A pragmatic, multicenter, national, phase III, single-blinded, randomized, comparative, non-inferiority trial (11), ASPIC, explores antimicrobial stewardship strategies for ventilator-associated pneumonia in intensive care units. Five hundred and ninety adult patients, hospitalized within 24 French intensive care units, diagnosed with a first, microbiologically confirmed case of ventilator-associated pneumonia (VAP) and treated with appropriate empirical antibiotics, will be included in the study group. Standard management, with a 7-day antibiotic duration set by international guidelines, or antimicrobial stewardship, guided by daily clinical cure assessments, will be randomly assigned to participants. Clinical cure assessments will be repeated daily until a minimum of three criteria are satisfied, leading to the termination of antibiotic treatment in the experimental group. The primary endpoint is defined as a composite outcome, comprising all-cause mortality at 28 days, treatment failure, or a new episode of microbiologically confirmed ventilator-associated pneumonia (VAP) up to day 28.
The French regulatory agency (Agence Nationale de Securite du Medicament et des Produits de Sante, ANSM), with EUDRACT number 2021-002197-78, approved the ASPIC trial on 19 August 2021, along with an independent ethics committee, the Comite de Protection des Personnes Ile-de-France III (CNRIPH 2103.2560729), which approved it on 10 October 2021. This approval covered the study protocol (version ASPIC-13; 03 September 2021) for all study centers. The process of recruiting participants is projected to begin in 2022. Subsequent to the analysis, the results will be published in established international peer-reviewed medical journals.
NCT05124977, a clinical trial identifier.
The identification code for a clinical trial is NCT05124977.
The early avoidance of sarcopenia is a crucial measure for decreasing the incidence of illness, fatality, and enhancing the quality of life experience. Several non-pharmaceutical interventions, aimed at decreasing the risk of sarcopenia in older adults living in communities, have been proposed. Latent tuberculosis infection For this reason, elucidating the span and differences between these interventions is critical. see more The current body of literature describing and investigating non-pharmacological interventions for community-dwelling older adults displaying signs of or diagnosed with sarcopenia will be summarized in this scoping review.
Employing the seven-stage review methodology framework is the prescribed approach. Database searches will encompass Embase, Medline, PsycINFO, CINAHL, All EBM Reviews, Web of Science, Scopus, CBM, CNKI, WANFANG, and VIP. Grey literature will be discovered by utilizing the Google Scholar database. From January 2010 up to December 2022, search results are only offered in English and Chinese. Quantitative and qualitative study designs from published research, alongside prospectively registered trials, will be the subjects of screening focus. When developing the search strategy for scoping reviews, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses, as extended for scoping reviews, will be the guiding principle. Quantitative and qualitative synthesis of findings will be performed, categorized using key conceptual frameworks. We will evaluate the inclusion of identified studies in systematic reviews and meta-analyses, and subsequently pinpoint and summarize potential research gaps and opportunities.
Ethical approval is not required for this review document. The results' dissemination will encompass peer-reviewed scientific journals as well as relevant disease support groups and conferences. The planned scoping review will serve to identify the current research status and gaps in the literature, subsequently leading to the development of a future research agenda.
In the case of this review, ethical approval is not sought. The peer-reviewed scientific journals will host the published results, with further dissemination to relevant disease support groups and conferences. A scoping review, scheduled to be conducted, will assist in pinpointing the current research status and knowledge gaps in the literature, which will support the development of a future research plan.
To analyze the relationship between involvement in cultural activities and mortality rates.
A 36-year longitudinal cohort study (1982-2017), monitored exposure to cultural attendance at three points separated by eight-year intervals (1982/1983, 1990/1991, 1998/1999) and included a follow-up period up to December 31, 2017.
Sweden.
A total of 3311 randomly selected individuals from Sweden, possessing complete data across all three measurements, were incorporated into the study.
Examining the connection between the level of cultural attendance and the total number of deaths during the study. Hazard ratios, accounting for potential confounders, were estimated using Cox regression models that included time-varying covariates.
Relative to the highest attendance level (reference; HR=1), attendance levels in the lowest and middle tiers demonstrated hazard ratios of 163 (95% confidence interval 134-200) and 125 (95% confidence interval 103-151), respectively.
The participation in cultural events demonstrates a gradient, whereby reduced cultural exposure is associated with a heightened risk of all-cause mortality during the follow-up.
Cultural event attendance exhibits a gradient, with a reduced cultural exposure correlating to a higher risk of mortality during the observation period.
To assess the frequency of long COVID symptoms in children, both those who did and did not have prior SARS-CoV-2 infection, and to identify elements linked to the development of long COVID.
A cross-sectional analysis of the entire country's population.
Prioritizing primary care leads to better patient management and outcomes.
3240 parents of children aged 5-18, with or without a history of SARS-CoV-2 infection, completed an online questionnaire. The remarkable 119% response rate comprised 1148 parents who hadn't been infected and 2092 parents who had been infected previously.
The primary outcome evaluated the frequency of long COVID symptoms in children, categorized by whether they had a prior infection or not. Children who had previously experienced an infection and subsequently exhibited long COVID symptoms or failed to recover to their baseline health status had their secondary outcomes evaluated, considering factors like gender, age, time elapsed since the illness began, symptoms experienced, and their vaccination status.
Children previously infected with SARS-CoV-2 exhibited a disproportionately higher incidence of long COVID symptoms, particularly headaches (211 (184%) vs 114 (54%), p<0.0001), weakness (173 (151%) vs 70 (33%), p<0.0001), fatigue (141 (123%) vs 133 (64%), p<0.0001), and abdominal pain (109 (95%) vs 79 (38%), p<0.0001). epigenetic reader For children who had contracted SARS-CoV-2, the prevalence of long COVID symptoms was noticeably higher among those aged 12 to 18 years, in comparison to those aged 5 to 11 years. Children who had not contracted SARS-CoV-2 exhibited increased rates of certain symptoms, including attentional problems impacting academic performance (225 (108%) versus 98 (85%), p=0.005), stress (190 (91%) versus 65 (57%), p<0.0001), social difficulties (164 (78%) versus 32 (28%)), and alterations in body weight (143 (68%) versus 43 (37%), p<0.0001).
Children with prior SARS-CoV-2 infection, especially adolescents, may experience a disproportionately high and prevalent burden of long COVID symptoms, according to this study. Children without past SARS-CoV-2 infection exhibited a greater frequency of somatic symptoms, showcasing the pandemic's larger impact independent of the actual virus.
This study proposes that adolescents with a history of SARS-CoV-2 infection might experience a more significant and prevalent manifestation of long COVID symptoms than younger children. Children without previous SARS-CoV-2 infection presented with a more pronounced occurrence of somatic symptoms, emphasizing the broader influence of the pandemic.
Numerous cancer patients endure persistent neuropathic pain. Current pain-relief treatments commonly exhibit psychoactive side effects, lack conclusive efficacy data for this particular use, and potentially involve medication-related risks. Neuropathic cancer-related pain may find relief through the continuous, extended subcutaneous administration of the local anesthetic lidocaine (lignocaine). Given the supportive data, lidocaine emerges as a promising and safe agent in this context, necessitating robust randomized controlled trials for further evaluation. This protocol for a pilot study details how this intervention is evaluated, referencing the existing pharmacokinetic, efficacy, and adverse event data.
A pilot study, employing mixed methods, will assess the feasibility of an initial international Phase III trial, a first in the world, to determine the effectiveness and safety of a continuous subcutaneous infusion of lidocaine for treating neuropathic cancer pain. A double-blind, randomized, parallel group pilot study (Phase II) will investigate the impact of subcutaneous infusions of lidocaine hydrochloride 10% w/v (3000mg/30mL) for 72 hours on neuropathic cancer pain, compared to placebo (sodium chloride 0.9%). Concurrently, a pharmacokinetic substudy and a qualitative substudy of patient and caregiver experiences will take place. The pilot study, aiming to gather critical safety data, will inform the definitive trial's methodology by assessing recruitment strategies, randomisation protocols, outcome measurements, and patient acceptance of the methodology, signaling whether further exploration of this field is warranted.
Standardized assessments for adverse effects are integral to the trial protocol, ensuring paramount participant safety. Formal presentations at academic conferences and peer-reviewed publications in journals are planned to share the findings. Only if the completion rate exhibits a confidence interval including 80% and not including 60% will this study move forward to phase III. The Patient Information and Consent Form, along with the protocol, have been approved by the Sydney Local Health District (Concord) Human Research Ethics Committee (reference number 2019/ETH07984) and the University of Technology Sydney Ethics Committee (reference number ETH17-1820).
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