bluuebunny/crossref_metadata_2025_split huggingface dataset:
Long-acting GLP-1RAs
Authors: Chun Ji Hyun , Butts Amy 
Published: July 2020

ABSTRACT
Over recent decades, an improved understanding of the pathophysiology of type 2 diabetes mellitus (T2DM) and glucose regulation has led to innovative research and new treatment paradigms. The discovery of the gut peptide glucagon-like peptide-1 (GLP-1) and its role in glucose regulation paved the way for the class of GLP-1 receptor agonist compounds, or GLP-1RAs. The long-acting GLP-1RAs (dulaglutide, exenatide extended-release, liraglutide, semaglutide [injectable and oral]) are classified as such based on a minimum 24-hour duration of clinically relevant effects after administration. In phase 3 clinical trial programs of long-acting GLP-1RAs, A1C typically was reduced in the range of 1% to 1.5%, with reductions close to 2% in some studies. GLP-1RAs when used alone (without sulfonylureas or insulin) have a low risk of hypoglycemia because, like endogenous GLP-1, their insulinotropic effects are glucose-dependent. In addition to local actions in the gastrointestinal (GI) tract, GLP-1RAs stimulate receptors in the central nervous system to increase satiety, resulting in weight loss. All long-acting GLP-1RAs have, at minimum, been shown to be safe and not increase cardiovascular (CV) risk and most (liraglutide, semaglutide injectable, dulaglutide, albiglutide) have been shown in CV outcomes trials (CVOTs) to significantly reduce the risk of major cardiac adverse events. The class has good tolerability overall, with generally transient GI adverse events being most common. The weekly injectable agents offer scheduling convenience and may promote treatment adherence. One long-acting GLP-1RA is available as an oral daily tablet, which may be preferable for some patients and providers.
Incorporating Future of Nursing Competencies Into a Clinical and Simulation Assessment Tool: Validating the Clinical Simulation Competency Assessment Tool
Authors: Beauvais Audrey Marie , Phillips Kathryn E. 
Published: July 2020

Abstract

AIM
The purpose of the study was to evaluate the validity of the Clinical Simulation Competency Assessment Tool (ClinSimCAT).

BACKGROUND
The 2011 Future of Nursing report encouraged nursing programs to move toward a competency-based approach to education. As no tool was found to holistically evaluate nursing student competency in clinical and simulation settings, we developed the ClinSimCAT based on the Institute of Medicine recommended competencies.

METHOD
A Delphi study with three rounds was conducted. A national sample of nursing education and simulation leaders was used to achieve consensus about the competencies.

RESULTS
The process resulted in a set of 20 competencies across eight domains (patient-centered care, teamwork and collaboration, evidence-based practice, quality improvement, safety, informatics, professionalism, and systems-based practice).

CONCLUSION
The ClinSimCAT has demonstrated evidence of content validity and can be used for evaluation of clinical and simulation across a variety of undergraduate nursing courses.
Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2): The Clinical Outcomes of a Multicenter 2 × 2 Factorial Randomized Controlled Pilot Trial in Young Femoral Neck Fracture Patients
Authors: Slobogean Gerard P. , Sprague Sheila , Bzovsky Sofia , Scott Taryn , Thabane Lehana , Heels-Ansdell Diane , O'Toole Robert V. , Howe Andrea , Gaski Greg E. , Hill Lauren C. , Brown Krista M. , Viskontas Darius , Zomar Mauri , Della Rocca Gregory J. , O'Hara Nathan N. , Bhandari Mohit ,   FAITH-2 Investigators*
Published: July 2020

Objective:
To assess whether the fixation method and vitamin D supplementation affect the risk of patient-important outcomes within 12 months of injury in nongeriatric femoral neck fracture patients.

Design:
A pilot factorial randomized controlled trial.

Setting:
Fifteen North American clinical sites.

Participants:
Ninety-one adults 18–60 years of age with a femoral neck fracture requiring surgical fixation.

Intervention:
Participants were randomized to a surgical intervention (sliding hip screw or cancellous screws) and a vitamin D intervention (vitamin D3 4000 IU daily vs. placebo for 6 months).

Main Outcome Measurements:
The primary clinical outcome was a composite of patient-important complications (reoperation, femoral head osteonecrosis, severe femoral neck malunion, and nonunion). Secondary outcomes included fracture-healing complications and radiographic fracture healing.

Results:
Eighty-six participants with a mean age of 41 years were included. We found no statistically significant difference in the risk of patient-important outcomes between the surgical treatment arms (hazard ratio 0.90, 95% confidence interval 0.40–2.02, P = 0.80) and vitamin D supplementation treatment arms (hazard ratio 0.96, 95% confidence interval 0.42–2.18, P = 0.92).

Conclusions:
These pilot trial results continue to describe the results of current fixation implants, inform the challenges of improving outcomes in this fracture population, and may guide future vitamin D trials to improve healing outcomes in young fracture populations. Although the pilot trial was not adequately powered to detect treatment effects, publishing these results may facilitate future meta-analyses on this topic.

Level of Evidence:
Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
A selective serotonin receptor agonist for weight loss and management of menopausal vasomotor symptoms in overweight midlife women: a pilot study
Authors: Kapoor Ekta , Faubion Stephanie , Hurt Ryan T. , Fischer Karen , Schroeder Darrell , Fokken Shawn , Croghan Ivana T. 
Published: July 2020

Abstract

Objective:
Weight gain and vasomotor symptoms (VMS) are common complaints in midlife women going through the menopause transition. A selective serotonin 2C (5-HT2C) receptor agonist, lorcaserin, which was previously approved by the Food and Drug Administration for weight loss, has unreported observational evidence suggesting improvement in VMS with its use. The goal of this pilot study was to evaluate the efficacy of lorcaserin for weight loss and management of VMS in overweight midlife women.

Methods:
This was a 24-week open label pilot study of 20 overweight midlife women, aged 45-60 years, who were experiencing severe VMS. Participants received lorcaserin at the standard dose of 10 mg twice daily for 12 weeks, followed by 12 weeks of observation off the drug. The primary outcomes were changes in weight and subjectively reported VMS.

Results:
At the end of 12 weeks, mean change in weight was −2.4 kg (90% CI, −3.2 to −1.7, P < 0.001). However, the participants returned to the baseline weight at 24 weeks. Participants also reported significant subjective improvement in VMS, with a mean ± SD change in self-reported hot flash frequency from baseline to week 12 of −5.4 ± 3.9 (decrease of 1.4 standard deviations). There was a rapid increase in the frequency of VMS within 2 weeks of discontinuation of lorcaserin with a tendency to approach the baseline frequency of VMS.

Conclusions:
In addition to its weight loss-inducing effect, 5-HT2C receptor modulation may have an additional beneficial effect on VMS in midlife women. A treatment option that targets both weight and VMS in midlife women is attractive.

Video Summary:

http://links.lww.com/MENO/A622.
17β-estradiol/progesterone in a single, oral, softgel capsule (TX-001HR) significantly increased the number of vasomotor symptom-free days in the REPLENISH trial
Authors: Kaunitz Andrew M. , Bitner Diana , Constantine Ginger D. , Bernick Brian , Graham Shelli , Mirkin Sebastian 
Published: July 2020

Abstract

Objective:
To examine responder rates and vasomotor symptom-free days with oral 17β-estradiol/progesterone (E2/P4; TX-001HR) versus placebo in the REPLENISH trial.

Methods:
REPLENISH (NCT01942668) was a phase 3, randomized, double-blind, placebo-controlled, multicenter trial, evaluating single, oral, softgel E2/P4 capsules in postmenopausal women (40-65 y) with a uterus and vasomotor symptoms (VMS). Women with moderate to severe hot flushes (≥7/d or ≥50/wk) were randomized (VMS substudy) to daily E2/P4 (mg/mg) of 1/100, 0.5/100, 0.5/50, 0.25/50, or placebo. Proportions of women with ≥50% or ≥75% reductions in moderate to severe VMS (responders), and those with no severe VMS as well as the weekly number of days without moderate to severe VMS with TX-001HR versus placebo were determined. Mixed model repeated measures was used to analyze data and Fisher exact test was employed to compare E2/P4 versus placebo.

Results:
Seven hundred twenty-six women were eligible for the VMS efficacy analysis (E2/P4 1/100 [n = 141], 0.5/100 [n = 149], 0.5/50 [n = 147], 0.25/50 [n = 154], or placebo [n = 135]). Significantly more women treated with all E2/P4 doses versus placebo were ≥50% responders and ≥75% responders at weeks 4 and 12 (P < 0.05) and also had significantly more days per week without moderate to severe VMS at week 12 (1.9-3.0 d for E2/P4 versus 1.3 d for placebo; P < 0.05). The proportion of women without severe hot flushes at week 12 was 43% to 56% for all E2/P4 doses versus 26% for placebo (P ≤ 0.01).

Conclusions:
Women treated with E2/P4 had a greater response to treatment with more VMS-free days than with placebo. The E2/P4 1/100 dose (Bijuva [E2 and P4] capsules) represents an oral treatment option for postmenopausal women with moderate to severe VMS and a uterus.
CHOROIDAL BLOOD FLOW
Authors: Spaide Richard F. 
Published: July 2020

Purpose:To review control mechanisms for blood flow in the choroid, propose a system by which venous outflow is controlled by a Starling resistor, and propose an explanation for the choroidal venous architectural anatomy.Methods:The main blood flow control mechanisms were reviewed including autoregulation, neurovascular coupling, and myogenic regulation. Applicable blood flow control mechanisms in the brain, a high flow organ in a low compliance outer shell, were used to examine analogous processes that may be occurring in the choroid.Results:There does not seem to be effective autoregulation in the choroid, although myogenic mechanisms may be present. There is a sophisticated neural innervation that provides partial control. Like the brain, the eye has a high pulsatile blood flow rate and is encased in a noncompliant casing. As part of modulating pulsatile pressure in the cranium, the brain uses venous storage and a Starling resistor effect to modulate venous outflow. An analogous function in the eye could be provided by the choroid, which contains fascicles of large veins that converge in vortices to drain out of the eye. This vortex area seems to be where the Starling resistor effect is possible. This mechanism would have important impact on theories of many ocular diseases including central serous chorioretinopathy and spaceflight-associated neuroocular syndrome.Conclusion:Control of blood flow is critical in the choroid, and this control seems to extend to the venous outflow system. Abnormalities in venous outflow may critically affect function in predictable pathogenic mechanisms.
PATTERN DYSTROPHY-LIKE CHANGES ASSOCIATED WITH A VERY HIGH SERUM FERRITIN LEVEL IN β-THALASSEMIA MAJOR
Authors: Kurnia King Hans , Elvioza Elvioza , Sidik Mohamad , Sari Teny Tjitra , Sitorus Rita S. 
Published: July 2020

Purpose:
To report a rare case of pattern dystrophy-like retinal changes in a young β-thalassemia major patient with a very high serum ferritin level.

Methods:
Observational case report of a β-thalassemia major patient with bilateral pattern dystrophy-like retinal changes.

Results:
An 18-year-old man experienced blurring of vision in both eyes. Patient had a very high serum ferritin level and had a history of using various iron-chelating drugs. Funduscopy revealed bilateral widespread retinal pigment epithelium changes with macular involvement, which resembled pattern dystrophy-like changes. Fundus autofluorescence imaging showed extensive area of decreased autofluorescence signal interspersed with increased autofluorescence signals, whereas optical coherence tomography demonstrated macular retinal pigment epithelium thinning and interdigitation zone disruption corresponding to retinal pigment epithelium damage and atrophy.

Conclusion:
Pattern dystrophy-like changes should be considered as a possible manifestation of retinal changes in patients with β-thalassemia major. Iron overload, which is indicated by a very high serum ferritin level, might have a role in the formation of this rare retinal manifestation in β-thalassemia major.
One-Year Clinical Outcomes of Preloaded Descemet Membrane Endothelial Keratoplasty Versus Non-Preloaded Descemet Membrane Endothelial Keratoplasty
Authors: Böhm Myriam S. , Wylegala Adam , Leon Pia , Ong Tone Stephan , Ciolino Joseph B. , Jurkunas Ula V. 
Published: July 2020

Purpose:
To compare the one-year outcomes of preloaded Descemet membrane endothelial keratoplasty (pDMEK) and non-preloaded DMEK (n-pDMEK) in patients with Fuchs endothelial corneal dystrophy (FECD).

Methods:
This retrospective comparative cohort study consecutively included 68 eyes with Fuchs endothelial corneal dystrophy who underwent either pDMEK (n = 38) or n-pDMEK (n = 30) performed by cornea fellows with an experienced surgeon between 2016 and 2018 at the Massachusetts Eye and Ear Infirmary. Exclusion criteria were previous surgery (other than uncomplicated cataract surgery) and any documented evidence of macular or other corneal diseases. Corrected distance visual acuity (CDVA), central corneal thickness, intraocular pressure, patient characteristics, postprocessing endothelial cell count, donor graft data, and complications were compared.

Results:
CDVA showed similar results for pDMEK (0.12 ± 0.11 logarithm of the minimal angle of resolution [LogMAR]) and n-pDMEK (0.13 ± 0.13 LogMAR) (P = 0.827). Sixty-six percent of the pDMEK eyes and 57% of the n-pDMEK eyes achieved a VA of ≥0.1 LogMAR, and 95% and 97%, respectively, achieved a CDVA ≥0.3 LogMAR. The preoperative central corneal thickness of pDMEK and n-pDMEK (644 ± 62.2 μm, 660.5 ± 56.2 μm) decreased significantly after surgery (525.1 ± 43.6 μm, 526.5 ± 45.2 μm, P < 0.001), with no difference between groups (P = 0.840). The postprocessing endothelial cell count did not differ between pDMEK (2959.2 ± 182.9 cells/mm2) and n-pDMEK (2939.3 ± 278.7 cells/mm2) (P = 0.484). Complication rates were comparable with just the rebubbling performed in a minor procedure room showing a lower rate for pDMEK (13.16%) compared with n-pDMEK (33.33%) (P < 0.045).

Conclusions:
One-year clinical outcomes were similar between pDMEK and n-pDMEK procedures, rendering eye bank–prepared pDMEK tissues a useful tool in the treatment of endothelial dysfunction.
Reliability of 3 Strategies of Orbital Tumor Volume Measurement Using Phantom Modeling
Authors: Tooley Andrea A. , Maher Mary , Cooper Cathleen , Godfrey Kyle J. , Tran Ann Q. , Kazim Michael 
Published: July 2020

Purpose:
The reliability of 3 volume measurement strategies was investigated using MRI and a simple method for creating phantom orbit tumors.

Methods:
Water-based starch was molded into orbital “tumors” of 3 shapes (sphere, ovoid, diffuse); water displacement was used to calculate volume. “Tumors” were placed into 3D-printed orbit phantoms, MRIs were obtained and volume analysis was performed. Observers measured tumor volume using ellipsoid volume (EV), manual segmentation, and semi-automated segmentation strategies. Intraclass correlation coefficients were calculated comparing observer measurements to true volumes. The coefficient of repeatability determined the percentage of tumor volume change required for each method to detect tumor growth.

Results:
Intraclass correlation coefficients comparing measured volumes to true volumes using EV, manual segmentation, and semi-automated segmentation were 0.61, 0.98, and 0.99 for spherical, 0.64, 0.97, and 0.98 for ovoid, and 0.18, 0.82, and 0.87 for diffuse tumors. Semi-automated segmentation followed by manual segmentation had the highest correlation between measured and true tumor volume for all 3 tumor geometries. EV had low correlation with true volume for all tumor geometries. Diffuse tumors had high variability and low correlation for all 3 measurement techniques.

Conclusions:
This study shows the reliability of 3 strategies to measure orbital tumor volume with MRI based on tumor geometry, using a simple phantom model. EV, the most commonly employed strategy in clinical practice, had low correlation and high variability across tumor shapes. Using manual segmentation and semi-automated segmentation, a measured change in volume greater than 25% may be considered true growth, while the EV strategy required a 40%–400% change in volume to reliably measure tumor growth.
Outcomes Associated With Antibiotic Cessation in Oncology Patients With Positive Respiratory Viral Panel Polymerase Chain Reaction Results
Authors: Smith Stephanie M. , Pineda Elmor D. , Oda Julie , Chavda Rihin , Herrington Jon D. 
Published: July 2020

Background
The discontinuation of antibiotics is ideal if a viral infection is diagnosed. However, it remains uncertain whether in clinical practice, this applies to immunocompromised patients.

Purpose
The purpose of this study was to evaluate the outcomes of hospitalized febrile oncology patients that cease or continue antibiotics with positive respiratory viral panels (RVP) with negative bacterial cultures.

Methods
This retrospective study evaluated hospitalized febrile oncology patients divided into 2 groups: patients with antibiotics discontinued within 72 hours of a positive RVP and those continued on antibiotics beyond 72 hours of a positive RVP. Patients were included if they were at least 18 years of age, had active malignant disease, a positive RVP result, and negative bacterial cultures. The primary endpoint was a composite of readmissions, escalation of care to intensive care unit, or death.

Results
A total of 243 charts were reviewed with 127 admissions meeting inclusion criteria. Sixty-three patients were included in the antibiotics discontinued within 72 hours group and 64 patients were included in the antibiotics continued after 72 hours group. The most common defined malignancy was lymphoma (22%), and the 3 most common viruses identified were rhinovirus/enterovirus (56.7%), influenza A (12.6%), and human metapneumovirus (12.6%). The composite primary outcome occurred in 26.2% of patients in the antibiotic-continued group compared with 27% in the antibiotic-discontinued group.

Conclusions
Discontinuing antibiotics in oncology patients with a positive RVP result without concurrent bacterial infections did not lead to a significant increase in 30-day readmission, intensive care unit admission, or death.
Prevalence of mitochondrial DNA common deletion in patients with gliomas and meningiomas: A first report from a Malaysian study group
Authors: Mohamed Yusoff Abdul Aziz , Mohd Khair Siti Zulaikha Nashwa , Abd Radzak Siti Muslihah , Idris Zamzuri , Lee Hsin-Chen 
Published: July 2020

Background:The 4977-bp common deletion (mtDNA4977) is a well-established mitochondrial genome alteration that has been described in various types of human cancers. However, to date, no studies on mtDNA4977in brain tumors have been reported. The present study aimed to determine mtDNA4977prevalence in common brain tumors, specifically, low- and high-grade gliomas (LGGs and HGGs), and meningiomas in Malaysian cases. Its correlation with clinicopathological parameters was also evaluated.Methods:A total of 50 patients with pathologically confirmed brain tumors (13 LGGs, 20 HGGs, and 17 meningiomas) were enrolled in this study. mtDNA4977was detected by using polymerase chain reaction (PCR) technique and later confirmed via Sanger DNA sequencing.Results:Overall, mtDNA4977was observed in 16 (32%) patients and it was significantly correlated with the type of tumor group and sex, being more common in the HGG group and in male patients.Conclusion:The prevalence of mtDNA4977in Malaysian glioma and meningioma cases has been described for the first time and it was, indeed, comparable with previously published studies. This study provides initial insights into mtDNA4977in brain tumor and these findings can serve as new data for the global mitochondrial DNA mutations database.
Effects of Hydraulic Ankle-Foot Prostheses on Gait in Individuals with Transtibial Limb Loss: A Scoping Review
Authors: Chang Sarah R. , Miller Corinne H. , Kaluf Brian 
Published: July 2020

ABSTRACT

Introduction
The purpose of this scoping review was to determine if sufficient evidence exists to conduct a formal systematic review or meta-analysis of hydraulic ankle-foot (HAF) prostheses and to determine if evidence statements could be synthesized relative to the effects of HAF prostheses on gait in individuals with transtibial limb loss.

Methods
Electronic database searches were conducted in MEDLINE, Embase, Web of Science, Scopus, and Proquest covering 1788 to 2017. Two reviewers independently completed screening and data extraction.

Results
The scoping review resulted in 15 articles that satisfied the inclusion/exclusion criteria. The majority of studies were completed in the United Kingdom and consisted of prospective protocols performed in research laboratories. All studies used the same HAF prosthesis intervention. The intervention studies reported a variety of biomechanical and patient-reported outcome measures.

Conclusions
Results of the scoping review indicate that there is a need to evaluate the quality of the HAF prosthetic literature with a systematic review or meta-analysis.

Clinical Relevance
There has been an increase in the number of commercially available passive hydraulic ankle-foot prostheses. This study provides an overview of evidence related to the effects of these HAF prostheses on transtibial prosthesis users' gait biomechanics and patient-reported outcomes. Walking speed was consistently reported as improved when using a hydraulic ankle-foot prosthesis as compared with a nonhydraulic ankle-foot prosthesis.
Colchicine therapy in patients with coronary artery disease: a systematic review and meta-analysis of randomized controlled trials
Authors: Al-Abdouh Ahmad , Barbarawi Mahmoud , Khan Safi U. , Osman Mohammed , Upadhrasta Sireesha , Solipuram Vinod , Abusnina Waiel , Radaideh Qais , Zhao Di , Michos Erin D. 
Published: July 2020

Introduction
Inflammation is a substantial mediator of atherosclerosis. Colchicine has anti-inflammatory effects and has been investigated in many randomized controlled trials (RCTs) in patients with coronary artery disease (CAD).

Methods
We searched PubMed/MEDLINE, Cochrane library, and Embase databases (inception through 28 February 2020) for RCTs evaluating colchicine in CAD patients. The outcomes of interest were major adverse cardiovascular events (MACE), myocardial infarction (MI), all-cause mortality, cardiovascular mortality, and stroke. Estimates were pooled using inverse-variance random-effects model. We reported effect sizes as risk difference (RD) with 95% confidence interval (CI).

Results
A total of six RCTs with 6154 patients were included. The mean age ± SD for the patients in the colchicine group was 61.6 ± 10.8 and control group was 61.5 ± 10.7 years. At the median follow-up of 3.5 months, use of colchicine in patients with CAD was not associated with statistically significant reduction of MACE (RD −0.032; 95% CI −0.083 to 0.018; P = 0.15; I2 = 75%; low level of evidence), MI (RD −0.011; 95% CI −0.030 to 0.007; P = 0.16; I2 = 11.3%; low level of evidence), all-cause mortality (RD −0.001; 95% CI −0.009 to 0.006; P = 0.65; I2 = 0%; low level of evidence), cardiovascular mortality (RD −0.003; 95% CI −0.010 to 0.004; P = 0.34; I2 = 0%; low level of evidence), and stroke (RD −0.001, 95% CI −0.005 to 0.004; P = 0.69; I2 = 0%; very low level of evidence).

Conclusion
This meta-analysis suggests that colchicine was not associated with a significant decrease in cardiovascular endpoints and mortality in patients with CAD.