Search Results for: Gestione del paziente con Lombalgia acuta e cronica in MG

Circulation, Ahead of Print. Background: There is sparse high-quality safety and effectiveness data for pulsed field ablation (PFA) of persistent atrial fibrillation (PerAF), where lesions beyond pulmonary vein isolation (PVI) are often placed. Additionally, no large trials have used insertable cardiac monitors (ICMs) for continuous rhythm monitoring post-ablation in PerAF patients, or after PFA inanyAF population. InADVANTAGE AF-Phase 2, PerAF patients underwent PFA for PVI and posterior wall ablation (PWA), and in a sub-cohort, cavotricuspid isthmus (CTI) ablation for typical atrial flutter.Methods: PerAF pts underwent PVI and PWA with the pentaspline PFA catheter, and CTI with a novel focal-linear PFA catheter after IV NTG prophylaxis. Patients were followed for 1 year with continuous rhythm monitoring after ablation with ICMs to 1) emulate traditional intermittent monitoring for the primary efficacy endpoint, and 2) examine atrial arrhythmia (AA) burden and episode duration.Results: This 255-patient cohort (age 66.7±9.3, female 29%, CHA2DS2-VASc 2.4±1.4, BMI 30.9±5.3, left atrium diameter 4.3±0.6 cm) underwent PVI plus PWA (99.6%/100% acute success); a subpopulation (n=141; 55.3%) also received CTI PFA, with 98.6% achieving bidirectional block without complications (ST changes, ventricular fibrillation). CTI ablation took 8±13 minutes, using 18±6 PF applications and 4±2 mg IV NTG. The total procedure and atrial dwell times were 105±36 and 59±24 minutes, respectively. Mimicking traditional monitoring, freedom from AA was 73.4% with adverse events in 2.4%, both meeting prespecified endpoint criteria. Freedom from recurrent atrial flutter was 97.2%. Detailed analysis of the full ICM data revealed freedom from AA ≥30 seconds in 52.0%, and no episode exceeded 24 hours in 94.0% of this PerAF cohort. An AA burden >0.1% or longest episode duration >1 hour were both predictive of increased healthcare utilization. One-year procedural effectiveness was 71.6% and 70.0% using these ≤0.1% burden and

Background
The KEYNOTE-966 study demonstrated that pembrolizumab combined with chemotherapy is more effective than chemotherapy alone as first-line treatment for patients with advanced biliary tract cancer (BTC). However, the cost-effectiveness of pembrolizumab combined with chemotherapy in the USA and China remains uncertain.

Objective
This study aimed to evaluate the cost-effectiveness of pembrolizumab plus chemotherapy compared with placebo plus chemotherapy from the perspective of US and Chinese payers.

Design
Markov models with three health states were developed to simulate the process of advanced BTC. Cost data were obtained from available databases and published literature in the US scenario, and from local institutions from the China scenario. Utility values were derived from previous studies.

Outcome measures
Primary outcomes included quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs).

Results
In the US scenario, pembrolizumab plus chemotherapy increased costs by US$97,222.13, compared with chemotherapy alone, with a gain of 0.12 QALYs, resulting in an ICER of US$810 184.42 per QALY. In the China scenario, the ICER was $360 933.50 per QALY. Sensitivity analyses indicated the costs of pembrolizumab had the greatest impact on the model in both scenarios. Further analyses suggested that the optimal price of pembrolizumab in the USA would be nearly US$10.33 /mg, while a price reduction of over 90% would be required for the combined therapy to be cost-effective for patients in China.

Conclusion
Based on the willingness-to-pay threshold set at three times the gross domestic product per capita, pembrolizumab plus chemotherapy is not a cost-effective option for patients with advanced BTC in either the USA or China. Significant price reduction for pembrolizumab may be necessary to achieve an acceptable ICER.

Trial registration number
NCT04003636; postresults.

Objective
To assess the association of C-reactive protein (CRP) with postoperative infections for eight different types of surgery using big data.

Design
A multicentre cohort study with longitudinally collected data from electronic health records, collected from 1 January 2011 to 22 September 2023.

Setting
Data of two tertiary medical centres in the Netherlands were used.

Participants
This study included all procedures (42 125 in total) in adult patients undergoing surgery in two tertiary medical centres in the Netherlands.

Outcome measures
The primary outcome was the association between CRP and a postoperative infection in the first 30 days postoperatively. Postoperative infection was defined by an action-based definition, that is, patients had to be treated for an infection with anti-microbial treatment and/or an intervention (eg, surgical drainage) to be classified as having a postoperative infection. CRP measurements were divided into a reference group (0–5.0 mg/dL) and four groups for comparison (5.1–10.0 mg/dL, 10.1–15.0 mg/dL, 15.1–20.0 mg/dL and >20.0 mg/dL). Subgroup analyses were performed for eight major surgical subspecialties and for the two medical centres separately.

Results
A total of 175,779 CRP measurements were performed, of which the majority was drawn in the first postoperative week. The ORs for developing a postoperative infection varied between 1.0 (0.9–1.1 95% CI) and 12.0 (9.5–15.1 95% CI), with a stronger association for the higher level of CRP categories and when more time had elapsed since surgery. Sensitivity ranged between 11% and 34%, specificity ranged between 64 and 95%, and the positive and negative predicting value ranged between 12% and 51% and 88% and 94%, respectively. For the surgical subspecialties and the two hospitals separately, similar results were found.

Conclusion
In this study, an elevated postoperative CRP was associated with postoperative infections with a stronger association for higher CRP levels. The association was stronger if a longer time had elapsed since surgery, which contrasts with the moment most CRP measurements were done, namely in the first postoperative week. Clinicians should take the evolving value of CRP in mind when using it in the diagnosis of postoperative infections.

Introduction
Irritable bowel syndrome (IBS) is one of the most common chronic gut–brain interaction disorders. Nevertheless, there is currently no treatment for IBS. Low-grade inflammation and oxidative stress are contributing factors to the increased perception of abdominal pain and heightened sensitivity of the nervous system in these patients. Spirulina platensis is a rich source of essential nutrients, including amino acids, vitamins, minerals, phytochemicals, essential fatty acids and fibre. It has been found that Spirulina possesses a variety of therapeutic properties such as antioxidant, anti-inflammatory and antidepressant effects, which may be advantageous in reducing complications of IBS. The aim of present randomised clinical trial (RCT) is to assess the efficacy of Spirulina supplementation on IBS.

Methods and analysis
This study is a 12-week, 1:1 parallel-group, double-blinded, randomised controlled trial. Sixty adult individuals diagnosed with IBS according to the Rome IV criteria will be randomised to consume either Spirulina capsules (500 mg) or a placebo, two times a day. The primary outcomes of this RCT are the changes in the IBS quality of life, severity of IBS symptoms, and gut permeability from baseline to 12 weeks of the intervention. The secondary outcomes are the changes in the serum total antioxidant capacity and serum malondialdehyde from baseline to the end of intervention. If this RCT demonstrates significant results in gut permeability, antioxidant status and reduction in IBS symptoms, it could support the use of Spirulina in managing IBS and could potentially reduce healthcare costs.

Ethics and dissemination
The study protocol has been approved by the Medical Ethics Committee of Isfahan University of Medical Sciences, Isfahan, Iran (ID: IR.MUI.RESEARCH.REC.1401.370). Findings will be presented in subsequent publications.

Trial registration number
IRCT20140208016529N8; Iranian Registry of Clinical Trials; registered on 25 April 2023.

Circulation, Ahead of Print. BACKGROUND:Patients with an autoimmune or inflammatory disease (AIID) are at increased cardiovascular risk and may benefit more from statin therapy. In the FOURIER trial (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), the PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor evolocumab lowered low-density lipoprotein cholesterol levels, but not hsCRP (high-sensitivity C-reactive protein) levels, and reduced the risk of cardiovascular events.METHODS:FOURIER was a randomized trial of evolocumab versus placebo in 27 564 patients with stable atherosclerosis who were taking statins. This analysis focused on the effect of evolocumab in patients with or without an AIID, defined as any autoimmune or chronic inflammatory condition. The primary end point was a composite of cardiovascular death, myocardial infarction, stroke, unstable angina, or coronary revascularization.RESULTS:At baseline, 889 patients (3.2%) had an AIID, most commonly rheumatoid arthritis (33.7%) or psoriasis (15.6%). Median (interquartile range) low-density lipoprotein cholesterol levels were 90.0 mg/dL (79.5–105.5) and 91.5 mg/dL (79.5–108.5) in patients with or without an AIID, respectively (P=0.025), and the placebo-adjusted percent reduction with evolocumab was consistent (60.2% versus 59.0%;P=0.57). Baseline hsCRP was higher in patients with an AIID (median 2.1 versus 1.7 mg/L;P

Complessa maratona operatoria per paziente con raro sarcoma

Ghebreyesus: “Siamo ancora nella fase acuta di questa epidemia”

Ghebreyesus: “Siamo ancora nella fase acuta di questa epidemia”

Al Policlinico Campus Biomedico di Roma. Il paziente è in fase di recupero

Intervento su un paziente 53enne di Tempio Pausania

Introduction
Prolonged grief disorder (PGD) represents a substantial public health issue, especially in oncology settings where it affects up to 30% of bereaved carers. Current best-practice treatments are lengthy, and up to 50% of participants have persistent PGD. Building on encouraging recent research with psychedelic-assisted therapies, the Psilocybin-Assisted suppoRtive psychoTherapy IN the treatment of prolonged Grief (PARTING) trial is the first study to consider psilocybin-assisted psychotherapy as a potential treatment for prolonged grief.

Methods and analysis
PARTING is an open-label pilot trial of psilocybin-assisted psychotherapy for approximately 15 people with cancer-related PGD. It aims to investigate feasibility, safety, acceptability, participant experience and participant-reported therapeutic effects. Over a 5-week intervention period, participants will undergo three preparation sessions before receiving a psychoactive (25 mg) dose of psilocybin alongside non-directive supportive guidance, followed by four integration sessions. All sessions will be delivered by a psychologist and either a nurse or Indigenous Therapist. An artificial intelligence-assisted tool will be used to create an artwork of participants’ psychedelic experience.
Outcomes will be investigated over a 12-month follow-up period. Feasibility will be assessed through recruitment/retention rates and completion of follow-up assessments. Safety will be evaluated via adverse events over 12 months and the comparison of physiological measures (vital signs, biochemistry, haematology, ECG) recorded during screening and 1 day after the psilocybin dose. Qualitative thematic analysis of semistructured interviews with participants and trial therapists will assess acceptability and the therapeutic potential of the treatment. Diagnostic clinical interviews for PGD and quantitative participant-reported measures of therapeutic effects are also being collected. Participant-reported measures include grief severity, depression, anxiety, grief avoidance, psychological flexibility, connectedness, and quality of life.

Ethics and dissemination
Ethics approval has been obtained from QIMR Berghofer Medical Research Institute Human Research Ethics Committee (P3801). Dissemination of results will occur via conference presentations, peer-reviewed publications and media.

Trial registration number
Australian New Zealand Clinical Trials Registry (ACTRN12623000827639).

Introduction
Increasing awareness of the high frequency, wide spectrum and disabling nature of symptoms that can persist following COVID-19 infection has prompted the investigation of management strategies. Our study aims to determine the effectiveness of atorvastatin on cognitive function, physical activity, mood, health-related quality of life and features of neurovascular impairment and neuroinflammation in adults with ongoing neurological symptoms after COVID-19 infection.

Methods and analysis
The STatin TReatment for COVID-19 to Optimise NeuroloGical recovERy study is an ongoing international, investigator-initiated and conducted, multicentre, prospective, randomised, open label, blinded endpoint trial with fixed time points for outcome assessments. A total of 410 participants with long covid neurological symptoms were planned to be randomly assigned to either the intervention group to receive 40 mg atorvastatin for 12 months or to a control group of no treatment, on top of usual care.

Ethics and dissemination
This study protocol was designed, implemented and reported, in accordance with the International Conference on Harmonisation guidelines for Good Clinical Practice, the National Health and Medical Research Council of Australia, the National Statement on Ethical Conduct in Human Research and with the ethical principles laid down in the World Medical Association Declaration of Helsinki. Central ethics committee approval was obtained from Sydney Local Health District Royal Prince Alfred Hospital Ethics (No: X21-0113 and 2021/ETH00777 10) in Australia. Site-specific ethics committee approvals were obtained elsewhere before any local study activities. All participants provided written informed consent.

Trial registration number
The study protocol is registered at Clinicaltrials.gov (NCT04904536).

Introduction
Osteoarthritis (OA) is a multifactorial disease in which low-grade inflammation is considered to play a pivotal role. Although colchicine is a widely used anti-inflammatory drug in the treatment of gout, its effect in OA is still disputed due to inconsistent results of short-term clinical trials. Therefore, we aim to evaluate the effect of long-term colchicine 0.5 mg once daily on the incidence of knee or hip replacements in patients with knee or hip OA.

Methods and analysis
The ECHO trial is a prospective, multicentre, randomised, double-blind, placebo-controlled, phase III trial in which 1200 participants with knee or hip OA tolerant to colchicine during a 30-day run-in period will be 1:1 randomised to colchicine 0.5 mg once daily or matching placebo using concealed allocation. The primary endpoint is the time from randomisation to the first knee or hip replacement assessed up to 4.5 years. Secondary endpoints include course of pain, physical function, joint space narrowing, low-grade inflammation, quality of life, clinical or radiological onset of OA in a new joint group other than present at baseline, number of participants using pain medication during the study, onset of new cardiovascular events (ie, myocardial infarction, ischaemia-driven coronary revascularisation, ischaemic stroke, peripheral artery disease or cardiovascular death) and direct and indirect costs related to treatment and disease burden due to OA. Harm-related endpoints include the number of (serious) adverse events, the number of withdrawals due to (serious) adverse events and changes in laboratory data (ie, serum creatinine, estimated glomerular filtration rate and alanine transferase) throughout the study. The primary analysis will be performed according to the intention-to-treat principle.

Ethics and dissemination
This trial has been approved by the Medical Ethics Review Committee East-Netherlands. Findings will be presented at scientific meetings and published in a peer-reviewed scientific journal.

Trial registration number
NCT06578182.