100 CCP donors, but a 13% decrease in antibodies level was detected in repeat donations. Blood type A was more predominant among CCP donors, when compared to MDA blood donors' data. A transfusion of CCP is a feasible and relatively safe therapeutic modality, mainly for patients with moderate COVID 19. CCP also serves as a source for the production of hyperimmune globulin for the treatment of COVID 19 and for passive immunization for populations at risk.

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