Nevin Manimala

Orv Hetil. 2026 Aug 30;167(35):1394-1401. doi: 10.1556/650.2026.33638. Print 2026 Aug 30.

ABSTRACT

INTRODUCTION: The incidence of inflammatory bowel diseases (IBDs) is increasing worldwide, with dietary factors playing a role in both their development and clinical course. The protective effect of the Mediterranean diet has been confirmed by several clinical studies; however, limited data are available on patients’ actual dietary habits – particularly during remission.

OBJECTIVE: The aim of our study was to assess adherence to the Mediterranean diet and the presence of Western-type dietary patterns among adolescent IBD patients in remission.

METHOD: In this cross-sectional study, 24 IBD patients receiving biologic therapy (mean age: 15.71 ± 2.31 years) were included. Adherence to the Mediterranean diet was assessed using the KIDMED questionnaire, while the consumption of Western dietary components was evaluated using a specific 23-item food frequency questionnaire.

RESULTS: Based on KIDMED scores, all participants showed low (n = 16) or moderate (n = 8) adherence, with no cases of high adherence (mean: 2.75 ± 1.78). According to the food frequency questionnaire, all patients regularly consumed foods characteristic of a Western dietary pattern, most commonly chocolate, high-fat processed meats, bakery products, and sugar-sweetened breakfast cereals. Participants consumed an average of 7.75 out of 23 listed food groups at least 1-3 times weekly. No significant associations were found between dietary habits and diagnosis (Crohn’s disease or ulcerative colitis) or sex; however, approximately one-third of the participants demonstrated an unfavorable dietary pattern. Furthermore, no significant correlation was identified between the results of the two questionnaires.

DISCUSSION: Our findings regarding Western dietary patterns are consistent with results from studies conducted in the healthy Hungarian population, which indicate low intake of vegetables, fruits, and dietary fiber. Adherence to the Mediterranean diet in our cohort appears less favorable compared to international data. The study highlights that adherence to dietary recommendations may decline during remission.

CONCLUSION: An unfavorable dietary pattern was observed among IBD patients, supporting the need for regular and targeted dietary interventions. Emphasizing a sustainable, balanced diet – particularly during remission – is essential for effective disease management. Orv Hetil. 2026; 167(35): 1394-1401.

PMID:42669145 | DOI:10.1556/650.2026.33638

Ther Innov Regul Sci. 2026 Aug 30. doi: 10.1007/s43441-026-01039-2. Online ahead of print.

ABSTRACT

Power-based sample size calculation is the standard approach in confirmatory clinical trials, where adequate statistical power is essential for study success. In other decision-making contexts, however, a precision-based approach to sample size determination is sometimes adopted. One such area is consumer studies that evaluate consumers’ ability to appropriately select nonprescription medications. Compared with power-based designs, precision-based approaches typically require fewer study participants and can therefore reduce study costs. However, the extent of loss in statistical power has not been well quantified. In this paper, we evaluate the statistical power of precision-based sample size determination and illustrate its practical implementation. Our analysis demonstrates that when the target precision is set to the difference between the expected proportion and the null threshold, the resulting design achieves only approximately 50% power. This underpowering is further exacerbated when normal approximation is used for sample size determination, commonly practiced for convenience, but exact methods are used for analysis. For studies that plan to use a precision-based approach to support hypothesis testing in decision-making contexts, it is important to be aware of the potential underpower issue in this approach.

PMID:42669109 | DOI:10.1007/s43441-026-01039-2

J Comput Aided Mol Des. 2026 Aug 30;40(1):221. doi: 10.1007/s10822-026-00934-y.

ABSTRACT

Lysine crotonylation (Kcr) is a vital posttranslational modification that plays a significant role in diverse biological processes such as DNA replication, the cell cycle, spermatogenesis, and embryonic stem cell differentiation. Abnormal Kcr levels are associated with multiple diseases including cancer, neurological disorders, and metabolic diseases, making it crucial for understanding disease pathogenesis and progression. In this study, we introduce ESM2-Kcr, a novel computational model designed for predicting Kcr sites. This model integrates the protein language model ESM2 with advanced deep learning techniques including LSTM, multi-head attention mechanism, and CNN. We elaborate on the specific feature extraction contributions of each deep learning module in ESM2-Kcr: LSTM captures the long-distance sequential dependency information of amino acid residues in protein sequences, CNN extracts the local short-range structural and functional features centered on lysine residues, and the multi-head attention mechanism adaptively assigns weight coefficients to key residue positions to highlight Kcr-related critical sequence information and filter out redundant noise. ESM2-Kcr encodes the protein sequences using ESM2_t30_150M_UR50D and further extracts comprehensive features. Through extensive comparisons with other protein language models like ProteinBERT and ProtT5, as well as different models within the ESM2 family, ESM2-Kcr demonstrates superior generalization ability and performance. The ESM2-Kcr model not only enhances our understanding of protein regulation but also holds great potential in identifying disease biomarkers and facilitating drug development. Future research directions may involve extending this framework to other posttranslational modifications. Data and codes are available at https://github.com/liukai23157/ESM2-Kcr .

PMID:42669100 | DOI:10.1007/s10822-026-00934-y

Eur Spine J. 2026 Aug 30. doi: 10.1007/s00586-026-10340-5. Online ahead of print.

ABSTRACT

PURPOSE: To investigate whether integrating Basic Body Awareness Therapy (BBAT) into a physiotherapeutic scoliosis-specific exercises (PSSE) program improves trunk proprioception in individuals with AIS.

METHODS: In this randomized, parallel-group controlled trial, 38 individuals with AIS (aged 10-17 years) were randomly allocated to the BBAT or the control group. The control group received PSSE only, whereas the BBAT group received a combined program of PSSE and BBAT for 16 weeks. Trunk proprioception was assessed using trunk repositioning tests at 15° and 30° and the Neutral Lumbar Positioning (NLP) Test. Cobb angles and axial trunk rotation (ATR) were measured. Outcomes were analyzed using ANCOVA adjusted for baseline values with Holm correction for multiple comparisons.

RESULTS: After adjustment for baseline values and Holm correction, trunk proprioceptive outcomes statistically favored the BBAT group at 15° (adjusted p < 0.001), 30° (adjusted p = 0.045), and in the NLP test (adjusted p < 0.001). However, none of the adjusted between-group differences exceeded the corresponding study-derived MDC₉₅ values; therefore, although statistically significant, the clinical relevance of the findings remains uncertain. No significant between-group differences were observed in Cobb angle or ATR (p > 0.05).

CONCLUSION: A combined PSSE-BBAT program was associated with statistically greater improvements in trunk proprioception than PSSE alone, although the clinical significance of these changes remains uncertain. BBAT may be considered a supportive body-awareness component within exercise-based scoliosis rehabilitation, but these findings reflect the combined intervention structure rather than the isolated additive effect of BBAT.

PMID:42669092 | DOI:10.1007/s00586-026-10340-5

Acta Neurol Belg. 2026 Aug 30. doi: 10.1007/s13760-026-03177-8. Online ahead of print.

ABSTRACT

BACKGROUND: Cardiac cephalalgia is a type of secondary headache that occurs in association with myocardial ischemia. It may present without typical chest pain, complicating early diagnosis and delaying optimal treatment. This study aims to evaluate the frequency of headache in a selected cohort of patients with myocardial infarction undergoing coronary angiography.

METHODS: We retrospectively reviewed 115 patients diagnosed with MI who underwent coronary angiography. The presence of headache prior to angiography was recorded, and follow-up was performed to assess its persistence after intervention. Statistical analyses included Chi-square, Mann-Whitney U and McNemar tests to evaluate associations between headache and clinical/laboratory parameters.

RESULTS: A total of 90 patients were included in the study (mean age 57.8 years; 71 males). Among them, 27 patients (30%) experienced headache prior to angiography. Following coronary intervention, headache persisted in only one patient, indicating a statistically significant reduction (p < 0.001). No significant relationship was found between headache presence and MI type (STEMI vs. NSTEMI), age, LDL cholesterol, blood pressure or other clinical parameters (p > 0.05).

CONCLUSIONS: Cardiac cephalalgia may be an overlooked presentation of myocardial infarction, occurring in a subset of patients. The complete resolution of symptoms following revascularization underscores the need to consider cardiac cephalalgia in the differential diagnosis of unexplained headaches, especially in the absence of classic cardiac symptoms. Greater clinical awareness could improve early diagnosis and patient outcomes.

PMID:42669089 | DOI:10.1007/s13760-026-03177-8

Urolithiasis. 2026 Aug 30;54(1):140. doi: 10.1007/s00240-026-02048-4.

ABSTRACT

Despite major advances in kidney-stone management, the clinical-trial landscape in nephrolithiasis has not been systematically characterized. We performed a 20-year registry-based landscape analysis of interventional kidney-stone trials, focusing on trial design, primary endpoint selection, infrastructure, and dissemination. ClinicalTrials.gov was searched for interventional kidney-stone trials with primary completion dates between June 23, 2005 and June 23, 2025. Trials were categorized by lead sponsor type, study design, center status, intervention category, and primary endpoint domain. Temporal trends in primary endpoint selection were assessed by registration era. Publication status, ClinicalTrials.gov results posting, and intervals from registration to results posting, study start to publication, and primary completion to publication were evaluated among completed trials. A total of 57 trials met inclusion criteria. Most had an academic lead sponsor (49/57, 86.0%), were randomized (43/57, 75.4%), completed (51/57, 89.5%), single-center (38/57, 66.7%) and US-based (53/57, 93.0%). Medical/pharmacologic interventions were most common (33/57, 57.9%), followed by procedural/device-based (17/57, 29.8%) and preventive/behavioral/other interventions (7/57, 12.3%). Primary endpoints most often focused on stone-related efficacy (25/57, 43.9%), followed by pain/quality-of-life/patient-reported outcomes (16/57, 28.1%), complication/safety outcomes (9/57, 15.8%), and operational/resource-use outcomes (7/57, 12.3%). By registration era, stone-related efficacy endpoints declined from 69% in 2005-2015 to 23% in 2016-2025, while pain/quality-of-life endpoints increased from 15% to 39%. Female representation averaged 43.3%, with a median of 47.9%. In the 2-year publication-mature cohort, 39 of 49 trials (79.6%) were published; among all 51 completed trials, 41 (80.4%) were published. Median registration-to-results and study-start-to-publication intervals were 45 and 48 months, respectively, while the median primary-completion-to-publication interval was 15 months. Within ClinicalTrials.gov, interventional kidney-stone trials remain largely academic and single-center, reflecting active but fragmented research infrastructure within this registry. Although stone-related efficacy remains the dominant primary endpoint, recent trials show increasing emphasis on patient-centered primary outcomes. A persistent unpublished fraction and publication commonly occurring more than one year after primary completion highlight the need for multicenter collaboration, standardized patient-centered endpoints, and timely dissemination.

PMID:42669083 | DOI:10.1007/s00240-026-02048-4

J Agromedicine. 2026 Aug 30:1-11. doi: 10.1080/1059924X.2026.2725616. Online ahead of print.

ABSTRACT

BACKGROUND: This study analyzed the incidence of skin cancer among rural workers in Brazil, considering the influence of ultraviolet (UV) radiation, skin color, and regional factors.

METHODS: Data from the National Cancer Institute (2008-2022) on skin cancer were used, using historical series of the Ultraviolet Index (UVI) obtained via satellite and cross-referenced with population information obtained from the Brazilian Institute of Geography and Statistics.

RESULTS: Between 2008 and 2022, Brazil recorded 81,378 cases of skin cancer related to rural workers, with an average incidence rate of 318.23 cases per 100,000. The UVI is high in the North and North-East regions of the country, but the highest rate of skin cancer occurs in the South, where 73% of the population is white and the UVI is lower. Correlation and regression analyses revealed that the UVI, the proportion of white people, and the percentage of rural workers significantly influence the skin cancer rate.

CONCLUSIONS: These results show that approximately 28% of a rural worker’s risk of developing skin cancer may be related to the interaction between biological and environmental factors and that prevention and sun protection strategies should take into account demographic and regional variability.

PMID:42669081 | DOI:10.1080/1059924X.2026.2725616

JACC CardioOncol. 2026 Aug 30:S2666-0873(26)00290-5. doi: 10.1016/j.jaccao.2026.08.001. Online ahead of print.

ABSTRACT

BACKGROUND: RADICAL PC-2 (RAndomizeD Intervention for CArdiovascular and Lifestyle Risk Factors in Prostate Cancer Patients) was a pragmatic randomized controlled trial that tested whether routine referral to a cardiologist or an internist for cardiovascular (CV) risk-factor and lifestyle modification improves outcomes in patients with prostate cancer or receiving androgen-deprivation therapy. The intervention group had more favorable outcomes overall, driven by improved cholesterol control, with no differences in rates of CV death, myocardial infarction (MI), stroke, or heart failure (HF).

OBJECTIVES: The authors aim to identify patient subgroups more likely to benefit from routine CV care referral.

METHODS: Prespecified subgroup analyses were used to assess whether patients at higher CV risk derived greater benefit from specialist referral, with treatment-effect heterogeneity assessed using interaction tests. The first primary outcome was a hierarchical composite of CV death, MI, stroke, HF, suboptimal cholesterol, and systolic blood pressure (SBP) control, evaluated using the win ratio. The second primary outcome was time to CV death, MI, stroke, or HF.

RESULTS: Among 2487 participants, treatment effect differed by baseline total cholesterol ≤4 mmol/L vs >4 mmol/L (interaction P = 0.016), with respective win ratios of 1.21 (95% CI: 0.89-1.64) and 1.75 (95% CI: 1.51-2.03), and by baseline BP status (SBP ≥130 mm Hg or diastolic BP ≥80 mm Hg vs BP <130/80 mm Hg; interaction P = 0.003), with respective subdistribution HRs (sHRs) for CV death, MI, stroke, or HF of 0.86 (95% CI: 0.61-1.21) and 4.85 (95% CI: 1.65-14.26). The interaction for diabetes did not reach statistical significance (interaction P = 0.054) although the intervention effect estimates suggested a potential difference by diabetes status, with sHRs of 0.53 (95% CI: 0.24-1.15) among participants with diabetes and 1.25 (95% CI: 0.88-1.78) among participants without diabetes. The win ratio was higher among participants with total cholesterol >4 mmol/L, and sHRs were numerically lower among those with SBP ≥130 mm Hg or diastolic BP ≥80 mm Hg and diabetes.

CONCLUSIONS: Uncontrolled modifiable CV risk factors may identify patients with prostate cancer who are more likely to benefit from routine CV care referral.

PMID:42669076 | DOI:10.1016/j.jaccao.2026.08.001

J Am Coll Cardiol. 2026 Aug 30:S0735-1097(26)07208-6. doi: 10.1016/j.jacc.2026.07.022. Online ahead of print.

ABSTRACT

BACKGROUND: Vutrisiran, an RNA interference therapeutic that suppresses hepatic transthyretin production, improved survival and cardiovascular outcomes in transthyretin amyloidosis with cardiomyopathy (ATTR-CM) in HELIOS-B (A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy). Tafamidis, a transthyretin stabilizer, also improves clinical outcomes. Although combining these therapies is mechanistically appealing, clinical evidence supporting this approach is limited.

OBJECTIVES: We sought to evaluate whether the treatment effects of vutrisiran differed according to baseline tafamidis use in HELIOS-B.

METHODS: In HELIOS-B, patients with ATTR-CM were randomized to vutrisiran 25 mg or placebo every 3 months for up to 36 months, with tafamidis use permitted and stratified. We assessed treatment effects according to baseline tafamidis use for the primary outcome of all-cause mortality and recurrent cardiovascular events and secondary endpoints, including individual components of the primary outcome, composite of all-cause mortality, cardiovascular events and outpatient worsening heart failure events, functional capacity (6-minute walk distance), and health status (Kansas City Cardiomyopathy Questionnaire-overall summary score [KCCQ-OSS]).

RESULTS: Among 654 participants, 259 (40%) were receiving tafamidis at baseline. Patients on tafamidis were slightly younger and had higher baseline 6-minute walk distance and higher KCCQ-OSS, while baseline characteristics were generally balanced between randomized groups. The treatment effect estimates of vutrisiran compared with placebo for the primary outcome were directionally consistent across baseline tafamidis strata (rate ratio: 0.79 [95% CI: 0.51-1.21] with tafamidis vs 0.67 [95% CI: 0.49-0.93] without), with no statistically significant interaction (P_interaction = 0.55). Similar patterns were observed for all-cause mortality, cardiovascular events, and outpatient worsening heart failure (all P_interaction > 0.20), although the magnitudes of the estimated effects were numerically smaller among patients receiving tafamidis at baseline. Vutrisiran preserved 6-minute walk distance in both baseline tafamidis strata (P_interaction = 0.24), whereas improvement in KCCQ-OSS appeared attenuated among patients receiving tafamidis at baseline.

CONCLUSIONS: Treatment effect estimates for vutrisiran on clinical outcomes were consistent across baseline tafamidis strata, with no statistically significant interaction according to baseline tafamidis use, with reduced effect size noted in those receiving baseline stabilizers in comparison to monotherapy. These data underscore the need for future prospective studies examining combination therapy in this population. (HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy; NCT04153149).

PMID:42669070 | DOI:10.1016/j.jacc.2026.07.022

J Am Coll Cardiol. 2026 Aug 5:S0735-1097(26)07209-8. doi: 10.1016/j.jacc.2026.07.023. Online ahead of print.

ABSTRACT

BACKGROUND: Vutrisiran, an RNA interference therapeutic, reduced all-cause mortality and recurrent cardiovascular events in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) in the HELIOS-B trial. Whether concomitant disease-modifying or heart failure therapy modifies the efficacy of vutrisiran has not been described.

OBJECTIVES: We aimed to characterize patterns of concomitant therapy use in HELIOS-B, describe medication initiation rates by treatment arm, and evaluate whether concomitant therapy modified vutrisiran’s treatment effect.

METHODS: In HELIOS-B, 654 randomized patients with ATTR-CM received vutrisiran or placebo. We assessed baseline use and postrandomization initiation of tafamidis, sodium-glucose cotransporter-2 (SGLT2) inhibitors, mineralocorticoid receptor antagonists (MRA), beta-blockers, and renin-angiotensin system inhibitors (angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors), and used time-updated Lin-Wei-Yang-Ying models to evaluate treatment effect modification on the primary composite endpoint of all-cause mortality and recurrent cardiovascular events.

RESULTS: At baseline, 40% of participants were receiving tafamidis and 77% at least 1 heart failure medication. MRAs and SGLT2 inhibitors were the most frequently initiated therapies during follow-up, with initiation rates numerically higher across all heart failure medication classes in the placebo group. There was no statistically significant evidence that the treatment effect of vutrisiran was modified by baseline or time-updated use of any medication class (P-interaction: tafamidis 0.95, SGLT2 inhibitors 0.59, MRA 0.92, beta-blockers 0.75, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors 0.82).

CONCLUSIONS: In HELIOS-B, there was no statistically significant evidence that the treatment benefit of vutrisiran on all-cause mortality and recurrent cardiovascular events was modified by concomitant use of tafamidis or heart failure therapies. These findings support the consistency of vutrisiran’s efficacy across the spectrum of contemporary ATTR-CM pharmacotherapy. (HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy; NCT04153149).

PMID:42669069 | DOI:10.1016/j.jacc.2026.07.023