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Nevin Manimala Statistics

Cohort study on the Effect of various nicotine consumption modalities on Mohs surgery complications

Arch Dermatol Res. 2025 Jan 18;317(1):281. doi: 10.1007/s00403-025-03819-6.

ABSTRACT

Knowledge on the effect of different nicotine consumption modalities on dermatologic surgical outcomes is limited, with conflicting conclusions. Cigarette smoking is known to adversely affect outcomes, but the impact of other nicotine consumption modalities like cigars, smokeless tobacco, and nicotine replacement therapy (NRT) is less understood. Our objective was to evaluate the impact of various nicotine consumption modalities on complication rates after Mohs micrographic surgery (MMS). We conducted a prospective cohort study of 404 MMS patients. Variables analyzed included patient age, sex, post-operative complications, and nicotine history via a questionnaire. We found that patients with any history of nicotine use had an 8.5% absolute risk of experiencing complications while the risk for patients without a history of nicotine use was 3.1%, representing a relative risk of 2.75. Cox proportional hazard testing found patient sex and past smoked tobacco use as statistically significant factors for complications. Patients who have smoked tobacco appear to be at a significantly increased risk of experiencing a complication following MMS compared to never-nicotine users. Larger studies are needed to clarify the surgical risks posed by smokeless nicotine products.

PMID:39825914 | DOI:10.1007/s00403-025-03819-6

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Efficacy of birthing ball exercises to reduce labor pain and cesarean rates: an updated meta-analysis of randomized controlled trials

Arch Gynecol Obstet. 2025 Jan 18. doi: 10.1007/s00404-024-07930-3. Online ahead of print.

ABSTRACT

PURPOSE: This updated systematic review and meta-analysis aims to evaluate the impact of a birthing ball (BB) exercises on low-risk parturients during labor, offering a more comprehensive understanding through a larger sample size, robust analysis, and focus on relevant endpoints that were underexplored in previous studies due to limited data.

METHODS: We searched PubMed, Embase, Scopus, and Cochrane Central for randomized controlled trials (RCTs) comparing BB (also named Swiss ball) exercises with no intervention or standard care in parturients undergoing low-risk labor. Risk ratios (RR) and mean differences (MD) were calculated using a random-effects model. I2 heterogeneity was assessed. All statistical analyses were performed using Review Manager 5.4.

RESULTS: We included 10 RCTs with 1,008 parturients, 51.2% of whom were assigned to BB exercises. In the pooled analysis, the BB group showed significantly lower cesarean section rates (MD 0.55, p = 0.007, I2 = 32%), reduced pain scores at 4 and 8 cm dilation by approximately 20% (p < 0.001), and a reduction of over two hours in the duration of the first stage of labor (MD -130.12 min, p < 0.001). There were no significant differences between groups in the duration of the second stage of labor (p = 0.090) and in the incidence of instrumental delivery, amniotomy, labor induction, oxytocin use, or epidural analgesia.

CONCLUSIONS: BB exercises significantly reduced cesarean section rates, alleviated labor pain, and shortened the first stage of labor, supporting their use as a safe and effective non-pharmacological intervention in low-risk labor management.

PMID:39825901 | DOI:10.1007/s00404-024-07930-3

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Robust discrimination between closely related species of salmon based on DNA fragments

Anal Bioanal Chem. 2025 Jan 18. doi: 10.1007/s00216-024-05724-9. Online ahead of print.

ABSTRACT

Closely related species of Salmonidae, including Pacific and Atlantic salmon, can be distinguished from one another based on nucleotide sequences from the cytochrome c oxidase sub-unit 1 mitochondrial gene (COI), using ensembles of fragments aligned to genetic barcodes that serve as digital proxies for the relevant species. This is accomplished by exploiting both the nucleotide sequences and their quality scores recorded in a FASTQ file obtained via Next Generation (NextGen) Sequencing of mitochondrial DNA extracted from Coho salmon caught with hook and line in the Gulf of Alaska. The alignment is done using MUSCLE (Muscle 5.2) (Edgar in Nat Commun 13:6968, 2022), applied to multiple versions of each fragment perturbed according to the nucleobase identification error probabilities underlying the quality scores. The Damerau-Levenshtein distance was used to determine the genetic barcode of the candidate species that is closest to each aligned, perturbed fragment. The “votes” that the sampled fragments cast for the different candidate species are then pooled and converted into identification probabilities, using weights determined by the entropy of the fragment-specific identification probability distributions. This novel approach to quantify the uncertainty associated with measurements made using NextGen Sequencing can be applied to discriminate closely related species, hence to value-assignment for reference materials supporting determinations of the authenticity of seafood, for example, NIST Reference Materials 8256 and 8257 (Coho salmon) (Ellisor et al., 2021).

PMID:39825896 | DOI:10.1007/s00216-024-05724-9

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Multicenter study of thermal ablation versus partial thyroidectomy for paratracheal papillary thyroid microcarcinoma

Eur Radiol. 2025 Jan 18. doi: 10.1007/s00330-024-11326-x. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare the clinical outcomes of patients with unifocal paratracheal papillary thyroid microcarcinoma (PTMC) after thermal ablation (TA) vs. partial thyroidectomy (PT).

MATERIALS AND METHODS: This retrospective multicenter study included 436 patients with unifocal, clinical N0 paratracheal PTMC who underwent TA (210 patients) or PT (236 patients) between June 2014 and December 2020. The propensity score matching method was used to mitigate confounding factors between the two groups. Disease progression, progression-free survival (PFS), complications, and treatment variables were compared. Adjusted Cox regression models were utilized to assess the impact of treatment on disease progression.

RESULTS: After matching, a comparable incidence of disease progression (3.3% vs. 2.2%, p = 0.79) and comparable 5-year PFS rates (97.0% vs. 97.4%, p = 0.75) were observed between the TA and PT groups. Adjusted Cox regression models showed no significant correlation between TA and disease progression. TA was associated with shorter hospitalization (0 vs. 6.0 days), less estimated blood loss (0 vs. 15.0 mL), shorter incision length (0.3 vs. 6.0 cm), and lower costs ($1748.3 vs. $2898.0) compared with PT (all p < 0.001). The complication rate was 1.1% after TA and 3.3% after PT (p = 0.28), with permanent complications were exclusively observed in the PT group.

CONCLUSION: The mid-term incidence of disease progression and PFS rates were similar between TA and PT in patients with unifocal paratracheal PTMC. TA might represent a promising alternative treatment to PT for eligible patients with paratracheal PTMC.

KEY POINTS: Question Is thermal ablation a viable alternative treatment to partial thyroidectomy for treating paratracheal papillary thyroid microcarcinoma? Findings Comparable incidence of disease progression and 5-year progression-free survival rates were observed between thermal ablation and partial thyroidectomy. Clinical relevance Thermal ablation, as a minimally invasive procedure, provides a promising alternative to partial thyroidectomy, with comparable clinical outcomes for patients with paratracheal papillary thyroid microcarcinoma.

PMID:39825891 | DOI:10.1007/s00330-024-11326-x

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Methodological Insights on Biomarker-Based Patient Selection: A Review of Scientific Advice Procedures at the European Medicines Agency

Clin Pharmacol Ther. 2025 Jan 18. doi: 10.1002/cpt.3558. Online ahead of print.

ABSTRACT

Biomarkers play a pivotal role in the selection and enrollment of trial participants. Particularly, predictive biomarkers help tailor medical care to individual patients; however, also prognostic biomarkers require consideration at the design stage. At the time of initiating a clinical trial, there may be uncertainty about whether a biomarker is predictive or prognostic, and the trial design may need to account for this. Relevant discussions between drug developers and regulators on the role of a biomarker in a specific drug development program are expected to take place during Scientific Advice (SA) procedures. SA procedures at the European Medicines Agency from January 1, 2018, to December 31, 2020, were systematically searched for methodological discussions around the use of predictive or prognostic biomarkers. The final analysis included 45 SA procedures for which key characteristics were summarized quantitatively. Selected methodological issues such as the cutoff selection of continuous biomarkers or study design considerations were elaborated in a qualitative summary. Our results identify commonly encountered points for discussion between drug developers and the European Medicines Agency for biomarker-informed patient selection and enrollment. Identified topics addressed during SA procedures include cutoff selection, study design, multiplicity control, and data-driven subgroup selection. The majority of the identified 45 SA procedures concern development programs in oncology. Addressing these issues upfront will allow for an improved dialogue between drug developers and regulators and support the drug development program and ultimately patient-centered access to medicines.

PMID:39825875 | DOI:10.1002/cpt.3558

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Deep Equilibrium Unfolding Learning for Noise Estimation and Removal in Optical Molecular Imaging

Comput Med Imaging Graph. 2025 Jan 8;120:102492. doi: 10.1016/j.compmedimag.2025.102492. Online ahead of print.

ABSTRACT

In clinical optical molecular imaging, the need for real-time high frame rates and low excitation doses to ensure patient safety inherently increases susceptibility to detection noise. Faced with the challenge of image degradation caused by severe noise, image denoising is essential for mitigating the trade-off between acquisition cost and image quality. However, prevailing deep learning methods exhibit uncontrollable and suboptimal performance with limited interpretability, primarily due to neglecting underlying physical model and frequency information. In this work, we introduce an end-to-end model-driven Deep Equilibrium Unfolding Mamba (DEQ-UMamba) that integrates proximal gradient descent technique and learnt spatial-frequency characteristics to decouple complex noise structures into statistical distributions, enabling effective noise estimation and suppression in fluorescent images. Moreover, to address the computational limitations of unfolding networks, DEQ-UMamba trains an implicit mapping by directly differentiating the equilibrium point of the convergent solution, thereby ensuring stability and avoiding non-convergent behavior. With each network module aligned to a corresponding operation in the iterative optimization process, the proposed method achieves clear structural interpretability and strong performance. Comprehensive experiments conducted on both clinical and in vivo datasets demonstrate that DEQ-UMamba outperforms current state-of-the-art alternatives while utilizing fewer parameters, facilitating the advancement of cost-effective and high-quality clinical molecular imaging.

PMID:39823663 | DOI:10.1016/j.compmedimag.2025.102492

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Feasibility of very low iodine dose aortoiliac CT angiography using dual-source photon-counting detector CT

Eur J Radiol. 2025 Jan 13;183:111919. doi: 10.1016/j.ejrad.2025.111919. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the feasibility of aortoiliac CT-Angiography (CTA) using dual-source photon-counting detector (PCD)-CT with minimal iodine dose.

METHODS: This IRB-approved, single-center prospective study enrolled patients with indications for aortoiliac CTA from December 2022 to March 2023. All scans were performed using a first-generation dual-source PCD-CT. Images were acquired with fast pitch and full spectral capabilities (collimation 144 × 0.4 mm). The contrast protocol included a mixture of sodium chloride and iodinated contrast agent (Iopromide, total iodine dose: 9.5-9.8 g). Virtual monoenergetic images (VMIs) were reconstructed at 40, 50, 60, and 68 keV. Two blinded radiologists evaluated image quality on a 4-point scale. Attenuation was measured across eight regions in the aorta and iliac arteries, and contrast-to-noise ratio (CNR) was calculated. Statistical comparisons were performed using repeated measures ANOVA and Bonferroni post-hoc tests.

RESULTS: The final cohort consisted of 39 subjects (mean age: 69.6 ± 9.6 years; 30.8 % female). VMI at 40 keV provided significantly higher attenuation: 478 ± 114 HU, compared to 50 keV (331 ± 74 HU), 60 keV (241 ± 51 HU), and 68 keV (190 ± 48 HU) (p < 0.01). This translated in increased CNR for 40 keV reconstructions (11.8 ± 3.9), followed by 50 keV (9.1 ± 3.0), 60 keV (7.0 ± 2.3), and 68 keV (6.1 ± 1.9) (p < 0.01). Subjective image quality was rated excellent at 40 keV (4 [3,4]), though associated with highest noise (38 ± 7.4 HU, p = 0.02).

CONCLUSION: Aortoiliac CTA using dual-source PCD-CT at 40 keV achieved high attenuation and CNR, enabling effective imaging with only 9.8 g of iodine.

PMID:39823660 | DOI:10.1016/j.ejrad.2025.111919

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Feasibility of on-site CT-FFR analysis on cardiac photon-counting CT in evaluation of hemodynamically significant stenosis in comparison to invasive catheter angiography

Eur J Radiol. 2025 Jan 10;183:111927. doi: 10.1016/j.ejrad.2025.111927. Online ahead of print.

ABSTRACT

OBJECTIVES: Coronary CT angiography (CCTA) is an excellent tool in ruling out coronary artery disease (CAD) but tends to overestimate especially highly calcified plaques. To reduce diagnostic invasive catheter angiographies (ICA), current guidelines recommend CT-FFR to determine the hemodynamic significance of coronary artery stenosis. Photon-Counting Detector CT (PCCT) revolutionized CCTA and may improve CT-FFR analysis in guiding patients.

METHODS: In this single-center study, patients with obstructive CAD who underwent CCTA using PCCT and subsequent ICA were included. Delta CT-FFR was calculated by subtracting the CT-FFR values 1.8 cm before and after the stenosis, with a cut-off value of ≥0.06 indicating hemodynamic significance. Revascularization during ICA defined a stenosis as hemodynamically significant. Sensitivity, specificity, negative and positive predictive value, and diagnostic accuracy of Delta CT-FFR have been determined. Patients were followed up to evaluate the rate of major adverse cardiovascular events (MACE) 6 months after CCTA.

RESULTS: A total of 28 patients (3 female, median age 68 years) were enrolled in this study. Delta CT-FFR was pathological in all patients who underwent revascularization. No patients with normal Delta CT-FFR required stent placement. In 39.29 % of the cases, calculation of Delta CT-FFR could have prevented patients from undergoing unnecessary ICA. The positive predictive value of Delta CT-FFR for CAD RADS 4a was 66.7 %, negative predictive value 100 %, and diagnostic accuracy 74 %.

CONCLUSION: Delta CT-FFR analysis using PCCT offers a feasible tool in identifying hemodynamically significant coronary artery stenosis and can help to reduce purely diagnostic ICA.

PMID:39823658 | DOI:10.1016/j.ejrad.2025.111927

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Clinical and radiographic comparison of robot-assisted single-position versus traditional dual-position lateral lumbar interbody fusion

J Neurosurg Spine. 2025 Jan 17:1-10. doi: 10.3171/2024.10.SPINE24808. Online ahead of print.

ABSTRACT

OBJECTIVE: The potential of robot-assisted (RA) single-position (SP) lateral lumbar interbody fusion (LLIF) warrants further investigation. This study aimed to assess the efficacy of RA-SP-LLIF in improving both clinical and radiographic outcomes in patients undergoing lumbar spinal fusion surgery.

METHODS: A total of 59 patients underwent either RA-SP-LLIF (n = 31 cases) or traditional LLIF (n = 28 cases). Surgical parameters including operative duration, estimated blood loss, and fluoroscopy duration were recorded. Clinical outcomes were assessed using the visual analog scale (VAS) for back and leg pain, Oswestry Disability Index (ODI), and the 36-item Short-Form Health Survey (SF-36). Radiographic parameters were also evaluated.

RESULTS: There were no significant differences between the two groups in terms of postoperative and last follow-up times, but both groups demonstrated significant improvements in VAS scores. Similarly, ODI and SF-36 scores showed comparable improvements. Radiographic parameters did not significantly differ between the groups preoperatively, postoperatively, and at last follow-up (p > 0.05). Neither group showed significant improvements in pelvic tilt and sacral slope parameters compared to baseline postoperatively and at last follow-up (p > 0.05). However, the RA-SP-LLIF group exhibited significantly greater improvements in lumbar lordosis (LL; p < 0.01), segmental lordosis (SL; p < 0.01), and pelvic incidence-LL mismatch (PI-LL; p < 0.01) immediately postoperatively compared to baseline, although these differences were not significant at subsequent evaluations. Similarly, the traditional LLIF group improved the LL, SL, and PI-LL parameters postoperatively. Importantly, there was no statistically significant difference in the Bridwell grade and complications between the two groups (p = 0.83 and p = 0.88, respectively). However, the RA-SP-LLIF group had significantly shorter operative and fluoroscopy durations compared to the traditional LLIF group (p = 0.04 and p < 0.01, respectively).

CONCLUSIONS: Both RA-SP-LLIF and traditional LLIF surgeries achieved satisfactory lordotic correction. However, RA-SP-LLIF surgery demonstrated shorter operative and fluoroscopy times compared to traditional LLIF surgery. Therefore, RA-SP-LLIF is a promising technique for enhancing surgical efficiency, safety, and precision in lumbar spinal fusion procedures.

PMID:39823634 | DOI:10.3171/2024.10.SPINE24808

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A randomized trial comparing endovascular and surgical management of ruptured intracranial aneurysms excluded from previous trials

J Neurosurg. 2025 Jan 17:1-9. doi: 10.3171/2024.8.JNS241276. Online ahead of print.

ABSTRACT

OBJECTIVE: Many patients with ruptured intracranial aneurysms (RIAs) underrepresented or excluded from previous randomized controlled trials (RCTs) comparing surgery with endovascular treatment (EVT) are still considered for surgical clipping, but the best management of these patients remains unknown.

METHODS: The International Subarachnoid Aneurysm Trial-2 was a randomized trial comparing surgical versus EVT of RIAs considered for surgical clipping, despite the results of previous RCTs, and also eligible for EVT. The primary endpoint was death or dependency according to the modified Rankin Scale score (mRS score > 2) at 1 year. Secondary endpoints included 1-year angiographic results and length of hospital stay. The primary hypothesis was that endovascular management would decrease the number of poor outcomes (mRS score > 2) from 30% to 23%, necessitating 1896 patients. The trial was interrupted after 10 years because of slow recruitment. Primary analysis was by intent-to-treat. There was no blinding.

RESULTS: From November 2012 to December 2022, 270 patients were recruited at 6 North American and European centers. After exclusions, 263 patients were randomly allocated to receive surgery (n = 133) or EVT (n = 130). There were 12 crossovers (9 from surgery to EVT). The primary outcome was reached in 40 of 133 surgical patients (30%, 95% CI 23%-38%) compared with 35 of 130 EVT patients (27%, 95% CI 20%-35%) (p = 0.572). Residual aneurysms at 1 year were less frequent with surgery (10/118 [8%, 95% CI 5%-15%]) than EVT (22/109 [20%, 95% CI 14%-29%]) (p = 0.015). Additional procedures (ventricular drainage and decompressive craniotomy, p < 0.05) and hospitalization > 20 days were more frequent in the surgery group (69/133 [52%, 95% CI 43%-60%]) than in the EVT group (38/130 [29%, 95% CI 22%-38%]) (p < 0.001).

CONCLUSIONS: This prematurely interrupted trial showed more frequent additional procedures and longer hospitalizations but better 1-year angiographic results with surgery. The primary clinical outcome, death or dependency at 1 year, was similar for EVT and surgery.

PMID:39823597 | DOI:10.3171/2024.8.JNS241276