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Nevin Manimala Statistics

Soft tissue evaluation of functional therapy in growing patients with Class II malocclusion: a long-term study

Eur J Orthod. 2021 Mar 19:cjab008. doi: 10.1093/ejo/cjab008. Online ahead of print.

ABSTRACT

OBJECTIVE: The objective of this study was to analyse the soft tissue changes produced by the functional treatment of mandibular advancement in growing Class II patients.

MATERIALS: The treated group consisted of 25 Caucasian patients (12 females and 13 males) with dento-skeletal Class II malocclusion treated with functional therapy (Activator). All patients were evaluated before treatment (T1; mean age, 9.9 years), at the end of functional treatment phase (T2; mean age, 11.9 years), and at a post-pubertal follow-up observation (T3; mean age, 18.5 years). The treated group was compared with a matched control group of 25 untreated subjects (13 females, 12 males) with untreated Class II division 1 malocclusion. Statistical comparisons between the two groups were performed with independent samples t-tests (P < 0.05).

RESULTS: Significant improvements were found during the long-term interval for mandibular sulcus (9.9°) and the profile facial angle (9.8°) in the treated group. No significant effects were found in terms of lower face percentage between the two groups.

CONCLUSION: Removable functional appliances induced positive effects on the soft tissue profile in Class II growing subjects with good stability in the long-term.

PMID:33740061 | DOI:10.1093/ejo/cjab008

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Evaluation of vestibular function following endolymphatic sac surgery

Eur Arch Otorhinolaryngol. 2021 Mar 19. doi: 10.1007/s00405-021-06743-3. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate objective vestibular function after endolymphatic sac surgery (ELSS) for Menière’s disease (MD), using comparative vestibular function tests: videonystagmography (VNG), vestibular evoked myogenic potentials (VEMP) and video head-impulse test (VHIT) METHODS: Patients with definite MD using the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) of 1995 criteria modified in 2015 and treated with ELSS (sac decompression or sac opening) were included. The primary outcome was the preservation of vestibular function, comparing pre- and postoperative vestibular function tests: VNG, VEMP, VHIT. Secondary outcomes were control of episodes of vertigo, hearing outcome using AAO-HNS criteria, and QoL using the Menière’s disease outcome questionnaire.

RESULTS: 73 patients were included in the study. We found a significant preservation of vestibular function as measured by VNG and VHIT. There was no statistical difference in the presence or absence of cervical and ocular (P13/N23 and N1/P1) waves on VEMP pre- and postoperatively. 67% of patients had good control of episodes of vertigo post-operatively, with significantly better results in the sac opening group (75%). There was no significant change in hearing postoperatively, and QoL scores were significantly improved after surgery (p < 0.0001).

CONCLUSION: Endolymphatic sac surgery (ELSS) is a conservative surgical treatment, which does not negatively impact vestibular function. It was associated with improved control of episodes of vertigo, preservation of hearing, and a clear improvement in QoL scores. Despite its pathophysiology not being fully understood, it remains a first-line procedure preserving vestibular function, for MD refractory to medical management.

PMID:33740085 | DOI:10.1007/s00405-021-06743-3

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Incidence of myelodysplastic syndrome and acute myeloid leukemia in patients receiving poly-ADP ribose polymerase inhibitors for the treatment of solid tumors: A meta-analysis of randomized trials

Gynecol Oncol. 2021 Mar 15:S0090-8258(21)00231-6. doi: 10.1016/j.ygyno.2021.03.011. Online ahead of print.

ABSTRACT

BACKGROUND: Clinical trials demonstrated that PARPi (poly [adenosine diphosphate-ribose]-ADP polymerase inhibitor) therapy is effective in solid tumors. However, long term effects such as therapy-related myelodysplastic syndrome or acute myeloid leukemia (MDS/AML) are poorly described. We sought to quantify whether PARPi therapy is associated with the development of MDS/AML.

METHODS: Medline, Embase, and Cochrane databases were searched (inception to January 6, 2020) and phase 2 and 3 clinical trials that randomized patients with solid tumors to a PARPi or control therapy were included. The PRISMA guidelines were used to extract data independently by multiple authors. We extracted person-time and number of cases of MDS/AML in the PARPi and control arms of each study and pooled results with a random-effects Poisson regression model. The pooled incidence rate ratio (IRR) for MDS/AML among patients randomized to PARPi therapy was compared to those randomized to a control.

RESULTS: We identified 14 studies that included 5739 patients. Accounting for intra-study clustering, the risk of MDS/AML was similar in patients who were randomly assigned to receive PARPi compared to controls (IRR 1.32, 95% confidence interval [CI] 0.78-2.26). In the front-line setting, PARPi therapy was associated with developing MDS/AML (IRR 5.43, 95% CI 1.51-19.60). Among patients treated for recurrence, however, the risk of MDS/AML appeared to be similar among patients randomized to PARPi or control treatment. Among studies that included only patients with a BRCA mutation, the risk of MDS/AML was similar in both treatment groups (IRR 0.83, 95% CI 0.45-1.53), but PARPi therapy was associated with MDS/AML in studies with an unrestricted population (IRR 2.43, 95% CI 1.17-5.06).

CONCLUSION: The pooled overall effect was not statistically significant. However, treatment with PARPi was associated with a statistically significant increase in the incidence of MDS/AML among patients receiving front-line cancer therapy and those with limited prior exposure to chemotherapy.

PMID:33736856 | DOI:10.1016/j.ygyno.2021.03.011

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Long-Term Outcomes of Patients Undergoing the Ross Procedure

J Am Coll Cardiol. 2021 Mar 23;77(11):1412-1422. doi: 10.1016/j.jacc.2021.01.034.

ABSTRACT

BACKGROUND: Treatment of aortic-valve disease in young patients still poses challenges. The Ross procedure offers several potential advantages that may translate to improved long-term outcomes.

OBJECTIVES: This study reports long-term outcomes after the Ross procedure.

METHODS: Adult patients who were included in the Ross Registry between 1988 and 2018 were analyzed. Endpoints were overall survival, reintervention, and major adverse events at maximum follow-up. Multivariable regression analyses were performed to identify risk factors for survival and the need of Ross-related reintervention.

RESULTS: There were 2,444 adult patients with a mean age of 44.1 ± 11.7 years identified. Early mortality was 1.0%. Estimated survival after 25 years was 75.8% and did not statistically differ from the general population (p = 0.189). The risk for autograft reintervention was 0.69% per patient-year and 0.62% per patient-year for right-ventricular outflow tract (RVOT) reintervention. Larger aortic annulus diameter (hazard ratio [HR]: 1.12/mm; 95% confidence interval [CI]: 1.05 to 1.19/mm; p < 0.001) and pre-operative presence of pure aortic insufficiency (HR: 1.74; 95% CI: 1.13 to 2.68; p = 0.01) were independent predictors for autograft reintervention, whereas the use of a biological valve (HR: 8.09; 95% CI: 5.01 to 13.08; p < 0.001) and patient age (HR: 0.97 per year; 95% CI: 0.96 to 0.99; p = 0.001) were independent predictors for RVOT reintervention. Major bleeding, valve thrombosis, permanent stroke, and endocarditis occurred with an incidence of 0.15% per patient-year, 0.07% per patient-year, 0.13%, and 0.36% per patient-year, respectively.

CONCLUSIONS: The Ross procedure provides excellent survival over a follow-up period of up to 25 years. The rates of reintervention, anticoagulation-related morbidity, and endocarditis were very low. This procedure should therefore be considered as a very suitable treatment option in young patients suffering from aortic-valve disease. (Long-Term Follow-up After the Autograft Aortic Valve Procedure [Ross Operation]; NCT00708409).

PMID:33736823 | DOI:10.1016/j.jacc.2021.01.034

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Comparative performance of the Phadebas® Forensic Press Test at room temperature and 37 °C for the detection of saliva stains on fabric exhibits

Sci Justice. 2021 Mar;61(2):170-174. doi: 10.1016/j.scijus.2020.11.001. Epub 2020 Nov 21.

ABSTRACT

The Phadebas® Forensic Press Test (PFPT) is an enzyme-based colorimetric test used to visualise and locate latent saliva stains on forensic exhibits. The test relies upon the presence of the enzyme α-amylase which is present in high levels in saliva. Even though the optimal in vitro temperature for α-amylase activity is 37 °C, the PFPT manufacturer’s protocol specifies that the PFPT should be carried out at room temperature (RT). In this study, we compared the performance of the PFPT at RT and 37 °C using combinations of four fabric types (cotton, polyester, acrylic and a cotton/polyester blend), three saliva dilutions (neat, 1:10 and 1:100) and stains aged for four time periods (1 day, 1 week, 1 month and 3 months). The intensity of the PFPT colour reactions at RT and 37 °C were not statistically different across all fabric types, saliva concentrations and stain ages, indicating that maximum sensitivity and performance of the PFPT can be achieved at RT.

PMID:33736849 | DOI:10.1016/j.scijus.2020.11.001

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Nevin Manimala Statistics

The contact area of static and dynamic footprints: Forensic implications

Sci Justice. 2021 Mar;61(2):187-192. doi: 10.1016/j.scijus.2020.10.003. Epub 2020 Oct 24.

ABSTRACT

When found at crime scenes, footprints may be evidentially valuable and can assist with the identity of a perpetrator based on their features and/or measurements. Footprints can be either static (made while standing) or dynamic (made while walking). While extensive research has been performed on the linear measurements obtained from static and dynamic footprints, research on the comparisons between the contact area of static and dynamic footprints in the forensic context are limited. The present study compares the contact area of static and dynamic bare footprints to determine if statistically significant differences exist between the two. Static and dynamic footprints were obtained from a sample of randomly-selected 461 Jatt Sikh adults (230 males and 231 females) of Indian origin between the ages of 19 and 32 years. The footprint contact area was calculated from each footprint (excluding the toes) using a PedoGRID® sheet. No statistically significant differences were observed between the contact area of static and dynamic footprints for each foot among males and females. However, statistically significant differences between both the sexes were found in the footprint contact areas of both footprint types. The right dynamic footprint contact area was found to be the most predictive measurement for classifying and estimating sex from a footprint’s contact area. The study has implications in the analysis of footprints recovered from crime scenes.

PMID:33736852 | DOI:10.1016/j.scijus.2020.10.003

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Nevin Manimala Statistics

Simultaneous combustion preparation for mercury isotope analysis and detection of total mercury using a direct mercury analyzer

Anal Chim Acta. 2021 Apr 15;1154:338327. doi: 10.1016/j.aca.2021.338327. Epub 2021 Feb 17.

ABSTRACT

Mercury (Hg) stable isotope signatures are widely used to understand Hg cycling in the environment. Sample preparation methods for determining Hg isotope ratios by CV-MC-ICP-MS vary widely among laboratory facilities and sample types. Here, we present a novel and rapid method for preparing solid samples prior to determining Hg isotope composition. We use a direct Hg analyzer (that measures total Hg) for sample combustion, amalgamation and analysis. During the thermal release of Hg from the amalgamator and following detection, the analyte gas enters a trapping solution consisting of 10% HCl/BrCl (5:1, vol/vol). We find Hg blank values are less than 1% of the Hg introduced during sample analysis, Hg detection is not altered by modifying the system, and more than 90% of the introduced Hg is recovered in the trapping solution. Hg isotope results are statistically indistinguishable from accepted values for previously published certified reference materials and uncertainty of 2σ (0.05-0.12‰) is similar to the solution standard RM8610 (2σ = 0.09‰). This new method allows for solid sample preparation for Hg isotope analysis in under 15 min. It has the additional advantage of minimizing use of sample mass during simultaneous detection and preparation.

PMID:33736793 | DOI:10.1016/j.aca.2021.338327

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Single molecule characterization of anomalous transport in a thin, anisotropic film

Anal Chim Acta. 2021 Apr 15;1154:338331. doi: 10.1016/j.aca.2021.338331. Epub 2021 Feb 17.

ABSTRACT

The diffusion of small, charged molecules incorporated in an anisotropic polyelectrolyte multilayer (PEM) was tracked in three dimensions by combining single-molecule fluorescence localization (to characterize lateral diffusion) with Förster resonance energy transfer (FRET) between diffusing molecules and the supporting surface (to measure diffusion in the surface-normal direction). Analysis of the surface-normal diffusion required model-based statistical analysis to account for the inherently noisy FRET signal. Combining these distinct single-molecule methods, which are inherently sensitive to different length-scales, permitted simultaneous characterization of severely anisotropic diffusion, which was more than three orders of magnitude slower in the surface-normal direction. We hypothesize that the anomalously slow surface-normal diffusion was related to the periodic distribution of charge in the PEM, which created electrostatic barriers. The motion was strongly subdiffusive, with anomalous temporal scaling exponents in lateral and normal directions, suggesting a connection to the transient, random fractal conformation of polymer chains in the film’s matrix.

PMID:33736806 | DOI:10.1016/j.aca.2021.338331

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Empagliflozin in Patients With Heart Failure, Reduced Ejection Fraction, and Volume Overload: EMPEROR-Reduced Trial

J Am Coll Cardiol. 2021 Mar 23;77(11):1381-1392. doi: 10.1016/j.jacc.2021.01.033.

ABSTRACT

BACKGROUND: Investigators have hypothesized that sodium-glucose cotransporter 2 (SGLT2) inhibitors exert diuretic effects that contribute to their ability to reduce serious heart failure events, and this action is particularly important in patients with fluid retention.

OBJECTIVES: This study sought to evaluate the effects of the SGLT2 inhibitor empagliflozin on symptoms, health status, and major heart failure outcomes in patients with and without recent volume overload.

METHODS: This double-blind randomized trial compared the effects of empagliflozin and placebo in 3,730 patients with heart failure and a reduced ejection fraction, with or without diabetes. Approximately 40% of the patients had volume overload in the 4 weeks before study enrollment.

RESULTS: Patients with recent volume overload were more likely to have been hospitalized for heart failure and to have received an intravenous diuretic agent in an outpatient setting in the previous 12 months, and to experience a heart failure event following randomization, even though they were more likely to be treated with high doses of a loop diuretic agent as an outpatient (all p < 0.001). When compared with placebo, empagliflozin reduced the composite risk of cardiovascular death or hospitalization for heart failure, decreased total hospitalizations for heart failure, and improved health status and functional class. Yet despite the predisposition of patients with recent volume overload to fluid retention, the magnitude of these benefits (even after 1 month of treatment) was not more marked in patients with recent volume overload (interaction p values > 0.05). Changes in body weight, hematocrit, and natriuretic peptides (each potentially indicative of a diuretic action of SGLT2 inhibitors) did not track each other closely in their time course or in individual patients.

CONCLUSIONS: Taken together, study findings do not support a dominant role of diuresis in mediating the physiological changes or clinical benefits of SGLT2 inhibitors on the course of heart failure in patients with a reduced ejection fraction. (EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction [EMPEROR-Reduced]; NCT03057977).

PMID:33736819 | DOI:10.1016/j.jacc.2021.01.033

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Interplay of Mineralocorticoid Receptor Antagonists and Empagliflozin in Heart Failure: EMPEROR-Reduced

J Am Coll Cardiol. 2021 Mar 23;77(11):1397-1407. doi: 10.1016/j.jacc.2021.01.044.

ABSTRACT

BACKGROUND: Mineralocorticoid receptor antagonists (MRAs) and sodium glucose co-transporter 2 inhibitors favorably influence the clinical course of patients with heart failure and reduced ejection fraction.

OBJECTIVES: This study sought to study the mutual influence of empagliflozin and MRAs in EMPEROR-Reduced (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Reduced Ejection Fraction).

METHODS: Secondary analysis that compared the effects of empagliflozin versus placebo in 3,730 patients with heart failure and a reduced ejection fraction, of whom 71% used MRAs at randomization.

RESULTS: The effects of empagliflozin on the primary endpoint, on most efficacy endpoints, and on safety were similar in patients receiving or not receiving an MRA (interaction p > 0.20). For cardiovascular death, the hazard ratios for the effect of empagliflozin versus placebo were 0.82 (95% confidence interval [CI]: 0.65 to 1.05) in MRA users and 1.19 (95% CI: 0.82 to 1.71) in MRA nonusers (interaction p = 0.10); a similar pattern was seen for all-cause mortality (interaction p = 0.098). Among MRA nonusers at baseline, patients in the empagliflozin group were 35% less likely than those in the placebo group to initiate treatment with an MRA following randomization (hazard ratio: 0.65; 95% CI: 0.49 to 0.85). Among MRA users at baseline, patients in the empagliflozin group were 22% less likely than those in the placebo group to discontinue treatment with an MRA following randomization (hazard ratio: 0.78; 95% CI: 0.64 to 0.96). Severe hyperkalemia was less common in the empagliflozin group.

CONCLUSIONS: In EMPEROR-Reduced, the use of MRAs did not influence the effect of empagliflozin to reduce adverse heart failure and renal outcomes. Treatment with empagliflozin was associated with less discontinuation of MRAs. (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Reduced Ejection Fraction [EMPEROR-Reduced]; NCT03057977).

PMID:33736821 | DOI:10.1016/j.jacc.2021.01.044