Search Results for: Passo 12. Ripulire in modo mirato le cartelle cliniche degli assisiti

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Introduction
The prevalence of food allergies, particularly IgE-mediated allergies, is rising in developed countries, with cashew nut allergy emerging as a significant public health concern due to its potential for severe anaphylaxis and frequent association with atopic disorders. Cashew nuts are among the most common allergens in Europe and Australia, often involving cosensitisation with pistachios, hazelnuts and other allergens. Diagnosis relies on clinical history, measurement of specific IgE (sIgE) levels, skin prick tests (SPT) and oral food challenges (OFCs). Current management strategies focus on allergen avoidance and emergency interventions, whereas oral immunotherapy (OIT) represents a promising approach to desensitisation. Recent studies, including the NUT CRACKER trial, have reported high desensitisation rates with cashew OIT, although these are associated with a risk of adverse events. This study introduces a novel randomised controlled trial aimed at evaluating the efficacy and safety of cashew immunotherapy in children.

Methods and analysis
This randomised, open-label, parallel-group trial, with a 2:1 allocation ratio, will be conducted at the Department of Paediatric Pneumology and Allergology, Medical University of Warsaw, Poland. Thirty-nine children, aged 4–17 years, with confirmed IgE-mediated cashew allergy via open OFC will be enrolled. Participants in the experimental group will undergo OIT, which involves gradually increasing doses of cashew protein up to a maintenance dose of 1200 mg. The duration of OIT will range from 12 to 60 weeks, depending on individual baseline tolerance. The control group will receive standard management, including strict cashew avoidance and emergency response strategies to accidental exposure, for 1 year.
The primary endpoint is to determine the proportion of participants tolerating a 4043 mg dose of cashew protein at the study’s end in the OIT group compared with the control group. Secondary outcomes include evaluating the safety profile of OIT, assessing changes in laboratory markers such as sIgE and IgG4 levels for cashew and the major cashew allergen Ana o 3, analysing basophil activation test responses and measuring changes in SPT wheal diameter at baseline and study completion.

Ethics and dissemination
The study has been approved by the Ethics Committee of the Medical University of Warsaw (approval number: KB/267/2023). Study findings will be published in peer-reviewed journals and presented at international conferences.

Trial registration number
NCT06328504.

Objective
To evaluate any association of the presence and severity of nine major symptoms (pain, tiredness, drowsiness, nausea, appetite, breathlessness, depression, anxiety, and perceived well-being) with sleep quality and duration in elderly men.

Design and setting
Cross-sectional analysis within the population-based VAScular and Chronic Obstructive Lung disease study (VASCOL) conducted in southern Sweden in 2019.

Participants
A total of 838 older men aged 73 years.

Measures
Severity of the symptoms was self-reported between 0 and 10 on a numerical rating scale. Breathlessness was also assessed using the Multidimensional Dyspnoea Profile and Dyspnoea-12. Sleep quality was reported on a 5-point Likert scale from ‘very well’ to ‘very bad’and sleep duration on a 7-point scale from ‘less than 4 hours’ to ‘more than 10 hours’. Associations of each symptom score with having worse sleep quality (‘bad’ or ‘very bad’) and/or shorter sleep duration (

Introduction
Amoxicillin is recommended for children with uncomplicated severe acute malnutrition (SAM). However, some trials have shown no difference in amoxicillin for nutritional recovery in children with SAM compared with placebo. In addition, amoxicillin treatment requires two times per day dosing for 7 days, which may influence adherence. Azithromycin is a broad-spectrum antibiotic that can be provided as a single dose and has reduced mortality in children aged 1–59 months when provided by mass drug administration. The AMOUR trial is designed to assess amoxicillin, azithromycin and placebo as part of outpatient treatment of uncomplicated SAM.

Methods and analysis
This double-masked randomised controlled trial will enrol 3000 children over 3 years in an individually randomised 1:1:1 allocation to azithromycin, amoxicillin or placebo arms and follow them for 12 months. Children eligible to enrol in the study will be aged 6–59 months and have uncomplicated non-oedematous SAM as defined by weight-for-height Z-score

We propose a global tracer indicator for measuring effective coverage of rehabilitation at the population level that is captured through population-based surveys. This global indicator uses chronic primary low back pain as the tracer health condition and World Health Organization Disability Assessment Schedule 2.0 12-item to assess whether quality interventions have been provided that produce the desired health gain.

This survey study examines attainment of professional and leadership milestones by middle to senior career women and men 12 to 15 years after receiving K awards.

Introduction
Aggressive natural killer cell leukaemia (ANKL) is a rare form of NK cell lymphoma with a very low incidence and poor prognosis. While multi-agent chemotherapy including L-asparaginase has been used to treat ANKL patients, they often cannot receive adequate chemotherapy at diagnosis due to liver dysfunction. PPMX-T003, a fully human monoclonal antibody targeting the transferrin receptor 1, shows promise in treating ANKL by helping patients recover from fulminant clinical conditions, potentially enabling a transition to chemotherapy. This study aimed to evaluate the tolerability, safety, efficacy, and pharmacokinetics of repeated continuous intravenous PPMX-T003 in patients with ANKL.

Methods and analysis
This multicentre, open-label, dose-escalation phase I/II study will be conducted at nine hospitals in Japan. Patients diagnosed with ANKL (whether as a primary or recurrent disease) and exhibiting abnormal liver function or hepatomegaly due to the primary disease will be included. The primary endpoint is the tolerability and safety of repeated continuous intravenous administration of PPMX-T003 in the first course, based on adverse events and dose-limiting toxicities. PPMX-T003 will be administered as a continuous intravenous infusion every 24 hours for five consecutive days, followed by a 2-day break. Pretreatment will be provided to minimise the risk of infusion-related reactions. Initial doses of PPMX-T003 will be 0.5, 1.0 or 2.0 mg/kg, with subsequent dose increases determined by the Data and Safety Monitoring Committee. The sample size is set at seven participants, with enrolment increased to up to 12 participants if dose-limiting toxicities occur, based on feasibility due to the rarity of ANKL. Descriptive statistics will summarise data according to initial dose, and pharmacokinetic analysis will be conducted based on administered dose.

Ethics and dissemination
This study was approved by the institutional review boards at participating hospitals. The results will be disseminated in peer-reviewed journals.

Trial registration number
jRCT2061230008 (jRCT); NCT05863234 (ClinicalTrials.gov).

Objectives
The Idea, Development, Evaluation, Assessment and Long-term follow-up (IDEAL) framework was designed to improve the quality of surgical research and evaluation of surgical innovation. It has become a widely cited tool for evaluating innovative devices and procedures, yet challenges remain concerning the definition and reporting of incremental innovative modifications, hindering evolution and evaluation of innovations and potentially risking patient safety. This systematic review examined IDEAL studies to identify such modifications and establish recent practices around modification reporting to inform the development of future guidance to facilitate safe, transparent and efficient surgical innovation.

Design
Systematic review and thematic synthesis of studies reporting surgical innovation.

Data sources
Web of Science and Scopus were searched in July 2023 using citation tools to identify studies following the IDEAL framework (citing any of 13 key IDEAL/IDEAL framework publications and guideline papers).

Eligibility criteria
Primary research studies of any design that involved invasive innovative devices or procedures.

Data extraction and synthesis
Study characteristics and verbatim text for all reported modifications, including contextual information, were extracted. Data were analysed and synthesised using thematic synthesis.

Results
Of 1071 records screened, 104 studies published between 2011–2023 were included (n=87 (83.6%) study reports; n=17 (16.3%) protocols). 425 modifications were reported in 76 (73.1%) studies, including modifications to procedures (n=283, 66.6%), devices (n=94, 22.1%) and patient selection (n=48, 11.3%). Procedure/device modifications included technical, non-technical and cessation (conversion to other procedures or abandonment). Modifications were most often reported within IDEAL stage 2a (n=30/44, 68.2%), whereas there was considerable variation across other stages, such as stage 0 (n=2/3, 66%) and stage 2b (n=4/12, 33.3%).

Conclusion
Reporting modifications is imperative for evaluating surgical innovation. However, this review found inconsistent approaches to reporting and describing modifications. Findings will inform the development of a checklist for reporting modifications that aims to complement the IDEAL framework and further promote shared learning, avoiding the repetition of harmful/ineffective modifications and enhancing patient safety.

PROSPERO registration number
CRD42023427704.

Niente più visita specialistica per il rinnovo dei Piani terapeutici da fare ogni 6-12 mesi e soprattutto la possibilità di trovare il farmaco di cui si ha bisogno nella farmacia…

Introduction
Cognitive frailty (CF) is a clinical syndrome characterised by the concurrent occurrence of physical frailty and cognitive impairment, excluding Alzheimer’s disease and other forms of dementia. Recent studies have shown that combining aerobic exercise (AE) and meditation (ME) effectively enhances both physical and cognitive functions in individuals with CF. The study aims to determine whether the combined application of AE and ME can elicit significantly greater improvements in physical and cognitive functions among individuals with CF compared with the independent practice of either AE or ME alone.

Methods and analysis
The research design employs a four-arm, assessor-blind randomised controlled trial. A total of 140 qualified subjects will be randomly allocated among four groups: AE, ME, AE combined with ME and a health education control group, ensuring equivalent distribution across groups. The intervention phase of the study will last for 12 weeks. The primary outcomes will include the Edmonton Frailty Scale, while secondary outcomes will encompass evaluations of cognitive functions (including global cognitive function, memory, attention, executive function and visuospatial abilities), physical performance (measured by gait speed and lower extremity strength), subjective experiences (such as fatigue, quality of life, mindfulness, mood and sleep quality), as well as structural and functional MRI assessments and serum biomarkers. Outcomes will be evaluated at baseline and following the 12-week intervention.

Ethics and dissemination
The Ethics Committee of the Affiliated Rehabilitation Hospital of the Fujian University of Traditional Chinese Medicine granted ethical approval for the study (2023KY-012–02). The findings will be disseminated through publications in peer-reviewed journals and presentations at academic conferences.

Trial registration number
ChiCTR2300073563.

Objectives
This scoping review aims to map existing evidence on knowledge, attitudes and practices (KAP) and barriers to preconception care in low- and middle-income countries. The primary objective is to identify key gaps and research priorities to guide future efforts to improve maternal and child health.

Design
This review followed Arksey and O’Malley’s scoping review framework, with a comprehensive search across Medline, EMBASE, CINAHL and Scopus from inception to May 2025. Eligible studies included original research on preconception care (PCC), KAP in low- and middle-income countries (LMICs) without date restrictions. Two independent reviewers conducted screening in Covidence. Findings were presented in graphical, tabular and narrative formats, adhering to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols Extension for Scoping Reviews (PRISMA-ScR) standard.

Setting
The review focused on PCC studies conducted in LMICs across various healthcare settings, emphasising primary and secondary levels of care. The geographical scope was global but limited to LMICs as defined by World Bank criteria.

Result
A total of 62 studies were included in the review. Of these, 42 employed quantitative methods, 18 used qualitative approaches and 2 used a mixed-methods design. Regarding focus areas, 25 studies assessed knowledge, 14 assessed practices, 12 studies assessed KAP comprehensively and 10 assessed attitudes. Participants were mainly women of reproductive age (44 studies), with only five studies including men. Among healthcare providers, KAP varied, with midwives being the most frequently studied group. Stakeholders such as policymakers were notably under-represented. Identified barriers included limited training, cultural beliefs and inadequate policies. Facilitators highlighted were targeted education, spousal support and policy advocacy, emphasising the need for gender-sensitive and systemic interventions.

Conclusion
LMICs face complex challenges in utilising PCC, influenced by socioeconomic, cultural, and healthcare system factors. To address these challenges, nuanced approaches incorporating intersectional perspectives and practical qualitative methodologies are essential for improving couples’ and child health outcomes.

Trial registration number
The study protocol was registered in the Open Science Framework (OSF) on December 23, 2022, with DOI: 10.17605/OSF.IO/H3MK6.

Objectives
This systematic review investigated available evidence on the stand-alone and incremental predictive performance of ophthalmic artery Doppler (OAD) for pre-eclampsia.

Design
Systematic review.

Data sources
We conducted a literature search from PubMed (Medline), the Cochrane CENTRAL, EMBASE and Scopus from inception to 8 April 2025.

Eligibility criteria
Studies eligible for inclusion were prospective or retrospective cohort studies, case-control studies or randomised controlled trials that reported on the predictive performance of OAD for pre-eclampsia in singleton pregnancies; and conducted in either high-income country (HIC) or low- and middle-income country (LMIC).

Data extraction and synthesis
Two reviewers independently screened and assessed articles for inclusion. One reviewer then extracted data using a standardised data extraction sheet, and any uncertainties were discussed with a second reviewer. The Prediction model Risk of Bias Assessment Tool was used for quality and risk of bias assessment. Findings were summarised and reported according to the Preferred Reporting Items for Systematic Review and Meta-Analyses statement and synthesised qualitatively.

Results
We identified and included 11 observational studies (3 from HIC and 8 from LMICs) with a total of 12 150 singleton pregnancies, of which 517 (4.3%) were complicated by pre-eclampsia at end of follow-up. The included studies were of varied quality, with three at low risk of bias, four at unclear risk and four at high risk. No interventional study was identified. Three studies (27.3%) recruited high-risk pregnancies (defined according to the American College of Obstetricians and Gynecologists (ACOG) criteria as one or more of the following: chronic hypertension, personal or family history of pre-eclampsia, early (≤18 years) or late (≥40 years) first pregnancy, primipaternity, chronic kidney disease, increased body mass index >30 kg/m2, presence of diabetes mellitus prior to pregnancy, autoimmune disease and thrombophilia), while eight studies (72.7%) recruited undetermined risk pregnancies. Stand-alone performance of OAD (interpreted by area under the receiver operating curve at 95% CI) showed that in the first trimester, the peak systolic velocity (PSV) ratio demonstrated very good predictive ability (0.97, 95% CI 0.92 to 1.0) (n=1 study), and the second PSV (PSV2) demonstrated very good predictive ability (0.91, 95% CI 0.82 to 0.99) (n=1 study). Also, PSV2 demonstrated fair predictive ability (0.61, 95% CI 0.42 to 0.79; and 0.53, 95% CI 0.40 to 0.66) for early and late pre-eclampsia, respectively (n=1 study). In the second trimester, the PSV ratio demonstrated very good predictive ability (0.88, 95% CI 0.84 to 0.91) (n=1 study), and PSV2 demonstrated good predictive ability (0.73, 95% CI 0.66 to 0.81; and 0.76, 95% CI 0.71 to 0.81) for pre-eclampsia (n=2 studies). In the third trimester, the PSV ratio demonstrated good predictive ability (0.82, 95% CI 0.73 to 0.89; and 0.77, 95% CI 0.71 to 0.82) for preterm and term pre-eclampsia, respectively (n=1 study). Also, PSV2 demonstrated good predictive ability 0.70 (0.57 to 0.84) (n=1 study).
Subsequently, in the second trimester, PSV ratio demonstrated better incremental predictive performance than uterine artery pulsatility index for preterm pre-eclampsia, when added to maternal factors and mean arterial pressure (MAP) (56.1%–80.2% vs 56.1%–74.8% detection rate (DR) at 10% FPR) (n=1 study). Also in the third trimester, adding PSV ratio to maternal factors and MAP was superior to soluble fms-like tyrosine kinase-1/placental growth factor ratio in predicting pre-eclampsia at

Objectives
To develop a teaching exemplar for optimising the safe and accessible delivery of chair-based yoga to multimorbid older adult populations.

Design
A qualitative process evaluation embedded within the multi-site, randomised controlled Gentle Years Yoga trial for older adults (65+ years) with two or more long-term health conditions (trial status: completed).

Setting
Online and face-to-face interviews were conducted with participants and yoga teachers involved in the 12-week chair-based yoga intervention. Interview data were supplemented with observations of in-person and online yoga class delivery.

Participants
All yoga teachers delivering the yoga intervention were invited to take part in the interviews, together with a subsample of participants receiving the yoga intervention. Participants were purposively selected to represent the trial cohort demographics of gender, age, ethnicity, index of multiple deprivation, and number and intensity of chronic health conditions.

Results
25 yoga participants and 11 yoga teachers took part in one (N=19) or two (N=17) interviews. Participants were aged 66–91 years (mean age 74 years), with 2–8 long-term health conditions, most commonly osteoarthritis (N=15, 60%), cardiovascular disease (N=14, 56%), sensory conditions (N=9, 36%) and depression or anxiety (N=8, 32%). Yoga teachers were predominantly female (N=10, 91%), with 4–35 years yoga teaching experience across multiple yoga styles. Feedback from yoga teachers and participants was classified into six categories, generating a 21-item teaching exemplar. These covered aspects of delivery including class size and delivery formats, choosing appropriate physical content, enhancing inclusivity of personal beliefs through non-physical content, proactive teaching styles, communication tips and ways to boost visibility.

Conclusions
This 21-item list adds to the current educational base of yoga for older adults. Addressing both face-to-face and online class formats, this exemplar offers pragmatic guidance for yoga teachers to enhance the safe and accessible delivery of chair-based yoga to older adults and multimorbid populations.

Trial registration number
ISRCTN13567538.

Stroke, Ahead of Print. BACKGROUND:The impact of covert cerebrovascular disease on falls in the general population is not well-known. Here, we determine the time to a first fall following incidentally detected covert cerebrovascular disease during a clinical neuroimaging episode.METHODS:This longitudinal cohort study assessed computed tomography (CT) and magnetic resonance imaging from 2009 to 2019 of patients aged >50 years registered with Kaiser Permanente Southern California which is a healthcare organization combining health plan coverage with coordinated medical services, excluding those with before stroke/dementia. We extracted evidence of incidental covert brain infarcts (CBI) and white matter hyperintensities/hypoattenuation (WMH) from imaging reports using natural language processing. We examined associations of CBI and WMH with falls requiring medical attention, using Cox proportional hazards regression models with adjustment for 12 variables including age, sex, ethnicity multimorbidity, polypharmacy, and incontinence.RESULTS:We assessed 241 050 patients, mean age 64.9 (SD, 10.42) years, 61.3% female, detecting covert cerebrovascular disease in 31.1% over a mean follow-up duration of 3.04 years. A recorded fall occurred in 21.2% (51 239/241 050) during follow-up. On CT, single fall incidence rate/1000 person-years (p-y) was highest in individuals with both CBI and WMH on CT (129.3 falls/1000 p-y [95% CI, 123.4–135.5]), followed by WMH (109.9 falls/1000 p-y [108.0–111.9]). On magnetic resonance imaging, the incidence rate was the highest with both CBI and WMH (76.3 falls/1000 p-y [95% CI, 69.7–83.2]), followed by CBI (71.4 falls/1000 p-y [95% CI, 65.9–77.2]). The adjusted hazard ratio for single index fall in individuals with CBI on CT was 1.13 (95% CI, 1.09–1.17); versus magnetic resonance imaging 1.17 (95% CI, 1.08–1.27). On CT, the risk for single index fall incrementally increased for mild (1.37 [95% CI, 1.32–1.43]), moderate (1.57 [95% CI, 1.48–1.67]), or severe WMH (1.57 [95% CI, 1.45–1.70]). On magnetic resonance imaging, index fall risk similarly increased with increasing WMH severity: mild (1.11 [95% CI, 1.07–1.17]), moderate (1.21 [95% CI, 1.13–1.28]), and severe WMH (1.34 [95% CI, 1.22–1.46]).CONCLUSIONS:In a large population with neuroimaging, CBI and WMH are independently associated with greater risks of an index fall. Increasing severities of WMH are associated incrementally with fall risk across imaging modalities.

Importance
Background rates are critical for contextualising safety signals arising from COVID-19-related interventions in investigational or real-world settings.

Objective
To estimate background rates of medical events of interest (MEI) for which COVID-19 infection and/or COVID-19 interventions may be risk factors in two US claims databases.

Design, setting and participants
This retrospective cohort study spans the pre-COVID-19 (2018–2019) and COVID-19 (2020–2021) periods. We constructed three cohorts, in each of Inovalon/HealthVerity (Inovalon/HV) and Optum databases: a COVID-19-positive adult cohort (2020–2021), a paediatric cohort (2018–2021) and a high-risk cohort (2018–2021) comprising patients at increased risk for severe COVID-19. Participants were indexed on the day they first qualified to enter each cohort during the study period. Background rates of 17 MEI were estimated per 1000 person-years (PY) with 95% CIs.

Main outcomes and measures
Annual incidence rates (IRs) of 17 MEI.

Results
Overall, 758 414 (COVID-19-positive adults; 57.8% women), 12 513 664 (high-risk adults; 56.8% women) and 8 510 627 (paediatric patients; 49.1% women) patients were identified in the HV database. IRs of MEI varied substantially by year, data source, study cohort and duration of follow-up. The IRs of MEI were highest among COVID-19-positive adults and lowest among paediatric patients. For example, IR of myocarditis/pericarditis per 1000 PY was 3.0 (95% CI: 2.6 to 3.4) in the COVID-19-positive adult cohort vs 0.36 (95% CI: 0.34 to 0.37) among high-risk adults and 0.05 (95% CI: 0.05 to 0.06) among paediatric patients. In the COVID-19-positive adult cohort, we observed higher IRs during 90-day follow-up (eg, IR of acute myocardial infarction (AMI) 26.5 (95% CI: 25.3 to 27.7)) vs 365-day follow-up (eg, IR of AMI 20.0 (95% CI: 9.2 to 20.8)) and during 2020 compared with 2021. IRs were higher in the high-risk adult and paediatric populations during the pre-COVID-19 period than during the COVID-19 pandemic.

Conclusions
Substantial variability was observed in IRs of MEI by study cohort, year, data source and follow-up duration. When generating background rates for contextualising safety signals from COVID-19 interventions, careful consideration must be given to the indicated subpopulation of interest, COVID-19-related temporal variations and data sources.