bluuebunny/crossref_metadata_2025_split huggingface dataset:
Standardized assessment of evidence supporting the adoption of mobile health solutions: A Clinical Consensus Statement of the ESC Regulatory Affairs Committee
Authors: Caiani Enrico G , Kemps Hareld , Hoogendoorn Petra , Asteggiano Riccardo , Böhm Allan , Borregaard Britt , Boriani Giuseppe , Brunner La Rocca Hans-Peter , Casado-Arroyo Ruben , Castelletti Silvia , Christodorescu Ruxandra Maria , Cowie Martin R , Dendale Paul , Dunn Fiona , Fraser Alan G , Lane Deirdre A , Locati Emanuela T , Małaczyńska-Rajpold Katarzyna , Merșa Caius O , Neubeck Lis , Parati Gianfranco , Plummer Chris , Rosano Giuseppe , Scherrenberg Martijn , Smirthwaite Amie , Szymanski Piotr 
Published: June 2024

Abstract
Mobile health (mHealth) solutions have the potential to improve self-management and clinical care. For successful integration into routine clinical practice, healthcare professionals (HCPs) need accepted criteria helping the mHealth solutions’ selection, while patients require transparency to trust their use. Information about their evidence, safety and security may be hard to obtain and consensus is lacking on the level of required evidence. The new Medical Device Regulation is more stringent than its predecessor, yet its scope does not span all intended uses and several difficulties remain. The European Society of Cardiology Regulatory Affairs Committee set up a Task Force to explore existing assessment frameworks and clinical and cost-effectiveness evidence. This knowledge was used to propose criteria with which HCPs could evaluate mHealth solutions spanning diagnostic support, therapeutics, remote follow-up and education, specifically for cardiac rhythm management, heart failure and preventive cardiology. While curated national libraries of health apps may be helpful, their requirements and rigour in initial and follow-up assessments may vary significantly. The recently developed CEN-ISO/TS 82304-2 health app quality assessment framework has the potential to address this issue and to become a widely used and efficient tool to help drive decision-making internationally. The Task Force would like to stress the importance of co-development of solutions with relevant stakeholders, and maintenance of health information in apps to ensure these remain evidence-based and consistent with best practice. Several general and domain-specific criteria are advised to assist HCPs in their assessment of clinical evidence to provide informed advice to patients about mHealth utilization.
E-vita OPEN NEO in the treatment of acute or chronic aortic pathologies: first interim results of the NEOS study
Authors: Tsagakis Konstantinos , Kempfert Joerg , Zierer Andreas , Martens Andreas , Dohle Daniel-Sebastian , Castiglioni Alessandro , Wong Randolph Hung-Leung , Widenka Kazimierz , Liakopoulos Oliver , Borger Michael A , Oo Aung Ye , Holubec Tomas , Luehr Maximilian , Legarra Calderón Juan José , Grabenwöger Martin 
Published: June 2024

Abstract

OBJECTIVES
The aim of this multicentre study was to demonstrate the safety and clinical performance of E-vita OPEN NEO Stent Graft System (Artivion, Inc.) in the treatment of aneurysm or dissection, both acute and chronic, in the ascending aorta, aortic arch and descending thoracic aorta.

METHODS
In this observational study of 12 centres performed in Europe and in Asia patients were enrolled between December 2020 and March 2022. All patients underwent frozen elephant trunk using E-vita OPEN NEO Stent Graft System. Primary end point was the rate of all-cause mortality at 30 days and secondary end points included further clinical and safety data are reported up to 3–6 months postoperatively.

RESULTS
A total of 100 patients (66.7% male; mean age, 57.7 years) were enrolled at 12 sites. A total of 99 patients underwent surgery using the E-vita OPEN NEO for acute or subacute type A aortic dissection (n = 37), chronic type A aortic dissection (n = 33) or thoracic aortic aneurysm (n = 29), while 1 patient did not undergo surgery. Device technical success at 24 h was achieved in 97.0%. At discharge, new disabling stroke occurred in 4.4%, while new paraplegia and new paraparesis was reported in 2.2% and 2.2%, respectively. Renal failure requiring permanent (&gt;90 days) dialysis or hemofiltration at discharge was observed in 3.3% of patients. Between discharge and the 3–6 months visit, no patients experienced new disabling stroke, new paraplegia or new paraparesis. The 30-day mortality was 5.1% and the estimated 6-month survival rate was 91.6% (standard deviation: 2.9).

CONCLUSIONS
Total arch replacement with the E-vita OPEN NEO can be performed with excellent results in both the acute and chronic setting. This indicates that E-vita OPEN NEO can be used safely, including in the setting of acute type A aortic dissection.
Two-year prognosis and cardiovascular disease prevention after acute coronary syndrome: the role of cardiac rehabilitation—a French nationwide study
Authors: Blacher Jacques , Olié Valérie , Gabet Amélie , Cinaud Alexandre , Tuppin Philippe , Iliou Marie-Christine , Grave Clémence 
Published: June 2024

Abstract

Aims
To evaluate the impact of cardiac rehabilitation (CR) on optimization of secondary prevention treatments for acute coronary syndrome (ACS), medication persistence, medical follow-up, rehospitalization, and all-cause mortality.

Methods and results
The National Health Insurance database was used to identify all patients hospitalized for ACS in France in 2019 and those among them who received CR. Patients’ characteristics and outcomes were described and compared between CR and non-CR patients. Poisson regression models were used to identify the impact of CR after adjusting for confounders. A Cox model was fitted to identify the variables related to mortality after adjustment for medication persistence and cardiologic follow-up. In 2019, 22% of 134 846 patients hospitalized for ACS in France received CR within 6 months of their discharge. After 1 year, only 60% of patients who did not receive CR were still taking BASI (combination of beta-blockers, antiplatelet agents, statins, and renin–angiotensin–aldosterone system inhibitors) drugs. This rate and the medical follow-up rate were higher in patients who received CR. Two years after the ACS event, patients who received CR had better medical follow-up and lower mortality risk, after adjusting for cofounding variables [adjusted hazard ratio all-cause mortality = 0.65 (0.61–0.69)]. After adjustment for the dispensing of cardiovascular drugs and cardiologic follow-up, the independent effect of CR was not as strong but remained significant [hazard ratio = 0.90 (95% confidence interval: 0.84–0.95)].

Conclusion
Patients who received CR after hospitalization for ACS had a better prognosis. Optimization of efficient secondary prevention strategies, improved medication persistence, and enhanced cardiologic follow-up seemed to play a major role.
Dosing of IV posaconazole to treat critically ill patients with invasive pulmonary aspergillosis: a population pharmacokinetics modelling and simulation study
Authors: Elkayal Omar , Mertens Beatrijs , Wauters Joost , Debaveye Yves , Rijnders Bart , Verweij Paul E , Brüggemann Roger J , Spriet Isabel , Dreesen Erwin 
Published: June 2024

Abstract

Background
Posaconazole is used for the prophylaxis and treatment of invasive fungal infections in critically ill patients. Standard dosing was shown to result in adequate attainment of the prophylaxis Cmin target (0.7 mg/L) but not of the treatment Cmin target (1.0 mg/L).

Objectives
To provide an optimized posaconazole dosing regimen for IV treatment of patients with invasive pulmonary aspergillosis in the ICU.

Methods
A population pharmacokinetics (popPK) model was developed using data from the POSA-FLU PK substudy (NCT03378479). Monte Carlo simulations were performed to assess treatment Cmin and AUC0–24 PTA. PTA ≥90% was deemed clinically acceptable. PopPK modelling and simulation were performed using NONMEM 7.5.

Results
Thirty-one patients with intensive PK sampling were included in the PK substudy, contributing 532 posaconazole plasma concentrations. The popPK of IV posaconazole was best described by a two-compartment model with linear elimination. Interindividual variability was estimated on clearance and volume of distribution in central and peripheral compartments. Posaconazole peripheral volume of distribution increased with bodyweight. An optimized loading regimen of 300 mg q12h and 300 mg q8h in the first two treatment days achieved acceptable PTA by Day 3 in patients &lt;100 kg and ≥100 kg, respectively. A maintenance regimen of 400 mg q24h ensured ≥90% Cmin PTA, whereas the standard 300 mg q24h was sufficient to achieve the AUC0–24 target throughout 14 days, irrespective of bodyweight.

Conclusions
We have defined a convenient, optimized IV posaconazole dosing regimen that was predicted to attain the treatment target in critically ill patients with invasive aspergillosis.
Unusual presentation of cutaneous myiasis in the knee: case report
Authors: Dahduli Omar S , Aldeghaither Sarah A , Alhossan Abdullah M 
Published: June 2024

Abstract
Myiasis is infestation of live human tissue by larva. It usually involves immunocompromised people or people living in unsanitary conditions. The cutaneous myiasis is most common type and can enter the skin with a pre-existing wound. Herein we present a case of an 18-year-old girl known case of Dystrophic Epidermolysis Bullosa with cutaneous myiasis affecting the knee managed surgically with full recovery. Such case has not reported previously in the literature, and detailed management plan is described.
Eosinophilic appendicitis: an insidious and fortuitous diagnosis
Authors: Llera Brent , Hanna Iman , Jureller Michael 
Published: June 2024

Abstract
Eosinophilic appendicitis is a rare inflammatory condition characterized by the infiltration of eosinophils into the appendix, which is often misdiagnosed as acute appendicitis given similarities in their clinical presentation. Acute eosinophilic appendicitis: a rare cause of lower gastrointestinal hemorrhage. Within this particular report, we present a case of eosinophilic appendicitis in a 42-year-old female who underwent a laparoscopic appendectomy. The purpose of this report is to increase awareness about this unique condition and emphasize the importance of considering eosinophilic appendicitis as a differential diagnosis in patients with appendicitis-like symptoms whose clinical examination and laboratory findings may suggest otherwise.
A rare case of small cell neuroendocrine carcinoma of gallbladder origin
Authors: Dülger Uğur Can , Erdem Şahin , Cünük Emine Sena , Altıntoprak Fatih 
Published: June 2024

Abstract
Neuroendocrine carcinomas (NECs) of the gallbladder are very rare and aggressive tumors with poor prognosis. Most of them are poorly differentiated and belong to the small cell type. We report a case of a 59-year-old woman who presented with abdominal pain and distension. Contrast-enhanced computed tomography revealed a large heterogeneous mass in the liver, adjacent to the gallbladder, and omental nodules. CA 19-9 level was elevated and ascitic fluid cytology was suspicious for malignancy. Percutaneous biopsy of the liver mass confirmed the diagnosis of small cell NEC of the gallbladder. The patient was considered inoperable and planned for chemotherapy, but she died 20 days after admission. This case illustrates the diagnostic challenges and the dismal outcome of small cell NEC of the gallbladder. Early detection and multimodal treatment are essential for improving the survival of these patients.
Experiences of Deployed Physicians in Support of Operation Allies Refuge/Operation Allies Welcome: Lessons to Inform Improvements in Training
Authors: Kiger Michelle E , Hickey Patrick W , Hammond Caitlin E , Knickerbocker Kara J , Wolf Lauren J , Lara Sebastian 
Published: June 2024

ABSTRACT

Introduction
Stability operations, including humanitarian assistance and disaster relief missions, are key functions of U.S. Military medicine and the Military Medical Humanitarian Assistance Course (MMHAC) is a 2-day course widely used to prepare military medical personnel for such missions. It focuses on caring for those most vulnerable in the wake of disasters, particularly children. The large-scale humanitarian deployment of military medical providers in support of Operation Allies Welcome/Operation Allies Refuge (OAW/OAR) presents an opportunity to evaluate the preparedness of these providers to care for the needs of the Afghan travelers, so we explored the experiences of military medical providers deployed in support of OAW/OAR to inform improvements in the MMHAC.

Materials and Methods
We conducted a qualitative study of military medical providers who were deployed in support of OAW/OAR using a series of three virtual focus groups. Focus group questions were structured around the main topics covered in the MMHAC (patient care, ethical considerations, logistical concerns, and preventive and public health) and explicitly asked about adaptive leadership challenges faced and strategies used to overcome them. We analyzed transcripts using inductive thematic analysis within a constructivist paradigm, with adaptive leadership as a sensitizing concept. The study was approved by the Institutional Review Board of Uniformed Services University.

Results
We constructed 4 themes from participant responses, each addressing challenges that medical providers faced during their mission: (1) Medical providers navigated tension between medical and public health priorities and military mission priorities; (2) Chronic and complex care needs posed unique challenges for medical personnel; (3) Challenges in patient care were compounded by logistical and system-based barriers; and (4) Cultural barriers led to ethical dilemmas that physicians felt inadequately prepared to handle, most notably with respect to gender-related concerns. Within each theme, participants described which aspects of MMHAC training were most helpful and which areas were inadequate.

Conclusions
Physicians found the OAR/OAW mission meaningful but also identified challenges related to medical care provision, public health, logistics, and ethical dilemmas that hindered their ability to carry out their medical mission. Lessons learned from OAW/OAR highlight several areas in which the MMHAC training could be augmented and improved to further mitigate these challenges.
Using a Fitbit-based Walking Game to Improve Physical Activity Among U.S. Veterans
Authors: Simmering Jacob E , Polgreen Linnea A , Francis Shelby L , Strom Austin J , Segre Alberto M , Polgreen Philip M 
Published: June 2024

ABSTRACT

Introduction
Physical inactivity, hereafter inactivity, is a serious health problem among U.S. veterans, hereafter veterans. Inactive adults are at risk for adverse cardiac events and premature mortality. Specifically, among veterans, inactivity has been associated with a 23% increase in mortality. In order to increase physical activity among veterans, we developed Veterans Affairs (VA) MapTrek, a mobile-phone-based web app that allows users to take a virtual walk in interesting locations around the world while tracking their progress against that of others like themselves on an interactive map. Steps are counted by a commercially available Fitbit triaxial accelerometer, and users see their progress along a predefined scenic path overlaid on Google Maps. The objective of this study was to determine the effectiveness of VA MapTrek to increase physical activity in a population of veterans at risk for obesity-related morbidity.

Materials and Methods
We recruited overweight and obese veterans obtaining care at the Iowa City Veterans Affairs Health Center. Half of the veterans were assigned to participate in VA MapTrek. Each week, participants were assigned virtual walking races (Monday through Saturday), which followed a predetermined route that is displayed on Google Maps. The participant’s position on the map is automatically updated each time their Fitbit syncs to their phone. In addition, challenges were issued periodically. Veterans in the control group were only given a Fitbit. We regressed daily step counts on the days of the week, the days since the start of the intervention period, whether the user was in the VA MapTrek or Control group, and an interaction between the study group and the days since the start of the intervention period. We included subject-specific random intercepts and subject-specific random slopes. This model was estimated using Bayesian Hamiltonian Monte Carlo using Stan’s No-U-Turns sampler. We set vague, uniform priors on all the parameters.

Results
We enrolled 276 participants, but only 251 (102 in the control group and 149 in the VA MapTrek group) contributed data during the intervention period. Our analysis suggests an 86.8% likelihood that the VA MapTrek intervention led to a minimum increase of 1,000 daily steps over the 8-week period, compared to the control group. Throughout the 8-week intervention, we project that VA MapTrek participants would have taken an extra 96,627 steps, equivalent to 77.8 additional kilometers (km) (48.3 additional miles), assuming an average of 1,242 steps per km (2,000 steps per mile).

Conclusions
Our study underscores the potential of VA MapTrek as an intervention for promoting walking among veterans who face elevated risks of obesity and cardiac issues. Rural veterans are a high-risk population, and new interventions like VA MapTrek are needed to improve veterans’ health.
Balance, Landing Biomechanics, and Functional Movement Screen Characteristics With and Without Knee Exoskeleton in Military Soldiers
Authors: Nagai Takashi , Zeppetelli David J , Sarantos Lucas C , Johnson Caleb D , Borden Charles Joseph B , Dempsey Cole A , Ramirez Vanessa 
Published: June 2024

ABSTRACT

Introduction
A light-weight pneumatic-powered knee exoskeleton could augment mobility and lifting capabilities for a variety of occupational settings. However, added weight/bulkiness and artificially produced knee extension torque could compromise sensorimotor characteristics.

Materials and Methods
Ten healthy participants conducted 3 visits within 10 days to the biomechanics laboratory. Participants were asked to complete the following tasks on each visit: single-leg balance, single-leg drop-landing, and select functional movement tasks. Balance characteristics (the ground reaction forces variability and center-of-pressure velocity) were derived from force plates while knee flexion angles during drop-landing and functional movement tasks were captured using a motion capture system. Descriptive statistics as well as paired t-tests or Wilcoxon signed-rank tests were used to compare between conditions. Significance was set at P &lt; .05 a priori.

Results
During single-leg balance, the ground reaction force variabilities were significantly increased (P = .013–.019) and the center of pressure velocity was decreased (P = .001–.017) when wearing knee exoskeleton. During single-leg drop-landing, the exoskeleton condition showed lower knee flexion angles at the initial contact (P = .004–.021) and peak (P = .006–.010). Additionally, the peak vertical ground reaction force was higher in the exoskeleton condition (P = .007). During functional movement tasks, the exoskeleton condition showed less knee flexion range-of-motion during the overhead squat (P = .007–.033) and hurdle step-over (P = .004–.005).

Conclusions
Participants exhibited stiffer landing technique with the exoskeleton. Given that these compromised sensorimotor characteristics have been associated with musculoskeletal injury risk, modifications to exoskeletons to promote softer landing and greater knee flexion range-of-motion during dynamic activities may be warranted.
Current Status of Cold Injuries in the South Korean Military Over the Past 5 Years: Analysis and Assessment Based on the 2023–2024 Surveillance System
Authors: Ha Beom-man , Lim Hunjong , Yu Jeong-A , Jung Jae-Hyeop 
Published: June 2024

ABSTRACT

Introduction
This study aimed to examine the prevalence of cold injuries and review the cold injury monitoring system in the South Korean military.

Materials and Methods
This study conducted a retrospective and cross-sectional analysis using data from the Defense Medical Statistic Information System (DMSIS) on cold injuries among military personnel from 2018 to 2023. It incorporated findings from the Korean Armed Forces Medical Command’s cold injury surveillance system and analyzed cases from the Armed Forces Capital Hospital, covering all branches of the military by status and rank.

Results
An analysis of cold injury in the South Korean military over the past 5 years revealed varying numbers of cases treated, from 799 in 2018-2019 to 467 in 2022-2023. According to the surveillance system in 2023-2024, the Army experienced the majority of these cases, with 94.5% of the total. The incidence per 1,000 personnel was the highest in the Army at 0.98 compared to the Air Force and Navy/Marine Corps. Rank-based analysis indicated the most affected were private first-class soldiers. Frostbite was the most frequent condition, alongside chilblains, hypothermia, and immersion injuries, with no marked difference in the type of illness across branches.

Conclusions
The study underscores the need for focused prevention and treatment, particularly in the Army. By analyzing data from a newly implemented surveillance system, it revealed a higher incidence of frostbite and chilblains among lower ranks. The findings highlight the importance of targeted educational measures and enhanced response strategies to protect personnel against cold injuries.
In silico design of DNA sequences for in vivo nucleosome positioning
Authors: Routhier Etienne , Joubert Alexandra , Westbrook Alex , Pierre Edgard , Lancrey Astrid , Cariou Marie , Boulé Jean-Baptiste , Mozziconacci Julien 
Published: June 2024

Abstract
The computational design of synthetic DNA sequences with designer in vivo properties is gaining traction in the field of synthetic genomics. We propose here a computational method which combines a kinetic Monte Carlo framework with a deep mutational screening based on deep learning predictions. We apply our method to build regular nucleosome arrays with tailored nucleosomal repeat lengths (NRL) in yeast. Our design was validated in vivo by successfully engineering and integrating thousands of kilobases long tandem arrays of computationally optimized sequences which could accommodate NRLs much larger than the yeast natural NRL (namely 197 and 237 bp, compared to the natural NRL of ∼165 bp). RNA-seq results show that transcription of the arrays can occur but is not driven by the NRL. The computational method proposed here delineates the key sequence rules for nucleosome positioning in yeast and should be easily applicable to other sequence properties and other genomes.