116,986 research outputs found

    ESPRIT study, analysis of the results of the pre-intervention survey in upper secondary schools

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    Background Sexually transmitted infections are a major public health problem, and their number is increasing in Italy. However, affective sexuality education is not yet part of the curricula. Therefore, a project entitled ESPRIT was launched, involving 3 regions (Friuli-Venezia Giulia, Lazio and Sicily), the IRCSS ‘Burlo Garofolo’ and the Istituto Superiore di Sanità, and implemented with the technical and financial support of the Ministry of Health - CCM. Methods A multicenter prospective intervention study was designed involving public upper secondary school students (grade 10-11). All target groups completed a KAP (knowledge, attitude, practice) questionnaire before and after participation in the educational intervention to measure its effectiveness. The questionnaires from the first phase were collected between January and April 2024, and the results were analyzed using R statistical software. Results The analysis of the overall results (463 students in total; female 58%, male 39%, other 2%; FVG 49%, Lazio 25%, Sicily 26%) showed that the group of upper secondary school students, targeted by peer education answered the knowledge part correctly by 56.6±13.8% on average. Applying the Kruskal-Wallis test showed that the percentage was significantly higher for females than males (p-value=0.005) and for licei students compared to technical and vocational schools (p-value=0.000). In terms of to attitudes, only 17% of students talked at length about sexually transmitted infections, and in 86.6% of cases, the interlocutors were friends or peers. Conclusions The results of the first phase show differences between the sexes and between the different types of educational institutions. The current level of knowledge still leaves much room for intervention and improvement. Analyzing the results of the follow-up phase will allow us to understand the effectiveness of the peer education intervention. Key messages • Adolescents’ knowledge of sexually transmitted infections needs to be improved. • Gender and the type of school attended affect the level of knowledge

    Regulatory approvals in a large multinational clinical trial: the ESPRIT experience

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    While accepted as serving an important function to safeguard human subjects, the process of obtaining regulatory approvals to conduct clinical trials is generally regarded as cumbersome and time-consuming. For large multinational trials, U.S. federally sponsored human subject research abroad involves specific U.S. regulatory requirements, in addition to those of the host country, that act as further hurdles. These requirements may include obtaining an Assurance of Protection for Human Subjects from the Office of Human Research Protection of the U.S. Department of Health and Human Services, maintaining specific Ethics Committee/Institutional Review Board (EC/IRB) composition, and incorporating mandated elements in informed consents, all of which may differ from local policies and guidelines. Specific examples of issues that led to delays in regulatory approvals for sites participating in the multinational clinical trial entitled Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT) are presented here. While the goal of these requirements is to protect the rights and welfare of human subjects, they may create substantial delays and engender resentment over the notion of lack of respect for individual country sovereignty. Substudies within ESPRIT have been undertaken to obtain feedback from EC/IRB chairpersons, site personnel responsible for processing the required assurances, ESPRIT investigators, and study participants regarding aspects of current U.S. regulatory requirements related to human subject protection and ethical issues in multinational research. The purpose of these substudies is to compare the attitudes and experiences across countries regarding important ethical issues associated with conducting ESPRIT. One objective of the substudies is to gather additional insight to the impact of U.S. regulatory processes. Another is to help to inform the debate about how to best maximize the rights and welfare of clinical trial participants without delaying the initiation of research, while respecting the importance of national sensitivities

    Evaluation of subcutaneous proleukin (Interleukin-2) in a randomized international trial (ESPRIT): Geographical and gender differences in the baseline characteristics of participants

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    Background: ESPRIT, is a phase III, open-label, randomized, international clinical trial evaluating the effects of subcutaneous recombinant interleukin-2 (rIL-2) plus antiretroviral therapy (ART) versus ART alone on HIV-disease progression and death in HIV-1-infected individuals with CD4+ T-cells ≥300 cells/μL. Objectives: To describe the baseline characteristics of participants randomized to ESPRIT overall and by geographic location. Method: Baseline characteristics of randomized participants were summarized by region. Results: 4,150 patients were enrolled in ESPRIT from 254 sites in 25 countries. 41%, 27%, 16%, 11%, and 5% were enrolled in Europe, North America, South America, Asia, and Australia, respectively. The median age was 40 years, 81% were men, and 76%, 11%, and 9% were Caucasian, Asian, and African American or African, respectively. 44% of women enrolled (n = 769) were enrolled in Thailand and Argentina. Overall, 55% and 38% of the cohort acquired HIV through male homosexual and heterosexual contact, respectively. 25% had a prior history of AIDS-defining illness; Pneumocystis jirovecii pneumonia, M. tuberculosis, and esophageal candida were most commonly reported. Median nadir and baseline CD4+ T-cell counts were 199 and 458 cells/μL, respectively. 6% and 13% were hepatitis B or C virus coinfected, respectively. Median duration of antiretroviral therapy (ART) was 4.2 years; the longest median duration was in Australia (5.2 years) and the shortest was in Asia (2.3 years). 17%, 13%, and 69% of participants began ART before 1995, between 1996 and 1997, and from 1998 onward, respectively. 86% used ART from two or more ART classes, with 49% using a protease inhibitor-based regimen and 46% using a nonnucleoside reverse transcriptase inhibitor-based regimen. 78% had plasma HIV RNA below detection (<500 cp/mL). Conclusion: ESPRIT has enrolled a diverse population of HIV-infected individuals including large populations of women and patients of African-American/African and Asian ethnicity often underrepresented in HIV research. As a consequence, the results of the study may have wide global applicability

    Final report and recommendations of the Health Information Exchange Use Case Design Group : report prepared for : the Connecticut Health IT Advisory Council / prepared by Michael Matthews (chief strategy officer), Carol Robinson (chief executive officer)

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    1 online resource (19 pages)"Contributors: Stacy Beck, Pat Checko, DrPH, Kathy DeMatteo, Gerard Muro, MD, Mark Raymond, Jake Star, Lisa Stump, MS, RPh."; "October 31, 2017."; Includes bibliographical reference

    Severity of cardiovascular disease outcomes among patients with hiv is related to markers of inflammation and coagulation

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    Background: In the general population, raised levels of inflammatory markers are stronger predictors of fatal than nonfatal cardiovascular disease (CVD) events. People with HIV have elevated levels of interleukin-6 (IL-6), high-sensitivity C-reactive protein (hsCRP), and D-dimer; HIV-induced activation of inflammatory and coagulation pathways may be responsible for their greater risk of CVD. Whether the enhanced inflammation and coagulation associated with HIV is associated with more fatal CVD events has not been investigated. Methods and Results: Biomarkers were measured at baseline for 9764 patients with HIV and no history of CVD. Of these patients, we focus on the 288 that experienced either a fatal (n=74) or nonfatal (n=214) CVD event over a median of 5 years. Odds ratios (ORs) (fatal versus nonfatal CVD) (95% confidence intervals [CIs]) associated with a doubling of IL-6, D-dimer, hsCRP, and a 1-unit increase in an IL-6 and D-dimer score, measured a median of 2.6 years before the event, were 1.39 (1.07 to 1.79), 1.40 (1.10 to 1.78), 1.09 (0.93 to 1.28), and 1.51 (1.15 to 1.97), respectively. Of the 214 patients with nonfatal CVD, 23 died during follow-up. Hazard ratios (95% CI) for all-cause mortality were 1.72 (1.28 to 2.31), 1.73 (1.27 to 2.36), 1.44 (1.15 to 1.80), and 1.88 (1.39 to 2.55), respectively, for IL-6, D-dimer, hsCRP, and the IL-6 and D-dimer score. Conclusions: Higher IL-6 and D-dimer levels reflecting enhanced inflammation and coagulation associated with HIV are associated with a greater risk of fatal CVD and a greater risk of death after a nonfatal CVD event. Clinical Trial Registration: URL: http://www.clinicaltrial.gov Unique identifier: SMART: NCT00027352, ESPRIT: NCT00004978, SILCAAT: NCT00013611

    The UN-SUSTAINABLE Match in HCV Recipients. Evidences from the Italian D-MELD Study on Balancing Donor-Recipient Risk Factors

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    The UN-SUSTAINABLE Match in HCV Recipients. Evidences from the Italian D-MELD Study on Balancing Donor-Recipient Risk Factor

    Unlocking the mysteries of the past: Searching for clues in medieval manuscripts

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    This project looks at the reproduction of one mid-12th-century Roman text by analyzing sixteen versions of it that still exist, copied from c. 1160 through c. 1325. The author was Nicolaus Maniacutius, a cleric at St. John Lateran Basilica in Rome. That original copy is lost, but versions quickly appeared in monasteries and cathedrals in Italy, Germany, France, and England. Somehow, through networks of communication and travel, reproductions were made and collected by prominent monasteries and churches, and by the Guildhall, a secular institution in the City of London

    Theoretical Models of the Antecedents and Consequences of Organizational, Workgroup, and Professional Esprit De Corps

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    This article formally defines the construct of esprit de corps and develops propositions which explain how it emerges in individuals and impacts on individual and group level behavior. Building from social exchange theory and Jones and James (1979) framework, we propose the premise that an individual can simultaneously develop three different types of esprit de corps: organizational esprit de corps, workgroup esprit de corps, and professional esprit de corps. Propositions that explain how high levels of these types of esprit de corps develop and the consequences they have on an individual's behavior and performance within a group or organization are presented.Esprit de corps Group cohesion Job satisfaction Organizational commitment Organizational esprit de corps Productivity Professional esprit de corps Professional standards Task Complexity Workgroup esprit de corps

    Pulse oximetry adoption and oxygen orders at paediatric admission over 7 years in Kenya: a multihospital retrospective cohort study

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    Objectives To characterise adoption and explore specific clinical and patient factors that might influence pulse oximetry and oxygen use in low-income and middle-income countries (LMICs) over time; to highlight useful considerations for entities working on programmes to improve access to pulse oximetry and oxygen. Design A multihospital retrospective cohort study. Settings All admissions (n=132 737) to paediatric wards of 18 purposely selected public hospitals in Kenya that joined a Clinical Information Network (CIN) between March 2014 and December 2020. Outcomes Pulse oximetry use and oxygen prescription on admission; we performed growth-curve modelling to investigate the association of patient factors with study outcomes over time while adjusting for hospital factors. Results Overall, pulse oximetry was used in 48.8% (64 722/132 737) of all admission cases. Use rose on average with each month of participation in the CIN (OR: 1.11, 95% CI 1.05 to 1.18) but patterns of adoption were highly variable across hospitals suggesting important factors at hospital level influence use of pulse oximetry. Of those with pulse oximetry measurement, 7% (4510/64 722) had hypoxaemia (SpO2 <90%). Across the same period, 8.6% (11 428/132 737) had oxygen prescribed but in 87%, pulse oximetry was either not done or the hypoxaemia threshold (SpO2 <90%) was not met. Lower chest-wall indrawing and other respiratory symptoms were associated with pulse oximetry use at admission and were also associated with oxygen prescription in the absence of pulse oximetry or hypoxaemia. Conclusion The adoption of pulse oximetry recommended in international guidelines for assessing children with severe illness has been slow and erratic, reflecting system and organisational weaknesses. Most oxygen orders at admission seem driven by clinical and situational factors other than the presence of hypoxaemia. Programmes aiming to implement pulse oximetry and oxygen systems will likely need a long-term vision to promote adoption, guideline development and adherence and continuously examine impact
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