Search Results for: Standard Italiani per la cura del diabete mellito

Introduction
Individuals with spinal cord injury (SCI) face heightened cardiovascular disease (CVD) risks. While general exercise guidelines are promoted for SCI individuals, when and how to incorporate exercise during the subacute phase post-SCI remains unclear. Consequently, early aerobic exercise to reduce CVD risks is not standard practice in subacute SCI care, potentially missing an opportunity for optimal cardiovascular rehabilitation, especially given observed reductions in cardiac structure and function within the first year post-SCI. Addressing this gap could improve long-term cardiovascular health and health-related quality of life (HRQOL) for individuals with SCI. Early intervention might prevent worsening cardiovascular function and establish beneficial exercise habits. However, few studies have evaluated the effectiveness of early exercise interventions in this population. This study aims to provide insight into the impact of moderate-intensity arm-crank exercise training (ACET) on cardiometabolic, HRQOL, functional and fitness parameters in individuals with subacute (

In this issue of JAMA Internal Medicine, Luo et al presented compelling evidence for awake prone positioning for patients with acute hypoxemic respiratory failure from COVID-19. Their meta-analysis based on individual patient data from 3019 patients in 14 randomized clinical trials demonstrated that awake prone positioning significantly improved survival without intubation and reduced both the risk of intubation and hospital mortality. The improved survival was most pronounced in individuals who had moderate to severe hypoxemia (pulse saturation to inhaled oxygen fraction ratio between 155 and 232), were younger than 68 years, had a body mass index between 26 and 30 (calculated as weight in kilograms divided by height in meters squared), and had prone positioning initiated within 1 day of hospitalization. Notably, patients who maintained prone positioning for at least 8.3 hours daily during the first 3 days of hospitalization had better outcomes than those with shorter prone times. This rigorous meta-analysis provides important evidence for managing critically ill patients with acute hypoxemic respiratory failure.

Introduction
Prehabilitation aims to improve preoperative health before surgery to reduce complications. Reducing anxiety helps prevent postoperative pain, stress and sleep disturbances. Listening to music through headphones or earpieces in the hospital directly preoperatively, intraoperatively and postoperatively has been shown to ameliorate anxiety, stress, pain and sleep disorders. This randomised controlled trial will investigate the effect of active music listening at home 1 week before surgery as a prehabilitation modality on preoperative anxiety compared with standard care.

Methods and analysis
This study is a multicentre randomised controlled trial that will include 116 patients. The study population consists of adults undergoing elective oncological colorectal surgery. The intervention group will be advised to listen to recorded music three times per day for 20 min, starting 1 week prior to surgery, using headphones or earpieces. Both groups will receive standard care during hospitalisation. The primary outcome is patient-reported preoperative anxiety using the State-Trait Anxiety IndexInventory 6. Secondary outcomes are patient-reported stress, delirium incidence, medication usage, postoperative pain, complication rate, length of stay, adherence to the intervention, quality of life and healthcare-related costs.

Ethics and dissemination
This study protocol has been approved by the Medical Ethical Review Board of Erasmus Medical Center on 15 December 2022 (MEC-2022-9415). The trial will be carried out following the updated Declaration of Helsinki principles and Good Clinical Practice guidelines. Study results will be published and reported in a peer-reviewed journal according to the Consolidated Standards of Reporting Trials guidelines.

Trial registration number
NCT05982184.

Introduction
Targeted therapy is now the standard treatment for patients with epidermal growth factor receptor (EGFR) mutations, yet resistance continues to be a significant challenge. Enhancing the efficacy of targeted therapies and prolonging patient survival remain critical clinical priorities. Although combining third-generation EGFR tyrosine kinase inhibitors (TKIs) with intravenous chemotherapy has demonstrated promising results, it is unclear if oral chemotherapy regimens combined with EGFR TKIs could also improve survival outcomes.

Methods and analysis
EVOLUTION is a multicentre, phase II clinical trial conducted across three tertiary hospitals in China: Shanghai Pulmonary Hospital (lead centre), Zhongshan Hospital Affiliated to Fudan University and Shanghai Fifth People’s Hospital Affiliated to Fudan University. The study will enrol 60 patients with locally advanced or metastatic lung cancer harbouring EGFR-sensitive mutations who have not previously undergone systemic therapy. Participants will be administered a combination regimen of aumolertinib (110 mg orally, once a day in a 28-day cycle, continuously) and Lastet (25 mg orally, administered in a 28-day cycle, with 2 weeks on followed by 2 weeks off). The primary endpoint is progression-free survival, and the secondary endpoints are overall survival, objective response rate, disease control rate and duration of response. Tumour response will be assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors 1.1. Patient enrolment is currently underway.

Ethics and dissemination
Ethical approval for this study was granted by the Ethics Committee of Shanghai Pulmonary Hospital in April 2024 (approval number: L23-334). Patients will participate after providing informed consent. The results of the study will be disseminated through peer-reviewed journals and presentations at academic conferences.

Trial registration number
NCT06463171.

Introduction
Falls can lead to serious health-related consequences in the older population. If an emergency occurs within the home environment of an older person living alone, the initiation of emergency care can be delayed, leading to even worse outcomes for this population. Smart home emergency call systems (HECSs) can detect falls and automatically trigger an emergency alarm, potentially reducing time to emergency care and improving outcomes. The INES (Intelligentes NotfallErkennungsSystem—smart emergency detection system) study is a prospective randomised controlled trial conducted in three German federal states that aims to investigate the effectiveness and cost-effectiveness of a smart HECS.

Methods and analysis
Following a telephone interview, individuals aged 70 years or older, living alone, at risk of falling and willing to participate are included in the study. Participants are assigned to one of two groups depending on their previous use of a HECS. Based on the sample size calculation, the study aims to recruit n=498 participants already using a standard HECS (group A) and n=1378 participants who have not used a HECS before (group B). Within both groups, participants are randomised into the intervention arm (IA) and control arm (CA). The IA receives a smart HECS during the 21-month follow-up period. In addition to a standard HECS with a base station and a wearable radio transmitter, the smart HECS includes sensors that can detect falls and automatically trigger an alarm. The primary outcome assessed will be the days spent in the hospital after an emergency admission. Secondary outcomes include the utilisation of healthcare services and their total costs, progression of care dependency, fear of falling (Falls Efficacy Scale—International), health-related quality of life (EQ-5D-5L) and well-being (ICEpop CAPability measure for Older people).

Ethics and dissemination
The design and conceptualisation of the INES study were approved by the ethics committee of the Hamburg Medical Association on 26 June 2023 (2023-101032-BO-ff). Results of the INES study will be published in peer-reviewed articles.

Trial registration number
Deutsches Register Klinischer Studien, German Clinical Trials Register DRKS00031408. Registered on 28 June 2023.

Gruppi elettrogeni e sistemi di backup attivi in pochi secondi

Introduction
The management of immunoglobulin A (IgA) nephropathy remains a topic of debate. Hydroxychloroquine and mycophenolate mofetil (MMF) are two immunosuppressive agents that have recently garnered increased attention among patients with IgA nephropathy in China. Several studies have shown the comparable efficacy between MMF and enteric-coated mycophenolate sodium (EC-MPS), with lower adverse event rates for EC-MPS. The present study aims to evaluate the efficacy and safety of EC-MPS combined with hydroxychloroquine as an immunosuppressive regimen for patients with high-risk progressive IgA nephropathy, despite receiving routine supportive treatment.

Methods and analysis
This study is a multicentre, prospective, randomised controlled, open-label, blinded endpoint trial. 96 patients diagnosed with IgA nephropathy and persistent proteinuria from 12 general hospitals in Shanxi Province of China will be recruited and randomly assigned to receive either EC-MPS plus hydroxychloroquine or hydroxychloroquine alone in a 1:1 ratio. We will compare the efficacy and safety of hydroxychloroquine combined with or without oral EC-MPS (720–1080 mg/day for 6 months, and tapered to 360–540 mg/day for another 6 months) on a background of supportive care. All enrolled patients will receive standard basic treatment to achieve optimum blood pressure and the maximum tolerated dose of ACE inhibitors or angiotensin receptor blockers. The primary outcome is the change in 24-hour urine protein at 6 months relative to baseline. Participants will be subject to regular follow-up for a duration of 12 months.

Ethics and dissemination
This study has received ethical approval from the Ethics Committee of Shanxi Medical University Second Hospital (No. 2024YX-481). A duly signed and dated informed consent form must be obtained from each participant or his/her legal guardian prior to any operational procedures related to the trial. The result of this study will be presented and published at international conferences and in scientific journals.

Trial registration number
ChiCTR2400093530.

Introduction
Liver cirrhosis and its severe complication, oesophageal variceal bleeding (EVB), pose significant health risks. Standard treatment for EVB combines non-selective beta-blockers (NSBB) with endoscopic variceal ligation (EVL). Carvedilol, an NSBB with additional benefits, is preferred for compensated cirrhosis. However, no randomised controlled trial (RCT) has compared carvedilol with propranolol, a conventional NSBB, in combination with EVL for secondary prophylaxis. This study aims to compare the effectiveness and safety of these treatments in preventing variceal rebleeding or death in patients with cirrhosis and EVB.

Methods and analysis
This multicentre, RCT is scheduled to begin in December 2024, with recruitment and follow-up continuing until December 2026. Eligible participants are patients with liver cirrhosis and EVB. Participants are randomly assigned in a 1:1 ratio to receive EVL combined with either carvedilol or propranolol. The primary endpoint is the incidence of variceal rebleeding or all-cause death. Secondary endpoints include all-cause death, liver-related death, each of the complications of portal hypertension (overt ascites, overt hepatic encephalopathy, spontaneous bacterial peritonitis, hepatorenal syndrome, portal vein thrombosis), hepatocellular carcinoma, changes in liver function (assessed by Child-Pugh and Model for End-Stage Liver Disease scores), changes in liver stiffness, changes in spleen stiffness, and adverse events. Subgroup and sensitivity analyses will be conducted to evaluate the consistency and robustness of the treatment effects. A total sample size of 524 patients (262 per group) is required to detect a significant difference between the treatment arms.

Ethics and dissemination
The study protocol has been approved by the ethics committee of the First Hospital of China Medical University (No. 2024-656-2). The study will follow the Declaration of Helsinki and Good Clinical Practice guidelines. The findings of this trial will be disseminated through peer-reviewed publications, conference presentations and healthcare professionals to guide future clinical practice.

Trial registration number
Chinese Clinical Trial Registry (Registration number: ChiCTR2400089692).

Introduction
Although most cochlear implant (CI) users achieve good speech understanding in quiet without visual cues, they may have limited speech understanding in noise and often have poor music perception. The present study was designed to investigate the degree to which the use of Meludia training can improve music perception, music enjoyment and speech understanding in paediatric and postlingually deafened adult CI users. The study also aims to assess the participants’ changes in cognitive skills (attention and memory) and quality of life.

Methods and analysis
This randomised controlled trial will randomise new CI users and experienced CI users older than 6 years who meet the inclusion criteria in a 1:1 ratio to either a musical training (MT) group or a non-MT (NMT) group. The NMT group will receive standard care that does not include MT. Participants in the MT group will practise with Meludia software for 4 weeks and later for 12 additional weeks. Outcomes will include scores in: ‘Listening Up’ exercises, the -Music-Related Quality of Life questionnaire, the Music Questionnaire for Paediatric Population, Disyllables in silence, Matrix test, Mini Mental State Examination, Performance IQ and the Wechsler intelligence scale for children and the Assessment of Quality of Life—8 Dimensions questionnaire. The NMT group will receive standard care that does not include MT.

Ethics and dissemination
On 16 October 2023, the study protocol was approved by the La Paz Hospital in Madrid (Spain). The findings of this study will be published in peer-reviewed publications and presented at appropriate conferences.

Trial registration number
NCT06540677.

Objective
Pneumonia is associated with four times higher odds of death among children with severe undernutrition. However, there is an equipoise for the mortality of children without severe undernutrition and the impact of macronutrient interventions. We collated evidence on mortality, anthropometric outcomes and the effect of macronutrient interventions in the management of non-severely undernourished children (28 days–17 years) with pneumonia globally.

Design
Systematic review and meta-analysis using a priori criteria developed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline.

Data sources
PubMed, Medline, EMBASE, Web of Science, Google Scholar, Scopus, Cochrane Central and bibliographies were searched between January 2000 and July 2024.

Eligibility criteria
We included articles conducted among children between 28 days and 17 years with pneumonia and non-severe malnutrition that reported on mortality and changes in anthropometric status or macronutrient supplementation. Studies conducted exclusively among adults, on micronutrient supplementation, case studies, commentaries and reviews were excluded.

Data extraction and synthesis
Two reviewers independently screened, abstracted the data and conducted risk of bias (RoB) using standard criteria including the RoB in non-randomised follow-up studies of exposure for observational studies and the revised Cochrane RoB assessment tool for randomised studies (RoB 2.0). Heterogeneity was assessed using the I2 statistic, and subgroup analysis was done. Data were analysed using both narrative and quantitative synthesis. Quantitative synthesis was done using the maximum likelihood random-effects model in STATA V.18.0, with the ‘meta_es’ command.

Results
A total of 15 articles were included (11 conducted in sub-Saharan Africa and four in Asia), with 169 901 participants overall. The mortality among non-severely undernourished children with pneumonia was 3.0% (95% CI 2% to 5%, I2=99.38%), with a range of 1–13% across studies. Children with moderate undernutrition had a higher overall mortality, 9.0% (95% CI 6% to 13%, I2=89.50%), than well-nourished children, with a range of 3–19% across studies. Only one of the 15 studies reported anthropometric outcomes during follow-up and compared mortality rates of those who did versus did not receive macronutrients. The study results were inconclusive.

Conclusions
Mortality among non-severely undernourished children with pneumonia ranges between 1–13% globally. There is inadequate follow-up nutritional assessment and management for non-severely undernourished children with pneumonia.

PROSPERO registration number
CRD42021257272.

Introduction
Out-of-hospital cardiac arrest is a public health concern with a high mortality rate. Hypoxic ischaemic brain injury is the primary cause of death in patients admitted to the intensive care unit (ICU) after return of spontaneous circulation (ROSC). Several systemic factors, such as hypotension, can exacerbate brain injuries. International guidelines recommend targeting a mean arterial pressure (MAP) of at least 65 mm Hg. Several observational studies suggest that a higher MAP may be associated with better outcomes, but no randomised trials have shown an effect of higher MAP. The ongoing METAPHORE (mean arterial pressure after out-of-hospital cardiac arrest) trial aims to compare a standard MAP threshold (MAP ≥65 mm Hg) with a high MAP threshold (MAP ≥90 mm Hg) to evaluate whether implementing a higher MAP threshold can improve neurological outcomes in patients admitted to ICU after cardiac arrest.

Methods and analysis
METAPHORE is a randomised, controlled, multicentre, open-label trial with a blinded primary outcome assessor, comparing two parallel groups of patients 18 years of age or older, receiving invasive mechanical ventilation for coma defined by a Glasgow Coma Score ≤8/15 after out-of-hospital cardiac arrest and sustained ROSC. Eligible patients are randomly assigned in a 1:1 ratio to either a MAP target threshold of 65 mm Hg or higher throughout the ICU stay (control group) or a MAP target threshold of 90 mm Hg or higher during the first 24 hours after randomisation, followed by 65 mm Hg or higher for the remainder of the ICU stay (intervention group). Both groups receive the same general care concerning post-cardiac arrest syndrome management according to international guidelines. The primary endpoint is the proportion of patients with a favourable neurological outcome as defined by a modified Rankin scale (mRS) of 0 to 3 measured on day 180 after inclusion by a psychologist blinded to the allocation of the intervention. Secondary outcomes are the proportion of patients alive at ICU and hospital discharge, at day 28 and day 180; proportion of patients alive at ICU discharge with a mRS of 0 to 3; the EuroQOL-5D-5L at day 180; the Clinical Frailty Scale at day 180; the number of ICU-free days, ventilator-free days, catecholamine-free days and renal replacement therapy-free days at day 28; the proportion of patients with acute kidney injury stage 3 and need for renal replacement therapy within ICU stay and proportion of patients with persistent need for renal replacement therapy at ICU discharge; and safety outcomes (cardiovascular, neurological, cutaneous, digestive and haemorrhagic complications within 7 days after inclusion). Subgroup analyses are planned according to initial cardiac arrest rhythm (shockable or non-shockable), chronic hypertension and Cardiac Arrest Hospital Prognosis score. Outcomes will be analysed on an intention-to-treat basis. Recruitment started in October 2024 in 27 French ICUs, and a sample of 1380 patients is expected by October 2027.

Ethics and dissemination
The study received approval from the national ethics review board on 8 February 2024 (Comité de Protection des Personnes Sud-Est V – 2023-A00257-38). Patients are included after informed consent has been obtained either from a proxy or through an emergency procedure. Results will be submitted for publication in peer-reviewed journals.

Trial registration number
ClinicalTrials.gov: NCT05486884.

Introduction
Standard premedication for paclitaxel-based chemotherapy includes dexamethasone and an histamine 1-antagonist to prevent hypersensitivity reactions (HSRs). However, the pharmacological rationale for dexamethasone is limited, and its use is associated with adverse effects such as hyperglycaemia, insomnia and immunodeficiency, negatively impacting health-related quality of life (HRQoL). No clear link has been established between dexamethasone dose, administration route and HSR incidence. Previous studies suggest that discontinuing dexamethasone beyond the second administration does not increase HSR risk. Despite this, dexamethasone remains standard practice. This trial evaluates whether complete omission of dexamethasone as paclitaxel premedication is non-inferior to the standard regimen in preventing clinically relevant HSRs (Common Terminology Criteria for Adverse Events (CTCAE) grade≥3).

Methods
The DEXASTOP trial is a prospective, multicentre, randomised, non-inferiority study conducted in four hospitals in the Netherlands. 500 adult patients receiving paclitaxel-based chemotherapy for any solid tumour indication will be randomised 1:1 to receive either standard premedication with dexamethasone or an experimental regimen without dexamethasone for up to five paclitaxel administrations. The primary endpoint is the incidence of clinically relevant HSRs (CTCAE grade≥3). Secondary endpoints include the incidence and severity of all-grade HSRs, the number of paclitaxel administrations before the first HSR, dexamethasone-related adverse events, HRQoL and cost-effectiveness from a healthcare and societal perspective.

Ethics and dissemination
This study has been approved by the Erasmus Medical Centre Ethics Committee (reference MEC-2024-0030, protocol version 3, May 2024). Study findings will be published open access in peer-reviewed journals and presented at national and international meetings. Results will be shared with patients, healthcare professionals and the public. Positive outcomes will be implemented in clinical practice, and trial data will be submitted to the EU Clinical Trials Information System for public access.

Trial registration number
NCT06118710.

A randomized trial showed no benefit for adding thoracentesis to standard therapy.

Per la Conferenza è ‘ridondante’. Campitiello, ‘è per il bene degli italiani’

Introduction
The human papillomavirus (HPV) vaccine can effectively prevent cervical cancer, yet HPV vaccine uptake is particularly low in some low-income settings, due to supply and vaccine confidence barriers. HPV vaccine confidence has also been found to be lacking among healthcare workers in some countries, including Nigeria. Nigeria has a long history of low vaccine confidence in some parts of the country. HPV vaccine rumours and concerns have been observed throughout the country, including among healthcare workers. Interventions that specifically address healthcare workers’ vaccine confidence are limited, since vaccine confidence is often assumed among this group. The aim of our pilot cluster randomised control trial (cRCT) is to evaluate the feasibility of conducting a trial that evaluates codesigned interventions to improve HPV vaccine confidence in healthcare workers and the acceptability and feasibility of delivering this intervention.

Methods and analysis
This is a 3-arm pilot cRCT, using a mixed-methods approach to assess the feasibility of the trial design, alongside the feasibility and acceptability of intervention delivery in two states in Nigeria (Jigawa and Oyo). We will implement two interventions: one with a focus on digital delivery, and one with an HPV champion present at a health facility. Both will be compared with a control arm, providing standard information on HPV vaccine only. Overall, 12 trial clusters (six in Jigawa and six in Oyo), defined as government primary healthcare facilities, will be randomised using a 1:1:1 ratio, stratified by state. All healthcare workers within these facilities will be eligible to take part in the intervention and evaluation. The primary outcome of interest will be intervention uptake, as a measure of subsequent trial feasibility given concerns around contamination in control clusters. This will be assessed through an endline healthcare worker survey. Intervention feasibility and acceptability will be assessed through quantitative intervention monitoring and qualitative interviews with healthcare workers.

Ethics and dissemination
We received approval from Jigawa State Ethics Committee (ref: JGHREC/2023/151), Jigawa Ministry of Health (ref: MOH/PH/PHRAT/MN/23/003), Oyo State Research Ethics Review Committee (ref: AD/13/479/362A), The University of Ibandan and University College Hospital Research Ethics Committee (UI/UCH Ethics Committee) (ref: UI/EC/23/308) and from the Swedish National Ethics Review Board (2023-04772-01-471058). Data will be presented in manuscript form and submitted to relevant conferences for dissemination.

Registration details
The pilot trial has been registered with ISRCTN—the UK’s Clinical Study Registry, registration number ISRCTN37847119.