Search Results for: Linee Guida per le cure post-parto

Introduction
Neck pain is highly prevalent worldwide with no reliable or approved therapies. Recently, percutaneous neuromodulation (PNM) has gained popularity as an alternative to conventional treatments for managing musculoskeletal disorders.

Objective
This study aims to assess the comparative effectiveness of PNM compared with therapeutic exercise in the management of patients with chronic non-specific neck pain (CNNP).

Methods and analysis
In this randomised, controlled, single-blind study, 100 patients with CNNP will be allocated in a 1:1 ratio into two study groups: treatment with PNM and treatment with therapeutic exercise (specific neck exercises). A total of 18 structured exercise sessions will be administered three times per week for 6 weeks. Disability, pain intensity, fear of movement, quality of life, quality of sleep, catastrophising, cervical range of motion and pressure pain threshold will be recorded at 6 weeks (immediately post-treatment) and 8 weeks after initiation (or the end of treatment).

Ethics and dissemination
Ethical approval was obtained from the provincial research ethics committee of Almeria (AP-0429-2023 C4-F2) in June 2024. The results of the study, including feasibility outcomes, will be published in peer-reviewed journals and presented at academic, clinical and healthcare conferences.

Trial registration number
ClinicalTrials.gov: NCT06695949.

Introduction
Diabetes during pregnancy poses significant health risks for both mothers and their offspring and requires comprehensive management throughout pregnancy and the postpartum period. The increasing global prevalence of diabetes during pregnancy requires effective and efficient management. The current healthcare system can be challenging because of need for frequent hospital visits and limited availability of gestational diabetes (GDM) specialists.
This study investigates the impact of a digital-based management system designed to support women with diabetes from pregnancy through the first year post partum. This system includes a mobile application (MomStart) that allows users to log health data, receive tailored educational content and communicate with healthcare providers. The primary objective of this study is to compare pregnancy outcomes with historical data. We will also investigate the usability of the MomStart application.

Methods and analysis
The study will enrol over 100 pregnant women with diabetes from two hospitals in South Korea for the main study and an additional 500 women from across the country for a supplementary usability study. Data will be collected and analysed to assess neonatal and maternal outcomes and the app’s retention and satisfaction rates.

Ethics and dissemination
The protocol was approved by the Institutional Review Board of the Catholic University of Korea (XC23OIDI0012). We will present our findings in a national conference and in peer-reviewed medical journals.

Clinical study registration number
This study was registered in Korea’s Clinical Research Information Service system (KCT0008483).

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Stroke, Ahead of Print. BACKGROUND:Ischemic stroke poses a significant threat to human health. FGF (fibroblast growth factor) 20 is involved in the repair of central nervous system diseases, but it has the shortcomings of short half-life and inability to penetrate the blood-brain barrier. Therefore, to overcome the drawbacks of rhFGF20 (recombinant human FGF20) and explore its role in ischemic stroke, the effects of intracerebral administration of rhFGF20 by heparin-poloxamer hydrogel (HP-rhFGF20 [heparin-poloxamer hydrogel-encapsulated rhFGF20]) in a rat stroke model were the focus of this study.METHODS:A rat model of middle cerebral artery occlusion/reperfusion and oxygen-glucose deprivation-reoxygenation models were established to mimic ischemic stroke in vivo and in vitro, respectively. Endogenous FGF20 levels were measured in patients, ischemic rats, and oxygen-glucose deprivation-reoxygenation–injured neurons. To assess the therapeutic potential, rhFGF20 was administered intracerebrally via heparin-poloxamer hydrogel implants (1 mg/mL, 20 μL) on day 5 poststroke. TTC staining, neurobehavioral tests (including the mNSS test, the corner test, the rotarod test, the cylinder test, and the Morris water maze test), and Nissl staining were performed to evaluate neurological recovery. Immunofluorescence and Western blotting were conducted to assess the brain repair processes (neurogenesis, neuronal remodeling, and angiogenesis).RESULTS:High expression of FGF20 was detected in the serum of patients with ischemic stroke, the cortex of ischemic rats, and oxygen-glucose deprivation-reoxygenation–injured neurons. Heparin-poloxamer increased the stability and bioavailability of rhFGF20. HP-rhFGF20 attenuated neurobehavioral deficits and infarct volume in ischemic stroke rats. HP-rhFGF20 inhibited neuronal cell death, microglial activation, and glial scar formation on day 7 post-implantation. Moreover, HP-rhFGF20 promoted the proliferation, migration, and differentiation of neural stem cells and improved neuronal plasticity and angiogenesis in ischemic stroke rats.CONCLUSIONS:HP-rhFGF20 promoted functional recovery in ischemic stroke rats by enhancing neurogenesis and angiogenesis. The combination of growth factors and biomaterials provides a promising therapeutic strategy for central nervous system diseases.REGISTRATION:URL:http://www.chictr.org.cn; Unique identifier: ChiCTR2100051104.

‘Impatto sulla salute degli operatori e sulla qualità delle cure’

Stroke, Ahead of Print. BACKGROUND:Early reocclusion following successful recanalization through mechanical thrombectomy is linked to poor clinical outcomes in patients with stroke with intracranial atherosclerotic occlusion (ICAS-O). However, the factors influencing early reocclusion remain inadequately understood. This study is a post hoc analysis of 24-hour reocclusion in patients with successfully recanalized ICAS-O from a multicenter trial.METHODS:Patients with successfully recanalized ICAS-O were selected from the ANGEL-REBOOT trial (Randomized Study of Bailout Intracranial Angioplasty Following Thrombectomy for Acute Large Vessel Occlusion). Reocclusion was defined as a 24-hour arterial occlusive lesion score of 0 to 1, determined by magnetic resonance or computed tomography angiography. Possible factors associated with early reocclusion were screened through univariable analysis, and then, multivariable logistic regression was used to identify independent factors associated with early reocclusion.RESULTS:Among the 348 patients in the ANGEL-REBOOT trial, 21 could not be diagnosed with ICAS-O, 14 failed recanalization by the end of the procedure, and 14 had no follow-up angiography data. Finally, a total of 299 subjects were included, with a median age of 63 (interquartile range, 55–69) years, and 77 of 299 (25.75%) were females. The 24-hour reocclusion rate was 9.7% (29/299). Through backward elimination, 3 independent factors remained in the final multivariable logistic regression model. Specifically, puncture-to-recanalization time (per hour increase: odds ratio, 1.80 [95% CI, 1.31–2.47]) was positively associated with reocclusion, while general anesthesia (odds ratio, 0.25 [95% CI, 0.10–0.65]) and a postprocedural expanded Thrombolysis in Cerebral Infarction score of 2c-3 (odds ratio, 0.35 [95% CI, 0.14–0.85]) were negatively associated with reocclusion. Compared with patients without reocclusion, those with reocclusion had significantly greater 90-day modified Rankin Scale scores (median 4 versus 1, Mann-WhitneyUtest;P

Da Calabria,Trentino e Basilicata più fughe per bypass e valvole

Rapporto Iss su equità e salute regionale, ancora ampi i divari

Background
Recent meta-analyses suggested diclofenac may be superior to indomethacin in preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). The aim of our study was to compare the efficacy of 100 mg rectal indomethacin versus diclofenac on PEP incidences.

Design
This multicentre, double-blinded, randomised controlled trial was conducted in nine tertiary centres in China. Patients with low and high risk for PEP and native papilla were randomly allocated (1:1) to receive 100 mg diclofenac or 100 mg indomethacin rectally before ERCP. The primary outcome was the occurrence of PEP defined by the Cotton consensus. The intention-to-treat principle was conducted for the analysis.

Results
The trial was terminated early for futility after the predetermined first interim analysis. Between June 2023 and May 2024, 1204 patients were randomised into the diclofenac group (n=600) or indomethacin group (n=604). Baseline characteristics were balanced. The primary outcome occurred in 53 patients (8.8%) of 600 patients allocated to the diclofenac group and 37 patients (6.1%) of 604 patients allocated to the indomethacin group (relative risk 1.44; 95% CI 0.96 to 2.16, p=0.074). PEP occurred in 35 (14.2%) of 247 high-risk patients in the diclofenac group and 26 (9.8%) of 266 high-risk patients in the indomethacin group (p=0.124). PEP incidences were also comparable in low-risk patients between the two groups (18/353 (5.1%) vs 11/338 (3.3%), p=0.227). Other ERCP-related complications did not differ between the two groups.

Conclusion
Pre-procedure 100 mg rectal diclofenac was not superior to the same dose of rectal indomethacin regarding preventing PEP. These findings supported current clinical practice guidelines of 100 mg indomethacin or diclofenac for PEP prophylaxis in patients without contraindications.

Trial registration number
ClinicalTrials.gov (NCT05947461).

Introduction
Spinal cord injury (SCI) has been linked to increased frequencies of sleep-related breathing disorders (SRBDs) (≤50% after paraplegia and ≤90% following tetraplegia). However, SRBDs have been under-recognised and undertreated among individuals with SCI. The OPTIMISE SCI (Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI) is an ongoing phase 3 clinical trial focused on the effects of the early use of continuous positive airway pressure (CPAP) therapy to treat individuals with moderate-to-severe SRBDs in the acute/subacute stage after SCI.

Methods and analysis
A total of 44 participants with SCI who are newly diagnosed with moderate-to-severe SRBD are randomised into early CPAP therapy (initiated within the first 8 weeks postinjury) versus delayed CPAP therapy (initiated at 6 months postinjury). Participants with no/mild SRBDs are included in the control group (n=22). Primary outcome measures include neurological and functional recovery after SCI.

Ethics and dissemination
The protocol for this randomised clinical trial (RCT) raised an interesting discussion with our research ethics board about delaying CPAP therapy by 3 months when a participant is diagnosed with moderate-to-severe SRBD. Given that the current standard of care does not include screening for SRBDs in individuals who are admitted for spinal cord rehabilitation, most individuals are screened for SRBDs during the chronic stage post-SCI, which represents a greater delay in the diagnosis and treatment of SRBDs in this population. Because the potential impact of the OPTIMISE SCI trial on the current standard of care outweighs the risk of delaying CPAP therapy by 3 months, this trial protocol was approved. The dissemination plan includes presentations at scientific meetings and publication of the results in a peer-reviewed scientific journal.

Trial registration number
ClinicalTrials.gov (NCT05473689).

Objectives
Prediction models for post-stroke mortality can support medical decision-making. Although numerous models have been developed, external validation studies determining the models’ transportability beyond the original settings are lacking. We aimed to assess the performance of two prediction models for post-stroke mortality in Berlin, Germany.

Design
We used data from the Berlin-SPecific Acute Treatment in Ischaemic or hAemorrhagic stroke with Long-term follow-up (B-SPATIAL) registry.

Setting
Multicentre stroke registry in Berlin, Germany.

Participants
Adult patients admitted within 6 hours after symptom onset and with a 10th revision of the International Classification of Diseases discharge diagnosis of ischaemic stroke, haemorrhagic stroke or transient ischaemic attack at one of 15 hospitals with stroke units between 1 January 2016 and 31 January 2021.

Primary outcome measures
We evaluated calibration (calibration-in-the-large, intercept, slope and plot) and discrimination performance (c-statistic) of Bray et al’s 30-day mortality and Smith et al’s in-hospital mortality prediction models. Information on mortality was supplemented by Berlin city registration office records.

Results
For the validation of Bray et al’s model, we included 7879 patients (mean age 75; 55.0% men). We observed 763 (9.7%) deaths within 30 days of stroke compared with 680 (8.6%) predicted. The model’s c-statistic was 0.865 (95% CI: 0.851 to 0.879). For Smith et al’s model, we performed the validation among 1931 patients (mean age 75; 56.2% men), observing 105 (5.4%) in-hospital deaths compared with the 92 (4.8%) predicted. The c-statistic was 0.891 (95% CI: 0.864 to 0.918). The calibration plots of both models revealed an underestimation of the mortality risk for high-risk patients.

Conclusions
Among Berlin stroke patients, both models showed good calibration performance for low and medium-risk patients and high discrimination while underestimating risk among high-risk patients. The acceptable performance of Bray et al’s model in Berlin illustrates how a small number of routinely collected variables can be sufficient for valid prediction of post-stroke mortality.

Purpose
The pathogenesis of the long-lasting symptoms which can follow an infection with the SARS-CoV-2 virus (‘long covid’) is not fully understood. The ‘COroNaVirus post-Acute Long-term EffectS: Constructing an evidENCE base’ (CONVALESCENCE) study was established as part of the Longitudinal Health and Wellbeing COVID-19 UK National Core Study. We performed a deep phenotyping case-control study nested within two cohorts (the Avon Longitudinal Study of Parents and Children and TwinsUK) as part of CONVALESCENCE.

Participants
From September 2021 to May 2023, 349 participants attended the CONVALESCENCE deep phenotyping clinic at University College London. Four categories of participants were recruited: cases of long covid (long covid(+)/SARS-CoV-2(+)), alongside three control groups: those with neither long covid symptoms nor evidence of prior COVID-19 (long covid(-)/SARS-CoV-2(-); control group 1), those who self-reported COVID-19 and had evidence of SARS-CoV-2 infection, but did not report long covid (long covid(-)/SARS-CoV-2(+); control group 2) and those who self-reported persistent symptoms attributable to COVID-19 but no evidence of SARS-CoV-2 infection (long covid(+)/SARS-CoV-2(-); control group 3). Remote wearable measurements were performed up until February 2024.

Findings to date
This cohort profile describes the baseline characteristics of the CONVALESCENCE cohort. Of the 349 participants, 141 (53±15 years old; 21 (15%) men) were cases, 89 (55±16 years old; 11 (12%) men) were in control group 1, 75 (49±15 years old; 25 (33%) men) were in control group 2 and 44 (55±16 years old; 9 (21%) men) were in control group 3.

Future plans
The study aims to use a multiorgan score calculated as the cumulative total for each of nine domains (ie, lung, vascular, heart, kidney, brain, autonomic function, muscle strength, exercise capacity and physical performance). The availability of data preceding acute COVID-19 infection in cohorts may help identify the consequences of infection independent of pre-existing subclinical disease and also provide evidence of determinants that influence the development of long covid.

Introduction
Hypernatraemia, defined as a plasma sodium concentration >145 mmol/L, is a frequent complication in critically ill patients treated in the intensive care unit (ICU) (= ICU-acquired hypernatraemia), with reported prevalence ranging from 4% to 26%. Hypernatraemia adversely affects various physiological functions and is associated with delirium, prolonged length of stay and increased ICU and post-discharge mortality. The sodium load from intravenous drug diluents significantly contributes to ICU-acquired hypernatraemia, with drug infusions comprising about 30% of the daily fluid volume of an average ICU patient. This study aims to investigate if using glucose 5% solution as the default drug diluent, instead of sodium chloride 0.9%, can reduce the prevalence of ICU-acquired hypernatraemia and improve patient outcomes.

Methods and analysis
To test the effectiveness of glucose 5% solution as the default drug diluent, we will conduct a multicentre, pragmatic, embedded, open-label, stepped-wedge, cluster-randomised trial. The study will include twelve clusters (ICUs and one intermediate care unit) across six hospitals in Germany, with a projected total sample size of 4485 patients. In line with the stepped-wedge cluster-randomised design, one ICU will transition every 4 weeks, in a randomised sequence, from using sodium chloride 0.9% as the default drug diluent to glucose 5%.
The primary endpoint is the prevalence of hypernatraemia >150 mmol/L through day 28. The number of days alive and free of the ICU through day 28 will be tested hierarchically as a key secondary endpoint. Other exploratory endpoints include ICU mortality, ICU-free days, hospital-free days and other clinical outcomes. The primary endpoint will be analysed using a logistic mixed-effects model.

Ethics and dissemination
The trial was approved by the Charité—Universitätsmedizin Berlin Ethics Board and by the ethics board of each enrolled hospital. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.

Trial registration number
The trial protocol was registered with the German Clinical Trials Register on 21 June 2024 prior to initiation of patient enrolment (DRKS00033397).

Introduction
Dyslipidaemia, affecting approximately 39% of adults worldwide, is a major risk factor for cardiovascular disease. Individuals with dyslipidaemia are often prescribed statins, which effectively lower plasma low-density lipoprotein cholesterol (LDL-C), thereby reducing the risk of cardiovascular events and mortality. Although statins lower LDL-C, emerging evidence suggests that they may counteract the beneficial adaptations to exercise in skeletal muscle mitochondria and whole-body aerobic capacity. The underlying mechanisms remain unclear, and there is a need for studies investigating how statins influence molecular adaptations to exercise. The primary objective of this study is to investigate the combined effects of statin therapy and focused exercise training on mitochondrial function and whole-body aerobic capacity in people with dyslipidaemia. The untargeted proteomic analysis will be incorporated to provide detailed insights into how statins may affect mitochondrial proteins and other muscle metabolic traits, offering molecular explanations for altered functional readouts at both the muscle and whole-body levels.

Methods and analysis
A total of 100 women and men (aged 40–65 years) diagnosed with dyslipidaemia without atherosclerotic cardiovascular disease will be enrolled in this 12-week, double-blinded, randomised, placebo-controlled trial. Participants will be randomised into one of four groups using a block randomisation approach to ensure an allocation ratio of 60:40 for exercise and non-exercise conditions, respectively. The four groups will be: (1) exercise+placebo, (2) exercise+atorvastatin (80 mg/day), (3) atorvastatin (80 mg/day) and (4) placebo. The primary outcome is mitochondrial function, measured by changes in skeletal muscle citrate synthase activity from baseline to post-intervention. Secondary outcomes include whole-body aerobic capacity (VO2peak) and proteomic analyses. Genetic analysis will be conducted to assess the role of genetic polymorphisms in individual responses to statins and exercise.

Ethics and dissemination
The trial has received ethical approval from the Faroe Islands Ethical Committee (2024-10) and adheres to the Declaration of Helsinki and General Data Protection Regulation (GDPR). Results will be published in peer-reviewed international journals.

Trial registration number
NCT06841536.

Introduction
Striking the balance in 24-hour movement behaviour (sedentary behaviour, physical activity and sleep) is expected to reduce the risk of a new major cardiovascular event or death (MACE). We aim to determine the effectiveness and cost-effectiveness of the RISE (Reduce and Interrupt sedentary behaviour using a blended behavioural intervention to Empower people at risk towards sustainable 24-hour movement behaviour change) intervention by improving 24-hour movement behaviour for prevention of MACE and gaining quality-adjusted life years (QALYs) in community-dwelling people at risk with a first-ever stroke.

Methods and analysis
This assessor-blinded multicentre randomised controlled trial includes about 1000 participants with a first-ever stroke, of which 752 participants require secondary prevention based on their 24-hour movement behaviour. Participants will be randomly assigned to the experimental group (RISE intervention + usual care) or control (usual care) group. RISE is a 15-week blended care intervention: primary care physiotherapists coach people in their home setting using behaviour change techniques and the RISE eCoaching system. This system consists of: (1) an activity monitor, (2) a smartphone application that provides real-time feedback and contains e-learning modules and (3) a monitoring dashboard for the physiotherapist. A close relative of the participant is involved during the intervention to provide social support. The primary outcome is the effectiveness of the RISE intervention regarding the prevention of MACE measured at one year post randomisation using survival analysis comparing the experimental and control groups. Secondary outcomes include cost-effectiveness for MACE prevention and QALYs and changes in 24-hour movement behaviour over time using compositional data analysis.

Ethics and dissemination
Ethical approval is obtained from Medical Ethics Review Committee Utrecht, NedMec NL83940.000.23. Findings will be disseminated through international peer-reviewed journals and conferences. A sustainable 24-hour movement behaviour change is needed to gain long-term benefits of lowering MACE in patients with stroke. The RISE intervention offers this foundation by integrating behaviour change techniques, the RISE eCoaching system, involvement of participatory support and extensively trained RISE physiotherapists. Consequently, the RISE intervention is expected to be (cost-)effective compared with usual care, and hence, this study will offer a foundation for implementing the RISE intervention in standard poststroke care.

Trial registration number
NCT06124248.

Introduction
The first 3 months post partum is a critical transition period for women and families, which is characterised by physical, psychological and social adaptation. The first year post partum is also a critical phase for women’s health, given their physical recovery and adjustment to motherhood. The WHO 2023 recommendations highlight the importance of a postnatal care focus, including maternal health assessment, mental health support, nutritional interventions, postpartum contraceptive use and home care visits. This scoping review aims to map the evidence of the effectiveness of postpartum care on women’s health and quality of life in the Southeast Asia region.

Methods and analysis
This scoping review will be guided by the methodological principles developed by Arksey and O’Malley. This review will also consider observational studies, including cohort studies, case-control studies and cross-sectional studies. For inclusion, studies should be selected for eligibility based on the following criteria: articles investigating the uptake of postpartum women (women who have had childbirth up to 42 days after delivery) in Southeast Asian countries. The search will comprise peer-reviewed articles from 2013 to 2023 from the following electronic databases: PubMed/MEDLINE, ProQuest, EBSCO, Scopus, Web of Science and Google Scholar. We use both keywords in the title and/or abstract and subject headings as appropriate. We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) Protocols to develop the protocol and use the PRISMA flow diagram to present the results for scoping reviews.

Ethics and dissemination
A scoping review is a novel approach for examining the breadth of literature regarding the connection between the effectiveness of postpartum care and women’s health and quality of life and, as a secondary analysis, does not require ethics approval. The results of this review will be submitted for publication in a peer-reviewed journal and presented at relevant conferences.