bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effect of Pregabalin on the Median Effective Plasma Concentration of Intravenous Alfentanil in Capsaicin-Induced Pain
Authors: Wallace Mark S 
Published: July 2021

AbstractObjectiveTo apply the sequential up–down method to a human experimental pain model in order to examine the opioid-sparing effect of oral pregabalin on intravenous alfentanil.DesignDouble-blind, randomized, crossover.SettingAcademic university medical center.SubjectsThirty-one healthy males.MethodsThe median effective plasma concentration of intravenous alfentanil was determined under two conditions: alfentanil alone (phase I) and alfentanil+ pregabalin (300 mg orally) (phase II). The alfentanil plasma level (after a computer-controlled infusion) producing a success criterion (at least 30% intradermal capsaicin-induced pain reduction compared with placebo) was used to determine higher or lower doses for each sequential subject. The median dose producing a success criterion and its confidence interval were determined.ResultsOn the basis of the t test for a difference across phase and regression coefficients across groups, there was no opioid-sparing effect of pregabalin on alfentanil. Four subjects in phase I and five subjects in phase II did not complete the study. Two in phase I were technical failures, with the rest in both phases stopped because of side effects. Of the subjects who completed the study, six of 19 subjects in phase I and 11 of 12 subjects in phase II reported side effects.ConclusionsWhen the intradermal capsaicin-induced pain model was used in healthy volunteers, oral pregabalin had no opioid-sparing effects on intravenous alfentanil. This experimental model may be useful in studying analgesic interactions.
Enhanced Recovery Components for Posterior Lumbar Spine Fusion
Authors: Echt Murray , Poeran Jashvant , Zubizarreta Nicole , Girdler Steven J. , Mazumdar Madhu , Galatz Leesa M. , Memtsoudis Stavros G. , Hecht Andrew C. , Chaudhary Saad 
Published: July 2021

Study Design:
This was a retrospective cohort study.

Objective:
The aim of this study was to assess the most commonly used components of enhanced recovery after surgery (ERAS) combinations and their relative effectiveness.

Summary of Background Data:
Data is lacking on use and effectiveness of various ERAS combinations which are increasingly used in spine surgery.

Materials and Methods:
Posterior lumbar fusion cases were extracted from the Premier Healthcare claims database (2006−2016). Seven commonly included components in spine ERAS protocols were identified: (1) multimodal analgesia, (2) tranexamic acid, (3) antiemetics on the day of surgery, (4) early physical therapy, (5) no urinary catheter, (6) no patient-controlled analgesia, and (7) no wound drains. Outcomes were: length of stay, “any complication,” blood transfusion, and hospitalization cost. Mixed-effects models measured associations between the most common ERAS combinations and outcomes, separately for 2006−2012 and 2013−2016. Odds ratios (ORs) and 95% confidence intervals (CIs) are reported.

Results:
Among 97,419 (74%; 2006−2012) and 34,932 (26%; 2013−2016) cases ERAS component variations decreased over time. The most commonly used combinations included multimodal analgesia, antiemetics, early physical therapy, avoidance of a urinary catheter, patient-controlled analgesia and drains (10% n=9401 and 19% n=6635 in 2006−2012 and 2013−2016, respectively), and did not include tranexamic acid. Multivariable models revealed minor differences between ERAS combinations in terms of length of stay and costs. The most pronounced beneficial effects in 2006−2012 were seen for the second most commonly (compared with less often) used ERAS combination(s) in terms of blood transfusion (OR: 0.65; CI: 0.59−0.71) and “any complication” (OR: 0.73; CI: 0.66−0.80), both P<0.05. In 2013−2016 the third most commonly used ERAS combination showed the strongest effect: blood transfusion OR: 0.63; CI: 0.50−0.78, P<0.05.

Conclusions:
ERAS component variations decreased over time; maximum benefits were particularly seen in terms of transfusion and complication risk reduction. These findings may inform future ERAS utilization and clinical trials comparing various ERAS protocols.
Safety and Efficacy of the Combination of Sacubitril/Valsartan and SGLT2i in HFrEF Patients (SECSI Registry)
Authors: Jiménez-Blanco Bravo Marta , Valle Alfonso , Gayán Ordás Jara , del Prado Díaz Susana , Cordero Pereda David , Morillas Climent Herminio , Bascompte Claret Ramón , Seller Moya Julia , Zamorano Gómez José Luis , Alonso Salinas Gonzalo Luis 
Published: July 2021

Abstract:
Recent studies have proven benefit of SGLT2i drugs in patients with heart failure with reduced ejection fraction (HFrEF), but their safety when combined with angiotensin-neprilysin inhibitor (ARNI) has not been established. The Safety and Efficacy of the Combination of Sacubitril/Valsartan and SGLT2i in HFrEF Patients registry was conducted to address this issue. SECSI registry is a consecutive, observational, retrospective, multicentre study conducted in 3 Heart Failure Units in Spain. It included 144 HFrEF patients who were treated with ARNI and iSGLT2. Data were collected at baseline, month 2, and month 6. The primary endpoint was the estimated glomerular filtration rate (eGFR), after the initiation of ARNI and sodium-glucose cotransporter-2 inhibitors (SGLT2i). Secondary endpoints included potassium levels and functional class (New York Heart Association class). There were 3 prespecified subgroup analyses: Elderly patients (≥70 years), patients with chronic kidney disease (KDIGO classification G3), and the sequence of drug initiation. Mean age was 69.9 ± 10.1 years, and 110 (76.4%) were men. Left ventricular ejection fraction was 32 ± 7.8%, and most patients were symptomatic [123 (87.2%) New York Heart Association II/III/IV]. eGFR decreased at month 2 and this trend was maintained at month 6 [eGFR baseline 68.5 ± 17.3, month 2 62 ± 19.7 and month 6 64.7 ± 8.6 mL/min/1.73 m2 (P < 0.01 for both)]. In prespecified analysis, elder patients and those who simultaneously initiate both treatments showed the steeper decrease in eGFR. To conclude, co-administration of SGLT2i and ARNI in routine care in HFrEF patients produced a slight decrease in eGFR at 6 months of follow-up. This decrease was especially significant in elder patients and those who initiate both drugs simultaneously.
Impact of Lisinopril on Cardiometabolic Risk Factors in Men With Hypertension and Early-onset Androgenetic Alopecia: A Pilot Study
Authors: Krysiak Robert , Basiak Marcin , Okopień Bogusław 
Published: July 2021

Abstract:
Women with polycystic ovary syndrome are at a high cardiometabolic risk. Early-onset male-pattern baldness is considered the phenotypic equivalent of polycystic ovary syndrome in men. The aim of this study was to assess whether early-onset androgenetic alopecia modifies cardiometabolic effects of lisinopril in men with arterial hypertension. The study population consisted of 62 young men with grade 1 hypertension, 31 of whom were diagnosed with early-onset male-pattern baldness (group A). Thirty-one blood pressure–matched men with normal hair growth (group B) served as a control group. All participants were treated with lisinopril (10–40 mg daily). Blood pressure, glucose homeostasis markers, urinary albumin-to-creatinine ratio (UACR), as well as plasma levels of uric acid, high-sensitivity C-reactive protein (hsCRP), fibrinogen, homocysteine, total and calculated free testosterone, dehydroepiandrosterone sulfate, and estradiol were assessed before lisinopril treatment and 6 months later. At baseline, levels of all cardiometabolic risk factors were higher in group A than group B. Although lisinopril reduced systolic and diastolic blood pressure, UACR, hsCRP, and fibrinogen in both study groups, these effects were stronger in group B than in group A. Only in group B, the drug decreased levels of uric acid and homocysteine, as well as improved insulin sensitivity. The impact of lisinopril on uric acid, hsCRP, fibrinogen, homocysteine, and UACR correlated weakly with its hypotensive properties, androgen levels, and insulin sensitivity. The obtained results suggest that cardiometabolic effects of lisinopril in men are less pronounced in case of coexisting early-onset androgenetic alopecia.
CircSCAP Aggravates Oxidized Low-density Lipoprotein-induced Macrophage Injury by Upregulating PDE3B by miR-221-5p in Atherosclerosis
Authors: He Qian , Shao Dandan , Hao Shengyun , Yuan Yuan , Liu Hanling , Liu Fuyi , Mu Qiong 
Published: July 2021

Abstract:
Atherosclerosis (AS) is a major risk factor for cardiovascular disease, in which circular RNAs play important regulatory roles. This research aimed to explore the biological role of circular RNA Sterol Regulatory Element Binding Transcription Factor Chaperone (circSCAP) (hsa_circ_0001292) in AS development. Real-time PCR or Western blot assay was conducted to analyze RNA or protein expression. Cell proliferation and apoptosis were analyzed by CCK-8 assay and flow cytometry. The levels of lipid accumulation–associated indicators and oxidative stress factors were detected using commercial kits. The levels of inflammatory cytokines were examined using enzyme-linked immunosorbent assay. Intermolecular interaction was verified by dual-luciferase reporter analysis or RNA pull-down analysis. CircSCAP and phosphodiesterase 3B (PDE3B) levels were elevated, whereas the miR-221-5p level was decreased in patients with AS and oxidized low-density lipoprotein (ox-LDL)-induced THP-1 cells. CircSCAP absence suppressed lipid deposition, inflammation, and oxidative stress in ox-LDL–induced THP-1 cells. MiR-221-5p was a target of circSCAP, and anti–miR-221-5p largely reversed si-circSCAP–induced effects in ox-LDL–induced THP-1 cells. PDE3B was a target of miR-221-5p, and PDE3B overexpression largely counteracted miR-221-5p accumulation–mediated effects in ox-LDL–induced THP-1 cells. NF-κB signaling pathway was regulated by circSCAP/miR-221-5p/PDE3B axis in ox-LDL–induced THP-1 cells. In conclusion, circSCAP facilitated lipid accumulation, inflammation, and oxidative stress in ox-LDL–induced THP-1 macrophages by regulating miR-221-5p/PDE3B axis.
Parent–Child Agreement on Quality of Life in Children With Hearing Loss Using the HEAR-QL
Authors: Zhang Amy L. , Wahba Brandon Malik , Lieu Judith E. C. 
Published: July 2021

Objective:
We explored whether children with hearing loss (HL) and their parents perceive the child's quality of life (QOL) similarly using the Hearing Environment And Reflections on Quality of Life (HEAR-QL) survey.

Study Design:
Cross-sectional study.

Setting:
Pediatric otolaryngology clinic.

Patients:
7 to 14 year old children with unilateral or bilateral HL and their parents.

Interventions:
None.

Main Outcome Measure:
The HEAR-QL is a validated hearing-related QOL survey and has three domains and total score, ranging from 0 to 100; higher scores indicate higher QOL.

Results:
HEAR-QL total score (r = 0.520, p = 0.011), Activities (r = 0.608, p = 0.002), and Feelings (r = 0.657, p = 0.001) domains correlated strongly, but the hearing Environments domain (r = 0.291, p = 0.178) correlated weakly. Children with mild HL scored total and Environments domains lower than their parents (mean difference [MD] −13.9 [95% CI −34.3, 6.6] and −19.2 [95% CI −41.2, 2.7]; Hedge's g 0.67, 0.77, respectively) compared to children with moderate-to-severe HL (moderate HL MD 8.3 [95% CI −15.7, 32.4] and 13.1 [95% CI −25.2, 51.5]; severe HL MD 9.5 [95% CI 0.6, 18.4] and 14.4 [95% CI 4.3, 24.6]).

Discussion:
Children and their parents correlated strongly on observable Feelings And Activities domains scores but correlated weakly on hearing difficulty in Environments scores. Parents of children with mild HL perceived their children's QOL to be better than the children themselves, differing from the moderate-to-severe HL groups.
Effects of Lifestyle Modification on Vestibular Migraine
Authors: Roberts Richard A. , Watford Kenneth E. , Picou Erin M. , Hatton Kelsey , Trone Timothy H. , Brignola Emily Y. 
Published: July 2021

Objective:
To evaluate effects of lifestyle modification on symptoms of dizziness and headache in patients diagnosed with definite vestibular migraine.

Study Design:
Prospective within-participants repeated-measures study.

Setting:
Otolaryngology tertiary care.

Participants:
Twenty-eight adults with definite vestibular migraine who were willing to be treated without pharmacological intervention.

Intervention(s):
Information and instructions were provided on lifestyle modification; participants were instructed to improve restful sleep, exercise, eat at regulated mealtimes, and avoid dietary triggers. Participants were asked to maintain the modifications for at least 60 days.

Main Outcome Measure(s):
Two self-report inventories were used pre- and post-intervention to evaluate participants’ perceived dizziness handicap and headache disability using the Dizziness Handicap Inventory and Headache Disability Inventory, respectively. Questions were also used to evaluate the extent to which participants reported compliance with lifestyle factors pre- and post-intervention.

Results:
Significant improvement was observed after the lifestyle intervention with mean improvements in Dizziness Handicap Inventory and Headache Disability Inventory of 14.3 points. As a group, improvement in restful sleep was related to improvement in both dizziness and headache symptoms. At the individual participant level, 39% and 18% of participants reported significant reduction in dizziness handicap and headache disability, respectively.

Conclusions:
Lifestyle modifications are an effective intervention for symptoms of dizziness and headache in participants with definite vestibular migraine. Participants who reported a larger increase in restful sleep were more likely to also report larger improvements in dizziness handicap and headache disability. Effect sizes using the current intervention were comparable or better than some reported pharmacological interventions but less than others. Our lifestyle modification intervention produced significant improvement in dizziness for a larger percentage of individual participants and in headache for a similar percentage of participants compared to data reported with other lifestyle modification interventions. Lifestyle modifications, especially restful sleep, have the potential to reduce the impact of vestibular migraine on patients’ lives, with limited risk.
Clinical Trials Registration: NCT03979677.
Impact of Hearing Disability and Ear Discharge on Quality-of-Life in Patients with Chronic Otitis Media: Data from the Multinational Collaborative COMQ-12 Study
Authors: Phillips John S. , Tailor Bhavesh V. , Nunney Ian , Yung Matthew W. , Doruk Can , Kara Hakan , Kong Taehoon , Quaranta Nicola , Peñaranda Augusto , Bernardeschi Daniele , Dai Chunfu , Kania Romain , Denoyelle Françoise , Tono Tetsuya 
Published: July 2021

Objective:
This study aimed to assess how two disease-related factors, hearing disability and ear discharge, affect health-related quality-of-life (HRQoL) in patients with chronic otitis media (COM).

Study Design:
Multinational prospective cohort study.

Setting:
Nine otology referral centers in eight countries.

Patients:
Adult patients suffering from COM.

Main Outcome Measure(s):
Hearing disability and ear discharge were assessed by audiometry (Department of Health and Social Security formula) and otoscopy, respectively. Participants completed a native version of the Chronic Otitis Media Questionnaire-12 (COMQ-12). We determined how the two disease-related factors affect HRQoL by performing two separate analyses: (1) using a 6-item score combining responses to COMQ-12 items independent of hearing loss and ear discharge and (2) using item 12 alone as a proxy for global HRQoL.

Results:
This study included 478 participants suffering from COM. There was a significant association between HRQoL and hearing disability in the adjusted analysis. For every unit increase in the Department of Health and Social Security average hearing threshold (1) there was an increase of 0.06 (95% CI [0.007, 0.121], p = 0.0282) in the 6-item score and (2) the adjusted odds of having a higher item 12 score was 1.03 (95% CI [1.01, 1.04], p = 0.0004). There was no association between the presence of ear discharge and HRQoL in both COMQ-12 score analyses.

Conclusions:
Knowledge of disease-related factors that influence HRQoL will aid interpretation of patient-reported measures for COM. Patients with a greater degree of hearing impairment appear to have poorer HRQoL, which is not exacerbated by the presence of ear discharge. The magnitude of postoperative hearing improvement rather than the attainment of a dry ear may be a better indicator of surgical success from the patient's perspective.
A Novel Topical Treatment for Keratosis Obturans
Authors: Zwemstra Max , Ebbens Fenna , de Wolf Maarten , van Spronsen Erik 
Published: July 2021

Objective:
To present and evaluate the treatment of keratosis obturans (KO) using miconazole/triamcinolone 0.1% crème gauzes.

Study Design:
A retrospective clinical capsule report.

Patients:
Twelve patients diagnosed with KO between January 2000 and July 2020 visiting our tertiary hospital setting, were retrospectively reviewed.

Interventions:
Either miconazole/triamcinolone 0.1% crème gauzes or periodic microscopic removal of the keratin plug.

Main Outcome Measures:
No evidence of disease during microscopic inspection of the ear canal.

Results:
Successful treatment with miconazole/triamcinolone 0.1% gauzes was seen in 4/7 patients (57%) and successful treatment of periodic cleaning of the ear canal was seen in 1/5 patients (20%).

Conclusions:
Topical treatment of KO with miconazole/triamcinolone 0.1% crème gauzes in the ear canal could be considered as a treatment option for patients diagnosed with KO.
Sudden Sensorineural Hearing Loss and Metabolic Syndrome: A Systematic Review and Meta-analysis
Authors: Lam Megan , Bao Yueyang , Hua Gordon B. , Sommer Doron D. 
Published: July 2021

Objective:
The objective of this systematic review and meta-analysis is to examine the association between sudden sensorineural hearing loss (SSNHL) and risk of metabolic syndrome (MetS), and the association between MetS and prognosis of SSNHL.

Databases Reviewed:
We systematically searched MEDLINE, Embase, and Cochrane Central Register electronic databases from their dates of conception to February 4, 2020.

Methods:
We included observational studies analyzing 1) the prevalence of MetS among SSNHL patients, or 2) the prognosis of SSNHL patients in MetS patients. A standardized form was completed in duplicate extracting data on study characteristics, participant demographics, and SSNHL outcome or recovery measures. Random-effects meta-analyses were performed pooling odds ratios using the generic inverse method. Risk of bias was assessed using the Newcastle Ottawa Scale.

Results:
Three studies examining the prevalence of MetS among patients with SSNHL (11,890 total participants; 3,034 SSNHL participants) yielded a significantly increased risk of MetS among SSNHL, with a pooled odds ratio of 1.88 (95% CI, 1.01–3.50). Three studies examining the association of SSNHL prognosis in patients with MetS (608 SSNHL participants, 234 concomitant SSNHL, and MetS participants) demonstrated that SSNHL patients with MetS were significantly more likely to have poorer recovery compared to SSNHL patients without MetS (pooled odds ratio 2.77; 95% CI, 2.33–3.28).

Conclusion:
Our findings suggest an association between prevalence of MetS and SSNHL, as well as poorer prognosis of SSNHL in patients with concomitant MetS.
Reconstruction of the Anterior External Auditory Canal With Mastoid Cortex Autologous Bone Graft
Authors: Lovett Braeden L. , Shearer Sarah C. , Kim H. Jeffrey 
Published: July 2021

Objective:
To describe the surgical management of temporomandibular joint (TMJ) herniation with external auditory canal (EAC) reconstruction using autologous bone grafting from the mastoid cortex.

Study Design:
Retrospective case series.

Setting:
A tertiary university medical center.

Patients:
Three patients who presented to our Otolaryngology clinic with evidence of TMJ herniation through an anterior EAC defect, both on otoscopy and computed tomography (CT) imaging.

Interventions:
Reconstruction of the anterior EAC with mastoid cortex bone grafting using an endaural approach.

Main Outcome Measures:
Successful reconstruction of anterior EAC bony defect without recurrence of herniation.

Results:
All three patients presented with otalgia, hearing loss, and either tinnitus or a clicking sensation with jaw movement. Etiologies for TMJ herniation included osteoradionecrosis following external beam radiation therapy for head and neck carcinoma and iatrogenic injury following multiple tympanoplasties and canalplasties. A mastoid cortex bone graft was placed and secured anterior to the bony EAC defect through an endaural approach. Two patients wore a dental retainer postoperatively to keep the condyle in an open position. After reconstruction, patients reported an improvement in their presenting symptoms. There was no recurrence of TMJ herniation in all cases after 1, 4, and 9 years.

Conclusions:
Anterior EAC reconstruction with autologous bone grafting can be an effective definitive treatment in TMJ herniation. To our knowledge, this is the first report of the use of bone grafting to reconstruct the canal defect in TMJ herniation.

Level of Evidence: V.
Volumetric Accuracy Analysis of Virtual Safety Barriers for Cooperative-Control Robotic Mastoidectomy
Authors: Ding Andy S. , Capostagno Sarah , Razavi Christopher R. , Li Zhaoshuo , Taylor Russell H. , Carey John P. , Creighton Francis X. 
Published: July 2021

Hypothesis:
Virtual fixtures can be enforced in cooperative-control robotic mastoidectomies with submillimeter accuracy.

Background:
Otologic procedures are well-suited for robotic assistance due to consistent osseous landmarks. We have previously demonstrated the feasibility of cooperative-control robots (CCRs) for mastoidectomy. CCRs manipulate instruments simultaneously with the surgeon, allowing the surgeon to control instruments with robotic augmentation of motion. CCRs can also enforce virtual fixtures, which are safety barriers that prevent motion into undesired locations. Previous studies have validated the ability of CCRs to allow a novice surgeon to safely complete a cortical mastoidectomy. This study provides objective accuracy data for CCR-imposed safety barriers in cortical mastoidectomies.

Methods:
Temporal bone phantoms were registered to a CCR using preoperative computed tomography (CT) imaging. Virtual fixtures were created using 3D Slicer, with 2D planes placed along the external auditory canal, tegmen, and sigmoid, converging on the antrum. Five mastoidectomies were performed by a novice surgeon, moving the drill to the limit of the barriers. Postoperative CT scans were obtained, and Dice coefficients and Hausdorff distances were calculated.

Results:
The average modified Hausdorff distance between drilled bone and the preplanned volume was 0.351 ± 0.093 mm. Compared with the preplanned volume of 0.947 cm3, the mean volume of bone removed was 1.045 cm3 (difference of 0.0982 cm3 or 10.36%), with an average Dice coefficient of 0.741 (range, 0.665–0.802).

Conclusions:
CCR virtual fixtures can be enforced with a high degree of accuracy. Future studies will focus on improving accuracy and developing 3D fixtures around relevant surgical anatomy.