Search Results (1,094)

This article describes the design, methods, and baseline characteristics of the social needs assessment (SNA) of participants enrolled in an ongoing randomized clinical trial implementing a comprehensive approach to improving diabetes self-management and providing an intensive Diabetes Self-Management Education and Support (iDSMES) Program at St. Vincent’s House Clinic, a primary care practice serving resource-challenged diverse populations in Galveston, Texas. Standardized SNA was conducted to collect information on financial needs, psychosocial well-being, and other chronic health conditions. Based on their identified needs, participants were referred to non-medical existing community resources. A series of in-depth interviews were conducted with a subset of participants. A team member independently categorized these SNA narratives and aggregated them into two overarching groups: medical and social needs. Fifty-nine participants (with a mean age of 53 years and equal representation of men and women) completed an SNA. Most (71%) did not have health insurance. Among 12 potential social needs surveyed, the most frequently requested resources were occupational therapy (78%), utility assistance (73%), and food pantry services (71%). SNA provided data with the potential to address barriers that may hinder participation, retention, and outcomes in diabetes self-management. SNA findings may serve as tertiary prevention to mitigate diabetes-related complications and disparities. Full article

Background/Objectives: Pancreatic ductal adenocarcinoma (PDAC) remains one of the deadliest solid tumors, with a five-year overall survival rate below 10%. While the introduction of multi-agent chemotherapy regimens has improved outcomes marginally, most patients with advanced disease continue to have limited therapeutic options. Molecular profiling has uncovered actionable genomic alterations in select subgroups of PDAC, yet the clinical impact of targeted therapies remains modest. This review aims to provide a clinically oriented synthesis of emerging molecular targets in PDAC, their therapeutic relevance, and practical considerations for biomarker testing, including current FDA and EMA indications. Methods: A narrative review was conducted using data from PubMed, Embase, Scopus, and international guidelines (NCCN, ESMO, ASCO). The selection focused on evidence published between 2020 and 2025, highlighting molecularly defined PDAC subsets and the current status of targeted therapies. Results: Actionable genomic alterations in PDAC include KRAS G12C mutations, BRCA1/2 and PALB2-associated homologous recombination deficiency, MSI-H/dMMR status, and rare gene fusions involving NTRK, RET, and NRG1. While only a minority of patients are eligible for targeted treatments, early-phase trials and real-world data have shown promising results in these subgroups. Testing molecular profiling is increasingly standard in advanced PDAC. Conclusions: Despite the rarity of targetable mutations, systematic molecular profiling is critical in advanced PDAC to guide off-label therapy or clinical trial enrollment. A practical framework for identifying and acting on molecular targets is essential to bridge the gap between precision oncology and clinical management. Full article

The early detection of Alzheimer’s disease (AD) is important for effective therapeutic interventions and optimized enrollment for clinical trials. Recent studies have shown high accuracy in identifying mild AD by applying visibility graph and machine learning methods to electroencephalographic (EEG) data. We present a novel analytical framework combining Weighted Visibility Graphs (WVG) and ensemble learning to detect individuals in the “preclinical” stage of AD (preAD) using a word repetition EEG paradigm, where WVG is an advanced variant of natural Visibility Graph (VG), incorporating weighted edges based on the visibility degree between corresponding data points. The EEG signals were recorded from 40 cognitively unimpaired elderly participants (20 preclinical AD and 20 normal old) during a word repetition task. Event-related potential (ERP) and oscillatory signals were extracted from each EEG channel and transformed into a WVG network, from which relevant topological features were extracted. The features were selected using t-tests to reduce noise. Subsequent statistical analysis reveals significant disparities in the structure of WVG networks between preAD and normal subjects. Furthermore, Principal Component Analysis (PCA) was applied to condense the input data into its principal features. Leveraging these PCA components as input features, several machine learning algorithms are used to classify preAD vs. normal subjects. To enhance classification accuracy and robustness, an ensemble method is employed alongside the classifiers. Our framework achieved an accuracy of up to 92% discriminating preAD from normal old using both linear and non-linear classifiers, signifying the efficacy of combining WVG and ensemble learning in identifying very early AD from EEG signals. The framework can also improve clinical efficiency by reducing the amount of data required for effective classification and thus saving valuable clinical time. Full article

Background/Objective: Sepsis is a leading cause of death in noncoronary intensive care units (ICUs). Fluids for intravascular resuscitation include crystalloids and colloids. There is extensive clinical evidence on colloid use, but large trials comparing gelatine with crystalloid regimens in ICU and septic patients are lacking. This study aimed to determine whether early, protocol-driven volume resuscitation using a gelatine-based regimen achieves hemodynamic stability (HDS) more rapidly than a crystalloid-based regimen in septic patients. Methods: This prospective, controlled, randomised, double-blind, multinational phase IV study compared two parallel groups of septic patients receiving a gelatine-based regimen (Gelaspan^® 4% and Sterofundin^® ISO, B. Braun Melsungen AG each, at a 1:1 ratio) or a crystalloid regimen (Sterofundin^® ISO). Primary endpoint was time to first HDS within 48 h after randomisation. Secondary endpoints included fluid overload, fluid balance, and patient outcomes. Results: 167 patients were randomised. HDS was achieved after 4.7 h in the gelatine group and after 5.8 h in the crystalloid group (p = 0.3716). The gelatine group had a more favourable fluid balance at 24 h (medians: 3463.00 mL vs. 4164.00 mL; p = 0.0395) and less fluid overload (medians: 4296.05 vs. 5218.75%; p = 0.0217). No differences were observed in serious adverse events or mortality. Conclusions: The study provided clinical evidence of balanced gelatine solution for volume resuscitation in septic patients, although it was terminated prematurely. The early and protocol-based administration of gelatine was safe and effective in the enrolled patient population. Time to HDS was not different between groups but the gelatine-based regimen led to better fluid balance and less fluid overload. Full article

Background/Objectives: Neonatal pain must be treated due to its potential short- and long-term adverse effects. A frenotomy is a painful procedure where common strategies to relieve pain (oral sucrose solutions and sucking) cannot be used because the technique is performed on the tongue. Lavender essential oil (LEO) is useful in treating pain during blood sampling, heel punctures, vaccination, and frenotomies. We aimed to determine whether smelling colostrum had similar effects as inhaled LEO during frenotomies. Methods: A prospective, randomized clinical trial was carried out with neonates who underwent a frenotomy for ankyloglossia between September 2023 and June 2024. We assessed pain using the NIPS score, heart rate, oxygen saturation, and crying time. After obtaining parental informed consent, we randomized patients into experimental and control groups. In both groups, we performed swaddling, administered 1 mL of oral sucrose, and let the newborn suck for 2 min. In the experimental group, we placed a gauze pad with two drops of colostrum, whereas in the control group, we used one drop of LEO 2 cm under the neonate’s nose prior to and during the frenotomy. Results: We enrolled 142 patients (71 experimental cases and 71 controls). The experimental group showed lower crying times (28.0 vs. 40.2 s, p = 0.03). Both groups showed similar NIPS scores (1.4 vs. 1.5, p = 0.28). We observed no side effects in either of the groups. Conclusions: Inhaled colostrum and LEO help relieve pain in neonates who undergo a frenotomy for ankyloglossia and have no side effects. Aromatherapy with colostrum may decrease crying time during the frenotomy. Full article

Background/Objective(s): Post-discharge clinical needs of extremely preterm (EP) infants are not well defined. The aim of this study is to evaluate healthcare utilization after discharge in infants born EP and compare it to the general pediatric population. Methods: This study involved a post hoc analysis of infants born 24-0/7 to 27-6/7 weeks’ gestation enrolled in the Preterm Erythropoietin Neuroprotection (PENUT) Trial who had at least one follow-up survey representing their course between 24 and 60 months of age. The results were compared to the general population data from the Kids’ Inpatient Database, Nationwide Emergency Department Sample, and National Health and Nutrition Examination Survey. Results: Maternal, infant, and hospitalization characteristics for PENUT infants who survived to discharge (n = 828) compared to those with follow-up (n = 569) were similar except for race and maternal age. Overall, EP infants had an overall lower rate of ED visits (31% vs. 68%) but a higher rate of hospitalizations (11% vs. 3%). EP infants were less likely to go to the ED for gastrointestinal (5% vs. 12%) and dermatologic (1% vs. 6%) concerns but more likely to go to the ED for procedures (7% vs. <1%). EP infants had a higher rate of medication use (56% vs. 14%) in all categories except psychiatric medications. Conclusions: While EP infants had higher rates of specialty healthcare utilization relative to the general pediatric population, they were less likely to visit the ED overall, particularly for common concerns in this age range. This may reflect improved access and navigation of the healthcare system by EP caregivers. Full article

Background: Despite being one of the most performed bariatric procedures, there is no consensus regarding optimal limb lengths for Roux-en-Y gastric bypass (RYGB), which may impact weight loss and obesity-related comorbidity resolution. We hypothesize that a ratio-adjusted small bowel to Roux and BP limb lengths in RYGB results in superior outcomes. Objectives: This study aims to define total intestinal length (TIL) and the feasibility of its intraoperative measurement during RYGB. The findings will serve as a foundation for a subsequent randomized trial evaluating different limb length ratios and their effect on postoperative outcomes. Setting: This was a single-center prospective cohort study conducted at Cleveland Clinic Foundation-Main Campus, a tertiary referral center in the United States. Methods: Between January and June 2023, 25 patients with BMI > 40 undergoing RYGB were enrolled. Total small bowel length was measured intraoperatively, and feasibility of measurement was assessed. Patient outcomes, including total weight loss, 30-day complications, and comorbidities at 1 year were captured. Results: Mean preoperative BMI was 47.6 ± 8.0 kg/m². Mean total small bowel length was 592 ± 93.3 cm, with a mean biliopancreatic (BP) limb length of 109 ± 29 cm (18.86% ± 5.84 of total length) and Roux limb length of 103 ± 15 cm (17.71% ± 3.06 of total length). Measurement added an average of 11.5 min to operative time. Measurement feasibility was rated as “moderate” or easier in 80% of cases. One-year postoperative outcomes included a mean total weight loss of 31% and significant reductions in antihypertensive and anti-diabetic medication use. Conclusions: Total small bowel length measurement during RYGB is safe and feasible. High variability in bowel length was observed, with no significant correlation to demographic factors. Establishing individualized limb length ratios may improve weight loss outcomes and comorbidity resolution. Further studies are warranted to evaluate the impact of tailored limb length strategies. Full article

Introduction/Objective: Peritonitis remains a serious complication in patients undergoing automated peritoneal dialysis (APD), requiring prompt and effective antibiotic administration. This study evaluated whether delivering antibiotics directly through APD bags is as effective as administering them via an additional manual daytime exchange. Methods: We conducted a randomized, single-blind, non-inferiority clinical trial involving patients diagnosed with peritonitis. Participants were randomly assigned to receive Ceftazidime and Vancomycin, either via APD bags or through a combined approach of continuous ambulatory peritoneal dialysis (CAPD) plus APD. A total of 64 patients (32 per group) were enrolled, with comparable baseline demographic and clinical profiles, including laboratory markers of infection severity and dialysis history. Results: Peritonitis resolved in 90.6% of the patients treated via APD bags and in 81.3% of those receiving antibiotics through manual exchange plus APD. Although this difference did not reach statistical significance ($p$ = 0.281), the observed absolute difference of 9.3% was well within the predefined non-inferiority margin of 30%, supporting the clinical non-inferiority of the APD-only method. The mean time to resolution was similar between groups ($p$ = 0.593). Post hoc power analyses indicated limited statistical power (18.5% for the resolution rate and 9.2% for time to resolution), suggesting that modest differences may not have been detectable given the sample size. Nevertheless, the high resolution rates observed in both groups reflect valid and encouraging clinical outcomes. Conclusion: Antibiotic administration via APD bags demonstrated comparable clinical effectiveness to the combined manual exchange plus APD method for treating peritonitis. Given its operational simplicity and favorable results, the APD-only strategy may offer a pragmatic alternative in routine care. Further studies with larger sample sizes are recommended to confirm these findings and optimize treatment protocols. Trial registration: NCT04077996. Funding source: None to declare. Full article

Background: Sarcopenic obesity, characterized by reduced skeletal muscle mass and excess adiposity, is strongly associated with chronic pain and functional decline in older adults. Objective: This prospective controlled trial without randomization investigated the effects of a structured, three-phase rehabilitation program on physical performance, pain, and sarcopenia-specific quality of life in elderly patients with sarcopenic obesity and chronic pain. Methods: In this study, 82 participants were enrolled and allocated to a study group (SG, n = 40), receiving supervised rehabilitation, nutritional counseling, and supplementation, or to a control group (CG, n = 42), which did not receive rehabilitation. The final analysis included 35 patients in SG and 36 in CG. Outcomes were assessed at baseline and six months using the Sarcopenia Quality of Life Questionnaire (SarQoL), Short Physical Performance Battery (SPPB), Numeric Rating Scale (NRS), and Pressure Pain Threshold (PPT). Results: The SG showed significant improvements in all outcomes: SarQoL increased from 57.02 to 63.98, SPPB increased from 7.14 to 8.4, PPT increased from 69.31 to 78.05, and NRS decreased from 6.94 to 4.65 (all p < 0.001). The CG showed no significant changes. Conclusions: The implementation of a structured, three-phase rehabilitation program resulted in clinically and statistically significant improvements in physical performance, pain perception, and sarcopenia-related quality of life in older adults with sarcopenic obesity and chronic pain. Full article

Posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) often co-occur and present significant treatment challenges. Cognitive Processing Therapy (CPT) is a widely used, efficacious treatment for PTSD, but the application of CPT among individuals with co-occurring PTSD/AUD has been limited. To address this gap, we developed a novel, 12-session trauma-focused treatment that combines CPT with Relapse Prevention (RP) for AUD (CPT+RP). This paper describes CPT+RP and presents preliminary outcomes from the first six participants enrolled in a larger, ongoing multisite clinical trial of CPT+RP. PTSD symptoms were assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and PTSD Checklist for DSM-5 (PCL-5). The Timeline Follow-Back (TLFB) assessed frequency (percent days drinking; PDD) and quantity (drinks per drinking day; DDD) of alcohol use, and craving was measured using the Penn Alcohol Craving Scale (PACS). The Client Satisfaction Questionnaire measured acceptability. Pre- to post-treatment reductions were observed in PTSD symptoms (ΔMCAPS-5 = 14.00; ΔMPCL-5 = 20.50), frequency and quantity of alcohol use (ΔMPDD = 38.65; ΔMDDD = 6.24), and craving (ΔPACS = 6.17). Most participants achieved clinically significant improvement in their PTSD symptoms and acceptability was high. Although preliminary, the findings suggest the new CPT+RP intervention is feasible, acceptable, and a promising treatment innovation for co-occurring PTSD and AUD. Full article

Background/Objectives: Embryo selection in IVF is traditionally based on morphology, yet many high-quality embryos fail to implant. Preimplantation genetic testing for aneuploidy (PGT-A) using next-generation sequencing (NGS) has been proposed to improve selection by identifying euploid embryos. However, its effectiveness in women of advanced maternal age remains unclear due to limited randomized data. This pilot trial assessed the feasibility of a full-scale RCT comparing PGT-A to morphology-based selection in women aged 35–42. Methods: This single-centre, two-arm parallel RCT (NCT05009745) enrolled women aged 35–42 undergoing IVF/ICSI with ≥3 good-quality day-3 embryos. Participants were randomized (1:1) to either embryo selection by morphology with fresh transfer or PGT-A with frozen transfer of a single euploid embryo. Allocation concealment was achieved via a secure web-based randomization platform; patients and clinicians were unblinded, but the biostatistician remained blinded. The primary outcome was feasibility of recruitment, randomization, and adherence. Results: Between June 2021 and January 2023, 138 women consented (recruitment rate: 55.8%, 95% CI: 49.7–62.0%) and 100 were randomized. Protocol adherence was 94%. Barriers to recruitment included preference for private PGT-A (19%) or fresh transfer (6%). Among biopsied embryos, 51.4% were euploid and 6.6% low-level mosaic. Intention-to-treat analysis showed no significant differences between PGT-A and control groups in clinical pregnancy rate (50% vs. 40%), live birth rate (50% vs. 38%), or miscarriage rate (12% vs. 8%). Cumulative live birth rate after up to three SETs was 72% vs. 52%, respectively (p > 0.05). No multiple pregnancies occurred. Conclusions: RCTs of PGT-A in older women are feasible. A multicentre design with broader inclusion criteria could improve recruitment and allow better assessment of clinical benefit. Full article

Introduction/Objectives: Osteoarthritis (OA) is a chronic systemic disease that affects the entire array of joint structures. It is one of the most common chronic, socially significant diseases, associated with a decline in the quality of life of patients and constantly increasing the cost of treatment. Clinical trial outcomes are largely inconclusive, and OA remains one of the few musculoskeletal diseases without an established disease-modifying therapy. One potential explanation is the use of ineffective tools for OA classification, patient stratification, and the assessment of disease progression. There is growing interest in musculoskeletal ultrasonography (MSK US), as it enables the dynamic visualization of the examined structures and gives information about both inflammatory and structural changes that have occurred. Determining the leading ultrasound phenotype, which depends on the most damaged tissue at a given time (bone, cartilage, synovial membrane, joint capsule, ligaments, tendons, menisci, etc.), can rationalize therapy use by selecting patients more suitable for specific treatments. This article aims to evaluate and summarize the potential of MSK US in the process of determining the clinical phenotype of OA and to emphasize the importance of this imaging modality in evaluating further therapeutic strategies. Method: A single-center prospective study conducted in the period of September 2023–June 2024 enrolled 259 consecutive patients with proven OA. The statistical program Minitab version 22.2.1 (2025) was used to analyze the data. The predominant and secondary phenotypes were tabulated for each OA localization and were presented numerically and as relative proportions (%). The rate of the most frequently occurring phenotypes was compared against that of the less frequent ones through paired z-tests. The initially acceptable type I error was set at 5%; it was further adjusted for the number of comparisons (Bonferroni). Results: The most frequent and predominant US phenotype for patients with knee OA was intra-articular effusion (n = 47, 37.90%). It was significantly higher compared to the rest of the US phenotypes: synovial proliferation (n = 22, 17.70%; p < 0.001), cartilage destruction (n = 26, 21%; p = 0.001), altered subchondral bone (n = 8, 6.50%; p < 0.001), extra-articular soft tissue changes (n = 12, 9.70%; p < 0.001), crystal deposits (n = 6, 4.8%; p < 0.001), and post-traumatic (n = 3, 2.40%; p < 0.001). The most common US phenotype for hip OA was altered subchondral bone (n = 32, 47.1%), with significant differences from intra-articular effusion (n = 12, 17.60%; p = 0.001), synovial proliferation (n = 5, 7.40; p = 0.001), cartilage destruction (n = 12, 17.60%; p = 0.001), extra-articular soft tissue changes (n = 3, 4.40%; p = 0.001), crystal deposits (n = 3, 4.40%; p = 0.001), and post-traumatic (n = 0). Altered subchondral bone was also the leading US phenotype for hand OA (n = 31, 55.40%), with significant differences compared to intra-articular effusion (n = 1, 1.80%; p < 0.001), synovial proliferation (n = 7, 12.50%; p < 0.001), cartilage destruction (n = 11, 19.60%; p < 0.001), extra-articular soft tissue changes (n = 2, 3.60%; p < 0.001), crystal deposits (n = 3, 5.40%; p < 0.001), and post-traumatic (n = 1, 1.80%, p < 0.001). For shoulder OA, extra-articular soft tissue changes were the most frequent (n = 8, 46.20%), followed by post-traumatic (n = 4, 30.70%), as the rate of both phenotypes was significantly higher compared to that of intra-articular effusion (n = 0), synovial proliferation (n = 0), cartilage destruction (n = 1, 7.70%; p = 0.003), and crystal deposits (n = 0). Conclusions: The therapeutic approach for OA is a dynamic and intricate process, for which the type of affected joint and the underlying pathogenetic mechanism at a specific stage of the disease’s evolution is essential. MSK US is one of the options for the clinical phenotyping of OA. Some of the suggested ultrasound subtypes may serve as the rationale for selecting a particular treatment. Full article

Pulmonary hypertension (PH) encompasses a group of conditions characterized by elevated pulmonary arterial pressure, with pulmonary arterial hypertension (PAH) representing a distinct and severe subset. This review provides a comprehensive overview of the current classification system, highlighting the five clinical groups of PH and the specific hemodynamic criteria defining PAH. We discuss the complex pathophysiological mechanisms underlying PAH, including vascular remodeling, endothelial dysfunction, and genetic predisposition. Advances in diagnostic approaches are explored. Current treatment strategies targeting key molecular pathways such as endothelin, nitric oxide, and prostacyclin are reviewed alongside novel and investigational therapies. Prognostic indicators and risk stratification tools are evaluated to guide clinical management. Finally, we underscore the critical role of expert centers in accurate diagnosis, multidisciplinary care, and enrollment in clinical trials, which collectively improve patient outcomes in this challenging disease spectrum. Full article

Background: Heart failure (HF) is frequently associated with skeletal muscle wasting, reduced functional capacity, and malnutrition. High-protein diets offer a promising nutritional intervention to improve these outcomes in individuals with HF. Objective: This systematic review evaluated randomized controlled trials of high-protein dietary interventions in HF populations, with emphasis on intervention characteristics, quantitative benefits, and risk of bias. Methods: We conducted a comprehensive search in PubMed, MEDLINE, Embase, and Cochrane CENTRAL from inception to June 2025. Eligible studies enrolled adults (≥18 years) with HF, implemented high-protein regimens (≥1.1 g/kg/day or ~25–30% of energy), and reported on functional capacity, body composition, muscle strength, clinical outcomes, or biochemical markers. Two reviewers independently screened, extracted data, and assessed bias (Cochrane RoB 2). Heterogeneity in dosing, duration, and outcomes precluded meta-analysis; we therefore provide a narrative synthesis. Results: Ten trials (nine randomized controlled trials, one pilot) involving 1080 patients (median n = 38; range 21–652) were included. High-protein interventions yielded mean improvements in six-minute walk distance of +32 ± 14 m, lean body mass gain of +1.6 ± 0.9 kg, and 9 ± 4% enhancement in quality-of-life scores; muscle strength effects varied from −2% to +11%. Two studies reported an 18% reduction in HF readmissions (p < 0.05). The risk-of-bias assessment identified two low-risk, three moderate-risk, and one high-risk study. Key limitations include small sample sizes, varied protein dosing (1.1–1.5 g/kg/day), short follow-up (2–6 months), and outcome heterogeneity. Conclusions: High-protein dietary strategies appear to confer modest, clinically relevant gains in functional capacity, nutritional status, and HF readmission risk. Larger, well-powered trials with standardized dosing and longer follow-up are necessary to establish optimal protein targets, long-term efficacy, and safety. Full article

Background: The European League Against Rheumatism (EULAR), in collaboration with the European Scleroderma Trial and Research group (EUSTAR), published the first set of treatment recommendations for systemic sclerosis (SSc) in 2009, with subsequent updates in 2016 and 2023. Objectives: This study aimed to evaluate how rheumatologists’ clinical approaches to the treatment of SSc evolved following the 2016 update of the clinical management guidelines. Methods: Medication use for SSc was analyzed in a cohort of 378 patients. The patients were stratified based on enrollment before (233 patients) and after (145 patients) the guideline update, and medication usage was compared between the two groups. Results: Although all patients presented with Raynaud’s phenomenon (RP), only 35% received calcium channel blockers. Medications such as iloprost, phosphodiesterase type 5 (PDE-5) inhibitors, fluoxetine, and bosentan, recommended for the treatment of RP and digital ulcers, were not approved for SSc by the Republic Health Insurance Fund. Treatment for pulmonary arterial hypertension (PAH) was administered to only 16 patients (4.2%), including 2 who received bosentan, 10 who received PDE-5 inhibitors, and 4 who were treated with riociguat. The use of PDE-5 inhibitors increased following the 2016 update of the guidelines. Cyclophosphamide was consistently prescribed for interstitial lung disease (ILD), with an increased frequency observed after the guideline update. No significant differences were observed in the use of methotrexate for skin involvement, ACE inhibitors for scleroderma renal crisis, or antibiotics for gastrointestinal symptoms. Proton pump inhibitors (PPIs) were prescribed to 87.3% of patients with gastrointestinal involvement, with an increase in use of both PPIs and prokinetic agents following the guideline update. Conclusions: Rheumatologists’ adherence to the EULAR/EUSTAR guidelines varied considerably, with 25% to 100% of eligible patients receiving the recommended treatments. Concordance improved in the management of PAH, ILD, and gastrointestinal involvement after the 2016 guideline update. Full article