bluuebunny/crossref_metadata_2025_split huggingface dataset:
A Long-Term Follow-Up Study of Sotatercept for Treatment of Pulmonary Arterial Hypertension: Interim Results of SOTERIA
Authors: Preston Ioana R. , Badesch David , Ghofrani Hossein-Ardeschir , Gibbs J. Simon R. , Gomberg-Maitland Mardi , Hoeper Marius M. , Humbert Marc , McLaughlin Vallerie V. , Waxman Aaron B. , Manimaran Solaiappan , Mikhailova Elina , Reddy Madhavi , Lau Anna , de Oliveira Pena Janethe , Souza Rogerio 
Published: February 2025

BackgroundSOTERIA (NCT04796337) is an ongoing open-label study evaluating long-term safety, tolerability, and efficacy of sotatercept in participants with pulmonary arterial hypertension (PAH).MethodsEligible adults with PAH on stable background therapy who completed a prior sotatercept study without early discontinuation were enrolled. Participants received subcutaneous sotatercept (≤0.7 mg·kg−1Q3W). Safety and tolerability (primary objective) were assessed by adverse events (AEs), vital signs, and laboratory assessments. Efficacy (secondary objective) was assessed by 6-minute walk distance (6MWD), N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels, WHO functional class (FC), clinical worsening events, and simplified French risk score (SFRS). The data cutoff date was 08NOV2023.ResultsAltogether, 426 participants were included in the analyses. Mean (sd) duration of exposure to sotatercept and follow-up in SOTERIA was 448.6 (172.93) days (range 21–923 days; 523 patient-years). Of 426 participants, 387 (90.8%) experienced AEs, 15 (3.5%) discontinued treatment, 129 (30.3%) had serious AEs, and 11 (2.6%) had serious AEs related to treatment. There were 12 deaths (2.8%). Among AEs of interest, epistaxis (22.1%) and telangiectasia (16.9%) were the most frequently reported individual events. Twenty-two (5.2%) participants had serious bleeding events, including 2 (0.5%) with serious bleeding leading to death (not related to treatment by investigator judgment). Improvements in 6MWD, NT-proBNP, WHO FC, and SFRS achieved from baseline of SOTERIA were largely maintained at one year, including in the placebo-crossed group.ConclusionInterim results of SOTERIA support the favorable benefit-risk of add-on sotatercept treatment in adults with PAH. Follow-up reports from this study will provide additional information on benefit/risk.
Heart Rate response and cardiovascular risk during OSA: an easy biomarker derived from pulse oximetry
Authors: Blanchard Margaux , Imler Théo , Hu Wen-Hsin , Waeber Adrien , Solelhac Geoffroy , Haba-Rubio José , Kerbrat Sandrine , Sabil Abdelkebir , Trzepizur Wojciech , Goupil François , Thomas Audrey , Bailly Sébastien , Azarbarzin Ali , Vollenweider Peter , Marques-Vidal Pedro , Vaucher Julien , Heinzer Raphael , Gagnadoux Frédéric 
Published: February 2025

BackgroundSleep apnoea specific heart rate response (ΔHR) has been identified as a promising biomarker for stratifying cardiovascular (CV) risk, and predicting positive airway pressure (PAP) benefit in obstructive sleep apnoea (OSA). However, the need for prior manual scoring of respiratory events potentially limits the accessibility and reproducibility of ΔHR. We aimed to evaluate the association of pulse rate response to oxygen desaturations automatically derived from pulse oximetry (ΔHRoxi) with CV risk in OSA.MethodsΔHRoxiand ΔHR were measured in OSA patients from theIRSR Pays de la Loire Sleep Cohort(PLSC;n=5,002) and theHypnoLauscohort (n=1,307). The primary outcome was major adverse CV events (MACEs), a composite of mortality, stroke, and cardiac diseases. Cox regressions analyses were conducted to evaluate the association of ΔHRoxiand ΔHR categorized into low, midrange and high categories, with MACEs.ResultsMACEs occured in 768 patients fromPLSCand 87 patients fromHypnoLaus(median follow-up: 8.0 and 7.5 years respectively). Multivariable Cox models showed that subjects with high ΔHRoxi(vs midrange) had higher risk of MACEs inPLSC(hazard ratio, HR: 1.42 [95% CI:1.18–1.71]) andHypnoLaus(HR: 1.72 [1.03–2.87]). Similar findings were observed for high ΔHR. Among 2,718 patients fromPLSCtreated with PAP, the association of PAP adherence (PAP use ≥4 h/night, vs non adherence) with MACEs was modified by baseline ΔHR and ΔHRoxi(p for interaction<0.05).ConclusionsΔHRoxicould constitute a reliable and easy to measure biomarker for stratifying CV risk and predicting CV benefit of PAP in OSA.
Incident tuberculosis in people with HIV across Europe from 2012–2022: incidence rates, risk factors, and regional differences in a multicentre cohort study
Authors: Kraef Christian , Roen Ashley , Podlekareva Daria , Bakowska Elzbieta , Nemeth Johannes , Knappik Michael , Payen Marie-Christine , Wit Ferdinand , Mussini Christina , d'Arminio Monforte Antonella , Castagna Antonella , Chkhartishvili Nikoloz , Neesgaard Bastian , Jaschinski Nadine , Anne Alain Volny , Borodulina Elena , Ballief Marie , Wallner Elmar , Israelski Dennis , Garges Harmony , Mocroft Amanda , Kirk Ole ,   the RESPOND Study Group
Published: February 2025

BackgroundTuberculosis remains the leading cause of death among people with HIV. The aim of this study was to describe the incidence of tuberculosis (TB), explore risk factors and to calculate their population attributable fractions (PAF) in people with HIV across Europe, stratified by region.MethodLongitudinal study of people with HIV aged>18 years with follow-up from either 1/1/2012, or cohort enrolment, until date of TB diagnosis, last visit, death, or 31/12/2022. Factors associated with TB, in particular antiretroviral therapy status and smoking, were analysed using multivariable Poisson regression.ResultsA total of 38 837 participants with HIV with a median follow-up of 7.7 (4.3–10.4) years. Overall, 306 TB cases were diagnosed during 275 811 person-years of follow-up (PYFU; incidence rate (IR) 1.03/1000 PYFU, 95% CI 0.91–1.11). 3.3% (n=81/2428) participants had incident TB in Eastern Europe (IR 6.13, 4.93–7.62). Overall, the IR decreased from 2.03 (1.53–2.68) in 2012 to 0.44 (0.20–0.97) in 2022. Modifiable risk factors were smoking (adjusted incidence rate ratio 2.94; 95%CI1.62–5.34) and not receiving antiretroviral therapy (versuson; 3.29; 2.36–4.58). A history of TB pre-baseline increased the risk of recurrence (aIRR 7.77; 95%CI 4.09–14.74). The PAF for not receiving antiretroviral therapy was 34.6% in Non-Eastern Europe and 31.2% in Eastern Europe.ConclusionsTB incidence has been decreasing among people with HIV, but remains more frequent in Eastern Europe. Improvement of antiretroviral therapy-coverage and adherence and a focus on non-communicable disease risk factors such as smoking could reduce the incidence of TB.
Post-Hospitalisation COVID-19 Rehabilitation (PHOSP-R): A randomised controlled trial of exercise-based rehabilitation
Authors: Daynes Enya , Evans Rachael A , Greening Neil J , Bishop Nicolette C , Yates Thomas , Lozano-Rojas Daniel , Ntotsis Kimon , Richardson Matthew , Baldwin Molly M , Hamrouni Malik , Hume Emily , McAuley Hamish , Mills George , Megaritis Dimitrios , Roberts Matthew , Bolton Charlotte E , Chalmers James D , Chalder Trudie , Docherty Annemarie B , Elneima Omer , Harrison Ewen M , Harris Victoria C , Ho Ling p , Horsley Alex , Houchen-Wolloff Linzy , Leavy Olivia C , Marks Michael , Poinasamy Krishna , Quint Jennifer K , Raman Betty , Saunders Ruth M , Shikotra Aarti , Singapuri Amisha , Sereno Marco , Terry Sarah , Wain Louise V , Man William D-C , Echevarria Carlos , Vogiatzis Ioannis , Brightling Christopher , Singh Sally J 
Published: February 2025

ObjectivePost-COVID syndrome involves prolonged symptoms with multi-system and functional impairment lasting at least 12 weeks after acute COVID-19. We aimed to determine the efficacy of exercise-based rehabilitation interventions, either face-to-face or remote, compared to usual care in individuals experiencing Post-COVID syndrome following a hospitalisation of acute COVID-19.DesignThis single-blind randomised controlled trial compared two COVID exercise-based rehabilitation interventions (face-to-face or remote) to usual care in participants with Post-COVID syndrome following a hospitalisation. The interventions were either a face-to-face or remote eight-week program of individually prescribed exercise and education. The primary outcome was the change in Incremental Shuttle Walking Test (ISWT) following eight weeks of intervention (either face-to-face or remote) compared to usual care. Other secondary outcomes were measured including health related quality of life (HRQoL), and exploratory outcomes included lymphocyte immunotyping.Results181 participants (55% male, mean [sd] age 59 [12] years, length of hospital stay 12 [19] days) were randomised. There was an improvement in the ISWT distance following face-to-face rehabilitation (mean 52 [95% CI 19 to 85]m, p=0·002) and remote rehabilitation (mean 34 [95% CI 1 to 66]m, p=0·047) compared to usual care alone. There were no differences between groups for HRQoL of self-reported symptoms. Analysis of immune markers revealed significant increases in naïve and memory CD8+ T cells following face-to-face rehabilitation versus usual care alone (p<0·001, n=31).ConclusionExercise-based rehabilitation improved short-term exercise capacity in Post-COVID syndrome following an acute hospitalisation and showed potential for beneficial immunomodulatory effects.
Relevance of telemonitoring algorithms for the management of home noninvasive ventilation
Authors: Bianquis Clara , El Husseini Kinan , Razakamanantsoa Léa , Kerfourn Adrien , Fresnel Emeline , Borel Jean-Christian , Cuvelier Antoine , Dupuis Johan , Gagnadoux Frédéric , Morélot-Panzini Capucine , Gonzalez-Bermejo Jesus , Muir Jean-François , Prigent Arnaud , Rabec Claudio , Trzepizur Wojciech , Winck Joao , Murphy Patrick Brian , Patout Maxime 
Published: February 2025

BackgroundThe increasing number of patients requiring home noninvasive ventilation (HNIV) is a challenge for our healthcare system. Telemonitoring may be used to facilitate the management of HNIV patients. We aimed to assess the ability of telemonitoring algorithms to identify patients not adequately ventilated. Our secondary aim was to assess the consequences related to these algorithms, including costs.MethodsEleven HNIV experts each provided an algorithm to identify patients with suboptimal ventilation. Each algorithm was tested using real-life data from a cohort of patients over a 90-day period.Inadequate HNIV was defined as the presence of at least one criterion amongst the following: uncontrolled hypoventilation, daily adherence <4 h·day−1, HNIV related severe side effect, a residual event index>10/h.ResultsOne hundred patients were included in the cohort. According to our criteria, HNIV was considered as inadequate in 66 (66%) patients, without difference between underlying respiratory disease. Telemonitoring algorithms correctly classified patients in 65 [52–66] % of cases. They had a global sensitivity of 78 [37–95] %, a specificity of 40 [19–78] %, a positive predictive value of 72 [65–77] % and a negative predictive value of 45 [37–51] %.Applying telemonitoring algorithms resulted in 127 [84–238] alerts across the study population with a median cost increase of €2064 [952–6262].ConclusionTelemonitoring algorithms have poor diagnostic performances in identifying inadequately ventilated patient. They increase workload for healthcare workers and costs.
The impact of bronchoscopic lung volume reduction with endobronchial valves with or without pulmonary rehabilitation on symptoms of fatigue, anxiety and depression: a multicentre randomised controlled trial
Authors: Posthuma Rein , van der Molen Marieke C. , Vaes Anouk W. , Hartman Jorine E. , Spruit Martijn A. , Slebos Dirk-Jan , Vanfleteren Lowie E.G.W. 
Published: February 2025

BackgroundBronchoscopic lung volume reduction using one-way endobronchial valves (BLVR-EBV) improves exercise capacity and quality of life in patients with severe emphysema. However, its effect on symptoms of fatigue, anxiety and depression is unclear. Furthermore, if the combination of pulmonary rehabilitation (PR) and BLVR-EBV yields additional impact on these symptoms remains unknown. We hypothesized that BLVR-EBV would reduce symptoms of fatigue, anxiety and depression and that the combination of BLVR-EBV with PR would lead to additional reduction when compared to BLVR-EBV alone.MethodsThe SoLVE study (NCT03474471) was a prospective multicentre randomised controlled trial to examine the impact and optimal timing of PR on exercise physiology and patient reported outcomes in patients receiving BLVR-EBV treatment. Subjects were randomised into three groups: PR before BLVR-EBV, PR after BLVR-EBV and BLVR-EBV alone.Fatigue severity was assessed using the Checklist Individual Strength fatigue subscale (CIS-fatigue). The Hospital Anxiety and Depression Scale evaluated symptoms of anxiety (HADS-A) and depression (HADS-D).ResultsNinety-seven participants were included. After 6-months follow-up the overall mean change after BLVR-EBV with or without PR was −8.2±10.6 points on CIS-fatigue score, −2.2±2.9 points on HADS-A and −2.3±3.0 points on HADS-D (p<0.001). No significant differences were observed between groups for changes in CIS-fatigue, HADS-A and HADS-D.ConclusionBLVR-EBV is an effective intervention to improve symptoms of fatigue, anxiety and depression. The combination of PR and BLVR-EBV did not result in additional improvement when compared to BLVR-EBV alone.
Clinical and prognostic role of tricuspid regurgitation in incident patients with pulmonary arterial hypertension
Authors: Ghio Stefano , Moschella Martina Marialaura , Baccelli Andrea , Savonitto Giulio , Maldera Martina , Haji Gulam , Davies Rachel , Howard Luke , Lo Giudice Francesco 
Published: February 2025

Question addressed by the studyThe clinical and prognostic role of tricuspid valve regurgitation (TR) in patients with pulmonary arterial hypertension (PAH) is still underappreciated. The main objective of the present study was to assess the prognostic value of TR in incident PAH patients.MethodsConsecutive incident PAH patients were enrolled from 2011 to 2021. Patients underwent right heart catheterization (RHC), CPET, echocardiography including the degree of TR, tricuspid annular plane systolic excursion (TAPSE), ratio of TAPSE to pulmonary artery pressure (TAPSE/PASP), right ventricular (RV) areas, right atrial area. The primary endpoint of survival analysis was all-cause death.ResultsCompared to patients with mild TR or no TR, those with TR of moderate degree or more had a worse TAPSE and TAPSE/PASP, similar RV areas at echocardiography, worse peak VO2 at CPET, higher right atrial pressure and pulmonary vascular resistance at RHC. TR of moderate degree or more was the only echocardiographic parameter associated with poor survival at Cox regression analyses, (HR 3.34, 95%CI 1.73–6.45, p <0.001). The assessment of TR severity was crucial to determine the prognosis of patients who would have been categorized as low risk based on normal values of TAPSE or TAPSE/PASP values.Answer to the questionIn treatment-naive PAH patients, TR is an important echocardiographic prognostic indicator. In particular, as an emerging concept, assessment of severity of TR is critical to stratify the prognosis of patients who would have been considered at low risk based on normal values of TAPSE or of TAPSE/PASP.
Long-term PM2.5exposure impairs lung growth and increases airway inflammation in Taiwanese school children
Authors: Tsai Yi-Giien , Wang Jiu-Yao , Yang Kuender D. , Yang Hsiao-Yu , Yeh Yen-Po , Chang Yu-Jun , Lee Jui Huan , Wang Shu-Li , Huang Shau-Ku , Chan Chang-Chuan 
Published: February 2025

RationaleProlonged exposure to fine particulate matter (PM2.5) may aggravate asthma, impair lung development, and increase airway inflammation.ObjectiveThis study investigated the impact of long-term PM2.5exposure on respiratory health, lung function growth, and fractional exhaled nitric oxide (FENO) in a large longitudinal cohort of school children.MethodsA total of 6120 elementary school children residing in townships near coal-fired power plants in Taiwan were prospectively enrolled from 2016 to 2018. Baseline and follow-up data on asthmatic symptoms, spirometry, FENO, and environmental factors were collected. Annual PM2.5exposure was estimated using land-use regression models based on school and home addresses, and associations were adjusted for SO2and NO2.ResultsThe final analysis included 5364 children and revealed that a 1 μg·m−3increase in annual PM2.5exposure was associated with higher odds of current wheezing (OR=1.07), “ever” wheeze (OR=1.03), diagnosed asthma (OR=1.03), and exercise-induced wheeze (OR=1.04) (p<0.05). Each unit increase in PM2.5exposure was associated with a decrease of 7 mLin FEV1, 5 mLin FVC, and a 0.479 ppb rise in FENO after adjusting for potential confounders (p<0.05). Among 207 new-onset wheezing patients, increased PM2.5exposure significantly decreased FEV1 by 13 mLand FVC by 15 ml, while increasing FENO levels by 0.847 ppb (p<0.05).ConclusionsLong-term PM2.5exposure significantly increases the risk of asthma symptoms, impedes lung growth, and triggers airway inflammation, particularly affecting children with new-onset wheezing in community settings.
Possible therapeutic effect on nocturia after radical prostatectomy by OnabotulinumtoxinA injection: a case series
Authors: Imasato Naoki , Yajima Shugo , Ogasawara Ryo Andy , Hirose Kohei , Sekiya Ken , Katsumura Sao , Kataoka Madoka , Nakanishi Yasukazu , Masuda Hitoshi 
Published: February 2025

Abstract

Background
Intravesical onabotulinumtoxinA (BTX-A) injection is an established treatment for overactive bladder (OAB) in patients who do not respond to conventional medical therapy. This study aimed to evaluate the safety and efficacy of BTX-A injections in patients with urinary dysfunction after radical prostatectomy (RP).

Methods
This retrospective case series included 11 post-RP patients with urinary dysfunction　who received intravesical BTX-A injections and were followed-up for 12 months. We measured and analyzed the efficacy of BTX-A treatment using the Overactive Bladder Symptom Score (OABSS), International Prostate Symptom Score (IPSS), quality of life score, and number of pad sheets used before and after intravesical BTX-A injection.

Results
Following BTX-A injections, significant improvements were observed in the OABSS Q2 score, which evaluates nocturia. The median (IQR) OABSS Q2 score improved from 3.0 (2.0–3.0) at baseline to 1.0 (1.0–2.0, p = 0.012) at 3 months. Similarly, the IPSS Q7 score showed notable changes. The baseline median (IQR) was 3.0 (2.0–4.0), which significantly reduced to 2.0 (2.0–2.5, p = 0.036) at 1 month. Further improvement was observed at 3 months, with a median (IQR) of 2.0 (1.0–2.5, p = 0.021). There were no statistically significant differences in the other categories. There were no statistically significant differences among the other categories.

Conclusion
Intravesical BTX-A injections significantly improved nocturia without complications in post-RP patients. This treatment represents a potential therapeutic option for managing refractory nocturia after RP.
A systematic review of mediation analysis frameworks in studies examining the determinants of cardiometabolic outcomes in people living with HIV
Authors: Ebasone Peter Vanes , Peer Nasheeta , Dzudie Anastase , Foaleng Merveille , Melpsa Johney , Kengne Andre Pascal 
Published: February 2025

Abstract

Introduction
Mediation analysis provides a more flexible mechanistic view of the causal relationship between HIV-related factors and cardiometabolic diseases. However, there is limited evidence on how mediation analysis is implemented in this specific research area. We aimed to describe the frameworks used in mediation analysis and examine how these analyses are conducted and reported in studies focusing on cardiometabolic outcomes among people living with HIV (PLWH).

Methods
Following the PRISMA 2020 Guidelines, we comprehensively searched Medline, CINAHL, Africa-Wide Information and SCOPUS to identify observational studies that employed mediation analysis before October 2023. Two reviewers independently screened studies for eligibility. One reviewer performed data extraction, and two others reviewed the extracted information.

Results
Nine studies met the inclusion criteria, predominantly focusing on the mediation effects of weight and obesity-related factors on the relationship between HIV serostatus, ART, and cardiometabolic outcomes. The review revealed a diverse application of both traditional and causal mediation frameworks. However, inconsistencies and gaps in reporting were noted, particularly in handling missing data, detailing identifiability assumptions, and the use of sensitivity analyses.

Conclusion
While some studies of cardiometabolic risks among PLWH have embraced causal mediation frameworks, their overall application remains limited. In addition, we identified notable inconsistencies and gaps in reporting practices. To advance the field, researchers should not only integrate more rigorous causal mediation methods but also closely follow established reporting guidelines, such as the AGReMA Statement, to ensure greater transparency, reliability, and impact of future research.
Supporting Educational Excellence in Diversity (SEED): faculty development and allyship
Authors: Chadha Puja , Kang Esther H. , Ngo Victoria , Jorrin Rebecca , Kochai Khoban , Ackerman-Barger Kupiri , Ton Hendry 
Published: February 2025

Abstract

Introduction
Bias, privilege, microaggressions, and other forms of mistreatment negatively impact students’ learning, professional development, wellness, and identity. Supporting Educational Excellence in Diversity (SEED) is an innovative faculty development curriculum co-founded and co-designed by medical students/trainees. SEED is unique given it provides vital yet practical communication tools and strategies to support cultural humility when navigating critical conversations related to diversity, inclusion, and harm.

Objective
This curriculum helps faculty to identify, redress, and prevent mistreatment within clinical and non-clinical learning environments while cultivating cultural humility.

Methods
SEED incorporated a sequential hybrid model approach through the use of interactive online modules, virtual asynchronous self-reflection assignments, followed by in-person discussions with role-play opportunities. Using novel tools, it taught faculty core knowledge and strategies to facilitate discussions in navigating harms related to diversity and inclusion. Authors measured impact via self-reported, de-identified pre-and-post questionnaires.

Results
An idependent t-test analysis pre-post-test study of 67 faculty participants revealed statistically significant (P < .001) differences from pre to post on all items with one item statistically significant at a p < .05. The overall effect size was 1.65 showing significant improvement in participants’ self-perceived ability to identify and address microaggressions, privilege, sources of bias, and related harm in the clinical and learning environments. These improvements were identified within themselves, faculty peers, teaching curricula, and teaching modalities. SEED was adopted health system-wide through customized departmental faculty offerings given the statistically and practically significant change in learning, awareness, and attitudes for respondents. SEED is currently under consideration as a maintenance of certification self-assessment course by a national board.

Conclusion
The innovative SEED faculty development curriculum was co-created and designed by students/trainees. SEED shows promising results in improving participants’ foundational learning in promoting inclusive change to enhance learning environments for healthcare trainees. SEED is unique in providing vital yet practical communication tools and strategies to support cultural humility when navigating critical conversations related to diversity, inclusion, and harm.