scholarly journals Come è cambiato il lavoro del pediatra al tempo del Covid

2021 ◽  
Vol 24 (4) ◽  
pp. 87-91
Author(s):  
Maria Gabriella Pediconi ◽  
Chiara Prinster ◽  
Laura Radice ◽  
Anna Saccaggi ◽  
Barbara Schiavo
Keyword(s):  
Professional Identity ◽  
Phase 1 ◽  
Clinical Work ◽  
Professional Activity ◽  
Clinical Activity ◽  
Italian Family ◽  
Anonymous Questionnaire ◽  
Family Paediatrician ◽  
Prevention Activity ◽  
The Impact

<b>Background -</b> International literature documents that children and adolescents infected with the coronavirus develop moderate symptoms and a favourable prognosis. However, the pandemic has had a major impact on children’s health and the paediatricians’ work. The clinical work of paediatricians has significantly changed. <br> <b>Aims, materials and methods -</b> A qualitative pilot research was conducted thanks to the participation of 13 privileged witnesses. Through an anonymous questionnaire, the present research detected the changes in the overall activity of the Italian family paediatrician and the impact of the pandemic on their professional activity during the lockdown. The thematic analysis of the answers made it possible to focus on the main changes of the paediatric profession and explore the characteristics of its resilience, highlighting the most significant difficulties that paediatricians faced during Phase 1. <br> <b>Results and discussion -</b> What was lost in the clinical activity, towards the patient with acute pathology or in the prevention activity, has been regained with a new use of known means, such as telephone and email, or thanks to the use of new tools such as WhatsApp and video (telemedicine): those that were subsidiary means before the pandemic have become effective and permanent endowments of the paediatrician after the lockdown. Together with the technical acquisition, the professional identity has been strengthened in terms of shared professionalism, especially as to relationships with colleagues and the collaboration of families.

scholarly journals The use of text mining to detect key shifts in Japanese first-year medical student professional identity formation through early exposure to non-healthcare hospital staff

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yayoi Shikama ◽  
Yasuko Chiba ◽  
Megumi Yasuda ◽  
Maham Stanyon ◽  
Koji Otani
Keyword(s):  
Text Mining ◽  
Professional Identity ◽  
Identity Formation ◽  
Role Models ◽  
Healthcare Professionals ◽  
Clinical Work ◽  
Working Environment ◽  
First Year ◽  
Professional Identity Formation ◽  
The Impact

Abstract Background Professional identity formation is nurtured through socialization, driven by interaction with role models, and supported through early clinical exposure (ECE) programmes. Non-healthcare professionals form part of the hospital community but are external to the culture of medicine, with their potential as role models unexplored. We employed text mining of student reflective assignments to explore the impact of socialization with non-healthcare professionals during ECE. Methods Assignments from 259 first-year medical students at Fukushima Medical University, Japan, underwent hierarchical cluster analysis. Interrelationships between the most-frequently-occurring words were analysed to create coding rules, which were applied to elucidate underlying themes. Results A shift in terms describing professional characteristics was detected, from “knowledge/skill” towards “pride [in one’s work]” and “responsibility”. Seven themes emerged: contribution of non-healthcare professionals, diversity of occupation, pride, responsibility, teamwork, patient care and gratitude. Students mentioning ‘contribution of non-healthcare professionals’ spoke of altruistic dedication and strong sense of purpose. These students expressed gratitude towards non-healthcare professionals for supporting clinical work, from a doctor’s perspective. Conclusion Socialization with non-healthcare professionals provides important insights into the hospital working environment and cultural working norms. Through role modelling altruism and responsibility, non-healthcare professionals positively influenced student professional identity formation, promoting self-conceptualisation as a doctor.

scholarly journals The Impact of the First Wave of the COVID-19 Pandemic on Providing Special Care Dentistry: A Survey for Dentists

2021 ◽  
Vol 18 (6) ◽  
pp. 2970
Author(s):  
Jacobo Limeres Posse ◽  
Maria T. van Harten ◽  
Caoimhin Mac Giolla Phadraig ◽  
Márcio Diniz Freitas ◽  
Denise Faulks ◽  
...  
Keyword(s):  
Online Survey ◽  
Geographical Area ◽  
Special Care ◽  
Urgent Care ◽  
Professional Activity ◽  
Clinical Activity ◽  
Protective Measures ◽  
Geographical Regions ◽  
The Impact ◽  
Area Of Origin

This study aimed to investigate the impact of COVID-19 on the experiences of special care dentistry providers worldwide. An online survey was administered from 10 to 31 July 2020. Age, sex, years of professional activity, COVID-19 status, geographical area of origin and length of lockdown period were recorded for all participating dentists. The relationships between these variables and the changes in clinical activity, the treated patients’ COVID-19 status and the implementation of protective measures in the dental clinic were analyzed. A total of 436 (70.6% women) dentists from 59 countries responded to the survey. Clinical activity was reduced or stopped for 79.1% of respondents. The most common change was to limit treatment to urgent care only (53.7%). Treatment under general anesthesia or deep sedation was discontinued (51.0%) or reduced (35.8%) for the majority of respondents. Male dentists were more likely to maintain their clinical activity than female dentists (p < 0.001), and respondents from North America were more likely to do so than participants from other geographical regions (p < 0.001). Dentists from Latin America and the Caribbean were more likely to report treatment of confirmed cases of COVID-19 than those from Europe (p < 0.001). The implementation of protective measures in the dental office was determined by the survey participant’s sex, intensity of clinical activity and geographical area of origin. To conclude, the provision of special care dentistry was considerably reduced in response to the pandemic. Service maintenance was mainly related to the geographical area in which the surveyed dentists worked, further exacerbating pre-existing inequalities.

scholarly journals Interim Data from a Randomized, Placebo Controlled, Phase 1 Study of Aln-AS1, an Investigational RNAi Therapeutic for the Treatment of Acute Hepatic Porphyria

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 2318-2318 ◽  
Author(s):  
Eliane Sardh ◽  
Pauline Harper ◽  
Nabil Al-Tawil ◽  
Manisha Balwani ◽  
Karl Anderson ◽  
...  
Keyword(s):  
Aminolevulinic Acid ◽  
Phase 1 ◽  
Controlled Study ◽  
Clinical Activity ◽  
Mrna Levels ◽  
Employment Equity ◽  
Phase 1 Study ◽  
Part C ◽  
Equity Ownership ◽  
The Impact

Abstract Acute hepatic porphyria (AHP) is a family of rare metabolic disorders including acute intermittent porphyria (AIP), hereditary coproporphyria (HCP), and variegate porphyria (VP), caused by a deficiency in one of the eight enzymes required for heme biosynthesis in the liver. When ALA synthetase (ALAS1), the first and rate limiting step in the pathway, is induced by triggers such as exposure to certain drugs or fasting, the neurotoxic heme intermediates aminolevulinic acid (ALA) and porphobilinogen (PBG) can accumulate upstream of the deficient enzyme leading to acute and potentially life threatening neurovisceral attacks in AHP patients. RNA interference is a naturally occurring cellular mechanism mediated by small interfering RNA (siRNA) that allows for the inhibition of protein synthesis through the cleavage and degradation of a specific mRNA. ALN-AS1 is an investigational RNAi therapeutic that targets ALAS1 in order to decrease ALA and PBG levels and subsequent porphyria attacks. We are currently conducting a phase 1, multinational, randomized, placebo-controlled, study in 3 parts; Part A single ascending dose (SAD), Part B multiple ascending dose (MAD) and Part C multiple dose (MD) study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics (i.e. changes in ALA, PBG and circulating ALAS1 mRNA levels) of subcutaneously administered ALN-AS1 in AIP patients. Part C also has exploratory analyses of clinical activity, including the impact of ALN-AS1 on porphyria attacks, acute healthcare visits, and heme treatment (ClinicalTrials.gov Identifier: NCT02452372). We previously presented interim SAD data demonstrating that ALN-AS1 was generally well tolerated with no serious adverse events (SAEs) or clinically significant laboratory abnormalities related to study drug, and no discontinuations due to AEs. Circulating ALAS1 mRNA levels had a mean (SEM) maximal reduction of 44% ± 8% relative to baseline (p ≤ 0.01 compared to placebo), with concomitant mean (SEM) maximal reductions in ALA and PBG of 77% ± 7% and 73% ± 6%, respectively (p= 0.03 and 0.06 compared to placebo, respectively) at the 0.35 mg/kg dose. In addition, changes in circulating ALAS1 mRNA were highly correlated with changes in urinary ALA and PBG (R2=0.82, p<10-15). We will now report interim progress and data from all 3 Parts of the phase 1 study including safety, pharmacodynamics, pharmacokinetics and exploratory clinical activity. Disclosures Sardh: Alnylam Pharmaceuticals: Consultancy. Harper:Alnylam Pharmaceuticals: Consultancy. Balwani:ICGG Gaucher Registry (Sanofi Genzyme sponsored): Membership on an entity's Board of Directors or advisory committees; Sanofi Genzyme: Honoraria, Speakers Bureau; Alnylam Pharmaceuticals: Consultancy. Anderson:Alnylam Pharmaceuticals: Consultancy. Bloomer:Alnylam Pharamceuticals: Consultancy. Bissel:Alnylam Pharmaceuticals: Consultancy. Desnick:Alnylam Pharmaceuticals: Consultancy. Bonkovsky:Alnylam Pharamceuticals: Consultancy. Penz:Alnylam Pharmaceuticals: Employment, Equity Ownership. Chan:Alnylam Pharmaceuticals: Employment, Equity Ownership. Soh:Alnylam Pharmaceuticals: Employment, Equity Ownership. Querbes:Alnylam Pharmaceuticals: Employment, Equity Ownership. Simon:Alnylam Pharmaceuticals: Employment, Equity Ownership. Rees:Alnylam Pharmaceuticals: Consultancy.

Safety and tolerability of MEDI0562 in combination with durvalumab or tremelimumab in patients with advanced solid tumors.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 3003-3003
Author(s):  
Jonathan Wade Goldman ◽  
Sarina Anne Piha-Paul ◽  
Brendan D. Curti ◽  
Katrina Pedersen ◽  
Todd Michael Bauer ◽  
...  
Keyword(s):  
T Cells ◽  
Solid Tumors ◽  
Memory T Cells ◽  
Phase 1 ◽  
Evaluation Criteria ◽  
Maximum Tolerated Dose ◽  
Clinical Activity ◽  
Advanced Solid Tumors ◽  
Open Label ◽  
The Impact

3003 Background: We report safety and tolerability of MEDI0562, a humanized IgG1κ OX40 monoclonal antibody (mAb), in combination with durvalumab (durva; anti-PD-L1 mAb) or tremelimumab (treme; anti-CTLA-4 mAb) in patients (pts) with previously treated advanced solid tumors. Methods: In this phase 1, open-label study (NCT02705482), adult pts received escalating doses of MEDI0562 (2.25, 7.5 or 22.5 mg/kg) every 2 wks (Q2W) in combination with durva (1500 mg/kg) or treme (75 or 225 mg/kg) Q4W, until confirmed disease progression or unacceptable toxicity. Tumor assessments were performed Q8W with immune-related Response Evaluation Criteria in Solid Tumors. Results: In total, 27 and 31 pts received MEDI0562 + durva or treme, across 5 dose combination cohorts (3 + 3 design), with a maximum tolerated dose of 7.5 mg MEDI0652 + 1500 mg durva and maximum administered dose of 10 mg MEDI0562 + 225 mg treme. Median duration of exposure was 12.0 (range 2.0–80.9) and 8.0 (range 2.0–42.0) wks, respectively. Two (22.5 mg MEDI10562 + durva) and 3 (2.25 mg MEDI0652 + 225 mg treme, 22.5 mg MEDI0562 + 75 and 225 mg treme) dose limiting toxicities were observed. For MEDI0562 + durva and MEDI0562 + treme groups respectively, treatment-emergent adverse events (TEAEs) were reported in 96.3% and 100% of pts; most common TEAEs were fatigue (55.6%) and pruritus (45.2%), Gr 3/4 TEAEs occurred in 74.1% and 67.7%; and MEDI0562-related AEs were reported in 20 (74.1%) and 24 (77.4%) pts. Six TEAEs in each group led to MEDI0562 discontinuation (22.2% and 19.4%, respectively), 2 led to death (renal failure [7.5 mg MEDI0562 + durva], multiple organ dysfunction syndrome [22.5 mg MEDI0562 + 225 mg treme]). Three response evaluable pts had PR (11.5% [7.5 and 22.5 mg MEDI0562 + durva, n = 26]). Median overall survival was 17.4 and 11.9 mos for MEDI0562 + durva and MEDI0562 + treme, with stable disease seen in 9 pts from each group, 34.6% vs 29.0%, respectively. Serum exposure of MEDI0562 increased dose proportionally. Post treatment serum antidrug antibody (ADA) was detected in 20 pts from MEDI0562 + durva and MEDI0562 + treme (74.1% and 71.4%, respectively). The impact of ADA on MEDI0562 pharmacokinetics was seen at all doses. Mean percentage of Ki67+CD4+ and Ki67+CD8+ memory T cells increased, while mean percentage of OX40+CD4+ memory T cells decreased following the first dose of MEDI0562 + durva or treme. Conclusions: The safety profile of MEDI0562 in combination with durva or treme was similar between groups. Clinical activity was observed with MEDI0562 + durva in pts with advanced solid tumors. Clinical trial information: NCT02705482 .

A phase 1 dose-escalation study of a PD-L1xCD27 bispecific antibody CDX-527 in patients with advanced malignancies.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 2585-2585
Author(s):  
Rachel E. Sanborn ◽  
Rodolfo Eduardo Bordoni ◽  
Gini F. Fleming ◽  
Mustafa Khasraw ◽  
Thomas Hawthorne ◽  
...  
Keyword(s):  
T Cell ◽  
T Cell Activation ◽  
Dose Escalation ◽  
Clinical Studies ◽  
Cell Activation ◽  
Bispecific Antibody ◽  
Phase 1 ◽  
Primary Study ◽  
Clinical Activity ◽  
The Impact

2585 Background: CDX-527 is a bispecific antibody (BsAb) targeting PD-L1 and CD27 that is designed to block immune checkpoint PD-L1/PD-1 interactions while providing immune costimulation through CD27 signaling. CD27 is a key immunostimulatory molecule that enhances T cell activation, effector function, and survival. Combining anti-PD-L1 and anti-CD27 mAbs synergize in preclinical studies, activating complementary cytotoxic and proliferative gene expression profiles, respectively. Clinical studies demonstrated the safety and biological activity of combining varlilumab, an agonist anti-CD27 mAb, with nivolumab or atezolizumab, along with modest clinical activity of the combinations. CDX-527 is a novel human BsAb containing a neutralizing, high affinity IgG1k PD-L1 mAb and the single chain Fv fragment (scFv) of an agonist anti-CD27 mAb genetically attached to the C-terminus of each heavy chain, thereby making CDX-527 bivalent for each target. Pre-clinical studies demonstrated enhanced T cell activation by CDX-527 and anti-tumor activity of a surrogate bispecific compared to individual mAb combinations. Methods: CDX527-01 is a phase 1 first-in-human, open-label, multi-center, dose-escalation (DE) and expansion study evaluating safety, pharmacokinetics (PK), pharmacodynamics (PD), and clinical activity of CDX-527 in patient with advanced solid tumors that have progressed on standard-of-care therapy. The primary study objective is to characterize the safety and tolerability of CDX-527. CDX-527 is administered intravenously Q2W with doses ranging from 0.03 mg/kg up to 10.0 mg/kg or until the maximum tolerated dose. The first 2 cohorts of the DE phase initiate with single patients and subsequent DE cohorts will be conducted in 3+3 manner. Tumor-specific expansion cohorts may be enrolled to further characterize the safety, PK, PD, and efficacy of CDX-527. Tumor assessments are performed Q8W by the investigator per iRECIST. Biomarker assessments include characterizing the effects on peripheral blood immune cells and cytokines, and for the expansion cohorts, the impact of CDX-527 on the tumor microenvironment in paired tumor biopsies. Results: To date, 8 patients have received CDX-527 in doses ranging from 0.03 mg/kg to 1 mg/kg and 3 are still on treatment. There has been no drug related SAEs, DLTs or discontinuations due to an AE. Most common treatment related AEs were influenza-like illness, fatigue, and arthralgia (all at 25%). All drug related AEs have been grade 1 or 2. Conclusions: Preliminary results indicate that the novel anti-PD-L1xCD27 bispecific antibody CDX-527 up to and including the 1 mg/kg dose level has been well tolerated. Additional data will be presented, including the safety profile at higher dose levels along with clinical activity, as well as PK and PD data. Clinical trial information: NCT04440943.

Tobacco Treatment Specialists: A New Profession

2007 ◽  
Vol 2 (S1) ◽  
pp. 2-7 ◽  
Author(s):  
John R. Hughes
Keyword(s):  
Professional Identity ◽  
Tobacco Cessation ◽  
Professional Organizations ◽  
Clinical Activity ◽  
Evidence Based ◽  
High Quality ◽  
Tobacco Treatment ◽  
Cessation Treatment ◽  
Prevention Activity ◽  
Based Medicine

AbstractTobacco treatment specialists (TTS) are essential to developing an adequate system of treatment for smoking. Tobacco cessation treatment should be seen, not solely as a public health or prevention activity, but rather as a clinical activity. TTS should increase their professionalism by embracing evidence-based medicine. TTS should form professional organizations and credentialing bodies to insure a high quality professional identity.

Conceptualizing the impact of machines, science and technologies on the sociocultural environment that shapes the teacher's paradigm of values and views of life

2020 ◽  
Vol 16 (11) ◽  
pp. 2161-2179
Author(s):  
A.B. Lanchakov ◽  
S.A. Filin ◽  
A.Zh. Yakushev ◽  
E.E. Zhusipova
Keyword(s):  
Social Relationships ◽  
Cognitive Activity ◽  
Environmentally Friendly ◽  
Professional Activity ◽  
Sociocultural Environment ◽  
Sociocultural Development ◽  
Prediction And Forecasting ◽  
The Impact ◽  
Positive Motivation ◽  
The Way

Subject. In this article we analyze how machinery, science and technologies influence the sociocultural environment that engenders the teacher's paradigm of values and views of life. Objectives. We herein outline guidance to predict the way teachers' views of life might evolve in corresponding sociocultural periods more precisely. The article analyzes making more precise forecasts of oncoming economic crises, which will cause some changes in teachers' mindset. Methods. The study involves learning methodologies, methods of prediction and forecasting, including foresight. Results. We propose and analyze the theory holding that the human civilization passes cycles during its sociocultural development in terms of a new set of values in contemporary teachers' views of life. The article sets forth our recommendations on innovation-driven views of life, mindset and thinking and, consequently, the development of intellectual qualities, knowledge, skills, cognitive activity, positive motivation to the professional activity of a teacher and alumni during more elevated periods, which requires to more precisely predict the way teachers’ mindset may change in certain sociocultural periods. Conclusions and Relevance. As the human civilization enters the innovation-driven sociocultural period, teachers and social relationships should demonstrate more innovative and environmentally-friendly attitudes and views of life.

scholarly journals Effect of COVID-19 on Thoracic Oncology Surgery in Spain: A Spanish Thoracic Surgery Society (SECT) Survey

Cancers ◽  
2021 ◽  
Vol 13 (12) ◽  
pp. 2897
Author(s):  
Néstor Martínez-Hernández ◽  
Usue Caballero Silva ◽  
Alberto Cabañero Sánchez ◽  
José Luis Campo-Cañaveral de la Cruz ◽  
Andrés Obeso Carillo ◽  
...  
Keyword(s):  
Overall Response Rate ◽  
Early Stage ◽  
Care Delivery ◽  
Public Hospitals ◽  
Clinical Activity ◽  
Spanish Society ◽  
Lung Cancer Patients ◽  
Oncological Patients ◽  
Multiple Choice Questionnaire ◽  
The Impact

After the first wave of COVID-19, the Spanish Society of Thoracic Surgeons (SECT) surveyed its members to assess the impact of the pandemic on thoracic oncology surgery in Spain. In May 2020, all SECT members were invited to complete an online, 40-item, multiple choice questionnaire. The questionnaire was developed by the SECT Scientific Committee and sent via email. The overall response rate was 19.2%. The respondents answered at least 91.5% of the items, with only one exception (a question about residents). Most respondents (89.3%) worked in public hospitals. The reported impact of the pandemic on routine clinical activity was considered extreme or severe by 75.5% of respondents (25.5% and 50%, respectively). Multidisciplinary tumour boards were held either with fewer members attending or through electronic platforms (44.6% and 35.9%, respectively). Surgical activity decreased by 95.7%, with 41.5% of centers performing surgery only on oncological patients and 11.7% only in emergencies. Nearly 60% of respondents reported modifying standard protocols for early-stage cancer and in the preoperative workup. Most centers (≈80%) reported using full personal protective equipment when operating on COVID-19 positive patients. The COVID-19 pandemic severely affected thoracic oncology surgery in Spain. The lack of common protocols led to a variable care delivery to lung cancer patients.

406 CDX527–01, a phase 1 dose-escalation and expansion study of the PD-L1xCD27 bispecific antibody CDX-527 in patients with advanced malignancies

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A431-A431
Author(s):  
Michael Yellin ◽  
Tracey Rawls ◽  
Diane Young ◽  
Philip Golden ◽  
Laura Vitale ◽  
...  
Keyword(s):  
T Cell ◽  
T Cell Activation ◽  
Dose Escalation ◽  
Clinical Studies ◽  
Cell Activation ◽  
Bispecific Antibody ◽  
Phase 1 ◽  
Clinical Activity ◽  
Tumor Types ◽  
Anti Tumor Activity

BackgroundCD27 ligation and PD-1 blockade elicit complementary signals mediating T cell activation and effector function. CD27 is constitutively expressed on most mature T cells and the interaction with its ligand, CD70, plays key roles in T cell costimulation leading to activation, proliferation, enhanced survival, maturation of effector capacity, and memory. The PD-1/PD-L1 pathway plays key roles in inhibiting T cell responses. Pre-clinical studies demonstrate synergy in T cell activation and anti-tumor activity when combining a CD27 agonist antibody with PD-(L)1 blockade, and clinical studies have confirmed the feasibility of this combination by demonstrating safety and biological and clinical activity. CDX-527 is a novel human bispecific antibody containing a neutralizing, high affinity IgG1k PD-L1 mAb (9H9) and the single chain Fv fragment (scFv) of an agonist anti-CD27 mAb (2B3) genetically attached to the C-terminus of each heavy chain, thereby making CDX-527 bivalent for each target. Pre-clinical studies have demonstrated enhanced T cell activation by CDX-527 and anti-tumor activity of a surrogate bispecific compared to individual mAb combinations, and together with the IND-enabling studies support the advancement of CDX-527 into the clinic.MethodsA Phase 1 first-in-human, open-label, non-randomized, multi-center, dose-escalation and expansion study evaluating safety, pharmacokinetics (PK), pharmacodynamics (PD), and clinical activity of CDX-527 is ongoing. Eligible patients have advanced solid tumor malignancies and have progressed on standard-of-care therapy. Patients must have no more than one prior anti-PD-1/L1 for tumor types which have anti-PD-1/L1 approved for that indication and no prior anti-PD-1/L1 for tumor types that do not have anti-PD-1/L1 approved for that indication. CDX-527 is administered intravenously once every two weeks with doses ranging from 0.03 mg/kg up to 10.0 mg/kg or until the maximum tolerated dose. The dose-escalation phase initiates with a single patient enrolled in cohort 1. In the absence of a dose limiting toxicity or any ≥ grade 2 treatment related AE, cohort 2 will enroll in a similar manner as cohort 1. Subsequent dose-escalation cohorts will be conducted in 3+3 manner. In the tumor-specific expansion phase, up to 4 individual expansion cohort(s) of patients with specific solid tumors of interest may be enrolled to further characterize the safety, PK, PD, and efficacy of CDX 527. Tumor assessments will be performed every 8-weeks by the investigator in accordance with iRECIST. Biomarker assessments will include characterizing the effects on peripheral blood immune cells and cytokines, and for the expansion cohorts, the impact of CDX-527 on the tumor microenvironment.ResultsN/AConclusionsN/ATrial RegistrationNCT04440943Ethics ApprovalThe study was approved by WIRB for Northside Hospital, approval number 20201542

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