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Nevin Manimala Statistics

Validation of the Sentinel Lymph Node Technique in Early-stage Ovarian Cancer (SENTOV II)

Int J Gynecol Cancer. 2025 Nov 21:102821. doi: 10.1016/j.ijgc.2025.102821. Online ahead of print.

ABSTRACT

BACKGROUND: Pelvic and para-aortic lymphadenectomy remains the standard procedure for nodal staging in apparent early-stage ovarian cancer, but it is associated with considerable morbidity and lacks clear evidence of improving survival. Sentinel lymph node mapping may offer a less invasive alternative while still enabling accurate upstaging in a sub-set of patients with occult lymph node metastasis.

PRIMARY OBJECTIVE: This study aims to evaluate the negative predictive value of the sentinel lymph node technique for detecting lymphatic metastases in early-stage ovarian cancer compared with systematic pelvic and para-aortic lymphadenectomy (gold standard).

STUDY HYPOTHESIS: The sentinel lymph node technique is non-inferior to systematic lymphadenectomy for detecting lymphatic metastasis.

TRIAL DESIGN: This is a multi-center phase III clinical trial. Eligible patients with confirmed early-stage ovarian cancer will undergoing sentinel lymph node mapping and a subsequently complete staging surgery, including systematic lymphadenectomy. The concordance between both methods will be analyzed.

MAJOR INCLUSION/EXCLUSION CRITERIA: Inclusion: Women aged ≥18 years, with histologically confirmed epithelial ovarian malignancy in apparent International Federation of Gynecology and Obstetrics I to II stage, planned for staging surgery either at the time of initial surgery (after intra-operative frozen section confirmation) or after a deferred histologic diagnosis.

EXCLUSION: Age <18 years, previous vascular or lymphatic pelvic/aortic surgery, previous lymphoma or abdominopelvic tumors, allergy to Technetium-99m or indocyanine green, pregnancy/lactation.

PRIMARY ENDPOINT: Negative predictive value of the sentinel lymph node technique compared to systematic lymphadenectomy for lymph node metastasis.

SAMPLE SIZE: The planned sample size is 100 patients with negative sentinel lymph node results to ensure adequate statistical power (80%) to detect a negative predictive value for the sentinel lymph node technique above 95%. An interim analysis will be performed once 50% of the recruitment has been reached to adjust the exact total sample size. Recruitment period is estimated at 24 to 36 months in 11 high-volume Spanish centers.

ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Patient accrual: November 2025 to November 2028.

FINAL RESULTS EXPECTED: January 2029.

TRIAL REGISTRATION: NCT06963268.

PMID:41763980 | DOI:10.1016/j.ijgc.2025.102821

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Quality of Life After Abdominal Wall Reconstruction and the Establishment of a Pathway for Renal Transplant Recipients

Transplant Proc. 2026 Feb 27:S0041-1345(26)00090-4. doi: 10.1016/j.transproceed.2026.01.025. Online ahead of print.

ABSTRACT

PURPOSE: The aims of this study were to evaluate outcomes and impact on quality of life (QoL) for patients undergoing abdominal wall reconstruction (AWR) and to describe the establishment of a pathway for renal transplant recipients.

METHODS: A retrospective study of renal transplant recipients undergoing AWR for incisional hernia repair from 2015 to 2024, which included the transition point when the AWR pathway for renal transplant recipients was initiated at a large teaching hospital. Baseline characteristics, operative variables and postoperative complications were collected from electronic patient records. QoL was assessed through the distribution of standardized Hernia-related Quality-of-Life surveys (HerQLes).

RESULTS: There were 34 patients with renal transplants who underwent AWR, and 26 were eligible to complete Hernia-related Quality-of-Life survey, with17 responding. Indications for transplantation varied; the most common was polycystic kidney disease (N = 7, 21%), and most patients had comorbidities (N = 33, 97%) and were overweight. Complications occurred in 13 patients (38%), most of which were Clavien-Dindo grades I/II (53%), and there was one death that prompted the formation of the pathway. Key pathway features discussed include prehabilitation, meticulous operative planning, and multidisciplinary input throughout. Following the establishment of the pathway, patients reported statistically significant improvements in all domains of QoL including psychological, physical, and sexual parameters.

CONCLUSIONS: Incisional hernias negatively impact QoL; this is the first study to provide insight into the change in QoL for patients receiving renal transplants following AWR and demonstrates how a multidisciplinary pathway can improve outcomes. Patient selection is crucial, and future work should identify risk factors for the development of incisional hernias after renal transplantation.

PMID:41763943 | DOI:10.1016/j.transproceed.2026.01.025

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A View of Cornea Transplantation From the Patient’s Perspective

Transplant Proc. 2026 Feb 27:S0041-1345(26)00089-8. doi: 10.1016/j.transproceed.2025.12.020. Online ahead of print.

ABSTRACT

BACKGROUND: To assess the patients’ satisfaction and health-related quality of life after the penetrating keratoplasty (PK).

METHODS: 100 consecutive patients who had undergone PK participated in a 16-question survey in our clinic. Quality of life, expectancy, mood, and satisfaction of the patients were graded.

RESULTS: The average age of 100 patients (45 female, 55 male) who responded to the survey was 47.2 ± 21.5 (10-85) years. The average follow-up period of the patients was at least 12 months. The indications of the patients were keratoconus (35%), bullous keratopathy (22%), keratitis sequela (18%), trauma sequelae (15%), and corneal dystrophy (10%). While the average preoperative visual acuity was counting fingers at 2 meters (Light sensation- 0.2), the postoperative visual acuity was 0.5 (Light sensation – 1.0). While visual acuity remained constant in 8 cases, it increased in 92 cases. As a result, visual acuity was the only parameter that was statistically significant (p < .01). When patients’ satisfaction was grouped according to indications, they were listed as follows: keratoconus, corneal dystrophies, keratitis sequelae, trauma, and bullous keratopathy. In general, corneal transplant patients were satisfied with the results and were happy.

CONCLUSIONS: The only significant parameter in terms of patient satisfaction after the PK was found to be the outcome of visual acuity. For this reason, patients who will undergo corneal transplantation should be provided with clear and understandable information about their diseases and complications that may develop after transplantation.

PMID:41763942 | DOI:10.1016/j.transproceed.2025.12.020

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Relationship Between Vitamin D Levels and Inflammatory Markers in Kidney Transplant Recipients: A Retrospective Study

Transplant Proc. 2026 Feb 27:S0041-1345(26)00114-4. doi: 10.1016/j.transproceed.2026.02.012. Online ahead of print.

ABSTRACT

BACKGROUND: This study aimed to evaluate the relationship between serum 25-hydroxyvitamin D [25(OH)D] levels and hematologic inflammatory markers such as neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), as well as other biochemical parameters, in patients who underwent renal transplantation due to chronic kidney disease (CKD).

METHODS: This study included 304 adult renal transplant recipients followed at a single transplant center between January 2015 and June 2025. Patients were divided into 2 groups according to serum 25(OH)D levels: deficient (<20 ng/mL) and nona-deficient (≥20 ng/mL). Demographic, clinical, and laboratory data-including NLR, PLR, C-reactive protein (CRP), parathyroid hormone (PTH), erythrocyte sedimentation rate (ESR), and procalcitonin-were retrospectively reviewed. Statistical analyses were performed using the Mann-Whitney U test, chi-square test, and Pearson correlation analysis.

RESULTS: Vitamin D deficiency was detected in 84.2% (n = 256) of patients. Serum 25(OH)D levels were significantly and inversely correlated with PTH levels (r = -0.241, p < .001), and the deficient group had higher PTH concentrations (p = .002). Weak positive correlations were observed between 25(OH)D and both procalcitonin (r = 0.122, p = .034) and ESR (r = 0.117, p = .041). However, no significant associations were found between vitamin D levels and NLR, PLR, CRP, lipid profile, or other parameters.

CONCLUSION: Vitamin D deficiency is highly prevalent among renal transplant recipients and is significantly associated with elevated PTH levels. The weak correlations observed with inflammatory markers suggest the multifactorial nature of inflammation in this population. Routine monitoring and appropriate replacement of vitamin D may contribute to improved bone metabolism and overall health in renal transplant patients.

PMID:41763939 | DOI:10.1016/j.transproceed.2026.02.012

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Physician knowledge and practices regarding cardiovascular risk assessment and LDL-cholesterol targets determination: A monocentric cross-sectional survey

Vasc Dis (Paris). 2026 Feb 27:S3050-6581(26)00179-2. doi: 10.1016/j.vasdi.2026.02.007. Online ahead of print.

ABSTRACT

BACKGROUND: Cardiovascular diseases (CVD) remain the leading global cause of mortality. Approximately 50% of the CVD burden is attributable to five modifiable risk factors, including dyslipidemia. Effective management of low-density lipoprotein cholesterol (LDL-C) through accurate cardiovascular (CV) risk stratification is fundamental to prevention. However, in daily practice, significant variability exists in how clinicians assess CV risk and determine appropriate LDL-C targets, potentially leading to suboptimal patient care.

OBJECTIVE: This cross-sectional survey aimed to evaluate the consistency and alignment with current guidelines of CV risk assessment and LDL-C target selection among clinicians working at Avicenne University Hospital, Assistance publique-Hôpitaux de Paris (Bobigny, France), when presented with diverse and challenging clinical scenarios, that formal risk calculation tools cannot assess.

METHODS: Between September and November 2025, a questionnaire-based cross-sectional survey was conducted at Avicenne University Hospital. Thirty doctors and residents from five departments (internal medicine, vascular-thoracic surgery, cardiology, geriatrics, endocrinology) participated. They were presented with six clinical vignettes designed to probe CV risk assessment in complex contexts such as heart failure, atherosclerotic cardiovascular disease (ASCVD), recurrent events, and chronic kidney disease. Responses were categorized into CV risk groups (low to extreme) based on the proposed LDL-C target, in accordance with the 2025 ESC/EAS dyslipidemia guidelines. Responses without a specific target were classified as “No category.”

RESULTS: Analysis revealed significant heterogeneity in responses. The “no category” response was the most frequent overall (29.4% of all answers), indicating substantial clinician uncertainty. Key discrepancies from guidelines included: high uncertainty (43.3% “no category”) in assigning risk after heart failure; underestimation of risk in confirmed ASCVD (most answers were moderate or high risk, not very high); reluctance to use the Extreme-risk category (<40mg/dL) for recurrent events; and insufficient recognition of moderate CKD as a High-risk factor. Vascular surgeons most frequently gave “no category” answers (54.8% of their responses) however, there was no statistically significant difference in the proportion of “no category” responses across departments (P=0.093).

CONCLUSION: This survey identified a notable gap between guideline recommendations and clinical practice in CV risk assessment at the hospital level. Clinicians demonstrated a tendency to underestimate risk in key areas like ASCVD and CKD, and exhibited significant uncertainty in complex scenarios such as heart failure and recurrent events. These findings underscore the need for targeted educational initiatives and strategies to promote more consistent, guideline-concordant CV risk stratification to optimize preventive therapy.

PMID:41763907 | DOI:10.1016/j.vasdi.2026.02.007

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Equity-Related Determinants of Frequent Emergency Department Visits for Substance Use Disorders: A Population-Based Study in Ontario, Canada

Int J Soc Psychiatry. 2026 Feb 28:207640261419135. doi: 10.1177/00207640261419135. Online ahead of print.

ABSTRACT

BACKGROUND: Substance use disorders (SUDs) represent a growing public health concern in Canada, contributing to emergency department (ED) overcrowding and high system costs. Despite rising rates of SUD-related ED visits, the role of equity-related determinants, such as socioeconomic status, households and dwellings marginalization, and access to coordinated care, remains insufficiently understood.

AIM: This study examined how equity-related and sociodemographic factors, along with clinical and service utilization characteristics, are associated with frequent ED visits for SUD in Ontario, Canada.

METHODS: Using provincial health administrative data from ICES, we conducted a retrospective cohort analysis of individuals aged 12 and older with an SUD-related ED visit between April 2022 and March 2023. Frequent ED visits were defined as three or more substance use-related emergency department visits in the 12 months preceding an individual’s index visit, excluding the index visit itself, which represented approximately the 90th percentile of visit frequency in the cohort. Logistic regression identified factors associated with frequent ED utilization (⩾3 annually).

RESULTS: Frequent SUD-related ED visitors were disproportionately young adults (25-44 years) and male. Individuals in the most housing-unstable areas had significantly higher odds of frequent ED visits. Racialized and newcomer indices were not statistically associated with frequent visits. Comorbid mental illness, chronic diseases, and alcohol use were strong clinical correlates. High service utilization patterns, including prior mental health and acute care hospitalizations, were also associated with frequent ED use.

CONCLUSION: High-frequency ED users with SUD reflect a convergence of clinical complexity, socioeconomic vulnerability, and systemic gaps. While households and dwellings marginalization emerged as a key factor, the absence of associations with racialized or newcomer indices should not be misread as a lack of need, as these indices were measured at the area level. These findings highlight the urgent need for equity-informed, integrated care to reduce preventable ED use.

PMID:41763904 | DOI:10.1177/00207640261419135

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The Incidence of Painful Neuroma After Digital Amputation Due to Trauma Versus Chronic Ischemia

Hand (N Y). 2026 Feb 28:15589447261416977. doi: 10.1177/15589447261416977. Online ahead of print.

ABSTRACT

BACKGROUND: Finger amputation is one of the most common surgical procedures conducted by hand surgeons. The purpose of the current study was to compare the incidence of painful neuromas requiring surgical interventions after finger amputation secondary to acute trauma versus chronic digital ischemia.

METHODS: A retrospective chart review was conducted at a single tertiary academic medical center. Patients who underwent finger amputation due to acute trauma or chronic ischemia were identified using Current Procedural Terminology codes. The primary outcome was the incidence of neuroma formation. Patient demographics, treatment types, and postoperative complications, such as infection, residual pain, and phantom limb, were also collected.

RESULTS: Between January 2013 and December 2023, there were 1150 patients who underwent finger or thumb amputations, 917 due to acute trauma and 233 associated with chronic ischemia. Men were more likely involved in traumatic amputations. Raynaud’s disease, scleroderma, and end-stage renal disease were the common causes for ischemic finger amputation. No significant difference was found between the 2 groups in postamputation complications. Thirty-eight in the traumatic group (4.1%) and 4 in the chronic ischemia group (1.7%) developed painful neuroma requiring surgical intervention. However, the difference was not statistically significant (P = .09).

CONCLUSIONS: The overall incidence of painful stump neuroma after digital amputation was low. While there was a stronger tendency in developing painful neuromas after finger amputation due to trauma compared with chronic ischemia, the difference was not statistically significant.

PMID:41763898 | DOI:10.1177/15589447261416977

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Statistical Fragility of Randomized Control Trials Comparing Surgical and Conservative Management of Distal Radius Fractures in Elderly Patients

Hand (N Y). 2026 Feb 28:15589447261416114. doi: 10.1177/15589447261416114. Online ahead of print.

ABSTRACT

Randomized controlled trials (RCTs) comparing surgical fixation versus conservative management of distal radius fractures (DRFs) among the elderly often rely on P values for outcomes despite small sample sizes, attrition, and nonsignificant findings. This study uses the reverse fragility index (rFI) and reverse fragility quotient (rFQ) to assess the statistical stability of re-intervention and complication outcomes in RCTs. PubMed and Embase were searched for RCTs between January 1, 2000, and May 2024 for RCTs that evaluated surgical management versus conservative management of DRFs in the elderly population were included. RCTs were included if they contained 2 treatment arms reporting categorical dichotomous outcomes and had an equal or longer than 1-year follow-up. Non-RCT studies, RCTs with more than 2 treatment arms, RCTs without 1 year or longer follow-up, and RCTs without DRFs in elderly cohorts were excluded. rFI were calculated as the number of outcome even reversals needed to change statistical significance for nonsignificant (P ≥ .05) outcomes. rFQ was calculated by dividing the rFI by the sample size of the study. One thousand three hundred sixty-one articles were screened, with 12 studies with 1495 patients included for final analysis. The median rFI for re-intervention was 4 (range: 1-18), with a median rFQ of 0.035 (3.5%) within all RCTs evaluated. In every trial, the number of patients lost to follow-up was higher than the rFI, suggesting fragile statistical conclusions. For fracture healing complications, the median rFI was 4, with an rFQ of 0.02 (2%). Minor and major complications had rFI of 3, with rFQ of 0.02 (2%) and 0.04 (4%), respectively. Randomized controlled trials (RCTs) comparing surgical and conservative management of DRFs among elderly patients are statistically fragile, with a median of only 4 event reversals needed to alter significance. Caution is warranted when interpreting RCT results to determine fracture management among this patient population. Authors recommend larger, well-powered trials with standardized rFI analyses to better interpret outcomes in DRF RCTs among elderly patients.Level of Evidence: Therapeutic Level III.

PMID:41763897 | DOI:10.1177/15589447261416114

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Identification of antihypertensive, antidiabetic, and antioxidant peptides derived from hydrolysates of dairy white wastewaters containing milk proteins using machine learning insights

Food Res Int. 2026 Apr 1;229:118496. doi: 10.1016/j.foodres.2026.118496. Epub 2026 Jan 21.

ABSTRACT

Dairy white wastewater (WW), a by-product of industrial cleaning processes, contains residual milk proteins that can be enzymatically converted into bioactive peptides. In this study, WW proteins were hydrolyzed using four enzymes, pepsin, trypsin, thermolysin, and pronase E, for up to 240 min, and the resulting hydrolysates were evaluated for ACE inhibition, DPP-IV inhibition, and antioxidant capacity. Thermolysin hydrolysates exhibited the strongest ACE inhibition, with IC50 values as low as 21.0 μg protein/mL, whereas pepsin and pronase E hydrolysates showed DPP-IV inhibitory activities with IC50 values of 2.4-3.1 mg protein/mL. Pepsin hydrolysates presented the highest antioxidant capacity, reaching 3.5 μM Trolox equivalents/mg protein. LC-MS/MS analysis combined with multivariate statistics identified 60 discriminant peptides, including 17 peptides previously reported to possess antihypertensive, antidiabetic, and/or antioxidant bioactivities. Based on a combination of PLS-DA loadings, QSAR scores, novelty relative to known bioactive peptides and physicochemical diversity, 20 peptides were synthesized and validated experimentally. Several peptides such as LRF, QW, GAWY, PPF, GPIVL, and SFNPTQL exhibited potent inhibitory effects, with micromolar IC50 values for ACE and/or DPP-IV. In comparison to chemically synthesized ACE inhibitors like captopril, the most potent peptide, LRF, is five times more active on a molar basis (11.34 μM vs 63.06 μM). These findings demonstrate that WW is a promising source of multifunctional peptides and that integrating peptidomics with machine learning accelerates peptide discovery and validation.

PMID:41763818 | DOI:10.1016/j.foodres.2026.118496

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Effects of different brewing conditions on the physicochemical, bioactive, antioxidant, flavor and sensory properties of Gastrodia elata tea

Food Res Int. 2026 Apr 1;229:118387. doi: 10.1016/j.foodres.2026.118387. Epub 2026 Jan 13.

ABSTRACT

Gastrodia elata, a recognized medicine food homology plant, has traditionally been consumed as a functional herbal tea owing to its rich bioactive composition and associated health benefits. Herein, we systematically investigated the effects of crushing degree (lamellated, granular, and powdered forms), brewing temperature (70-100 °C), and time (3-10 min) on the physicochemical properties, total phenolics, total flavonoids, individual bioactives (adenosine; gastrodin; p-hydroxybenzyl alcohol; p-hydroxy benzaldehyde; and parishin compounds A, B, C, and E), flavor, and sensory characteristics of Gastrodia elata tea by using advanced analytical equipment combined with chemometrics methods. Among the different crushing degrees, granular Gastrodia elata tea exhibited the most favorable properties. Upon increasing brewing temperature and time, the bioactive levels, scavenging capacities against DPPH and ABTS free radicals, and sensory attributes of Gastrodia elata tea generally followed parabolic and incremental trends. Notably, granular Gastrodia elata tea treated at 90 °C for 10 min showed the highest total phenolics, flavonoids, and sugar contents. Non-targeted metabolomics analysis further revealed the differences in metabolites of Gastrodia elata tea under different brewing conditions. Through multivariate statistical analysis, the internal relationships among different brewing conditions, volatile and non-volatile components and quality characteristics were established, and 11 potential characteristic markers closely related to the quality of Gastrodia elata tea were obtained. Results underscored the role of brewing conditions in enhancing the dissolution of quality-related volatile and nonvolatile bioactives. Collectively, the findings provided a scientific guidance for the consumption of Gastrodia elata tea to support daily nutritional and health needs.

PMID:41763758 | DOI:10.1016/j.foodres.2026.118387