Difference In Percentage Change Research Articles

The effect of haemolysis on the direct and indirect ion selective electrode measurement of sodium.

We compared the effect of haemolysis in sodium measurement using indirect and direct ion-selective electrodes to test the hypothesis that haemolytic effect on sodium would be greater with indirect ion-selective electrode due to electrolyte exclusion effect from released intracellular proteins. Plasma lithium heparin samples (n = 36) from four volunteers were prepared to give a range of haemolytic indices (H-indices). Samples were analysed for sodium by indirect ion-selective electrode, H-index and total protein on an Abbott Architect c16000 and sodium by direct ion-selective electrode on a Siemens RAPIDPoint 500. Percentage changes in sodium in paired direct and indirect ion-selective electrode values were compared. Abbott H-index, which represents haemoglobin concentration in g/L, correlated with percentage negative change in sodium by direct ion-selective electrode (ρ 0.995, P < 0.001) and indirect ion-selective electrode (ρ 0.991, P < 0.001). Percentage negative change was less when sodium was measured by direct ion-selective electrode compared to indirect ion-selective electrode (Wilcoxon signed-rank Z = 3.46, P = 0.01). The difference in percentage change in sodium between direct ion-selective electrode and indirect ion-selective electrode correlated with total protein (ρ 0.751, P < 0.001). The negative bias in sodium results exceeded the reference change value of 2.2% at an H-index of 8.31 for indirect ion-selective electrode and 9.26 for direct ion-selective electrode. Haemolysis causes negative influence with sodium measured by both indirect and direct ion-selective electrode due to a dilutional hyponatremia. The additional interference in indirect ion-selective electrode is due to the electrolyte exclusion effect but this is unlikely to be clinically significant as it is small in magnitude.

Changes of intrathoracic trachea with respiration in children: A metrical assessment based on 3D CT models

AimTo assess the tracheal volume and the effect of respiration through segmentation on CT-scans in children. Material and methodsChest-CT of 100 patients divided into males and females, aged 3–16 years, were retrospectively assessed. Subjects underwent inspiratory and expiratory CT-scans. Tracheal volume was segmented through ITK-SNAP software. Volume, length, anteroposterior, laterolateral diameters, and T1-T10 distance were measured. The percentage ratio between expiratory and inspiratory phases was calculated: significant differences according to sex for inspiratory and expiratory measurements were assessed through a one-way ANCOVA test using T1-T10 distance as covariate (p < 0.05). Differences in percentage changes according to sex and age were assessed through Mann-Whitney test and calculation of Pearson's correlation coefficient, respectively (p < 0.05). ResultsNo statistically significant difference according to sex was found for any measurement (p > 0.05). For the percentage ratio between inspiratory and expiratory phase, no difference was found according to sex for any measurement (p > 0.05). The percentage ratio of tracheal volume and length between expiratory and inspiratory phases showed a negative correlation with age (p < 0.05). ConclusionsThis study provides a novel contribution to the assessment of tracheal size in healthy children: future studies will verify the same measurements in patients affected by tracheomalacia to improve diagnosis.

Abstract 13314: Effect of Eicosapentaenoic Acid and Docosahexaenoic Acid on Epicardial Fat Volume; Results From a Randomized Controlled Trial

Introduction: Epicardial adipose tissue is an ectopic fat depot that may be associated with coronary artery atherosclerosis. Reduction in weight has been associated with a reduction in epicardial fat volume in several studies. Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are known to lower triglyceride level. Whether the reduction in triglyceride level is associated with a reduction in epicardial fat volume is unknown. Hypothesis: We hypothesize that EPA and DHA reduce triglyceride levels and possibly can cause regression of epicardial fat volume after 30 months of therapy. Methods: A total of 139 patients with stable coronary artery disease on statins were randomized to EPA and DHA versus none for 30 months. Epicardial fat volume was measured with coronary computed tomographic angiography at baseline and 30 months. Change in epicardial fat volume was calculated. Results: No difference in baseline characteristics was observed (Table). At 30-month follow-up, those on EPA and DHA had a significant 6.7% reduction in triglyceride level compared to a 12.6% increase in controls (p=0.02). However, there was no difference in percent change in epicardial fat volume between control and EPA/DHA groups at 30 months (-3.1% [-16.7, 4.9] vs. -5.0% [-13.1,7.3], p-value=0.80, respectively). There was no significant change in body mass index in either group at 30-month follow-up. Conclusions: EPA and DHA led to a significant reduction of triglyceride level; however, there was no corresponding significant reduction in epicardial fat volume. This finding suggests that lowering triglyceride level does not affect epicardial fat volume.

Efficacy of telmisartan for the treatment of persistent renal proteinuria in dogs: A double-masked, randomized clinical trial.

BackgroundInformation regarding efficacy of the angiotensin II receptor blocker, telmisartan, for treatment of proteinuria in dogs is limited.ObjectiveTo evaluate the antiproteinuric efficacy of telmisartan, as compared to enalapril, in dogs with chronic kidney disease and persistent, renal proteinuria.AnimalsThirty‐nine client‐owned dogs with chronic kidney disease and urinary protein‐to‐creatinine ratio (UPC) > 0.5 (if azotemic) or ≥ 1.0 (if nonazotemic).MethodsIn this prospective, randomized, double‐masked clinical trial, dogs were block randomized, according to presence or absence of azotemia and systemic arterial hypertension, to receive telmisartan (1.0 mg/kg PO q24h), or enalapril (0.5 mg/kg PO q12h), and followed for 120 days. Up‐titration of study drug dosage on days 30 and 60, and addition of the other study drug at day 90, were performed if UPC > 0.5 was noted at these visits. Percentage change in UPC relative to baseline was calculated for all time points. Data are presented as median (range).ResultsThirty‐nine (20 telmisartan‐treated, 19 enalapril‐treated) dogs were included. At day 30, percentage change in UPC was greater for telmisartan‐treated (−65% [−95% to 104%]) vs enalapril‐treated (−35% [−74% to 87%]) dogs (P = .002). Among dogs persistently proteinuric at earlier visits, telmisartan remained superior to enalapril at days 60 (P = .02) and 90 (P = .02). No difference in percentage change in UPC between study groups was observed at day 120, when combination therapy was allowed. Combination therapy resulted in relevant azotemia in 4/13 (31%) dogs.Conclusions and Clinical ImportanceTelmisartan might be a suitable first‐line therapy for dogs with renal proteinuria.

An Investigation into the Change in Customer Complaints about Takeaway during COVID-19

The study examined the change in customer complaints about takeaway during COVID-19. The data of the study were obtained from www.sikayetvar.com by scanning the complaints of customers who ordered food online from www.yemeksepeti.com. In order to reach meaningful statistical results in line with the purpose of the study, a total of 800 complaints were reviewed, 400 of which were backward and 400 of which were forward from March 21, 2020. The reviewed data were coded in two groups as before COVID-19 and during COVID-19. The codes created in the light of the studies in the literature on the subject were determined as payment, speed, taste, hygiene, health, heat, incomplete delivery, behaviour, and return, respectively. According to the frequency analysis, while the first five rankings in customer complaints before COVID-19 were behaviour, payment, speed, return, and incomplete delivery, it was determined that this order was ranked as taste, hygiene, speed, health and heat during COVID-19. It was revealed that the biggest difference in percentage change in the customer complaints based on gender during COVID-19 was in health, speed, and hygiene respectively, and women were found to be more sensitive to these issues than men.

Neurovascular Coupling in Special Operations Forces Combat Soldiers.

The purpose of this study was to investigate how concussion history affects neurovascular coupling in Special Operations Forces (SOF) combat Soldiers. We studied 100 SOF combat Soldiers [age = 33.5 ± 4.3 years; height = 180.4 ± 6.0 cm; 55 (55.0%) with self-reported concussion history]. We employed transcranial Doppler (TCD) ultrasound to assess neurovascular coupling (NVC) via changes in posterior cerebral artery (PCA) velocity in response to a reading and a visual search task. Baseline TCD data were collected for 2 min. NVC was quantified by the percent change in overall PCA response curves. We employed linear mixed effect models using a linear spline with one knot to assess group differences in percent change observed in the PCA velocity response curves between SOF combat Soldiers with and without a concussion history. Baseline PCA velocity did not significantly differ (t98 = 1.28, p = 0.20) between those with and without concussion history. Relative PCA velocity response curves did not differ between those with and without a concussion history during the reading task (F1,98 = 0.80, p = 0.37) or the visual search task (F1,98 = 0.52, p = 0.47). When assessing only SOF combat Soldiers with a concussion history, differential response to task was significantly greater in those with 3 or more concussions (F1,4341 = 27.24, p < 0.0001) relative to those with 1-2 concussions. Despite no main effect of concussion history on neurovascular coupling response in SOF combat Soldiers, we observed a dose-response based on lifetime concussion incidence. While long-term neurophysiological effects associated with head impact and blast-related injury are currently unknown, assessing NVC response may provide further insight into cerebrovascular function and overall physiological health.

Association Between Routine Nephropathy Monitoring and Subsequent Change in Estimated Glomerular Filtration Rate in Patients With Diabetes Mellitus: A Japanese Non-Elderly Cohort Study.

BackgroundsCurrent guidelines recommend routine nephropathy monitoring, including microalbuminuria or proteinuria testing, for people with diabetes mellitus; however, its effect in terms of preserving renal function remains unclear. We conducted this study to examine the impact of routine nephropathy monitoring on subsequent changes in estimated glomerular filtration rate.MethodsWe retrospectively identified non-elderly individuals with diabetes mellitus based on the prescription of hypoglycemic agents from a large Japanese database (JMDC, Tokyo, Japan) of screening for lifestyle diseases linked with administrative claims data. We collected data on baseline characteristics including age, sex, comorbidity, and laboratory data. We then examined the association between routine nephropathy monitoring results and change in estimated glomerular filtration rate using a propensity-score inverse probability of treatment weighting method.ResultsAmong 1,602 individuals who started taking hypoglycemic agents between 2005 and 2016, 102 (6.0%) underwent routine nephropathy monitoring during the first year of medication for diabetes mellitus. After adjusting for multiple confounding factors, there was no significant difference in subsequent estimated glomerular filtration rate changes between individuals with and without routine nephropathy monitoring (difference in percent change 0.11; 95% confidence interval −2.74 to 2.95).ConclusionRoutine nephropathy monitoring was not associated with preserved renal function. Current recommendations for the universal application of nephropathy monitoring may have limited value to prevent renal dysfunction in non-elderly individuals with diabetes mellitus.

An Ex Vivo Study to Evaluate the Effect of Tegaserod on Platelet Activation and Aggregation

Tegaserod, an orally active, potent 5-hydroxytryptamine-4 serotonin receptor agonist, was previously indicated for irritable bowel syndrome but was voluntarily withdrawn due to potential cardiovascular side effects. In vitro studies suggested that tegaserod increased platelet aggregation, but these results were not reproduced or were inconclusive. We sought to assess ex vivo effects of tegaserod on platelet aggregation. In this double-blind, placebo-controlled, crossover study, we randomized a majority of healthy patients with no history of cardiovascular risk factors (n = 21) to receive tegaserod or matching placebo for 7 + 2 days followed by a 7- to 10-day washout period, and then patients were crossed over to the other study drug for the next 7 + 2 days. Unstimulated and agonist-stimulated platelet aggregation; P-selectin expression; serum thromboxane (Tx)B2 and urinary 11-dehydro (11-dh) TxB2; and tegaserod and M29.0 concentrations were serially assessed. There was no significant difference in percentage change in unstimulated or adenosine diphosphate (ADP)- and ADP + serotonin-, collagen- and thrombin receptor activating peptide-induced maximum platelet aggregation and in platelet P-selectin expression in the presence of tegaserod at any time point when compared to placebo. Similarly, there was no significant difference in percentage change in serum TxB2 or urinary 11-dhTxB2 levels between placebo and tegaserod. No new or unexpected findings were observed in evaluations of safety or pharmacokinetic parameters. This comprehensive pharmacodynamic study, by employing established markers used in prior investigations, which have been considered by the Food and Drug Administration to indicate drug-related platelet effects, does not demonstrate any influence of tegaserod treatment on platelet function.

EFFECT OF FORCE ACTIVATION OF NOTCH SIGNALING ON MTOR

PURPOSE: Notch signaling is a prominent pathway necessary for repair of injured muscle. The interactions of Notch with other signaling pathways, specifically mechanistic/ mammalian target of rapamycin (mTOR), in regulating myogenesis is not well known. Studies have been conducted on Notch inhibition, but little research has been performed on activated Notch and the interactions with mTOR. This study was implemented to develop a Notch force activation protocol and to measure the effect of overexpressed Notch on C2C12 proliferation, differentiation and mTOR signaling. METHODS: Notch signaling was force activated via suspension or adhesion. For suspension, Notch-1 antibody was introduced to a 12-well plate with C2C12 cells at a concentration of 1:10. For adhesion, Notch ligand, Delta-like Ligand 1 (DLL1), was mixed with Extracellular Matrix (ECM) and coated on a 12-well plate at different concentrations (control, 2.5ug, 5ug, and 10 ug) for 12 hours. C2C12 cells were seeded at a concentration of 15,000 cells/well and differentiated for 96 hours. Following designated time period, lysates were collected for Western Blots. Primary antibodies probed for Notch (Hes1), total mTOR signaling (TmTOR), and β-actin. RESULTS: Preliminary data for suspension was analyzed via a two-way ANOVA (time x treatment). There is a significant difference in percent change of proliferation at 48 hours (p=0.02). Preliminary data of adhesion was analyzed via one-way ANOVA. There is a trend between Hes1 concentration in ligand concentration of 2.5 ug (p=0.0739). It shows no significant difference in TmTOR concentrations between the various Notch force activation concentrations in proliferating C2C12 cells (p=.4298). CONCLUSIONS: Preliminary data shows a stronger effect of suspension over adhesion for force activating Notch. A concentration of 2.5ug of ligand is possibly sufficient to force activate Notch, any higher appears too concentrated to activate Notch. Preliminary data also suggests that force activating Notch does not affect mTOR signaling. Experiments are currently testing the ideal DLL1 to activate Notch signaling, as well as examining the effect of force activating Notch on proliferation, differentiation and other markers of mTOR signaling. Different time points for differentiation should be tested in future research.

A Nutritional Intervention In Exercising Women With Oligo/Amenorrhea Improved Energy Availability

Reduced energy availability (EA) suppresses reproduction and induces oligo/amenorrhea (O/A) in exercising women. Treatment goals are to increase energy intake (EI) to improve EA and restore menstrual function. PURPOSE: Determine if a nutritional intervention that increased EI in exercising women with O/A improved EA and energetic status. METHODS A 12 month randomized controlled trial designed to increase energy intake 20-30% above baseline energy needs in exercising women with O/A randomized participants into O/A+CAL (n=13) and Control (n=10) groups. EI and exercise energy expenditure (EEE) were assessed throughout the intervention. EA was calculated as EI-EEE/fat free mass (FFM). Fasting blood samples were collected to assess TT3 and leptin. Independent t-tests/Mann-Whitney U tests compared differences between groups and correlations were run between changes in energy and hormones. Data are mean ± SE. RESULTS Subjects were 22±1 yr, BMI 20.0±0.4 kg/m2. Menstrual recovery was observed and previously reported. There were no pre intervention differences in EI (1837±95 kcal/d), EEE (390±40 kcal/d), FFM (41.5±0.8 kg) or EA (37.2±2.7 kcal/kg FFM/d) between groups. During the intervention there were greater absolute and percent increases in EI in O/A+CAL vs Control (448±170 vs -117±147 kcal/d, p=0.02; 23.6±8.6 vs -4.6±8.4%, p=0.03). There were no differences between groups in absolute or percent change for EEE (133±46 kcal/d, p=0.07; 38.8±11.3%, p=0.10) or FFM (0.6±0.3kg, p=0.60; 1.6±0.7%, p=0.51). Absolute increase in EA was greater in O/A+CAL vs Control (10.8±5.5 vs -6.0±3.9 kcal/kg FFM/d, p=0.03), but no difference in percent change (29.2±13.4 vs -6.7±12.5%; p=0.07). Absolute and percent increase in fat mass (2.3±0.3 vs 0.7±0.5, p<0.01; 20.6±3.1 vs 5.4±3.2%, p<0.01) and body mass (3.2±0.3 vs 0.8±0.8, p<0.01; 6.1±0.7 vs 1.5±1.3%, p<0.01) were greater in O/A+CAL vs Control. O/A+CAL had larger absolute and percent increases in TT3 (10.3±5.0 vs -6.7±5.3 ng/dL, p=0.03; 17.2±7.4 vs -8.3±5.5%, p=0.02) and percent increase in leptin (85.1±24.0 vs -13.3±18.0%) vs Control. Changes in EI and EA were not associated with changes in hormonal markers. CONCLUSION An intervention designed to improve EI can be considered an effective nutritional intervention for managing oligo/amenorrhea in exercising women.

Six Months Comparative Evaluation of Efficacy and Safety of Wockhardt's Biosimilar Insulin Glargine (Glaritus&amp;reg;) with Reference Insulin Glargine (Lantus&amp;reg;) in Type 2 Diabetes Mellitus in India: Results of Interim Analysis

Objective: To compare the change in immunogenic response, safety and efficacy of insulin glargine in Glaritus® and Lantus® treatment arms from baseline to six months in patients with type 2 diabetes mellitus (T2DM) uncontrolled on oral antidiabetic drugs (OADs). Material and methods: In an ongoing prospective, open-label, randomized, parallel-group, comparative, multicenter, phase IV study, adult patients with uncontrolled T2DM are treated with either Glaritus® once daily or Lantus® once daily for six months, both given subcutaneously. Glaritus® treatment arm is to be continued for another six months. The primary endpoint for the study was the percentage change in anti-insulin antibodies (AIA) titer to glargine in both treatment arms from baseline to six months. Results: Ninety patients were randomized to each group. Baseline characteristics were comparable between the groups (p>0.05). There was no significant difference in percent change in the AIA titer between the two treatment arms at the end of six months in ITT (intent-to-treat) and mITT(modified intent to treat) population (LS mean diff [95% CI]: 2.2% (-15.1%, 19.6%), p=0.7987 and 3.4% (-15.1%, 21.9%), p=0.7181, respectively). No significant between-group difference was seen in change in the HbA1c level at the end of six months in ITT and mITT population [LS mean diff (95% CI): -0.2 (-0.4, 0.0), p=0.1072 for ITT population; and -0.1 (-0.3, 0.1), p=0.2283, for mITT population]. There was also no significant difference between two groups for the incidence of adverse events [Glaritus® 17 (18.9%) and Lantus® 20 (22.2%) p=0.5800]. Conclusion: Glaritus® was found to be non-inferior to Lantus® in glycaemic control and comparable in immunogenic response and safety at the end of six months in patients with T2DM uncontrolled on OADs.

LB002ILLUMINATE-A, A PHASE 3 STUDY OF LUMASIRAN, AN INVESTIGATIONAL RNAI THERAPEUTIC, IN CHILDREN AND ADULTS WITH PRIMARY HYPEROXALURIA TYPE 1 (PH1)

Abstract Background and Aims PH1 is a rare genetic disorder characterized by hepatic oxalate overproduction, leading to recurrent kidney stones, nephrocalcinosis, progressive kidney failure, and multiorgan damage from systemic oxalosis. There are no approved pharmacologic therapies for PH1. Lumasiran is a subcutaneously-administered investigational RNAi therapeutic that targets glycolate oxidase to reduce hepatic oxalate production. We report the first results from the six-month, double-blind period of ILLUMINATE-A, a randomized, placebo-controlled Phase 3 study to evaluate lumasiran in patients with PH1. Method Key inclusion criteria: age≥6 years, 24hr urinary oxalate (UOx)≥0.70 mmol/24hr/1.73m2, confirmed PH1 diagnosis, eGFR≥30 mL/min/1.73m2. Randomization: 2:1; lumasiran (n=26), placebo (n=13). Dosing: 3 mg/kg monthly×3, then quarterly. Primary endpoint: percent change in 24hr UOx excretion from baseline to month (M) 6. Primary comparison: least square (LS) mean treatment difference in percent change from baseline (average of M3-6). Results Lumasiran led to a statistically significant percent reduction in 24hr UOx excretion compared to placebo: the LS mean change from baseline to M6 (average of M3-6) was −65.4% with lumasiran and −11.8% with placebo (LS mean difference: −53.5%; p=1.7 × 10−14). Subgroup analyses of the primary endpoint showed a consistent effect of lumasiran across age, baseline UOx, eGFR, and concomitant pyridoxine use. Lumasiran led to statistically significant improvements in all hierarchically tested secondary endpoints, including: proportion of lumasiran-treated patients that achieved normalization or near-normalization of 24hr UOx at M6 (84% vs 0% of placebo-treated patients, p=8.3 × 10−7), and percent change in plasma oxalate from baseline to M6 (average of months 3-6) (-39.5%, p=2.9 × 10−8). There were no serious or severe adverse events. The most common adverse events related to lumasiran were mild, transient injection site reactions. Conclusion Lumasiran resulted in clinically meaningful, rapid, sustained, and statistically significant reductions in urinary and plasma oxalate levels compared to placebo during the six-month double-blind period. Lumasiran has a favorable safety profile.

SAT-021 Effects of E2/P4 Oral Capsules on Bone Turnover in Women with Vasomotor Symptoms

Menopausal hormone therapy slows bone turnover and reduces the risk of osteoporotic fractures. The objective of this post hoc analysis was to evaluate bone turnover markers (BTM) in the phase 3 REPLENISH trial, which evaluated vasomotor symptoms (VMS) with an oral estradiol/progesterone (E2/P4) in postmenopausal women with a uterus.Eligible women for this analysis had ≥50 moderate to severe VMS/week, <5 years since last menstrual period, and BTM measurements at baseline, and months 6 and 12. Percent changes for 3 BTM (bone specific alkaline phosphatase [BSAP], C-terminal telopeptide of type I collagen [CTX-1], and N-terminal propeptide of type I procollagen [PINP]) assessed by immunoassay methods were evaluated from baseline to months 6 and 12 for the 1/100, 0.5/100 and placebo groups.A total of 157 women (40–61 years, 69% White) were analyzed (56 for each 1/100 and 0.5/100; 45 for placebo). Mean baseline values ranged from 14.0–14.3 U/L for BSAP, 0.34–0.39 ng/mL for CTX-1, and 76.9–79.3 ng/mL for PINP. Mean differences in percent change from baseline versus placebo significantly decreased with both E2/P4 doses for all 3 BTM at months 6 and 12. Mean differences from placebo for E2/P4 at months 6/12 ranged from -8.1% to -17.8% for BSAP (all, P≤0.02), -30% to -41% for CTX-1 (all, P≤0.001), and -14% to -29% for PINP (all, P≤0.007).REPLENISH data provide support for a potential skeletal benefit of E2/P4 when used for the treatment of moderate to severe VMS.

The Effect of an Oxytocin Rest Period on Cesarean Delivery Blood Loss [35P

INTRODUCTION: Studies have demonstrated that two hours of oxytocin exposure can desensitize uterine oxytocin receptors; which may increase blood loss during delivery. Oxytocin's half-life is 10–15 minutes, previous work suggests that it takes approximately 60 minutes to be eliminated. Our objective was to determine if a greater than 60-minute oxytocin rest period prior to cesarean delivery had an impact on blood loss. METHODS: An IRB-approved retrospective cohort study of 272 women who underwent primary cesarean delivery after oxytocin augmentation between January 2013 and December 2017 at Stony Brook University Hospital was conducted. Women with a prior cesarean delivery, a cesarean hysterectomy, multiple gestation, and a greater than 240 minute oxytocin rest period were excluded. The primary outcome was percentage change between pre- and post-operative hematocrit (Hct) in women with less than 60-minute oxytocin rest period (60 min). RESULTS: There was no difference in demographic or obstetric characteristics between the groups. Women in the &gt;60 min group had a higher cumulative dose (5112+4765 mU vs. 77017325 mU, P=.003), longer duration of oxytocin administration (671±458 min vs. 892±558 min, P=.001), and were more likely to receive uterotonics (6.7% vs. 15.2%, P=.047). No significant difference in percent change in HCT (-17.3±8.6 vs. -17.8±8.7, P=.635) was identified. Linear regression demonstrated a weak relationship between cervical dilation and percent change in Hct. (R2=0.048, P&lt;.001). CONCLUSION: No significant correlation between duration of oxytocin rest period and blood loss was found. Women receiving oxytocin augmentation do not appear to benefit from oxytocin rest periods before proceeding to cesarean delivery.

Effects of E2/P4 Oral Capsules on Bone Turnover in Women With Vasomotor Symptoms [06F

INTRODUCTION: Menopausal hormone therapy slows bone turnover and reduces the risk of osteoporotic fractures. The objective of this post hoc analysis was to evaluate bone turnover markers (BTM) in the phase 3 REPLENISH trial, which evaluated vasomotor symptoms (VMS) with an oral estradiol/progesterone (E2/P4) in postmenopausal women with a uterus. METHODS: Eligible women for this analysis had ≥50 moderate to severe VMS/week, &lt;5 years since last menstrual period, and BTM measurements at baseline, and months 6 and 12. Percent changes for 3 BTM (bone specific alkaline phosphatase [BSAP], C-terminal telopeptide of type I collagen [CTX-1], and N-terminal propeptide of type I procollagen [PINP]) assessed by immunoassay methods were evaluated from baseline to months 6 and 12 for the 1/100, 0.5/100 and placebo groups. RESULTS: A total of 157 women (40-61 years, 69% white) were analyzed (56 for each 1/100 and 0.5/100; 45 for placebo). Mean baseline values ranged from 14.0-14.3 U/L for BSAP, 0.34-0.39 ng/mL for CTX-1, and 76.9-79.3 ng/mL for PINP. Mean differences in percent change from baseline versus placebo significantly decreased with both E2/P4 doses for all 3 BTM at months 6 and 12. Mean differences from placebo for E2/P4 at months 6/12 ranged from -8.1% to -17.8% for BSAP (all, P≤0.02), -30% to -41% for CTX-1 (all, P≤0.001), and -14% to -29% for PINP (all, P≤0.007). CONCLUSION: REPLENISH data provide support for a potential skeletal benefit of E2/P4 when used for the treatment of moderate to severe VMS.

Value of silicone gel in prevention of cobblestoning following punch minigrafting in vitiligo

Background Cobblestoning is the most common complication of minipunch grafting. Objective To assess the value of silicone gel application following minipunch grafting and the histopathological and immunohistochemical changes in cases with cobblestoning. Methods Minipunch grafting was performed in two similar vitiligo lesions in 27 cases with stable vitiligo. After healing, silicone gel was applied twice daily on one lesion while zinc oxide ointment was applied to the other lesion serving as a control. Four biopsies were taken from each case; normal, vitiliginous skin before treatment and the two treated lesions 3 months after therapy, for histopathology and immunohistochemical staining for MMP9 & tenascin-C. Results Repigmentation occurred in 19 cases (70.7%). The number of lesions showing excellent and good response was significantly higher on the silicone gel side (p < .001). In 20 cases, cobblestoning either occurred or was absent on both sides. Histopathologically, cobblestoning was similar to hypertrophic scarring. Both markers were elevated after therapy on both sides with no significant difference in percentage change between lesions showing positive and negative cobblestoning. Conclusion Silicone gel application after minigrating improved the final response with no significant effect on the occurrence of cobblestoning. Cobblestoning resembled hypertrophic scarring histopathologically.

MP33-10 SAFETY AND EFFICACY OF INTRALESIONAL COLLAGENASE CLOSTRIDIUM HISTOLYTICUM INJECTION THERAPY IN THE ACUTE PHASE OF PEYRONIE’S DISEASE: A SINGLE-CENTER, RETROSPECTIVE COHORT STUDY

You have accessJournal of UrologySexual Function/Dysfunction: Peyronie's Disease (MP33)1 Apr 2020MP33-10 SAFETY AND EFFICACY OF INTRALESIONAL COLLAGENASE CLOSTRIDIUM HISTOLYTICUM INJECTION THERAPY IN THE ACUTE PHASE OF PEYRONIE’S DISEASE: A SINGLE-CENTER, RETROSPECTIVE COHORT STUDY Dyvon Walker*, Robert Shahinyan, Arash Amighi, Keith Regets, Sriram Eleswarapu, and Jesse Mills Dyvon Walker*Dyvon Walker* More articles by this author , Robert ShahinyanRobert Shahinyan More articles by this author , Arash AmighiArash Amighi More articles by this author , Keith RegetsKeith Regets More articles by this author , Sriram EleswarapuSriram Eleswarapu More articles by this author , and Jesse MillsJesse Mills More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000877.010AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The clinical trials for intralesional collagenase Clostridium histolyticum (CCH) injection therapy excluded men in the acute phase. The acute phase is inconsistently defined in the literature. Our objective was to evaluate the safety and efficacy of intralesional CCH for off-label use in acute phase PD compared to chronic phase using a single-surgeon retrospective database. METHODS: Men receiving intralesional CCH during 1/2016-10/2019 at our institution were included in an IRB-approved database. Curvature outcomes and adverse events were retrospectively assessed. To account for varying definitions in literature, we first used a 6 month temporal cutoff for acute phase: all men treated with CCH when deformity ≤ 6 mo and all men treated when deformity > 6 mo. We next used pain as a differentiator: all men treated having deformity with pain ≤ 6 mo and all men treated having deformity without pain > 6 mo. We repeated these groupings for a 12 month cutoff. Each temporal pairing was assessed for change in penile deformity and adverse events (swelling, bruising, hematoma, corporal rupture). Wilcoxon rank sum test analyzed percent change in deformity between groups; 1-way ANOVA analyzed adverse events. RESULTS: 116 patients were identified. Data for percent change in curvature and adverse event rates are shown in Table 1. With a 6 month cutoff, 9 (7.8%) were acute, 107 (92.2%) chronic. Differentiating with pain, 3 (2.6%) were acute with pain, and 84 (72.4%) were chronic without pain. With a 12 month cutoff, 37 (31.9%) were acute, 79 (68.1%) were chronic; differentiating with pain, 10 (8.6%) were acute with pain, and 63 (54.3%) were chronic without pain. There were no differences in percent change in curvature or frequencies of bruising, swelling, or hematoma among each temporal pairing. No patient experienced corporal rupture. CONCLUSIONS: This single-center, retrospective cohort analysis suggests that intralesional CCH is both safe and effective for the treatment of men with acute phase PD. In practice, shared decision making will be important for determining which men may be good candidates for off-label use in the acute phase. Prospective, randomized studies will be required to evaluate and confirm these findings. Source of Funding: Research Scholar Award from the Urology Care Foundation & American Urological Association. © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e498-e498 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Dyvon Walker* More articles by this author Robert Shahinyan More articles by this author Arash Amighi More articles by this author Keith Regets More articles by this author Sriram Eleswarapu More articles by this author Jesse Mills More articles by this author Expand All Advertisement PDF downloadLoading ...

The effects of hypoxia and fatigue on skeletal muscle electromechanical delay.

What is the central question of this study? What are the mechanisms underlying impaired muscular endurance and accelerated fatigue during acute hypoxia? What is the main finding and its importance? Hypoxia had no effect on the electrochemical latency associated with muscle contraction elicited by supramaximal electrical motor nerve stimulation in vivo. This provides greater insight into the effects of hypoxia and fatigue on the mechanisms of muscle contraction in vivo. Acute hypoxia impairs muscle endurance and accelerates fatigue, but the underlying mechanisms, including any effects on muscle electrical activation, are incompletely understood. Electromyographic, mechanomyographic and force signals, elicited by common fibular nerve stimulation, were used to determine electromechanical delay (EMDTOT ) of the tibialis anterior muscle in normoxia and hypoxia ( 0.125) at rest and following fatiguing ankle dorsiflexor exercise (60% maximum voluntary contraction, 5s on, 3s off) in 12 healthy participants (mean (SD) age 27.4 (9.0) years). EMDTOT was determined from electromyographic to force signal onset, electrical activation latency from electromyographic to mechanomyographic (EMDE-M ) and mechanical latency from mechanomyographic to force (EMDM-F ). Twitch force fell significantly following fatiguing exercise in normoxia (46.8 (14.7) vs. 20.6 (14.3) N, P=0.0002) and hypoxia (52.9 (15.4) vs. 28.8 (15.2) N, P=0.0006). No effect of hypoxia on twitch force at rest was observed. Fatiguing exercise resulted in significant increases in mean (SD) EMDTOT in normoxia (Δ 4.7 (4.57) ms P=0.0152) and hypoxia (Δ 3.7 (4.06) ms P=0.0384) resulting from increased mean (SD) EMDM-F only (normoxia Δ 4.1 (4.1) ms P=0.0391, hypoxia Δ 3.4 (3.6) ms P=0.0303). Mean (SD) EMDE-M remained unchanged during normoxic (Δ 0.6 (1.08) ms) and hypoxic (Δ 0.25 (0.75) ms) fatiguing exercise. No differences in percentage change from baseline for twitch force, EMDTOT , EMDE-M and EMDM-F between normoxic and hypoxic fatigue conditions were observed. Hypoxia in isolation or in combination with fatigue had no effect on the electrochemical latency associated with electrically evoked muscle contraction.

Intrauterine Infusion of Autologous Platelet-Rich Plasma Affects the Endometrial Thickness, Epidermal Growth Factor and Pregnancy Outcome in Patients Undergoing IUI

Despite developments in assisted reproductive technology, there is immaterial progress in the implantation and pregnancy rates. Intrauterine infusion (IUIF) of autologous platelet-rich plasma (PRP) might renew implantation rates through its paracrine properties by progression cytokines and growth factors which favor implantation. Here we determine whether the IUIF of autologous PRP had a role in pregnancy outcome through its outcome on epidermal growth factor and endometrial thickness. An overall of 43 patients where prospectively randomly dispersed into two groups subjected to a superovulation program using Letrozole® tablet orally 2.5 mg twice daily 12 hours apart from day 2 for 5 days for one cycle. 20 women were considered as control receiving the conventional intrauterine insemination (IUI) management while 23 of them were given PRP by IUIF on the day of human chorionic gonadotrophin injection. The IUI was done for both groups 36-48 hours after confirming ovulation. The blood samples were collected from both groups on the day of IUI for the valuation of epidermal growth factor and an ultrasound was done on the day of human chorionic gonadotrophin injection and day of IUI for assessment of endometrial thickness. The mean endometrial thickness in the PRP group at the day of IUI was significantly thicker than that of the control group and the difference in percentage change of endometrial thickness between PRP group and controls significantly higher in PRP group. The mean epidermal growth factor and the pregnancy rate were significantly superior in the PRP group than that of controls. In conclusion, autologous PRP IUIF was well-tolerated and resulted in a significant expansion in endometrial thickness, epidermal growth factor Level and, subsequent pregnancy rate in an infertile woman undergoing IUI.

014 Regional Cardiac Dysfunction Determined by Radiation Dose in Patients With Breast Cancer: A Longitudinal Follow-Up Study

Subclinical left ventricular (LV) dysfunction by 2D global longitudinal strain (GLS) immediately post radiotherapy (RT) and persisting at 12 months has been described in breast cancer patients. We hypothesised that persistent LV dysfunction may be regional and correlate with segmental RT. Echocardiography was performed at baseline, 6 weeks and 12 months post-RT on 61 chemotherapy-naïve women with left sided breast cancer. The amount of radiation received by individual LV regions and segments was quantified. Anterior and anteroseptal regions received the highest radiation dose, and inferior and inferolateral regions the lowest radiation dose. Within each region, there was a progressive increase in the radiation dose received from base to apex (apical>mid>basal segment). At 6 weeks, the greatest reduction in strain was in the anterior and anteroseptal regions, with the most significant reduction in the apical segments. At 12 months, despite improvement in strain, the percentage reduction in strain demonstrated a similar pattern. There was a significant interaction between both region and segment, on the percentage change in strain at 6 weeks (p<0.001) and 12 months (p=0.007). Mean differences in percentage change in strain between mid and basal regions, and apical and basal regions, demonstrated the most significant reductions in the anterior region at 6 weeks and 12 months (Table). RT causes segmental myocardial dysfunction, with areas receiving the highest RT demonstrating the largest impairment in strain, and these changes persist at 12 months. Correlation with clinical outcomes is required.Tabled 1TimeSegmentDifference Mid – BasalDifference Apical – BasalMean %SEp valueMean %SEp value6 weeksAnterior-6.611.72<0.001-19.542.08<0.001Anteroseptal-2.831.180.019-18.201.06<0.00112 monthsAnterior-4.541.970.023-15.792.18<0.001Anteroseptal-4.381.18<0.001-14.761.73<0.001 Open table in a new tab