Significant Difference In Percentage Change Research Articles

Factors Influencing Music Therapists' Retention of Clinical Hours with Autistic Clients over Telehealth During the COVID-19 Pandemic.

The 2019 coronavirus disease pandemic influenced music therapists to migrate services to online platforms, though some lost clinical hours during the pandemic when telehealth was not a viable option. This survey study aimed to ascertain factors that helped music-based therapists to continue serving autistic clients over telehealth during the pandemic. We surveyed 193 accredited music therapists located mainly in Canada and the US. In addition to gathering data on general perceptions of telehealth music therapy and Neurologic Music Therapy (NMT), one-way ANOVAs were applied to determine differences in percent-change loss of clinical hours for music therapists: (1) working in different employment settings; (2) serving children, youth, adults, or a mixture of ages; and (3) practicing NMT or not. The general perception of telehealth music therapy was positive, and NMTs believed that the clear protocols and transformation design model were helpful to them in adapting services to telehealth. There were no significant differences in percent-change of clinical hours among music therapists in different employment settings or serving different client age groups. Music therapists who said they practiced within the NMT treatment model lost a significantly lower percentage of clinical hours with autistic clients than those who did not practice NMT. Possible reasons for this result and the need for further research are discussed.

(210) Four-Year Surgical and Sexual Function Outcomes of Rezum Therapy Across a Broad Range of Prostate Volumes

Abstract Introduction Benign prostatic hyperplasia (BPH) often leads to the development of lower urinary tract symptoms (LUTS), which can result in significant deterioration in quality of life (QoL). Rezum therapy has demonstrated efficacy in alleviating LUTS secondary to BPH across a broad range of prostate volumes (PVs). However, there is a scarcity of long-term real-world data on Rezum outcomes across a wide range of PVs. Objective To evaluate surgical and sexual function Rezum outcomes over a 4-year period in patients with PVs <30cc, 30-80cc, or >80cc. Methods A retrospective study was conducted on patients from a multiethnic population treated with Rezum between 2017 and 2019. Patients were stratified into three cohorts based on PV: <30cc, 30-80cc, or >80cc. Outcome measures, including International Prostate Symptom Score (IPSS), QoL, International Index of Erectile Function (IIEF)-Erectile and Orgasmic function, maximum urinary flow rate (Qmax), BPH medication usage, adverse events (AEs), and decisional regret scores were collected and compared at baseline and 1-, 3-, 6-, 12-, and/or 48-months follow-up. Results A total of 252 patients were analyzed, with 35 (13.9%), 196 (77.8%), and 21 (8.3%) patients in the 30cc, 30-80cc, and >80cc cohorts, respectively. The >80cc cohort was significantly older (66.9 years [8.1]) than the <30cc cohort (63.4 years [8.5], p = 0.02). The <30cc cohort had a significantly higher baseline IPSS (21 [15-28]) and QoL (5 [4-6]) than the 30-80cc (IPSS 17 [10-23], p = 0.003; QoL 4 [3-5], p=0.02) and >80cc (IPSS 16 [6.5-22.5], p = 0.01; QoL 4 [3-5], p = 0.006) cohorts. The number of injections utilized per lateral prostatic lobe significantly increased with PV (<30cc: 1 injection [0-1] vs 30-80cc: 2 injections [1-2] vs >80cc: 3 injections [2-3.5], p < 0.001). When compared to baseline, the combined cohort saw significant percent changes at 48-months in IPSS (-70.6%, p < .001), QoL (-80%, p < .001), and Qmax (52%, p = 0.003). Within each PV cohort, significant improvements in IPSS and QoL were found at all follow-ups when compared to baseline. Qmax improvements were significant only in the 30-80cc cohort at all follow-ups. There were no significant differences in percent changes in IPSS, QoL, or Qmax between cohorts at 3-, 6-, 12-, or 48-months when compared to baseline. The <30cc and 30-80cc cohorts had significant decreases in BPH medication usage as early as 3-months that remained durable through 48-months (all p < 0.05). The >80cc cohort experienced a significant decrease in BPH medication usage at 3-months but it did not remain durable to 12- or 48-months. No significant differences in postoperative AEs or decision regret scores were observed between cohorts. There were no significant changes in erectile function and orgasmic function at 12-months within cohorts. No significant differences were found in 48-months reoperation rates between the <30cc, 30-80cc, and >80cc cohorts (0% vs 4.9% vs 5%, p = 0.49). Conclusions Rezum effectively improved LUTS secondary to BPH irrespective of PV, with improvements being durable over 4 years. However, patients with PVs >80cc should be counseled on the possibility of continuing their BPH medications following treatment. Disclosure No.

Skeletal muscle mitochondrial capacity in patients with statin-associated muscle symptoms (SAMS)

ObjectiveThe objective of this article is to evaluate near-infrared spectroscopy (NIRS), a non-invasive technique to assess tissue oxygenation and mitochondrial function, as a diagnostic tool for statin-associated muscle symptoms (SAMS).MethodsWe...

1985. A Prospective, Randomized Trial to Assess a Protease Inhibitor–based Regimen Switch Strategy to Manage Integrase Inhibitor–related Weight Gain

Abstract Background Integrase inhibitor (INI)–based antiretroviral (ARV) therapies are associated with greater weight gain than non-nucleoside reverse transcriptase inhibitor– or boosted protease inhibitor–based regimens, disproportionately affecting Black and Hispanic individuals and women. The mechanisms underlying this weight gain are unknown, and there are no prospective, randomized data exploring the impact of switching ARV classes to mitigate or reverse ARV-related weight gain. Methods DEFINE (ClinicalTrials.gov: NCT04442737) is a randomized (1:1), prospective, 48-week, active-controlled, open-label, multicenter phase 4 study evaluating switching to darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) versus continuing INI+TAF/emtricitabine (FTC) in virologically-suppressed HIV-1–infected adults who had ≥10% weight gain while on the INI-based regimen. The primary objective was to assess percent change in body weight from baseline to Week 24 in both arms. The primary endpoint was analyzed using a mixed model for repeated measures in the intent-to-treat set of randomized participants who had received ≥1 dose of study drug. Secondary endpoints included change in body mass index (BMI), waist circumference (WC), efficacy, and safety. Data through Week 24 are reported. Results Overall, 103 adults were randomized to D/C/F/TAF (n=53) or continued INI+TAF/FTC (n=50); 30% were female and 61% were Black/African American, with median 27.0 months virologic suppression on INI+TAF/FTC (Table 1). Discontinuation rates were low and similar between arms. At Week 24, there was no significant difference in percent change in body weight from baseline between the D/C/F/TAF and INI+TAF/FTC arms (Figure). Most participants in each arm had body weight changes of ≤±3% and remained within baseline BMI and WC categories. Percent body weight changes for key subgroups are shown in Table 2. Switching to D/C/F/TAF was safe and well tolerated, and efficacy was maintained.Table 1.Demographics and Baseline Characteristics (ITT Set)BMI, body mass index; D/C/F/TAF, darunavir/cobicistat/emtricitabine/tenofovir alafenamide; FTC, emtricitabine; INI, integrase inhibitor; ITT, intent-to-treat; TAF, tenofovir alafenamide. *One participant in the D/C/F/TAF arm did not have available data. Percent Change From Baseline in Body Weight Over Time for Participants Who Switched to D/C/F/TAF and Those Who Continued Their Current INI+TAF/FTC Regimen (ITT Set) D/C/F/TAF, darunavir/cobicistat/emtricitabine/tenofovir alafenamide; FTC, emtricitabine; INI, integrase inhibitor; ITT, intent-to-treat; LS, least-squares; TAF, tenofovir alafenamide. LS means percent changes in body weight were calculated in the ITT set of randomized participants who had received ≥1 dose of study drug using a mixed model for repeated measures, in which the dependent variable was percent change from baseline in body weight; independent variables were treatment, baseline body mass index, sex, and race (Black/African American vs non–Black/African American); and visits were repeated measures. Participants in the ITT set with baseline records and ≥1 postbaseline record were included. Conclusion There was no significant difference in weight change through 24 weeks after switching from an INI-based regimen to D/C/F/TAF in adults with INI-related weight gain. Additional analyses are ongoing, including follow up through Week 48 and evaluation of changes in biomarkers and body composition (DEXA).Table 2.Percent Change From Baseline in Body Weight at Week 24 Among Key Subgroups (ITT Set)BMI, body mass index; D/C/F/TAF, darunavir/cobicistat/emtricitabine/tenofovir alafenamide; FTC, emtricitabine; INI, integrase inhibitor; ITT, intent-to-treat; TAF, tenofovir alafenamide. Disclosures William R. Short, MD, Gilead Sciences: Advisor/Consultant|ViiV: Advisor/Consultant|ViiV: Honoraria Moti Ramgopal, MD, FACP, FIDSA, AbbVie: Honoraria|Gilead Sciences, Inc.: Advisor/Consultant|Gilead Sciences, Inc.: Honoraria|Janssen Pharmaceuticals: Advisor/Consultant|Janssen Pharmaceuticals: Honoraria|Merck: Advisor/Consultant|ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Honoraria Debbie P. Hagins, MD, FAPCR, AAHIVS, Janssen Pharmaceuticals: Advisor/Consultant Johnnie Lee, MD, Janssen Pharmaceuticals: Employee|Janssen Pharmaceuticals: Stocks/Bonds Richard Bruce Simonson, BS, Janssen Pharmaceuticals: Employee|Janssen Pharmaceuticals: Stocks/Bonds Tien-Huei Hsu, PhD, Janssen Pharmaceuticals: Employee|Janssen Pharmaceuticals: Stocks/Bonds Ping Xu, PhD, Janssen Pharmaceuticals: Employee|Janssen Pharmaceuticals: Stocks/Bonds David Anderson, MD, Janssen Pharmaceuticals: Employee|Janssen Pharmaceuticals: Stocks/Bonds

FRI681 OsteoboostTm Is Effective In Preserving Bone Strength And Density Of The Spine In Women With Low Bone Mass

Abstract Disclosure: L.D. Bilek: Grant Recipient; Self; Bone Health Technologies. Stock Owner; Self; Bone Health Technologies. L.E. Flores: Employee; Self; Bone Health Technologies. N. Waltman: None. L.R. Mack: None. K. Smith: None. D. Hillstrom: Employee; Self; Bone Health Technologies. M. Griffin: Consulting Fee; Self; Bone Health Technologies. Stock Owner; Self; Bone Health Technologies. L. Yecies: Employee; Self; Bone Health Technologies. Stock Owner; Self; Bone Health Technologies. M. Jaasma: Consulting Fee; Self; Bone Health Technologies. Stock Owner; Self; Bone Health Technologies. Introduction: Fragility fractures result in significant morbidity and mortality, which is of particular concern in postmenopausal women who are at high risk of fractures due to loss of estrogen. Pharmaceutical interventions are effective but have low uptake and adherence and are generally not indicated for patients with osteopenia. Vibration has the potential to prevent bone loss and holds promise as an effective, yet minimal risk, treatment. The Osteoboost, a novel wearable device delivering targeted vibration to the lumbar spine and hips, is designed to improve bone strength and bone density. Thus, this study aims to evaluate the efficacy of a 12-month intervention with the OsteoboostTM on preserving strength of the first lumbar vertebrae in postmenopausal women with low bone mass. Methods: This double-blinded, randomized controlled trial enrolled postmenopausal women with low bone mass who were not taking bone-active medications. Women had a bone density DXA and assessment of thyroid function to screen for eligibility Those who qualified were randomized to receive Osteoboost treatment 5x/week for 12 months with the belt in either the active or sham setting. The sham device created a sound but did not deliver vibration. Compressive strength (N) and volumetric density of the 1st lumbar vertebra (L1) was analyzed using Finite Element Analysis (FEA) of computed tomography (CT) scans of lumbar spine by ON Diagnostics. Results: 126 women (64 Active, 62 Sham) with low bone mass participated in the study, with an average age of 62.1 years (SD ± 5.8) and 60.6 years (± 5.3) in the Active and Sham groups, respectively. Most participants were of White race (98%) and non-Hispanic (96%). There were no significant differences in baseline demographics between the sham and active groups. Intent to treat analysis revealed no significant difference in percent change in vertebral bone strength between the Active and Sham groups over time (baseline to 12 months). When stratified by age category, significant differences in percent change in vertebral bone strength were present in the 50-60 year old category; the Sham group lost 3.4% of their vertebral bone strength compared to a 0.5% loss in the Active group (p=0.018). While bone was preserved in the active group relative to the sham in the women over 60, it was not significant (p=0.20). With analysis of those who met the compliance criterion of 3x/week, the Sham group lost 2.84% compared to 0.48% in the Active group (p=0.014); representing a 5 times greater loss in the Sham group. Additionally, the Osteoboost treatment preserved volumetric bone density of L1, with the Active treatment group losing 0.29% BMD relative to a 1.97% loss in the Sham group; representing a 6.8 times greater loss in the Sham group (p=0.008). Conclusion: The Osteoboost holds promise as a therapeutic intervention for women with low bone mass to prevent decline to osteoporosis and reduce fracture risk. Presentation: Friday, June 16, 2023

The comparable efficacy of denosumab on bone mineral density in rheumatoid arthritis patients with postmenopausal osteoporosis: A retrospective case-control study.

Little is known about differences in the therapeutic efficacy of denosumab in subjects with and without rheumatoid arthritis (RA). This study compares the changes in bone mineral density (BMD) between RA patients and controls without RA who had been treated with denosumab for 2 years for postmenopausal osteoporosis. A total of 82 RA patients and 64 controls were enrolled, who were refractory to selective estrogen receptor modulators (SERMs) or bisphosphonates and completed the treatment of denosumab 60 mg for 2 years. The efficacy of denosumab in RA patients and controls was assessed using areal BMD (aBMD) and T-score of the lumbar spine, femur neck, and total hip. A general linear model with repeated measures analysis of variance was used to determine differences in aBMD and T-score between 2 study groups. No significant differences in percent changes in aBMD and T-scores by denosumab treatment for 2 years at the lumbar spine, femur neck, and total hip were evident between RA patients and controls (P > .05 of all), except T-score of the total hip (P = .034). Denosumab treatment equally increased aBMD at the lumbar spine and T-scores at the lumbar spine and total hip between RA patients and controls without statistical differences, but RA patients showed less improvement in aBMD at the femur neck (ptime*group = 0.032) and T-scores at the femur neck and total hip than controls (ptime*group = 0.004 of both). Changes in aBMD and T-scores after denosumab treatment in RA patients were not affected by previous use of bisphosphonates or SERMs. Differences of T-score at the femur neck among previous bisphosphonate users and aBMD and T-score at the femur neck and T-scores at the total hip were evident. This study revealed that 2 years of denosumab treatment in female RA patients achieved comparable efficacy on BMD to controls at the lumbar spine, but showed somewhat insufficient improvement at the femur neck and total hip.

Efficacy of deep brain stimulation for the treatment of anorexia nervosa: a systematic review and network meta-analysis of patient-level data.

Deep brain stimulation (DBS) has been approved as a therapy for movement disorders and obsessive-compulsive disorder. Recently, DBS has been studied in patients with anorexia nervosa (AN), which is a debilitating and life-threatening psychiatric disorder. Several stimulation locations have been tested without a clear indication of the best region. In this systematic review and network meta-analysis, the authors used patient-level data to identify stimulation targets with the greatest evidence for efficacy in increasing body mass index (BMI). A systematic search was performed on or before August 4, 2022, using PubMed/MEDLINE, Ovid, and Scopus. Articles were included if patient-level data were presented, patients were diagnosed with AN and treated with DBS, and 6 months or more of postoperative follow-up data were reported. Quality and risk of bias were assessed with the NIH assessment tools. Patient data were collected and stratified by stimulation location. A network meta-analysis was performed. This review was written in accordance with PRISMA guidelines for systematic reviews. Eleven studies consisting of 36 patients were included. The mean age and BMI at the time of surgery were 38.07 (SD 11.64) years and 12.58 (SD 1.4) kg/m2, respectively. After 6 months of DBS, a significant difference in percentage change in BMI was found between the nucleus accumbens and subcallosal cingulate cortex (SCC) (SMD 0.78; 95% CI 0.10, 1.45) and between the SCC and ventral anterior limb of the internal capsule (SMD -1.51; 95% CI -2.39, -0.62). Similarly, at 9-12 months, a significant difference in percentage change in BMI was found between the SCC and ventral anterior limb of the internal capsule (SMD -1.18; 95% CI -2.21, -0.15). With hierarchical ranking, this study identified SCC as the most supported stimulation location for BMI change at 6 and 9-12 months (P-scores 0.9449 and 0.9771, respectively). Several DBS targets have been tested for AN, and this study identified the SCC as the most supported region for BMI change. However, further studies with blinded on/off periods are necessary to confirm this finding.

Toxicity and efficacy of stereotactic body radiation therapy vs. intensity-modulated radiation therapy for the treatment of locally advanced pancreatic cancer in a phase 3 trial.

713 Background: Locally advanced pancreatic cancer (LAPC) remains one of the deadliest cancers. Radiation is listed as a first line therapy option in treatment guidelines and remains a common treatment for this patient population primarily for local disease control and symptoms. Herein, we performed an exploratory analysis to compare the toxicity and efficacy between patients receiving either stereotactic body radiation therapy (SBRT) or intensity-modulated radiation therapy (IMRT) during the induction phase (prior to randomization) of a Phase 3 trial for localized intra-arterial gemcitabine therapy. Methods: As part of the TIGeR-PaC Phase 3 trial, patients with LAPC and an ECOG of 0-1 underwent an induction phase and were treated with 2 cycles of gemcitabine and nab-paclitaxel prior to receiving SBRT (n=59; 33Gy in 5 Fractions) or IMRT (n=75; 50Gy in 25 fractions) with concurrent PO capecitabine BID Monday-Friday. We performed Mann-Whitney analyses to compare mean percent changes in tumor size (imaging performed prior and 1-month after radiation) and CA 19-9 tumor markers. Adverse event (AE) incidence data during and 2 weeks after completion of the last fraction of radiation was used to compare toxicity via a contingency table. Results: A total of 134 patients across 22 sites (63 male/71 female; median age: 68.5 years) underwent radiation with no significant difference in baseline demographics between SBRT and IMRT patients. The decision for SBRT vs. IMRT was site-driven and not pre-specified by the protocol. Of these, 104 had analyzable imaging data, 50 SBRT and 54 IMRT, with a mean baseline tumor size of 4.3 cm and 4.0 cm (p=0.17), respectively. Pancreatic tumor location included head (n=63), body (n=36), or other (n=5). There was no statistical significance between the mean percent change of tumor size between SBRT (-13.3%) and IMRT (-10.8%; p=0.834). Both arms had similar RECIST partial response (approximately 18% of patients) after treatment. Patients with analyzable CA 19-9 tumor marker data (14 SBRT, 17 IMRT) showed no significant difference in percent change (mean, 9.8%±111%, -40.7%±40%; p=0.262). The SBRT subgroup had significantly less patients drop-out due to clinical deterioration (1 SBRT, 9 IMRT; p=0.025) and experience any AE (26 SBRT, 49 IMRT; p=0.014), gastrointestinal AE (10 SBRT, 33 IMRT; p<0.001), grade 3 or higher AE (6 SBRT, 20 IMRT; p=0.017), and serious AE (2 SBRT, 10 IMRT; p=0.045) p=0.014, 0.017, 0.045, respectively). The main AEs and serious AEs were gastrointestinal events. Conclusions: When compared to IMRT, SBRT demonstrates improved tolerability for treatment of patients with LAPC with comparable clinical efficacy. Clinical trial information: NCT03257033 .

Towards detection of early response in neoadjuvant chemotherapy of breast cancer using Bayesian intravoxel incoherent motion.

The early identification of good responders to neoadjuvant chemotherapy (NACT) holds a significant potential in the optimal treatment of breast cancer. A recent Bayesian approach has been postulated to improve the accuracy of the intravoxel incoherent motion (IVIM) model for clinical translation. This study examined the prediction and early sensitivity of Bayesian IVIM to NACT response. Seventeen female patients with breast cancer were scanned at baseline and 16 patients were scanned after Cycle 1. Tissue diffusion and perfusion from Bayesian IVIM were calculated at baseline with percentage change at Cycle 1 computed with reference to baseline. Cellular proliferative activity marker Ki-67 was obtained semi-quantitatively with percentage change at excision computed with reference to core biopsy. The perfusion fraction showed a significant difference (p = 0.042) in percentage change between responder groups at Cycle 1, with a decrease in good responders [-7.98% (-19.47-1.73), n = 7] and an increase in poor responders [10.04% (5.09-28.93), n = 9]. There was a significant correlation between percentage change in perfusion fraction and percentage change in Ki-67 (p = 0.042). Tissue diffusion and pseudodiffusion showed no significant difference in percentage change between groups at Cycle 1, nor was there a significant correlation against percentage change in Ki-67. Perfusion fraction, tissue diffusion, and pseudodiffusion showed no significant difference between groups at baseline, nor was there a significant correlation against Ki-67 from core biopsy. The alteration in tumour perfusion fraction from the Bayesian IVIM model, in association with cellular proliferation, showed early sensitivity to good responders in NACT. https://clinicaltrials.gov/ct2/show/NCT03501394, identifier NCT03501394.

A Comparison of Functional and Oncologic Outcomes between Partial Nephrectomy and Radiofrequency Ablation in Patients with Chronic Kidney Disease after Propensity Score Matching.

Purpose: This study aimed to compare functional and oncological outcomes between partial nephrectomy (PN) and radiofrequency ablation (RFA) for a small renal mass (SRM, ≤4 cm) in patients with chronic kidney disease (CKD). Materials and Methods: Patients with CKD who underwent either PN or RFA for SRM between 2005 and 2019 were included. Patients were stratified into two categories: CKD stage 2 and CKD stage 3 or higher. We performed propensity score matching (PSM) analysis in patients with CKD stage 2 and CKD stage 3 or higher. We compared the functional and oncological outcomes between two groups according to CKD stage before and after PSM. Results: Among 1332 patients, 1195 patients were CKD stage 2 and 137 patients were CKD stage 3 or higher. After PSM analysis using age, pre-treatment eGFR, and clinical tumor size as matching variables, the PN and RFA groups had 270 and 135 CKD stage 2 patients, respectively, and both had 53 patients each with CKD stage 3 or higher. There were no significant differences in percent change in eGFR at 1 year post-operation between groups in patients with CKD stage 2 and stage 3 or higher. Among all patients with tissue-proven malignancy, the 5-year recurrence-free survival (RFS), cancer-specific survival, and overall survival were significantly higher in the PN group. However, only the 5-year RFS was significantly higher in the PN group after matching. Conclusion: Mortality is low in patients with SRM, and functional outcomes were not significantly different between the two treatments. RFA could be an alternative treatment modality in patients who are poor candidates for surgery.

N-3 fatty acid supplementation mediates lipid profile, including small dense LDL, when combined with statins: a randomized double blind placebo controlled trial

BackgroundEpidemiological and clinical evidence suggests that high-dose intake of omega 3 fatty acids (n-3 FA) have a favorable role in altering serum triglycerides (TG) and non-high density lipoprotein cholesterol (non-HDL-C) when combined with statins in hyperlipidemic patients. Their efficacy in altering low-density lipoprotein cholesterol (LDL-C) particle size is yet to be established.AimThis study evaluated the effects of supplementing 4 g/day Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA) on serum blood lipids, including small, dense LDL-C particle concentration, in hyperlipidemic patients receiving stable statin therapy.MethodsIn this randomized, placebo-controlled, double-blind parallel group study, 44 patients on statin therapy for > 8 weeks with non-HDL-C concentrations above 130 mg/dL were randomized into two groups. For 8 weeks, together with their prescribed statin, the intervention group received 4 g/day EPA + DHA (3000 mg EPA + 1000 mg DHA in ethyl ester form) and the placebo group received 4 g/day olive oil (OO). Measurements of serum non-HDL-C, TG, total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), LDL-C (including large - LDL I; intermediate - LDL II; and small - LDL III subclasses), very-low-density lipoprotein cholesterol (VLDL-C) concentration, were taken at baseline and post-intervention. Dietary intake was assessed with a weighed intake, 3-day food diary at week 4. Primary outcome measures were percent change in LDL III, non-HDL-C and LDL particle number.ResultsAt the end of treatment, the median percent change in serum LDL III concentration was significantly greater in the n-3 FA group plus atorvastatin compared to placebo (− 67.5% vs − 0%, respectively; P < 0.001). Supplementation with n-3 FA plus atorvastatin led to significant reductions in serum non-HDL-C (− 9.5% vs 4.7%, P < 0.01), TG (− 21.5% vs 6.2%, P < 0.001) and VLDL-C (− 36.9% vs 4.0%, P < 0.001) and TC (− 6.6% vs 2.1%, P < 0.001). Between the groups, no significant difference in percent change in the serum concentration of LDL-C, HDL-C, as well as in the LDL I and LDL II subclasses was observed.ConclusionIn this group of hyperlipidemic patients on a stable statin prescription, OM3 plus atorvastatin improved small dense LDL concentrations, non-HDL-C, VLDL-C and TG to a greater extent than atorvastatin alone. Further studies are warranted in this area.Trial registrationThis trial was retrospectively registered on 23 May 2019 on ClinicalTrials.gov with ID: NCT03961763.

Estrogen-Associated Headaches Can Be Treated by Surgery: A Multicenter Retrospective Cohort Study.

Nerve decompression surgery has been successful in treating headaches refractory to traditional medical therapies. Nevertheless, a subset of patients remains unresponsive to surgical treatment. The authors conducted a retrospective chart review of the two senior authors' (J.E.J. and W.G.A.) patient data from 2007 to 2020 to investigate differences in surgical outcomes in women reporting estrogen-associated headaches (headaches associated with menstrual period, oral contraceptives, pregnancy, or other hormonal drugs) compared with those who did not. For these two groups, the authors used the migraine headache index as the metric for headache severity and compared the mean percent change in migraine headache index score at 3 months and 1 year. Of the 99 female patients who underwent nerve decompression surgery and met inclusion criteria, 50 reported estrogen-associated headaches and were found to have significantly earlier age of onset ( p = 0.017) and initial presentation to clinic ( p = 0.046). At 1 year postoperatively, migraine headache index score had improved more than 80 percent in the majority of patients (67 percent), but there was a subset of patients whose score improved less than 5 percent (12.5 percent). The authors did not find a significant difference in percent change in postoperative migraine headache index score between women with estrogen-associated headaches and those without such headaches. Women with estrogen-associated headaches have surgical outcomes comparable to those of women without this association. Nerve decompression surgery should be offered to women experiencing estrogen-associated headaches as an option for treatment. Risk, II.

Examining Sex Differences in Visual Reliance During Postural Control in Intercollegiate Athletes.

BackgroundRisk factors for different sports injuries vary between sexes. Deficits in postural stability have been associated with several lower extremity injuries. The purpose of this study was to examine the differences in static postural stability between male and female intercollegiate athletes with and without visual information. # HypothesisThere will be no difference in visual reliance between sexes during static postural stability.Study DesignCross-sectional StudyMethodsStatic postural stability was assessed during a single session for football, soccer, basketball, and volleyball intercollegiate athletes (males, n=135, females, n=51) under eyes open (EO) and eyes closed (EC) conditions via performance of single limb stance on a force plate. Ground reaction force component data in all directions were quantified as a unitless composite score (COMP) where lower values indicated better postural stability. The absolute change and percentage change between EO and EC conditions were calculated for each sex. Two-sample Kolmogorov-Smirnov tests were used to compare differences between sexes.ResultsMales had greater EO COMP (males=7.77±3.40; females=6.48±4.61; p=0.038; Cohen’s d=0.343) and EC COMP (males=19.43±8.91; females 14.66±6.65; p=0.001; Cohen’s d=0.571) than females. A significant difference in absolute change from EO to EC was observed between sexes (males=-11.65±7.05; females=-8.18±5.61; p=0.01, Cohen’s d=-0.520) indicating that males had a greater change between conditions for the worse. There was no significant difference in percent change from EO to EC between sexes (males=159.2±90.7; females=156.7±109.2; p=0.39; Cohen’s d=0.026).ConclusionsThe observed differences between males and females in EO COMP, EC COMP, and absolute difference in COMP indicate that there is some factor that causes a difference in static postural stability between sexes. No difference in percent change between groups indicates that the difference in static postural stability between sexes may not be due to visual reliance. Female athletes may inherently have better postural stability than males, but both sexes were able to compensate for the loss of visual input.Level of Evidence3

Optimal Phosphate Control Related to Coronary Artery Calcification in Dialysis Patients.

In patients on maintenance dialysis, cardiovascular mortality risk is remarkably high, which can be partly explained by severe coronary artery calcification (CAC). Hyperphosphatemia has been reported to be associated with the severity of CAC. However, the optimal phosphate range in patients on dialysis remains unknown. This study was planned to compare the effects on CAC progression of two types of noncalcium-based phosphate binders and of two different phosphate target ranges. We conducted a randomized, open-label, multicenter, interventional trial with a two by two factorial design. A total of 160 adults on dialysis were enrolled and randomized to the sucroferric oxyhydroxide or lanthanum carbonate group, with the aim of reducing serum phosphate to two target levels (3.5-4.5 mg/dl in the strict group and 5.0-6.0 mg/dl in the standard group). The primary end point was percentage change in CAC scores during the 12-month treatment. The full analysis set included 115 patients. We observed no significant difference in percentage change in CAC scores between the lanthanum carbonate group and the sucroferric oxyhydroxide group. On the other hand, percentage change in CAC scores in the strict group (median of 8.52; interquartile range, -1.0-23.9) was significantly lower than that in the standard group (median of 21.8; interquartile range, 10.0-36.1; P=0.006). This effect was pronounced in older (aged 65-74 years) versus younger (aged 20-64 years) participants (P value for interaction =0.003). We observed a similar finding for the absolute change in CAC scores. Further study with a larger sample size is needed, but strict phosphate control shows promise for delaying progression of CAC in patients undergoing maintenance hemodialysis. Evaluate the New Phosphate Iron-Based Binder Sucroferric Oxyhydroxide in Dialysis Patients with the Goal of Advancing the Practice of EBM (EPISODE), jRCTs051180048.

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.

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.

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.

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.

Small Steps for a Big Change: Attention towards Preanalytical Error

Aims: The study aimed to evaluate the preanalytical errors in the Indoor patient department in tertiary care Hospital. To calculate the percentage of preanalytical errors in the Indoor patient department in our Hospital and to recommend standard operative interventions to improve quality of results. To test the effectiveness of attention by continuous educational action at reducing preanalytical errors and improving patient care.&#x0D; Study Design: An observational study.&#x0D; Place and Duration of Study: The work was done from July 2014 to July 2015 at a tertiary care Hospital India.&#x0D; Methodology: We retrospectively reviewed the samples and test request forms received at Biochemistry laboratory for one month. The outcome measures were incomplete laboratory forms, mislabeling samples, inappropriate tests, wrong container, poor quality of samples and transportation problems. Two weeks of interventions in the form of continuous educational training and education regarding standard operative procedures were given to stakeholders to raise awareness towards the preanalytical phase. Two weeks later, data was monitored again for one month.&#x0D; Results: 2330 and 2130 samples and request forms were monitored before-after intervention respectively from wards for one month each. Of the total chances of preanalytical errors, 22.17% were due to inappropriate tests, 81.5% were related to incomplete patient information, 97% lacking clinical information, 18.8% errors related to specimen information, 3.5% errors were of the deranged quality of the specimen, and in4.5% transportation problems were observed. Subsequently, these were reduced to 10%, 20%, 16.4%, 7.5%, 2.3%, 3.1% respectively. A significant difference in percentage change was observed in all the above errors after the one-month interventions for the reduction in preanalytical errors.&#x0D; Conclusion: The results of the present study revealed that taking small steps in the form of implementing standard operative procedures for collection, storage and transport facilities and continuous educational training of stakeholders would reduce big errors occurring due to human factors in preanalytical phase. We need good interdepartmental communication and cooperation to achieve good laboratory results and patient well being. This study improved the quality of test results and patient care.