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Randomized adaptive assessment of post COVID syndrome treatments (RAPID): a study protocol for a multicenter, randomized, controlled adaptive platform trial of treatment options for Post Covid Syndrome (PCS) on patients physical function including the first intervention specific appendix RAPID_REVIVE (reducing inflammatory activity in patients with PCS)
No full textAbstract Background The majority of patients recovers from severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) coronavirus disease 2019 (COVID-19) without obvious sequelae, but a significant proportion suffers long-term consequences which have been termed post COVID syndrome (PCS). Despite a wide range of considerations on treatment options in PCS and a significant number of trials initiated, only very few results from randomized controlled trials are currently available. In conclusion, there is an evident medical need to identify treatments for patients with PCS. Methods The primary objective of the platform trial RAPID is to assess the impact of different PCS treatments on the overall physical function of patients. Designed as a master protocol, RAPID contains all information that is generic to this adaptive platform trial. Current and future study treatments are specified in intervention-specific appendices (ISA). The first ISA, RAPID_REVIVE is presented in this manuscript. General sections of the master protocol are named as such. RAPID_REVIVE is a double-blind, placebo-controlled, phase II clinical trial evaluating antiviral PCS treatment with vidofludimus calcium (IMU-838). Patients are randomized at a 1:1 ratio to 45 mg/day vidofludimus calcium (22.5 mg for the first 7 days) or placebo during an initialization phase and thereafter using a response-adaptive randomization procedure. The trial includes a screening period of 7 days, a double-blind treatment period of 56 days and a follow-up period of 28 days. The primary outcome is the intra-patient change in physical function measured by the Short Form-36 Physical Function (SF-36-PF) from baseline to day 56. Secondary endpoints include mental and physical health, intensity of fatigue, severity of mental disorder symptoms, and cognitive function. Discussion PCS is a major problem for global health care and the identification of treatment options is urgently needed. Currently, PCS patients are in a situation without evidence-based treatment options, and quality of life, and often mental health are significantly impaired. The purpose of RAPID is to establish an adaptive platform trial protocol which will concert and quicken clinical trials to evaluate the efficacy and safety of different potential treatments for PCS with the aim to expand the very limited evidence base for the treatment of PCS. Trial registration EU Clinical Trials Register (CTIS) ID: 2024–511628-16–00 (RAPID_REVIVE). Registered on 18.03.2024.Bundesministerium für Bildung und Forschung http://dx.doi.org/10.13039/501100002347Johann Wolfgang Goethe-Universität, Frankfurt am Mai
Predicting Postoperative Delirium in Older Patients Before Elective Surgery: Multicenter Retrospective Cohort Study
No full textAbstract Background Elective surgeries for older adults are increasing. Machine learning could enhance risk assessment, influencing surgical planning and postoperative care. Preoperative cognitive assessment may facilitate early detection and management of postoperative delirium (POD). Objective This study aims to assess machine learning models' predictive ability for POD, focusing on the added predictive value of the neuropsychological assessments before elective surgery. Methods This retrospective cohort study analyzed data from the multicenter PAWEL (Patient safety, Efficiency and Life quality in elective surgery) and PAWEL-R (risk) studies, encompassing older patients (≥70 y) undergoing elective surgeries from July 2017 to April 2019. A total of 1624 patients (52.3% male, N=850; age: mean 77.9, SD 4.9 years) were included, with a POD diagnosis made before discharge. Sociodemographic, clinical, surgical, and neuropsychological features were collected pre- and intraoperatively by care providers. Machine learning models’ performance was evaluated using the area under the receiver operating characteristic curve (AUC), with permutation testing for significance, and Shapley Additive Explanations to identify effective neuropsychological assessments. Results Predicting POD before surgery with a random forest model achieved an AUC of 0.760. Incorporating all pre- and intraoperative features into the model yielded a slightly higher AUC of 0.783, with no statistically significant difference observed ( P =.24). While cognitive factors alone were not strong predictors (AUC=0.617), specific tests within neuropsychological assessments, such as the Montreal Cognitive Assessment and Trail Making Tests, showed high feature attribution and played a crucial role in further enhancing prediction before surgery. Conclusions Preoperative risk prediction for POD can increase risk awareness in presurgical assessment and improve perioperative management in older patients at a high risk for delirium
Perspectives: State of national forest damage survey programmes in Europe and ways toward improved harmonization and data sharing
No full textFrom narrative to actions: Theoretical framework for the integration of reframed narratives into New Zealand's agricultural policy
No full texthttp://dx.doi.org/10.13039/501100003524 New Zealand Ministry of Business Innovation and Employmen
A comprehensive review of AI-driven plant stress monitoring and embedded sensor technology: Agriculture 5.0
No full textA Leishmania virulence factor harnesses an allosteric kinase switch to regulate its ubiquitin ligase activity
No full textSearch for a new scalar decaying into new spin-1 bosons in four-lepton final states with the ATLAS detector
No full textImpact of radiation dose on immune cells (EDIC) on oncologic outcome in small cell lung cancer (SCLC)
No full texthttp://dx.doi.org/10.13039/501100002347 BMBF Bon
Safety and prognostic value of left ventricular endomyocardial biopsy in dilated cardiomyopathy
No full textAims The need to perform endomyocardial biopsy (EMB) in patients with non‐ischaemic dilated cardiomyopathies (DCM) is debated. Here we sought to determine the extent of left ventricular collagen volume fraction (LV‐CVF) in DCM patients and to evaluate it as a prognostic marker. Methods and results In this retrospective longitudinal study, we included 524 patients with suspected DCM who underwent left ventricular EMB (LV‐EMB) as a part of their clinical work‐up. LV‐CVF was quantified using automated image processing of high‐resolution scans of LV‐EMB. Deep phenotyping was performed including assessment of late gadolinium enhancement on cardiac magnetic resonance imaging. Endpoints were (i) composite endpoint of heart failure‐related death, sudden cardiac death, aborted sudden cardiac death (appropriate implantable cardioverter‐defibrillator shock, reported sustained ventricular tachycardia, or cardiopulmonary resuscitation), or cardiac transplantation, and (ii) all‐cause mortality. LV‐EMB was associated with 0.76% major and 2.1% minor complications. No death occurred due to EMB. LV‐CVF could be reliably quantified using Bayesian classification. During a median follow‐up of 43.2 months (2084 patient‐years), 48 patients with LV‐CVF >32% and 14 patients with LV‐CVF ≤32% reached the composite endpoint (log‐rank p 32% and 17 with LV‐CVF ≤32% (log‐rank p = 0.009). In multivariable analyses, LV‐CVF and N‐terminal pro‐B‐type natriuretic peptide (NT‐proBNP) (hazard ratio 2.03, 95% confidence interval 1.32–3.11) were independent predictors of unfavourable outcome. Conclusions Left ventricular EMB is a safe diagnostic procedure. The extent of CVF in LV‐EMB provides prognostic information in patients with DCM in addition to existing measures of left ventricular ejection fraction or NT‐proBNP
Towards more balanced dietary guidelines: connecting climate, culture, and nutrition
No full textAbstract Objective: The transformation of food systems has emerged as a critical component of global climate action, with food-based dietary guidelines (FBDGs) increasingly recognised as a key policy tool to promote both public health and environmental sustainability. However, despite their importance, many national FBDGs fail to integrate sustainability considerations or adequately support diverse plant-based dietary patterns. Design: This review proposes a socioecological framework for enhancing the inclusivity and adaptability of FBDGs, enabling them to better reflect evolving food systems and consumer behaviours while strengthening their role in promoting sustainable and health-conscious diets. Results: Five key gaps in current FBDGs worldwide were identified: (1) the need for more inclusive food-group classifications that accommodate plant-based protein sources; (2) clearer recommendations for limiting the consumption of animal-sourced foods (ASF) for health and environmental reasons; (3) guidance on obtaining essential macro- and micronutrients from plant-based sources; (4) the inclusion of plant-based alternatives to ASF within dietary recommendations; and (5) comprehensive advice on well-planned vegetarian and vegan diets. Conclusion: Addressing these gaps is crucial to ensuring that FBDGs remain relevant to a broad spectrum of dietary preferences, including those motivated by ecological, ethical, religious, and cultural factors