Journal of Clinical Medicine

12 pages, 1482 KiB

Open AccessArticle

Ophthalmic Artery Doppler Indices at 11–13 Weeks of Gestation in Relation to Early and Late Preeclampsia

by Nicoleta Gana, Savia Pittokopitou, Filippos Solonos, Alina Perdeica, Marina Fitiri and Kypros H. Nicolaides

J. Clin. Med. 2025, 14(13), 4811; https://doi.org/10.3390/jcm14134811 - 7 Jul 2025

Viewed by 171

Abstract

Background/Objective: Preeclampsia (PE) remains a leading cause of maternal and fetal morbidity and mortality. Early prediction is crucial for timely intervention and management. The ophthalmic artery (OA) Doppler assessment in the first trimester has emerged as a potential tool for predicting PE, particularly [...] Read more.

Background/Objective: Preeclampsia (PE) remains a leading cause of maternal and fetal morbidity and mortality. Early prediction is crucial for timely intervention and management. The ophthalmic artery (OA) Doppler assessment in the first trimester has emerged as a potential tool for predicting PE, particularly early PE, with delivery <37 weeks of gestation. This study aimed to evaluate and compare the relationship of ophthalmic artery Doppler parameters at 11–13 weeks of gestation with the subsequent development of early and late PE. Methods: A prospective observational analysis was conducted on 4054 pregnant women, including 114 who developed PE. OA Doppler assessment of the pulsatility index (PI) and peak systolic velocity (PSV) ratio, mean arterial pressure (MAP), uterine artery PI (UtA-PI), and serum placental growth factor (PlGF) were compared between women who later developed early PE and late PE with those who did not develop PE. Results: In the PE groups, particularly those with early PE, compared to the no PE group, the OA PSV ratio and UtA-PI were higher and PlGF was lower. Conclusion: A first-trimester OA Doppler assessment shows promise as a non-invasive method for the prediction of PE. Further prospective, multicenter studies are needed to validate these findings. Full article

(This article belongs to the Section Obstetrics & Gynecology)

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14 pages, 751 KiB

Open AccessArticle

Comparison of Validity and Reliability of Manual Consensus Grading vs. Automated AI Grading for Diabetic Retinopathy Screening in Oslo, Norway: A Cross-Sectional Pilot Study

by Mia Karabeg, Goran Petrovski, Katrine Holen, Ellen Steffensen Sauesund, Dag Sigurd Fosmark, Greg Russell, Maja Gran Erke, Vallo Volke, Vidas Raudonis, Rasa Verkauskiene, Jelizaveta Sokolovska, Morten Carstens Moe, Inga-Britt Kjellevold Haugen and Beata Eva Petrovski

J. Clin. Med. 2025, 14(13), 4810; https://doi.org/10.3390/jcm14134810 - 7 Jul 2025

Viewed by 141

Abstract

Background: Diabetic retinopathy (DR) is a leading cause of visual impairment worldwide. Manual grading of fundus images is the gold standard in DR screening, although it is time-consuming. Artificial intelligence (AI)-based algorithms offer a faster alternative, though concerns remain about their diagnostic reliability. [...] Read more.

Background: Diabetic retinopathy (DR) is a leading cause of visual impairment worldwide. Manual grading of fundus images is the gold standard in DR screening, although it is time-consuming. Artificial intelligence (AI)-based algorithms offer a faster alternative, though concerns remain about their diagnostic reliability. Methods: A cross-sectional pilot study among patients (≥18 years) with diabetes was established for DR and diabetic macular edema (DME) screening at the Oslo University Hospital (OUH), Department of Ophthalmology, and the Norwegian Association of the Blind and Partially Sighted (NABP). The aim of the study was to evaluate the validity (accuracy, sensitivity, specificity) and reliability (inter-rater agreement) of automated AI-based compared to manual consensus (MC) grading of DR and DME, performed by a multidisciplinary team of healthcare professionals. Grading of DR and DME was performed manually and by EyeArt (Eyenuk) software version v2.1.0, based on the International Clinical Disease Severity Scale (ICDR) for DR. Agreement was measured by Quadratic Weighted Kappa (QWK) and Cohen’s Kappa (κ). Sensitivity, specificity, and diagnostic test accuracy (Area Under the Curve (AUC)) were also calculated. Results: A total of 128 individuals (247 eyes) (51 women, 77 men) were included, with a median age of 52.5 years. Prevalence of any vs. referable DR (RDR) was 20.2% vs. 11.7%, while sensitivity was 94.0% vs. 89.7%, specificity was 72.6% was 83.0%, and AUC was 83.5% vs. 86.3%, respectively. DME was detected only in one eye by both methods. Conclusions: AI-based grading offered high sensitivity and acceptable specificity for detecting DR, showing moderate agreement with manual assessments. Such grading may serve as an effective screening tool to support clinical evaluation, while ongoing training of human graders remains essential to ensure high-quality reference standards for accurate diagnostic accuracy and the development of AI algorithms. Full article

(This article belongs to the Special Issue Artificial Intelligence and Eye Disease)

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15 pages, 1081 KiB

Open AccessSystematic Review

Effectiveness of Robot-Assisted Gait Training in Stroke Rehabilitation: A Systematic Review and Meta-Analysis

by Jun Hyeok Lee and Gaeun Kim

J. Clin. Med. 2025, 14(13), 4809; https://doi.org/10.3390/jcm14134809 - 7 Jul 2025

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Abstract

Background/Objectives: Robotic-assisted gait training (RAGT) is a promising adjunct to conventional rehabilitation for stroke survivors. However, its additive benefit over standard therapy remains to be fully clarified. This systematic review and meta-analysis evaluated the effectiveness of combining RAGT with conventional rehabilitation in improving [...] Read more.

Background/Objectives: Robotic-assisted gait training (RAGT) is a promising adjunct to conventional rehabilitation for stroke survivors. However, its additive benefit over standard therapy remains to be fully clarified. This systematic review and meta-analysis evaluated the effectiveness of combining RAGT with conventional rehabilitation in improving gait-related outcomes among individuals with stroke. Methods: We searched PubMed, Embase, CINAHL, and Cochrane CENTRAL through September 2024 for randomized controlled trials (RCTs) comparing combined RAGT and conventional rehabilitation versus conventional rehabilitation alone in adults post-stroke. Data were synthesized using a random-effects model, and subgroup analyses examined effects by intervention duration, stroke chronicity, and robotic system type. Results: Twenty-three RCTs (n = 907) were included. The combined intervention significantly improved gait function (SMD = 0.51, p = 0.001), gait speed (SMD = 0.47, p = 0.010), balance (MD = 4.58, p < 0.001), and ADL performance (SMD = 0.35, p = 0.001). Subgroup analyses revealed that end-effector robotic systems yielded superior outcomes compared to exoskeletons, particularly in subacute stroke patients. The most pronounced benefits were seen in gait velocity and dynamic balance, especially with ≤15 training sessions. Conclusions: Integrating RAGT with conventional rehabilitation enhances motor recovery and functional performance in stroke survivors. End-effector devices appear most effective in subacute phases, supporting individualized RAGT application based on patient and device characteristics. Full article

(This article belongs to the Section Clinical Rehabilitation)

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10 pages, 1472 KiB

Open AccessArticle

A Multi-Institutional Study on the Efficacy and Safety of Wearing a Custom-Made Compression Elastic Garment for 6 Months for Klippel–Trenaunay Syndrome with Venous Malformation

by Miho Noguchi, Sadanori Akita, Fumio Nagai, Tadashi Nomura, Tsuyoshi Morishita and Shunsuke Yuzuriha

J. Clin. Med. 2025, 14(13), 4808; https://doi.org/10.3390/jcm14134808 - 7 Jul 2025

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Abstract

Background: Klippel–Trenaunay syndrome (KTS) is a congenital vascular malformation syndrome characterized by low-flow vascular anomalies, including venous malformation (VM) and lymphatic involvement. These anomalies may lead to limb asymmetry due to soft tissue and/or bone overgrowth. Compression therapy using elastic garments is considered [...] Read more.

Background: Klippel–Trenaunay syndrome (KTS) is a congenital vascular malformation syndrome characterized by low-flow vascular anomalies, including venous malformation (VM) and lymphatic involvement. These anomalies may lead to limb asymmetry due to soft tissue and/or bone overgrowth. Compression therapy using elastic garments is considered a conservative and minimally invasive first-line treatment option for KTS. However, the benefits of compression therapy for low-flow vascular malformations, particularly limb VMs, have not been sufficiently evaluated. This prospective, multi-center study assessed the efficacy and safety of compression therapy for KTS with VM. Methods: After measuring the affected limb, a custom-made elastic garment providing 30 mmHg of compression was manufactured (THUASNE, France). A total of 20 patients (7 male, 13 female; mean age: 10.9 years) underwent compression therapy for 26 weeks at four nationwide institutions in Japan. The primary outcome was the change in lower limb circumference. Secondary outcomes included pain, modified Rankin Scale (mRS) score, body water content, vital signs, changes in garment elasticity, and adverse events. Results: All 20 patients completed the study. At the study endpoint, the circumference ratio of the affected to unaffected limbs was significantly reduced at the superior end of the tibial tuberosity (p = 0.02) and the thinnest part of the ankle (p < 0.001). The elastic force of the garment declined by approximately 50% over 26 weeks. No serious adverse events related to the intervention were reported. Conclusions: Compression therapy using a custom-made elastic garment appears to be a safe and effective approach for managing limb overgrowth in patients with KTS and VM. To maintain the therapeutic effect, garment replacement is recommended at least every six months. Full article

(This article belongs to the Topic Diagnosis, Management, and Prognostic Assessment of Chronic Disease)

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13 pages, 237 KiB

Open AccessArticle

Can Adjunctive Lithium Therapy Influence Emotional Dysregulation in Adolescents? Findings from a Retrospective Study

by Federica Gigliotti, Luca Cammisa, Sara Riezzo and Arianna Terrinoni

J. Clin. Med. 2025, 14(13), 4807; https://doi.org/10.3390/jcm14134807 - 7 Jul 2025

Viewed by 82

Abstract

Background: Emotional dysregulation (ED) is a transdiagnostic feature of multiple adolescent psychiatric disorders and a predictor of functional impairment and self-harming behaviors. Despite its clinical relevance, pharmacological treatments targeting ED in youth remain underexplored. This retrospective study investigated the clinical effectiveness and [...] Read more.

Background: Emotional dysregulation (ED) is a transdiagnostic feature of multiple adolescent psychiatric disorders and a predictor of functional impairment and self-harming behaviors. Despite its clinical relevance, pharmacological treatments targeting ED in youth remain underexplored. This retrospective study investigated the clinical effectiveness and tolerability of adjunctive lithium therapy in adolescents with severe ED, independent of specific diagnostic categories. Methods: A total of 35 inpatients (13–17 years) with significant ED were divided into two groups based on pharmacological treatment: lithium add-on therapy (Li group, n = 17) and standard therapy without lithium (Control group, n = 18). Clinical severity (CGI-S) and global functioning (C-GAS) were assessed at baseline (T0), 6 months (T1), and 12 months (T2). A mixed-design ANOVA was performed to assess group × time interactions. Adverse events and treatment adherence were also examined. Results: At T1, the Li group showed a significantly greater reduction in symptom severity (CGI-S) compared to the Control group (p = 0.029). Global functioning (C-GAS) improved over time in both groups (p < 0.001), with no significant interaction effects. Adverse effects, primarily metabolic and endocrine, were more frequent in the Li group but did not reduce adherence. Conclusions: Adjunctive lithium therapy may reduce symptom severity in adolescents with severe ED without negatively affecting treatment tolerability or adherence. These findings support the potential utility of lithium in complex adolescent cases and warrant further prospective research. Full article

(This article belongs to the Section Mental Health)

20 pages, 2879 KiB

Open AccessReview

Optimizing Outcomes in Oncoplastic Breast-Conserving Surgery

by Aileen Gozali and Merisa Piper

J. Clin. Med. 2025, 14(13), 4806; https://doi.org/10.3390/jcm14134806 - 7 Jul 2025

Viewed by 190

Abstract

Oncoplastic breast-conserving surgery (OBCS), or oncoplastic surgery, has revolutionized the surgical management of breast cancer by integrating oncologic principles with reconstructive techniques to optimize both cancer control and aesthetic outcomes following breast-conserving surgery (BCS). Since its inception in the 1980s, the field has [...] Read more.

Oncoplastic breast-conserving surgery (OBCS), or oncoplastic surgery, has revolutionized the surgical management of breast cancer by integrating oncologic principles with reconstructive techniques to optimize both cancer control and aesthetic outcomes following breast-conserving surgery (BCS). Since its inception in the 1980s, the field has evolved significantly, incorporating a range of volume displacement and volume replacement strategies to restore breast contour after partial mastectomy. This review explores the current practices and key surgical considerations of OBCS. It highlights the role of preoperative multidisciplinary planning, patient selection, anatomical and vascular knowledge, and intraoperative technique in optimizing results. Barriers to access—including disparities in training, insurance, and geographic availability—are addressed, alongside efforts by professional societies like the American Society of Breast Surgeons (ASBS) to standardize definitions and practices. The review also outlines strategies for minimizing complications and enhancing oncologic, reconstructive, and patient-reported outcomes. By offering a comprehensive framework for clinical decision-making, this paper aims to support broader adoption and refinement of OBCS as a standard component of breast cancer care. Full article

(This article belongs to the Special Issue Current State of the Art in Breast Reconstruction)

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16 pages, 1146 KiB

Open AccessReview

Wnt Signaling and Circular RNAs in Esophageal and Gastric Cancers: Opportunities for Early Detection and Targeted Therapy

by Piotr Paweł Chmielewski, Bartłomiej Strzelec and Julia Rudno-Rudzińska

J. Clin. Med. 2025, 14(13), 4805; https://doi.org/10.3390/jcm14134805 - 7 Jul 2025

Viewed by 74

Abstract

Aberrant activation of Wnt/β-catenin signaling, frequently caused by oncogenic mutations, plays a crucial role in the development, progression, and therapy resistance of gastric, esophageal, hepatic, pancreatic, and colorectal cancers. Concurrently, circular RNAs (circRNAs), produced by back-splicing of precursor mRNAs (pre-mRNAs), have emerged as [...] Read more.

Aberrant activation of Wnt/β-catenin signaling, frequently caused by oncogenic mutations, plays a crucial role in the development, progression, and therapy resistance of gastric, esophageal, hepatic, pancreatic, and colorectal cancers. Concurrently, circular RNAs (circRNAs), produced by back-splicing of precursor mRNAs (pre-mRNAs), have emerged as critical modulators of this pathway. Accumulating evidence indicates that specific circRNAs regulate Wnt/β-catenin signaling by sponging microRNAs, interacting with RNA-binding proteins, modulating protein function, and altering the expression of pathway components. Some circRNAs are also subject to feedback regulation by Wnt signaling itself. Clinically, tumor-associated circRNAs are present in body fluids and correlate with disease stage, metastatic burden, and patient survival, underscoring their potential as early and minimally invasive biomarkers. Moreover, targeting oncogenic circRNAs has shown promise in preclinical models of Wnt-driven gastrointestinal malignancies. In this review, we summarize the current understanding of the interplay between circRNAs and Wnt/β-catenin signaling in gastric and esophageal cancers. We discuss the translational challenges and emerging opportunities for biomarker development and targeted therapy. Full article

(This article belongs to the Special Issue Gastroesophageal Cancer: Outcomes and Therapeutic Management)

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14 pages, 2179 KiB

Open AccessArticle

Hepatic Artery Thrombosis After Orthotopic Liver Transplant: A 20-Year Monocentric Series

by Vincenzo Tondolo, Gianluca Rizzo, Giovanni Pacini, Luca Emanuele Amodio, Federica Marzi, Giada Livadoti, Giuseppe Quero and Fausto Zamboni

J. Clin. Med. 2025, 14(13), 4804; https://doi.org/10.3390/jcm14134804 - 7 Jul 2025

Viewed by 132

Abstract

Background/Objectives: Hepatic artery thrombosis (HAT) is a serious vascular complication in patients undergoing orthotopic liver transplantation (OLT). It is associated with a high risk of graft loss, re-transplantation (re-OLT), and mortality. This study aimed to evaluate the incidence and management of HAT, [...] Read more.

Background/Objectives: Hepatic artery thrombosis (HAT) is a serious vascular complication in patients undergoing orthotopic liver transplantation (OLT). It is associated with a high risk of graft loss, re-transplantation (re-OLT), and mortality. This study aimed to evaluate the incidence and management of HAT, analyzing potential risk factors. The secondary objectives included quantifying 90-day postoperative morbidity and mortality rates. Methods: In this retrospective, observational, single-center study, data from liver transplant donors and recipients who underwent OLT between 2004 and 2024 were analyzed. HAT was classified as early (e-HAT, ≤30 days) or late (l-HAT, >30 days). Univariate statistical analysis was performed to identify the risk factors associated with HAT occurrence. Multivariate analysis was not performed due to the small number of HAT events, which would increase the risk of model overfitting. Results: In the 20 year study period, a total of 532 OLTs were performed, including 37 re-OLTs. The rates of major morbidity, reoperation, and mortality within 90 days were 44.5%, 22.3%, and 7.1%, respectively. HAT occurred in 2.4% of cases (e-HAT: 1.6%; l-HAT: 0.7%). Among e-HAT cases, 66.6% were asymptomatic and identified through routine postoperative Doppler ultrasound. All e-HAT cases were surgically treated, with a re-OLT rate of 33.3%. Three l-HAT cases required re-OLT. Overall, the HAT-related mortality and re-OLT rates were 7.6% and 46.1%, respectively. At a follow-up of 86 months, the rate of graft loss was 9.2%, and the rate of post-OLT survival was 77%. Patients who developed HAT had a higher donor-to-recipient body weight ratio and longer warm ischemia times (WITs). Additionally, patients undergoing re-OLT had a higher risk of developing HAT. Conclusions: Although the incidence of HAT is low, its clinical consequences are severe. Early Doppler ultrasound surveillance is crucial for detecting e-HAT and preventing graft loss. A high donor-to-recipient body weight ratio, a prolonged warm ischemia time, and re-OLT seem to be associated with a high risk of HAT. Full article

(This article belongs to the Section General Surgery)

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14 pages, 566 KiB

Open AccessArticle

Impact of RSV Infection in Transplant and Immunocompromised Population: Incidence and Co-Infections: Retrospective Analysis of a Single Centre

by Paolo Solidoro, Antonio Curtoni, Sara Minuto, Nour Shbaklo, Francesco Giuseppe De Rosa, Alessandro Bondi, Francesca Sidoti, Filippo Patrucco, Elisa Zanotto, Silvia Corcione, Massimo Boffini, Matteo Marro, Cristina Costa and Rocco Francesco Rinaldo

J. Clin. Med. 2025, 14(13), 4803; https://doi.org/10.3390/jcm14134803 - 7 Jul 2025

Viewed by 98

Abstract

Respiratory syncytial virus (RSV) represents one of the main respiratory infections found among immunocompromised patients. Objective: The study analyzes the incidence of RSV infection in different populations of immunocompromised patients as organ transplant recipients (lung, other solid organs, hematopoietic stem cells) and [...] Read more.

Respiratory syncytial virus (RSV) represents one of the main respiratory infections found among immunocompromised patients. Objective: The study analyzes the incidence of RSV infection in different populations of immunocompromised patients as organ transplant recipients (lung, other solid organs, hematopoietic stem cells) and oncologic patients (solid organ malignancy and hematological malignancy) compared to a group of non-immunocompromised patients. We also assessed the prevalence of viral, bacterial, and mycotic coinfection. Moreover, we aimed at evaluating the efficacy of ribavirin treatment in terms of mortality reduction. Methods: We conducted a retrospective analysis on a total of 466 transplant patients undergoing bronchoscopy with bronchoalveolar lavage for suspected viral disease or surveillance between 2016 and 2023, compared to 460 controls. Results: The incidence of RSV was significantly higher in immunocompromised patients, particularly in those with lung and bone marrow transplants. Among RSV+ patients, a higher prevalence of viral (influenza virus), bacterial (S. pneumoniae, M. pneumoniae, Nocardia spp.), and fungal (Aspergillus spp.) coinfections were observed. The efficacy of ribavirin in reducing mortality did not show significant differences compared to supportive therapy alone. Conclusions: The results of our exploratory study suggest that immunocompromised patients are particularly vulnerable to RSV infection and coinfections. Our hypothesis-generating data warrant the need for future studies aimed at exploring preventive and therapeutic strategies for RSV infection in these high-risk patient groups. Full article

(This article belongs to the Special Issue Lung Transplantation: Current Strategies and Future Directions)

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13 pages, 567 KiB

Open AccessArticle

Correlation Between Dental Health and Aesthetic Components of Malocclusion in Junior High and High School Students: An Epidemiological Study Using Item Response Theory

by Hiromi Sato, Yudai Shimpo, Toshiko Sekiya, Haruna Rikitake, Minami Seki, Satoshi Wada, Yoshiaki Nomura and Hiroshi Tomonari

J. Clin. Med. 2025, 14(13), 4802; https://doi.org/10.3390/jcm14134802 - 7 Jul 2025

Viewed by 135

Abstract

Background: The Index of Orthodontic Treatment Need (IOTN) is widely used to assess the need for orthodontic treatment. IOTN consists of the Dental Health Component (DHC) and the Aesthetic Component (AC), evaluating malocclusion morphologically and aesthetically, respectively. However, the discriminatory power of individual [...] Read more.

Background: The Index of Orthodontic Treatment Need (IOTN) is widely used to assess the need for orthodontic treatment. IOTN consists of the Dental Health Component (DHC) and the Aesthetic Component (AC), evaluating malocclusion morphologically and aesthetically, respectively. However, the discriminatory power of individual DHC items and their relationship with AC grades remain unclear. Objective: This study aimed to evaluate the effectiveness of individual DHC items in school dental examinations and investigate their contribution to AC grades among junior high and high school students. Methods: A total of 726 students (443 males, 283 females; aged 12–18 years) from Tsurumi University Junior and Senior High School, excluding 168 students undergoing or having completed orthodontic treatment, were included. Nine calibrated orthodontists assessed DHC and AC using IOTN during standardized school examinations. The discriminatory power and information precision of DHC items were evaluated by Item Response Theory (IRT) analysis using three-, two-, or one-parameter logistic models depending on convergence. Correspondence analysis visualized the correlation between DHC and AC grades. Simple linear regression analyzed the contribution of each DHC item to AC grades. Results: Orthodontic treatment need was identified in 21.1% of students. Females showed a higher rate of treatment need than males. Correspondence analysis suggested that aesthetic evaluations were more lenient than morphological evaluations. IRT and regression analysis revealed that crowding (4.d), increased overjet (2.a), and increased overbite (2.f) demonstrated high discriminatory power and significant contributions to AC grades. Conclusions: Among the DHC items, crowding, increased overjet, and increased overbite had higher discriminatory power for malocclusion and contributed more significantly to AC evaluations compared to other items. Full article

(This article belongs to the Section Dentistry, Oral Surgery and Oral Medicine)

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16 pages, 1640 KiB

Open AccessReview

Hepatitis C—Everything a Primary Care Physician Needs to Know About Diagnosis, Management, and Follow-Up

by Sindhuri Benjaram, Shweta Kapur, Anusha McKay, Mohamad Khaled Almujarkesh, Kassandra S. Carter, Alexandra Picardal, Diane Levine and Prateek Lohia

J. Clin. Med. 2025, 14(13), 4801; https://doi.org/10.3390/jcm14134801 - 7 Jul 2025

Viewed by 91

Abstract

Hepatitis C virus (HCV) infection is a major public health concern, with more than 58 million people chronically infected worldwide. The management of HCV, once the domain of specialists only, has been revolutionized by the advent of direct-acting antiviral therapies. To reduce the [...] Read more.

Hepatitis C virus (HCV) infection is a major public health concern, with more than 58 million people chronically infected worldwide. The management of HCV, once the domain of specialists only, has been revolutionized by the advent of direct-acting antiviral therapies. To reduce the burden of HCV in the United States (US), emphasis is now being placed on the involvement of primary care physicians in the management of HCV patients. Inclusion of more primary care providers in the HCV diagnosis and treatment initiatives can assist in achieving the goal of HCV elimination, especially in the medically underserved areas. To actively engage in the management of HCV, primary care providers must understand its epidemiology, risk factors, natural history, current treatment regimen, and potential complications. This manuscript reviews these key areas, along with presenting the cost-effectiveness of treatment and evidence-based guidelines for follow-up care in adults with chronic HCV infection who have undergone HCV treatment. Equipped with this foundational knowledge about HCV management, primary care physicians can play a vital role in eliminating HCV. Full article

(This article belongs to the Section Gastroenterology & Hepatopancreatobiliary Medicine)

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15 pages, 1910 KiB

Open AccessSystematic Review

Training Interventions Used in Postmenopausal Women to Improve Pelvic Floor Muscle Function Related to Urinary Continence—A Systematic Review

by Magdalena Piernicka, Justyna Labun and Anna Szumilewicz

J. Clin. Med. 2025, 14(13), 4800; https://doi.org/10.3390/jcm14134800 - 7 Jul 2025

Viewed by 157

Abstract

Background: The aim of this review was to analyze training interventions used and their effectiveness in improving pelvic floor muscle function related to urinary continence in postmenopausal women. We then characterized the recommended pelvic floor muscle training programs used in experimental studies based [...] Read more.

Background: The aim of this review was to analyze training interventions used and their effectiveness in improving pelvic floor muscle function related to urinary continence in postmenopausal women. We then characterized the recommended pelvic floor muscle training programs used in experimental studies based on four training components: frequency, intensity, duration, and type of pelvic floor muscle exercise. Methods: For this purpose, we conducted a literature review of works published up until the end of 2024, available in the Web of Science, PubMed, MEDLINE, and SPORTDiscus with Full Text databases. We used the keywords “pelvic floor muscle”, “training”, and “postmenopausal women”. Initially, we identified 205 articles published between 1997 and 2024. Then, based on specific criteria, we qualified 15 for analysis. Results: Thirteen studies included only PFMT, while three of them combined PFMT with other physical activity. In two studies, training was conducted in the form of a virtual video game using a pressure platform. We have noted that researchers most often use a 1 h pad test, digital palpation, and surface electromyography to assess the function of pelvic floor muscles. In improving pelvic floor muscle function related to urinary incontinence, 14 out of the 15 analyzed studies showed improvement. In only eight of the fifteen articles, researchers characterized all components of the implemented PFMT that enable full replication of the training intervention. In four of the studies, only one of the required components, namely intensity, was missing. The recommended number of training sessions was 2 to 7 per week, on average 3 ± 2 (M ± SD). Training interventions lasted from 2 to 24 weeks, on average 10 ± 6 weeks. Conclusions: Regardless of the chosen form of training intervention, PFMT is an effective method in improving the function of pelvic floor muscles in postmenopausal women. Full article

(This article belongs to the Section Sports Medicine)

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17 pages, 1315 KiB

Open AccessArticle

Clinical Predictors of Inpatient Mortality and Poor Postoperative Course After aSAH Microsurgical Clipping: A 10-Year Experience from a Peruvian Tertiary Care Center

by Fernando Terry, Alejandro Enríquez-Marulanda, Nathaly Chinchihualpa-Paredes, Meiling Carbajal-Galarza, Claudia L Vidal-Cuellar, Guiliana Mas-Ubillus, Bruno Diaz-Llanes, Carlos Quispe-Vicuña, Niels Pacheco-Barrios, Rommel Arbulu-Zuazo, Ziev B. Moses, Joel Sequeiros, Evan Luther, Robert M. Starke, Philipp Taussky and Jaime Lopez-Calle

J. Clin. Med. 2025, 14(13), 4799; https://doi.org/10.3390/jcm14134799 - 7 Jul 2025

Viewed by 150

Abstract

Background/Objectives: Aneurysmal subarachnoid hemorrhage (aSAH) is a medical emergency with a high mortality rate requiring urgent treatment. This study aimed to identify clinical predictors of inpatient mortality and poor postoperative course after aSAH surgical clipping. Methods: We performed a retrospective review [...] Read more.

Background/Objectives: Aneurysmal subarachnoid hemorrhage (aSAH) is a medical emergency with a high mortality rate requiring urgent treatment. This study aimed to identify clinical predictors of inpatient mortality and poor postoperative course after aSAH surgical clipping. Methods: We performed a retrospective review of medical records for 210 patients with aSAH treated via surgical clipping at our institution between 2010 and 2019. Baseline demographic data and clinical characteristics related to aSAH were collected. To identify factors associated with inpatient mortality and a poor postoperative course after aSAH microsurgical clipping, we conducted a univariate and bivariate analysis, as well as a multivariate analysis via the Poisson regression model. Results: The overall cumulative mortality over the 10-year study period was 11.43%. A severe WFNS scale score (aRR: 2.86; 95% CI: 1.28–6.39; p = 0.011) and having 1 (aRR: 5.76; 95% CI: 2.02–16.39, p = 0.001) or ≥2 (aRR: 18.86; 95% CI: 5.16–68.90, p < 0.001) postoperative neurosurgical complications were associated with an increased risk of inpatient mortality. A moderate (aRR: 3.71; 95% CI: 1.45–9.50; p = 0.006) or severe (aRR: 4.18; 95% CI: 1.12–15.60; p = 0.034) Glasgow scale score on admission, and presenting 1 (aRR: 2.31; 95% CI: 1.27–4.19; p = 0.006) or ≥2 postoperative clinical complications (aRR: 3.34; 95% CI: 1.83–6.10; p < 0.001) were associated with an increased risk of a poor postoperative course. Conclusions: While promising and widely supported by the published literature, these findings require further validation in a larger prospective and multi-centered study to adequately propose health policies on neurointensive care for the Peruvian population. Ultimately, developing socioeconomic setting-focused intervention algorithms and clinical practice guidelines could enhance the survival and postoperative course of patients presenting with aSAH. Full article

(This article belongs to the Special Issue Acute Care for Traumatic Injuries and Surgical Outcomes)

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22 pages, 5786 KiB

Open AccessReview

Narrative and Pictorial Review on State-of-the-Art Endovascular Treatment for Focal Non-Infected Lesions of the Abdominal Aorta: Anatomical Challenges, Technical Solutions, and Clinical Outcomes

by Mario D’Oria, Marta Ascione, Paolo Spath, Gabriele Piffaretti, Enrico Gallitto, Wassim Mansour, Antonino Maria Logiacco, Giovanni Badalamenti, Antonio Cappiello, Giulia Moretti, Luca Di Marzo, Gianluca Faggioli, Mauro Gargiulo and Sandro Lepidi

J. Clin. Med. 2025, 14(13), 4798; https://doi.org/10.3390/jcm14134798 - 7 Jul 2025

Viewed by 170

Abstract

The natural history of focal non-infected lesions of the abdominal aorta (fl-AA) remains unclear and largely depends on their aetiology. These lesions often involve a focal “tear” or partial disruption of the arterial wall. Penetrating aortic ulcers (PAUs) and intramural hematomas (IMHs) are [...] Read more.

The natural history of focal non-infected lesions of the abdominal aorta (fl-AA) remains unclear and largely depends on their aetiology. These lesions often involve a focal “tear” or partial disruption of the arterial wall. Penetrating aortic ulcers (PAUs) and intramural hematomas (IMHs) are examples of focal tears in the aortic wall that can either progress to dilatation (saccular aneurysm) or fail to fully propagate through the medial layers, potentially leading to aortic dissection. These conditions typically exhibit a morphology consistent with eccentric saccular aneurysms. The management of focal non-infected pathologies of the abdominal aorta remains a subject of debate. Unlike fusiform abdominal aortic aneurysms, the inconsistent definitions and limited information regarding the natural history of saccular aneurysms (sa-AAAs) have prevented the establishment of universally accepted practice guidelines for their management. As emphasized in the latest 2024 ESVS guidelines, the focal nature of these diseases makes them ideal candidates for endovascular repair (class of evidence IIa—level C). Moreover, the Society for Vascular Surgery just referred to aneurysm diameter as an indication for treatment suggesting using a smaller diameter compared to fusiform aneurysms. Consequently, the management of saccular aneurysms is likely heterogeneous amongst different centres and different operators. Endovascular repair using tube stent grafts offers benefits like reduced recovery times but carries risks of migration and endoleak due to graft rigidity. These complications can influence long-term success. In this context, the use of endovascular bifurcated grafts may provide a more effective solution for treating these focal aortic pathologies. It is essential to achieve optimal sealing regions through anatomical studies of aortic morphology. Additionally, understanding the anatomical characteristics of focal lesions in challenging necks or para-visceral locations is indeed crucial in device choice. Off-the-shelf devices are favoured for their time and cost efficiency, but new endovascular technologies like fenestrated endovascular aneurysm repair (FEVAR) and custom-made devices enhance treatment success and patient safety. These innovations provide stent grafts in various lengths and diameters, accommodating different aortic anatomies and reducing the risk of type III endoleaks. Although complicated PAUs and focal saccular aneurysms rarely arise in the para-visceral aorta, the consequences of rupture in this segment might be extremely severe. Experience borrowed from complex abdominal and thoracoabdominal aneurysm repair demonstrates that fenestrated and branched devices can be deployed safely when anatomical criteria are respected. Elective patients derive the greatest benefit from a fenestrated graft, while urgent cases can be treated confidently with off-the-shelf multibranch systems, reserving other types of repairs for emergent or bail-out cases. While early outcomes of these interventions are promising, it is crucial to acknowledge that limited aortic coverage can still impede effective symptom relief and lead to complications such as aneurysm expansion or rupture. Therefore, further long-term studies are essential to consolidate the technical results and evaluate the durability of various graft options. Full article

(This article belongs to the Special Issue Clinical Advances in Aortic Disease and Revascularization)

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13 pages, 1574 KiB

Open AccessArticle

Multi-Stage Cascaded Deep Learning-Based Model for Acute Aortic Syndrome Detection: A Multisite Validation Study

by Joseph Chang, Kuan-Jung Lee, Ti-Hao Wang and Chung-Ming Chen

J. Clin. Med. 2025, 14(13), 4797; https://doi.org/10.3390/jcm14134797 - 7 Jul 2025

Viewed by 171

Abstract

Background: Acute Aortic Syndrome (AAS), encompassing aortic dissection (AD), intramural hematoma (IMH), and penetrating atherosclerotic ulcer (PAU), presents diagnostic challenges due to its varied manifestations and the critical need for rapid assessment. Methods: We developed a multi-stage deep learning model trained [...] Read more.

Background: Acute Aortic Syndrome (AAS), encompassing aortic dissection (AD), intramural hematoma (IMH), and penetrating atherosclerotic ulcer (PAU), presents diagnostic challenges due to its varied manifestations and the critical need for rapid assessment. Methods: We developed a multi-stage deep learning model trained on chest computed tomography angiography (CTA) scans. The model utilizes a U-Net architecture for aortic segmentation, followed by a cascaded classification approach for detecting AD and IMH, and a multiscale CNN for identifying PAU. External validation was conducted on 260 anonymized CTA scans from 14 U.S. clinical sites, encompassing data from four different CT manufacturers. Performance metrics, including sensitivity, specificity, and area under the receiver operating characteristic curve (AUC), were calculated with 95% confidence intervals (CIs) using Wilson’s method. Model performance was compared against predefined benchmarks. Results: The model achieved a sensitivity of 0.94 (95% CI: 0.88–0.97), specificity of 0.93 (95% CI: 0.89–0.97), and an AUC of 0.96 (95% CI: 0.94–0.98) for overall AAS detection, with p-values < 0.001 when compared to the 0.80 benchmark. Subgroup analyses demonstrated consistent performance across different patient demographics, CT manufacturers, slice thicknesses, and anatomical locations. Conclusions: This deep learning model effectively detects the full spectrum of AAS across diverse populations and imaging platforms, suggesting its potential utility in clinical settings to enable faster triage and expedite patient management. Full article

(This article belongs to the Section Nuclear Medicine & Radiology)

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20 pages, 653 KiB

Open AccessArticle

Prophylactic Intra-Aortic Balloon Pump Implantation Reduces Peri-Interventional Myocardial Injury During High-Risk Percutaneous Coronary Intervention in Patients Presenting with Low Normal Blood Pressure and with Heart Failure

by Sascha d’Almeida, Stefanie Andreß, Sebastian Weinig, Benjamin Mayer, Wolfgang Rottbauer, Sinisa Markovic and Dominik Buckert

J. Clin. Med. 2025, 14(13), 4796; https://doi.org/10.3390/jcm14134796 - 7 Jul 2025

Viewed by 154

Abstract

Background: Intra-aortic balloon pump (IABP) augments coronary perfusion during high-risk percutaneous coronary interventions (PCI). We sought to identify patients who benefited from prophylactic IABP (P-IABP) compared to rescue-IABP (R-IABP). Methods: All consecutive non-cardiogenic shock patients undergoing high-risk PCI with IABP support [...] Read more.

Background: Intra-aortic balloon pump (IABP) augments coronary perfusion during high-risk percutaneous coronary interventions (PCI). We sought to identify patients who benefited from prophylactic IABP (P-IABP) compared to rescue-IABP (R-IABP). Methods: All consecutive non-cardiogenic shock patients undergoing high-risk PCI with IABP support at Ulm University Hospital, Germany, between 2012 and 2020 were grouped based on the timing of IABP insertion in the pre-interventional P-IABP or peri-interventional R-IABP group. We compared the primary endpoint peri-interventional high-sensitivity Troponin T (hsTnT) increase, sought baseline characteristics associated with the endpoint in the R-IABP group, and compared their correlation strengths between the groups. Results: Interventional outcomes of 44 patients with P-IABP implantation were compared with those of 15 patients with R-IABP implantation. P-IABP was associated with a lower peri-interventional hsTnT increase (p = 0.008, r = 0.390). In the R-IABP group, the presence of ST-segment elevation (p = 0.037, r = 0.631), low systolic blood pressure (RRsyst) (p = 0.007, r = 0.893 (inverse correlation)), and elevated NT-proBNP levels (p < 0.001, r = 0.953) were associated with higher hsTnT increases. HsTnT increase was significantly smaller in the P-IABP group in patients with low RRsyst (IZI = 2.6) and high NT-proBNP levels (IZI = 3.36). Patients with RRsyst < 120 mmHg (p = 0.007) and NT-proBNP levels ≥ 900 pg/mL (Cohen’s d = 0.70, respectively 1.17 for ≥5000 pg/mL and 5.01 for ≥10,000 pg/mL) showed lower peri-interventional hsTnT increase when treated with P-IABP compared to R-IABP, while patients with NT-proBNP levels < 900 pg/mL showed a contrary effect (Cohen’s d = −0.90). Cox regression analysis showed that a high peri-interventional hsTnT increase was significantly associated with a shorter survival time (p = 0.046). Conclusions: P-IABP use in high-risk PCI was associated with reduced peri-interventional myocardial injury, as measured by lower hsTnT increase, which was associated with improved survival in patients with low systolic blood pressure and elevated NT-proBNP levels. Thus, these conditions should be considered for indicating P-IABP. Full article

(This article belongs to the Special Issue Clinical Management for Coronary Artery Disease and Revascularization)

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Graphical abstract

18 pages, 587 KiB

Open AccessReview

The Role of C-Reactive Protein in Acute Myocardial Infarction: Unmasking Diagnostic, Prognostic, and Therapeutic Insights

by Andreas Mitsis, Stefanos Sokratous, Georgia Karmioti, Michaela Kyriakou, Michail Drakomathioulakis, Michael M. Myrianthefs, Christos Eftychiou, Nikolaos P. E. Kadoglou, Stergios Tzikas, Nikolaos Fragakis and George Kassimis

J. Clin. Med. 2025, 14(13), 4795; https://doi.org/10.3390/jcm14134795 - 7 Jul 2025

Viewed by 212

Abstract

C-reactive protein (CRP) has emerged as a valuable biomarker in acute myocardial infarction (AMI), offering multiple insights into diagnosis, prognosis, and therapeutic strategies. In the diagnostic domain, elevated CRP levels serve as an early indicator of AMI, aiding in prompt identification and initiation [...] Read more.

C-reactive protein (CRP) has emerged as a valuable biomarker in acute myocardial infarction (AMI), offering multiple insights into diagnosis, prognosis, and therapeutic strategies. In the diagnostic domain, elevated CRP levels serve as an early indicator of AMI, aiding in prompt identification and initiation of treatment. Prognostically, CRP is a strong predictor of adverse outcomes post-AMI, correlating with increased mortality and cardiovascular events. Beyond its diagnostic and prognostic roles, CRP also exposes therapeutic avenues in AMI management. Targeting CRP through pharmacological interventions has shown promise in reducing inflammatory responses, thereby mitigating myocardial damage and improving clinical outcomes. However, CRP’s low specificity, influenced by elevation in non-cardiac conditions, remains a clinical limitation that warrants consideration. This review comprehensively examines the evolving role of CRP in AMI, exploring its diagnostic accuracy, prognostic significance, and potential as a therapeutic target. The understanding of the complex role of CRP in AMI provides clinicians with valuable tools for risk stratification, treatment optimization, and personalized patient care in the acute setting. Full article

(This article belongs to the Special Issue Acute Coronary Syndromes: From Diagnosis to Treatment)

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14 pages, 1402 KiB

Open AccessArticle

E-Gastryal^® + Magnesium Alginate Plus PPI vs. PPI Alone in GERD: Results from the GENYAL^® Randomized Controlled Trial

by Cristiano Spada, Daniele Salvi, Silvia Pecere, Francesca Mangiola, Simone Varca, Serban Rosu, Vora Prateek, Petru Vasile Ciobanca, Adrian Goldis, Dionisio Franco Barattini and Guido Costamagna

J. Clin. Med. 2025, 14(13), 4794; https://doi.org/10.3390/jcm14134794 - 7 Jul 2025

Viewed by 77

Abstract

Background: Up to one-third of patients with gastroesophageal reflux disease (GERD) have persistent symptoms despite proton-pump inhibitor (PPI) therapy. E-Gastryal^® + MgAlg (Aurora Biofarma, Italy) is a mucosal protective agent that enhances barrier function against acid and non-acidic reflux. This study [...] Read more.

Background: Up to one-third of patients with gastroesophageal reflux disease (GERD) have persistent symptoms despite proton-pump inhibitor (PPI) therapy. E-Gastryal^® + MgAlg (Aurora Biofarma, Italy) is a mucosal protective agent that enhances barrier function against acid and non-acidic reflux. This study assessed its efficacy in combination with omeprazole versus omeprazole alone and as maintenance therapy. Methods: Patients with symptomatic GERD and Grade A reflux esophagitis confirmed by endoscopy were randomized to receive omeprazole 20 mg plus E-Gastryal^® + MgAlg or omeprazole 20 mg alone. The primary endpoint was the number of rescue medications used over 28 days. Secondary endpoints included symptom relief and quality-of-life assessments using the Reflux Symptom Index (RSI), Gastroesophageal Reflux Disease Impact Scale (GIS), GERD-Health-Related Quality of Life (GERD-HRQL), and Global Assessment of Performance (IGAP). Results: Ninety-six patients were included. The combination group used significantly fewer rescue medications (mean: 21 vs. 40.9 tablets; p = 0.002). At week 4, the combination group showed greater improvement in RSI, GIS, and GERD-HRQL scores (p < 0.001). Symptom relief was sustained during weeks 5–26 with E-Gastryal^® + MgAlg alone. Conclusions: E-Gastryal^® + MgAlg combined with omeprazole improves symptom control compared to PPI monotherapy. Continued use as maintenance therapy supports its role in long-term GERD management (NCT04130659). Full article

(This article belongs to the Section Gastroenterology & Hepatopancreatobiliary Medicine)

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13 pages, 1654 KiB

Open AccessArticle

Effect of Complete Revascularization in STEMI: Ischemia-Driven Rehospitalization and Cardiovascular Mortality

by Miha Sustersic and Matjaz Bunc

J. Clin. Med. 2025, 14(13), 4793; https://doi.org/10.3390/jcm14134793 - 7 Jul 2025

Viewed by 127

Abstract

Background: Patients with ST-elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MVD) who undergo complete revascularization (CR) have a more favorable prognosis than those who receive incomplete revascularization (IR), as evidenced by recent randomized controlled trials. Despite the absence of a [...] Read more.

Background: Patients with ST-elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MVD) who undergo complete revascularization (CR) have a more favorable prognosis than those who receive incomplete revascularization (IR), as evidenced by recent randomized controlled trials. Despite the absence of a survival benefit associated with CR in these trials, positive outcomes were ascribed to combined endpoints, such as repeat revascularization, myocardial infarction, or ischemia-driven rehospitalization. In light of the significant burden that rehospitalization from STEMI imposes on healthcare systems, we examined the long-term effects of CR on ischemia-driven rehospitalization and cardiovascular (CV) mortality in STEMI patients with MVD. Methods: In our retrospective study, we included patients with STEMI and MVD who underwent successful primary percutaneous coronary intervention (PCI) at the University Medical Centre Ljubljana between 1 January 2009, and 11 April 2011. The combined endpoint was ischemia-driven rehospitalization and CV mortality, with a minimum follow-up period of six years. Results: We included 235 participants who underwent CR (N = 70) or IR (N = 165) at index hospitalization, with a median follow-up time of 7 years (interquartile range 6.0–8.2). The primary endpoint was significantly higher in the IR group than in the CR group (47.3% vs. 32.9%, log-rank p = 0.025), driven by CV mortality (23.6% vs. 12.9%, log-rank p = 0.047), as there was no difference in ischemia-driven rehospitalization rate (log-rank p = 0.206). Ischemia-driven rehospitalization did not influence CV mortality in the CR group (p = 0.49), while it significantly impacted CV mortality in the IR group (p = 0.03). After adjusting for confounders, there were no differences in CV mortality between CR and IR groups (p = 0.622). Predictors of the combined endpoint included age (p = 0.014), diabetes (p = 0.006), chronic kidney disease (CKD) (p = 0.001), cardiogenic shock at presentation (p = 0.003), chronic total occlusion (CTO) (p = 0.046), and ischemia-driven rehospitalization (p = 0.0001). Significant risk factors for the combined endpoint were cardiogenic shock at presentation (p < 0.001), stage 4 kidney failure (p = 0.001), age over 70 years (p = 0.004), female gender (p = 0.008), and residual SYNTAX I score > 5.5 (p = 0.017). Conclusions: Patients with STEMI and MVD who underwent CR had a lower combined endpoint of ischemia-driven rehospitalizations and CV mortality than IR patients, but after adjustments for confounders, the true determinants of the combined endpoint and risk factors for the combined endpoint were independent of the revascularization method. Full article

(This article belongs to the Special Issue Acute Myocardial Infarction: Clinical Advances in Prognostic Stratification, Diagnosis, and Treatment)

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16 pages, 1455 KiB

Open AccessArticle

Comparison of Magnetic Resonance Imaging Scales for Assessment of Interval Changes of Arthropathy in Boys with Severe Hemophilia

by Ningning Zhang, Manuel Carcao, Danial M. Ignas, Brian M. Feldman, Pamela Hilliard, Rahim Moineddin, Ann Marie Stain, Paul Babyn, Victor S. Blanchette and Andrea S. Doria

J. Clin. Med. 2025, 14(13), 4792; https://doi.org/10.3390/jcm14134792 - 7 Jul 2025

Viewed by 135

Abstract

Background/Objectives: The variety of magnetic resonance imaging (MRI) scales available to measure soft tissue and osteochondral changes in joints of persons with hemophilia poses challenges in evaluating published clinical/research studies. To evaluate the value of four MRI scales [(i) the 17-point International Prophylaxis [...] Read more.

Background/Objectives: The variety of magnetic resonance imaging (MRI) scales available to measure soft tissue and osteochondral changes in joints of persons with hemophilia poses challenges in evaluating published clinical/research studies. To evaluate the value of four MRI scales [(i) the 17-point International Prophylaxis Study Group [IPSG] additive scale; (ii) and (iii) the compatible IPSG progressive (P) and additive (A) scales; and (iv) the Denver progressive scale] to assess joint change in boys with hemophilia participating in a prospective two-year prophylaxis study. Methods: Boys with severe hemophilia A (ages, 7–16 years) followed at the Hospital for Sick Children, Toronto, Canada had MRI evaluations of six index joints (ankles, knees, elbows) at study entry and exit. Musculoskeletal (MSK) outcomes included in the study were the Colorado Child Physical Examination (PE) scale; the Pettersson (X-ray) scale; and the aforementioned 4 MRI scales. Results: Very strong (r ≥ 0.80) correlations were observed between the IPSG 17-point, the IPSG progressive (P) and the Denver MRI scales, and moderate (r = 0.40–0.59) to strong (r = 0.60–0.79) correlations for the IPSG 17 point and the IPSG additive (A) MRI scales. Very weak (r = 0.20–0.39) or no correlations were observed between soft tissue MRI scores and the swelling item of the Child PE scale. Conclusions: All four MRI scales demonstrated relative comparability of their construct validities for assessing mild/moderate hemophilic arthropathy. The 17-point IPSG additive scale is recommended as a reference standard in future long-term studies of young boys with hemophilia receiving factor and non-factor-based preventive therapies. Full article

(This article belongs to the Section Hematology)

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13 pages, 1778 KiB

Open AccessArticle

Association of Atrial Fibrillation with Incident Probable Dementia and Cognitive Impairment in the Systolic Blood Pressure Intervention Trial (SPRINT)

by Parham Samimisedeh, Richard Kazibwe, Christopher L. Schaich, Timothy M. Hughes and Elsayed Z. Soliman

J. Clin. Med. 2025, 14(13), 4791; https://doi.org/10.3390/jcm14134791 - 7 Jul 2025

Viewed by 79

Abstract

Background: The association between atrial fibrillation (AF) and dementia and cognitive decline in individuals with hypertension is not well established. Methods: The Systolic Blood Pressure Intervention Trial (SPRINT) enrolled participants with hypertension at high risk of cardiovascular disease (CVD) but without diabetes [...] Read more.

Background: The association between atrial fibrillation (AF) and dementia and cognitive decline in individuals with hypertension is not well established. Methods: The Systolic Blood Pressure Intervention Trial (SPRINT) enrolled participants with hypertension at high risk of cardiovascular disease (CVD) but without diabetes or a history of stroke. Participants with baseline pre-existing clinical dementia, prescribed dementia medications, or missing AF or cognition data were excluded. AF was identified using centrally read electrocardiograms. Mild cognitive impairment (MCI) and probable dementia (PD) were determined during follow-up by an adjudication committee. Multivariable Cox proportional hazards regression models were employed to assess the association of time-dependent AF with MCI, PD, and a composite endpoint of MCI/PDI. Results: A total of 8539 participants (mean age: 67.9 years; 35.1% female) were included in the analysis. Of these, 264 had AF at baseline or during follow-up. Over a median follow-up period of 5 years, 318 PD, 625 MCI, and 849 composite PD or MCI events occurred. In models adjusted for treatment assignment, baseline sociodemographics, CVD risk factors, and potential confounders, time-dependent AF was associated with incident PD, MCI, and a composite endpoint of MCI/PDI [HR (95% CI): 1.84 (1.09, 3.13), 1.59 (1.01, 2.53), and 1.63 (1.12, 2.38), respectively]. Further adjustment for incident stroke did not significantly change these associations. Conclusions: AF is associated with an increased risk of dementia and cognitive impairment in patients with hypertension but not diabetes or stroke. Further research is needed to determine whether AF management strategies can mitigate cognitive decline. Full article

(This article belongs to the Section Cardiology)

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14 pages, 1568 KiB

Open AccessArticle

The Efficacy of Albumin Infusion in Septic Patients with Hypoalbuminemia: An International Retrospective Observational Study

by Hsin-Yu Liu, Yu-Ching Chen, Ju-Fang Liu, Pei-Sung Hsu, Wen-Pin Cheng and Shih-Sen Lin

J. Clin. Med. 2025, 14(13), 4790; https://doi.org/10.3390/jcm14134790 - 7 Jul 2025

Viewed by 93

Abstract

Background/Objectives: Albumin supplementation is widely used for hypoalbuminemia treatment in patients with critical illness, especially those with cirrhosis. However, studies have demonstrated that routine albumin administration is not always advantageous. We examined how albumin supplementation affects survival outcomes in patients with sepsis [...] Read more.

Background/Objectives: Albumin supplementation is widely used for hypoalbuminemia treatment in patients with critical illness, especially those with cirrhosis. However, studies have demonstrated that routine albumin administration is not always advantageous. We examined how albumin supplementation affects survival outcomes in patients with sepsis with hypoalbuminemia. Methods: This study was conducted by researchers in Taiwan using data from the TriNetX research platform, covering the period from 1 April 2014 to 30 April 2024. This platform aggregates real-world data from healthcare organizations worldwide. From this dataset, 1,147,433 patients who developed sepsis and hypoalbuminemia with albumin levels <3.5 g/dL were identified. The study population was stratified into two groups on the basis of whether they received albumin infusion or not. To compare outcomes, hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated between propensity-score-matched patients who did and did not receive albumin supplementation. Subgroup analysis by albumin levels was conducted. Results: Albumin infusion was linked to increased risks of 30-day mortality (HR [95% CI] = 1.800 [1.774–1.827], p < 0.05), shock (HR [95% CI] = 1.436 [1.409–1.465], p < 0.05), septic shock (HR [95% CI] = 1.384 [1.355–1.415], p < 0.05), hypovolemic shock (HR [95% CI] = 1.496 [1.391–1.608], p < 0.05), cardiogenic shock (HR [95% CI] = 1.553 [1.473–1.637], p < 0.05), heart failure (HR [95% CI] = 1.098 [1.080–1.116], p < 0.05), and pulmonary edema (HR [95% CI] = 1.479 [1.438–1.520], p < 0.05). The subgroup analysis by albumin levels revealed a trend of increased mortality risk with albumin supplementation in patients with high baseline albumin levels. Conclusions: Patients with sepsis with hypoalbuminemia who received albumin supplementation exhibited high 30-day mortality rates and increased risks of shock, heart failure, and pulmonary edema compared with those who did not. These findings indicate that routine albumin administration may be linked with unfavorable outcomes in these patients. Full article

(This article belongs to the Special Issue Sepsis: New Insights into Diagnosis and Treatment)

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33 pages, 17821 KiB

Open AccessSystematic Review

Pregestational Diabetes Mellitus and Adverse Perinatal Outcomes: A Systematic Review and Meta-Analysis

by Dionysios Gazis, Antigoni Tranidou, Antonios Siargkas, Aikaterini Apostolopoulou, Georgia Koutsouki, Dimitrios G. Goulis, Christos Tsakalidis, Ioannis Tsakiridis and Themistoklis Dagklis

J. Clin. Med. 2025, 14(13), 4789; https://doi.org/10.3390/jcm14134789 - 7 Jul 2025

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Abstract

Background/Objectives: As the incidence of diabetes mellitus (DM) is increasing rapidly worldwide, it is anticipated that an increasing number of women will enter pregnancy with pregestational diabetes mellitus (PGDM) in the future. Compelling evidence suggests that hyperglycemia in pregnancy is related to multiple [...] Read more.

Background/Objectives: As the incidence of diabetes mellitus (DM) is increasing rapidly worldwide, it is anticipated that an increasing number of women will enter pregnancy with pregestational diabetes mellitus (PGDM) in the future. Compelling evidence suggests that hyperglycemia in pregnancy is related to multiple adverse perinatal outcomes. This systematic review and meta-analysis aims to assess and quantify the association of PGDM with a range of adverse perinatal outcomes, providing a comprehensive understanding of its impact on pregnancy. Methods: The data sources of this systematic review and meta-analysis were Medline/PubMed, Scopus and Cochrane Library (January 1999 to August 2023), complemented by hand-searching for additional references. Observational studies reporting perinatal outcomes of pregnancies with PGDM diagnosed before pregnancy versus control pregnancies were eligible for inclusion. A systematic review and meta-analysis were conducted as per the PRISMA guidelines. Pooled estimate odds ratios (ORs) with 95% confidence intervals (CIs) were calculated to determine the risk of adverse pregnancy outcomes between PGDM and control pregnancies. Results: The systematic search of the literature yielded 81 observational studies meeting inclusion criteria and in total, 137,237,640 pregnancies were included in the analysis. A total of 19 adverse perinatal outcomes were assessed, revealing a significant association with PGDM. In pregnancies with PGDM there was an increased risk of adverse perinatal outcomes, including gestational hypertension (OR 3.16, 95% CI 2.65–3.77), preeclampsia (OR 4.46, 95% CI 3.94–5.05), preterm delivery (OR 3.46, 95% CI 3.06–3.91), cesarean delivery (OR 3.12, 95% CI 2.81–3.47), induction of labor (OR 2.92, 95% CI 2.35–3.63), macrosomia (OR 2.23, 95% CI 1.76–2.83), LGA neonates (OR 3.95, 95% CI 3.47–4.49), low 5-min Apgar score (OR 2.49, 95% CI 2.07–2.99), shoulder dystocia (OR 3.05, 95% CI 2.07–4.50), birth trauma (OR 1.40, 95% CI 1.22–1.62), polyhydramnios (OR 5.06, 95% CI 4.33–5.91), oligohydramnios (OR 1.61, 95% CI 1.19–2.17), neonatal hyperbilirubinemia (OR 3.45, 95% CI 2.51–4.74), neonatal hypoglycemia (OR 19.19, 95% CI 2.78–132.61), neonatal intensive care unit (NICU) admission (OR 4.54, 95% CI 3.87–5.34), congenital malformations (OR 2.44, 95% CI 1.96–3.04), stillbirth (OR 2.87, 95% CI 2.27–3.63) and perinatal mortality (OR 2.94, 95% CI 2.18–3.98). Subgroup analyses indicated a higher risk of neonatal hypoglycemia, stillbirth and perinatal mortality in T1DM pregnancies compared with T2DM pregnancies. Conclusions: This study provides a robust synthesis of evidence underlying the strong association between PGDM and several adverse perinatal outcomes. Early detection, optimal glycemic control during the periconceptional and pregnancy periods, and proper antenatal care are critical to mitigate these risks. Full article

(This article belongs to the Special Issue Clinical Risks and Perinatal Outcomes in Pregnancy and Childbirth: 2nd Edition)

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21 pages, 5728 KiB

Open AccessReview

Clinical Application of rhBMP-2 and Three-Dimensinal Preformed Titanium Mesh with Allograft and Xenograft for Peri-Implant Horizontal and Vertical Bone Augmentation–A Narrative Review with Technical Report

by Yeong Wook Kim, Saverio Cosola, Young Sam Kim, Young Min Park, Ugo Covani, Aimone Fabbri and Giovanni Battista Menchini-Fabris

J. Clin. Med. 2025, 14(13), 4788; https://doi.org/10.3390/jcm14134788 - 7 Jul 2025

Viewed by 120

Abstract

The reconstruction of a severely resorbed alveolar bone is a significant challenge in dental implantology and maxillofacial surgery. Traditional bone grafting materials, including autogenous, allogeneic, xenogeneic, and alloplastic materials, have limitations such as donor site morbidity, limited availability, and prolonged maturation periods. To [...] Read more.

The reconstruction of a severely resorbed alveolar bone is a significant challenge in dental implantology and maxillofacial surgery. Traditional bone grafting materials, including autogenous, allogeneic, xenogeneic, and alloplastic materials, have limitations such as donor site morbidity, limited availability, and prolonged maturation periods. To address these challenges, recombinant human bone morphogenetic protein-2 (rhBMP-2) has emerged as a potent osteoinductive factor that facilitates bone regeneration without the need for additional donor site surgery. This study introduces a box technique which combines rhBMP-2 (CowellBMP^®, Cowellmedi, Busan, Republic of Korea) with a 3D-preformed titanium mesh (3D-PFTM), utilizing a mixture of allografts and xenografts for horizontal and vertical alveolar ridge augmentation. The technique leverages the structural stability provided by the OssBuilder^® (Osstem, Seoul, Republic of Korea), a preformed titanium mesh, that allows for simultaneous implant placement and vertical ridge augmentation. This technique not only reduces the treatment time compared to traditional methods but also minimizes post-operative discomfort by eliminating the need for autogenous bone harvesting. Clinical outcomes from this technique demonstrate successful bone regeneration within a shorter period than previously reported techniques, with excellent bone quality and implant stability being observed just four months after vertical augmentation. In conclusion, the so called BOXAM (BMP-2, Oss-builder, Xenograft, Allograft, Maintenance) technique presents a promising therapeutic strategy for alveolar bone reconstruction, particularly in cases of severe bone resorption. Further studies are needed to evaluate the long-term outcomes and potential limitations of this approach, especially in scenarios where the inferior alveolar nerve proximity poses challenges for fixture placement. Full article

(This article belongs to the Special Issue Oral and Maxillofacial Surgery: Current Advances and Future Directions)

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9 pages, 914 KiB

Open AccessArticle

Three-Dimensional Model Improves Body Image Perception After Bariatric Surgery

by Cyril Gauthier, Matthieu Poussier, Célia Lloret-Linares, Marc Danan and Anamaria Nedelcu

J. Clin. Med. 2025, 14(13), 4787; https://doi.org/10.3390/jcm14134787 - 7 Jul 2025

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Abstract

Background: Despite losing weight, the majority of subjects retained an obese view of themselves. The aim of the study was to evaluate the usefulness of a 3D modeling tool in improving the body image of patients who have undergone bariatric surgery. Methods [...] Read more.

Background: Despite losing weight, the majority of subjects retained an obese view of themselves. The aim of the study was to evaluate the usefulness of a 3D modeling tool in improving the body image of patients who have undergone bariatric surgery. Methods: Morbidly obese subjects involved in a medico-surgical obesity management program and having undergone a Roux en Y Gastric Bypass (RYGB) or a sleeve gastrectomy (SG) were prospectively included during their usual postoperative medical follow-up. The figure rating scale (FRS), body image questionnaire, and Hospital Anxiety Depression Scale test were performed. The FRS was assessed before and after visualizing their body image using a 3D modeling tool. Distributions between the groups for gender (female vs. male) and type of surgery (gastric bypass vs. sleeve gastrectomy) were tested with a Pearson’s chi² independence test. The significance threshold was p < 0.05. Results: We included 140 adults with sleeve gastrectomy (72.9%; n = 102) or gastric bypass (27.1%; n = 38). The mean time from surgery was 308.3 ± 111.4 days (63–511). Participants were mostly female (77.9%; n = 109). Nearly half of the subjects who had undergone bariatric surgery almost one year before modified their body perception after visualizing their avatar thanks to a 3D modeling tool. One third reduced their FRS score (“perceived body”) after visualizing their avatar. FRS score and body mass index (BMI) following surgery (“real body”) were significantly correlated before and after visualizing the 3D avatar, with a stronger correlation after visualizing the 3D avatar. Conclusions: A 3D modeling tool may improve body perception after weight loss in subjects with bariatric surgery. Being simple, non-invasive, not expansive, and easy to use during a consultation and to understand for the patient, a regular use of this tool may be largely implemented in clinical practice. Its usefulness in improving body image, mood disorders, and eating disorders and the further success of the surgery should be further evaluated. Full article

(This article belongs to the Special Issue New Approaches in Bariatric Surgery)

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15 pages, 268 KiB

Open AccessReview

Intraoperative Cell Salvage in Oncologic Surgery: A Comprehensive Review

by Ward H. van der Ven and Markus W. Hollmann

J. Clin. Med. 2025, 14(13), 4786; https://doi.org/10.3390/jcm14134786 - 7 Jul 2025

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Abstract

Intraoperative cell salvage (ICS) is a blood conservation technique utilized in major surgery, yet its application in oncologic procedures remains debated. Concerns persist about the theoretical risk of metastasis through reinfusion of tumor cells, despite the established disadvantages of allogeneic blood transfusion (ABT), [...] Read more.

Intraoperative cell salvage (ICS) is a blood conservation technique utilized in major surgery, yet its application in oncologic procedures remains debated. Concerns persist about the theoretical risk of metastasis through reinfusion of tumor cells, despite the established disadvantages of allogeneic blood transfusion (ABT), such as transfusion-related reactions and immunosuppression. In this review, we discuss the historical development of ICS, the technical processes of ICS including leukocyte depletion filtration and irradiation, and experimental and clinical data regarding its safety and efficacy. In vitro studies suggest that tumor cells undergo significant structural alterations during ICS processing, and additional filtration further reduces cell load, although complete removal is not always achieved. Observational studies of predominantly moderate quality, aggregated in multiple systematic reviews, consistently report no increased recurrence rates or reduced disease-free and overall survival in patients receiving ICS. Accordingly, national and international guidelines endorse the use of ICS during oncologic surgery. Although high-quality data—preferably from randomized controlled trials—are lacking, and certainty of available evidence from observational studies is low, ICS appears to be effective and safe. The broader adoption of its use during oncologic surgery may be warranted to minimize reliance on ABT and its associated risks. Full article

(This article belongs to the Section Anesthesiology)

21 pages, 1162 KiB

Open AccessFeature PaperReview

Transthyretin Amyloid Cardiomyopathy—2025 Update: Current Diagnostic Approaches and Emerging Therapeutic Options

by Carsten Tschöpe, Ahmed Elsanhoury and Arnt V. Kristen

J. Clin. Med. 2025, 14(13), 4785; https://doi.org/10.3390/jcm14134785 - 7 Jul 2025

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Abstract

Transthyretin-related (ATTR) amyloidosis is a progressive, multisystem disease caused by the extracellular deposition of misfolded transthyretin (TTR) monomers as insoluble amyloid fibrils. Clinical manifestations vary widely and may include cardiomyopathy (ATTR-CM), polyneuropathy (ATTR-PN), or mixed phenotypes. The condition is increasingly recognized as an [...] Read more.

Transthyretin-related (ATTR) amyloidosis is a progressive, multisystem disease caused by the extracellular deposition of misfolded transthyretin (TTR) monomers as insoluble amyloid fibrils. Clinical manifestations vary widely and may include cardiomyopathy (ATTR-CM), polyneuropathy (ATTR-PN), or mixed phenotypes. The condition is increasingly recognized as an underdiagnosed contributor to heart failure, particularly in elderly patients. ATTR amyloidosis exists in two major forms: hereditary (ATTRv), resulting from mutations in the TTR gene, and wild-type (ATTRwt), typically affecting men over 70 years of age. Advances in disease understanding have led to a paradigm shift in management, with the introduction of targeted therapies that slow disease progression and improve prognosis. First-generation therapies such as tafamidis have demonstrated survival benefits in ATTR-CM. More recently, second-generation agents—such as the TTR stabilizer acoramidis and RNA silencers including vutrisiran and eplontersen—have shown promising efficacy in clinical trials. Additional strategies under investigation include gene editing and monoclonal antibodies targeting TTR amyloid deposits. This review outlines current diagnostic strategies and therapeutic options for ATTR amyloidosis, emphasizing the need for early detection and individualized treatment approaches. The expanding therapeutic landscape highlights the importance of accurate phenotyping and timely intervention to optimize clinical outcomes. Full article

(This article belongs to the Special Issue Cardiomyopathies: Current Treatment and Future Options: Second Edition)

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16 pages, 736 KiB

Open AccessArticle

Right Atrial Pressure/Pulmonary Capillary Wedge Pressure Ratio Predicts In-Hospital Mortality in Left Ventricular Assist Device Recipients

by Berhan Keskin, Aykun Hakgor, Bilge Yilmaz, Korhan Erkanli, Beytullah Cakal, Arzu Yazar, Yahya Yildiz, Bilal Boztosun and Ibrahim Oguz Karaca

J. Clin. Med. 2025, 14(13), 4784; https://doi.org/10.3390/jcm14134784 - 7 Jul 2025

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Abstract

Background/Objectives: Right ventricular failure (RVF) is a major contributor to early mortality after left ventricular assist device (LVAD) implantation. While various markers of right ventricular function and right ventriculoarterial coupling have been proposed, their value in predicting in-hospital mortality remains unclear. This [...] Read more.

Background/Objectives: Right ventricular failure (RVF) is a major contributor to early mortality after left ventricular assist device (LVAD) implantation. While various markers of right ventricular function and right ventriculoarterial coupling have been proposed, their value in predicting in-hospital mortality remains unclear. This study aimed to investigate the prognostic significance of the right atrial pressure/pulmonary capillary wedge pressure (RAP/PCWP) ratio—a surrogate of RV–pulmonary artery (PA) coupling—for in-hospital mortality following LVAD implantation. Methods: This retrospective single-center study included 44 patients who underwent LVAD implantation. Preoperative clinical, echocardiographic, and invasive hemodynamic parameters were collected. The optimal RAP/PCWP ratio cut-off was determined using receiver operating characteristic (ROC) analysis. Predictors of in-hospital mortality were assessed using univariate and multivariate logistic regression. Results: Patients were stratified into high (≥0.47) and low (<0.47) RAP/PCWP ratio groups. In-hospital mortality was significantly higher in the high RAP/PCWP group (46% vs. 10%, p = 0.020). The optimal cut-off for the RAP/PCWP ratio was 0.47 (AUC: 0.829). In multivariate analysis, RAP/PCWP ratio (OR: 3.48 per 0.1 increase, p = 0.020) and INTERMACS 1–2 profile (OR: 39.19, p = 0.026) were independent predictors of in-hospital mortality. Conclusions: Preoperative RAP/PCWP ratio, as a surrogate of right ventriculoarterial coupling, independently predicts in-hospital mortality following LVAD implantation. Its incorporation into preoperative assessment may enhance risk stratification and guide clinical management in this high-risk population. Full article

(This article belongs to the Special Issue Advanced Therapy for Heart Failure and Other Combined Diseases)

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10 pages, 733 KiB

Open AccessArticle

Microencapsulated Sodium Butyrate in the Prevention of Acute Radiotherapy Proctitis: Single-Center Prospective Study

by Renato Cannizzaro, Stefania Maiero, Paola Pelizzo, Marco Gulotta, Sonia Facchin, Giulia Tessarolo, Antonella Zucchetto, Fabio Matrone, Stefano Realdon and Roberto Bortolus

J. Clin. Med. 2025, 14(13), 4783; https://doi.org/10.3390/jcm14134783 - 7 Jul 2025

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Abstract

Background/Objectives: Prostate cancer is the most frequent cancer in men, for which Radiotherapy (RT) is used as a radical or post-surgical treatment. Actinic proctitis is one of the most disabling side effects of RT. Intestinal microbiome studies have highlighted the importance of [...] Read more.

Background/Objectives: Prostate cancer is the most frequent cancer in men, for which Radiotherapy (RT) is used as a radical or post-surgical treatment. Actinic proctitis is one of the most disabling side effects of RT. Intestinal microbiome studies have highlighted the importance of short-chain fatty acids, in particular butyric acid, for their beneficial effects over intestinal epithelial cells. The aim of this prospective study is to evaluate if treatment with micro-encapsulated sodium butyrate (MESB) can reduce the incidence of actinic proctitis during RT in prostate cancer patients. Methods: In total, 122 consecutive patients with prostate cancer treated in Radiotherapy Unit, Centro di Riferimento Oncologico, IRCCS Aviano, were enrolled. Patients received MESB (3 tablets/day) from one week before until four weeks after RT. They completed a diary, tracking daily bowel movements, rectal bleeding, abdominal pain, and perceived health status before, at the end, and one month after RT. Results: Although an improvement in symptoms was observed, when comparing interpatient data before RT vs. one month after the end of RT, statistically significant differences emerged only regarding abdominal pain (94.2% vs. 81.6% vs. 81.6%) (McNemar’s test p < 0.002). Conclusions: MESB appears effective in reducing radiation-induced bowel toxicity during RT, minimizing stool changes, incontinence, and abdominal pain. Although patients’ health perception declined at RT completion, it improved after one month, suggesting MESB may support clinical recovery post-treatment. Full article

(This article belongs to the Section Gastroenterology & Hepatopancreatobiliary Medicine)

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18 pages, 251 KiB

Open AccessProtocol

Glucose Homeostasis, Metabolomics, and Pregnancy Outcomes After Bariatric Surgery (GLORIA): Protocol for a Multicentre Prospective Cohort Study

by Ellen Deleus, Niels Bochanen, Dries Ceulemans, Hanne Debunne, Bénédicte Denys, Roland Devlieger, Ina Geerts, Annouschka Laenen, Lisbeth Jochems, Els Lannoey, Matthias Lannoo, Anne Loccufier, Toon Maes, Joke Marlier, Astrid Morrens, Nele Myngheer, Luna Tierens, Griet Vandenberghe, Annick Van den Bruel, Lien Van den Haute, Bart Van der Schueren, Inge Van Pottelbergh and Katrien Benhalima Show full author list Hide full author list

J. Clin. Med. 2025, 14(13), 4782; https://doi.org/10.3390/jcm14134782 - 7 Jul 2025

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Abstract

Background: Metabolic bariatric surgery is a highly effective and long-lasting treatment for obesity and related chronic conditions. Women of reproductive age represent the largest group undergoing these procedures. Observational studies suggest an increased risk of preterm birth and impaired foetal growth in this [...] Read more.

Background: Metabolic bariatric surgery is a highly effective and long-lasting treatment for obesity and related chronic conditions. Women of reproductive age represent the largest group undergoing these procedures. Observational studies suggest an increased risk of preterm birth and impaired foetal growth in this population, though the underlying mechanisms remain unclear. A key hypothesis is that altered glucose metabolism, characterised by frequent hypoglycaemia and glycaemic fluctuations, may contribute to these adverse outcomes. While glycaemic variability following metabolic bariatric surgery has been documented, its pattern during pregnancy and impact on pregnancy outcomes are still underexplored. Methods: In this Belgian multicentre prospective cohort study, we will investigate glycaemic patterns during pregnancy in women who have undergone metabolic bariatric surgery. Women aged 18–45 years with a confirmed singleton pregnancy up to 11 weeks and 6 days and a history of Roux-en-Y gastric bypass or sleeve gastrectomy will be eligible for inclusion. Women with pregestational diabetes or those taking medication known to interfere with glucose metabolism will be excluded. All participants will receive blinded continuous glucose monitoring (Dexcom^® G6) for a 10-day period at four time points throughout the pregnancy. Foetal body composition and growth will be measured during routine ultrasound; skinfolds will be measured in the neonate. The primary outcome is the association between mean glycemia and glycaemic variability on continuous glucose monitoring and birth weight. The planned sample size is ninety-five women. Linear mixed models for repeated measurements will be used for analysis. Confounders such as smoking, micronutrient deficiency, and surgery-to-conception interval will be added to the model as covariates. In a second exploratory phase, each participant in the surgical group will be matched with a control participant—without a history of metabolic bariatric surgery—based on pre-pregnancy BMI and age. Control participants will undergo the same study procedures, allowing for exploratory comparison of glycaemic patterns and other study outcomes. Discussion: This prospective longitudinal study will be the largest study using continuous glucose monitoring to investigate glucose metabolism during pregnancy after metabolic bariatric surgery and its impact on foetal growth and newborn body composition. Trial registration: ClinicalTrials.gov: NCT05084339. Registration date: 15 October 2021. Full article

(This article belongs to the Section Obstetrics & Gynecology)

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J. Clin. Med., Volume 14, Issue 13 (July-1 2025) – 424 articles

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