bluuebunny/crossref_metadata_2025_split huggingface dataset:
Time to first occurrence of breast pain and vaginal bleeding in phase 3 trials of CE/BZA
Authors: Pinkerton JoAnn V. , Bushmakin Andrew G. , Bobula Joel , Lavenberg Joanne , Komm Barry S. , Abraham Lucy 
Published: June 2017

Abstract

Objective:
In studies of the menopausal therapy, conjugated estrogens/bazedoxifene, breast pain and vaginal bleeding rates were comparable to placebo and lower than conjugated estrogens/medroxyprogesterone acetate (MPA). This post hoc analysis determined median time to occurrence of these events.

Methods:
Participants in phase 3 conjugated estrogens/bazedoxifene trials recorded breast pain and vaginal bleeding in daily diaries. Median time to first incident was determined in women taking conjugated estrogens 0.45 mg/bazedoxifene 20 mg, conjugated estrogens 0.625 mg/bazedoxifene 20 mg, placebo, and conjugated estrogens 0.45 mg/MPA 1.5 mg (active control in Selective estrogens, Menopause, And Response to Therapy [SMART]-5 trial). We included on-treatment data (12 weeks-2 years) in healthy postmenopausal women (SMART-1), those seeking treatment for menopausal symptoms (SMART-5), and those with moderate/severe vasomotor symptoms (SMART-2). Analyses were performed using SAS Proc Lifetest.

Results:
With conjugated estrogens/MPA as comparator, median time to breast pain was 299 days for conjugated estrogens/MPA, 353 for placebo, and more than 365 (median not reached) for conjugated estrogens 0.45 mg/bazedoxifene 20 mg and conjugated estrogens 0.625 mg/bazedoxifene 20 mg. Median time to vaginal bleeding was 314, 341, 357, and 362 days, respectively. Breast pain and vaginal bleeding survival curves were not significantly different for conjugated estrogens/bazedoxifene and placebo in any study, but were (P < 0.0001) when conjugated estrogens/MPA was added to the sample in SMART-5.

Conclusions:
The time course of breast pain and vaginal bleeding with conjugated estrogens/bazedoxifene was similar to that of placebo during treatment for up to 2 years. Events occurred significantly earlier with conjugated estrogens/MPA versus conjugated estrogens/bazedoxifene or placebo.
Placebo effects of a sham opioid solution: a randomized controlled study in patients with chronic low back pain
Authors: Klinger Regine , Kothe Ralph , Schmitz Julia , Kamping Sandra , Flor Herta 
Published: June 2017

Abstract
This study tested the experimental placebo effect in a group of chronic pain patients. Forty-eight patients having chronic back pain participated in a randomized clinical trial that tested the efficacy of a sham opioid solution (NaCl) compared with an alleged neutral, completely inactive solution (NaCl). We shaped the placebo effect by 2 interventions: verbal instruction and conditioning. The patients were either told that the “solution reduces pain and improves physical capacity” or the “solution is neutral, a placebo.” Half of each group was additionally conditioned (coupling solution with reduced experimental pain), yielding 4 subgroups with 12 participants each. Outcome measures were as follows: the patients' clinical back pain ratings and acute pain ratings (both examined by numerical rating scale 0-10) and self-rated functional capacity (0%-100%; time required for the exercise). Expected pain relief before and after solution intake was also assessed. The inactive solution (NaCl), when presented as an effective treatment (sham “opioid” solution), induced placebo analgesia as evident in lower ratings of the patients' clinical back pain (F(3.12,144.21) = 25.05, P < 0.001), acute pain ratings (F(1.99,87.40) = 18.12, P < 0.01), and time needed to complete a series of daily activities exercises (F(1,44) = 8.51, P < 0.01) as well as increased functional capacity (F(1,44.00) = 19.42, P < 0.001). The 2 manipulations (instruction and conditioning) changed pain expectations, and they were maintained in both sham opioid groups. The results suggest that it may be clinically useful to explicitly integrate placebo analgesia responses into pain management.
The Affordable Care Act Reduces Hypertension Treatment Disparities for Mexican-heritage Latinos
Authors: McKenna Ryan M. , Alcalá Héctor E. , Lê-Scherban Félice , Roby Dylan H. , Ortega Alexander N. 
Published: June 2017

Objectives:
Mexican-heritage Latinos have lower prevalence of hypertension, but have worse patterns of treatment and control compared with non-Latino whites. This study examined the impact of the Affordable Care Act (ACA) insurance expansion on reducing disparities in treatment and medication use among Mexican-heritage Latinos with hypertension.

Research Design:
Using the 2009–2014 waves of the California Health Interview Survey, we examine health care access, utilization, and medication use among Mexican-heritage Latinos and non-Latino whites with hypertension. Multivariable logistic regression analyses were performed to adjust for socioeconomic and demographic factors. Interactions between race/ethnicity and year variables were conducted to capture the effects of the passage of the ACA.

Results:
Among those with hypertension, the full implementation of the ACA (year 2014) is associated with a greater likelihood of being insured, but the race/ethnicity interaction indicates that this gain is less substantial for Mexican-heritage Latinos. The odds of having a usual source of care other than the emergency department increased after the passage of the ACA, and interaction effects indicate that this gain was more substantial for Mexican-heritage Latinos. The odds of having any physician visit and taking blood pressure mediations decreased among non-Latino whites but increased among Mexican-heritage Latinos.

Conclusions:
The implementation of the ACA in California has helped reduce some of the disparities in health care access, utilization, and medication use between non-Latino whites and Mexican-heritage Latinos with hypertension. However, sustained progress is threatened by looming repeals of ACA provisions.
Surround Propinquity and Tonic Accommodation
Authors: Nguyen Tammy , Stark Lawrence R. 
Published: June 2017

ABSTRACT

Purpose
Previous studies of dark focus have found evidence of a propinquity response, in which subjects accommodate to the perceived distance of their surroundings despite being in absolute darkness. Their distance perception in a lighted room allows a spatial representation to persist within the darkened room. This study sought to establish the significance and magnitude of the propinquity response in a large sample of young adults, and to determine whether the propinquity response can be predicted by a subject’s initial dark focus in an unknown dark room.

Methods
Dark focus was measured with a dynamic infrared optometer (Plusoptix PowerRef 3) in 30 young adult subjects, 26 of whom were naive to the testing room and its dimensions. Dark focus was then measured at varying dioptric wall distances of 0.25–4D. The subject viewed the lighted room before each measurement. For each individual, the dark focus was plotted as a function of dioptric wall distance. The slope of this function was used as a measure of the propinquity response.

Results
The mean initial dark focus value was 1.05D (SD 1.04D) for the 26 naive subjects. The mean slope of the plot of dark focus as a function of dioptric wall distance was small (+0.097), yet highly statistically significant (P = .0002). The propinquity response function showed no statistically significant quadratic or cubic trends, and so may be considered linear. No statistically significant correlation was found between naive dark focus and propinquity response (r = +0.246, P = .226).

Conclusions
Propinquity seems to be a small but statistically significant factor in dark focus measurements. Though it is unlikely to contaminate tonic accommodation measurements in large samples under normal laboratory conditions, a minority of individuals exhibit large propinquity responses equal to that of proximal accommodation in lighted conditions.
Visually Evoked Potential Markers of Concussion History in Patients with Convergence Insufficiency
Authors: Poltavski Dmitri , Lederer Paul , Cox Laurie Kopko 
Published: June 2017

ABSTRACT

Purpose
We investigated whether differences in the pattern visual evoked potentials exist between patients with convergence insufficiency and those with convergence insufficiency and a history of concussion using stimuli designed to differentiate between magnocellular (transient) and parvocellular (sustained) neural pathways.

Methods
Sustained stimuli included 2-rev/s, 85% contrast checkerboard patterns of 1- and 2-degree check sizes, whereas transient stimuli comprised 4-rev/s, 10% contrast vertical sinusoidal gratings with column width of 0.25 and 0.50 cycles/degree. We tested two models: an a priori clinical model based on an assumption of at least a minimal (beyond instrumentation’s margin of error) 2-millisecond lag of transient response latencies behind sustained response latencies in concussed patients and a statistical model derived from the sample data.

Results
Both models discriminated between concussed and nonconcussed groups significantly above chance (with 76% and 86% accuracy, respectively). In the statistical model, patients with mean vertical sinusoidal grating response latencies greater than 119 milliseconds to 0.25-cycle/degree stimuli (or mean vertical sinusoidal latencies >113 milliseconds to 0.50-cycle/degree stimuli) and mean vertical sinusoidal grating amplitudes of less than 14.75 mV to 0.50-cycle/degree stimuli were classified as having had a history of concussion. The resultant receiver operating characteristic curve for this model had excellent discrimination between the concussed and nonconcussed (area under the curve = 0.857; P < .01) groups with sensitivity of 0.92 and specificity of 0.80.

Conclusions
The results suggest a promising electrophysiological approach to identifying individuals with convergence insufficiency and a history of concussion.
Retinal Macroaneurysm Associated with Congenital Anomalous Retinal Artery
Authors: Kumar Vinod , Agarwal Rinky , Chandra Parijat 
Published: June 2017

ABSTRACT

Purpose
Retinal arteriolar macroaneurysms are a common cause of vision loss in elderly patients with hypertension and cardiovascular disease. Their occurrence in the young, however, is not well known. The purpose of this article is to describe an unusual cause of retinal arteriolar macroaneurysm in a healthy young man.

Case report
A 30-year-old man presented with preretinal hemorrhage and macular exudation due to ruptured retinal artery macroaneurysm. The patient was treated with intravitreal bevacizumab and laser photocoagulation to the macroaneurysm. The exudation and preretinal hemorrhage resolved over several months. Fluorescein angiogram at this stage revealed a congenital anomalous retinal artery.

Conclusions
Congenital anomalous retinal artery may be associated with retinal artery macroaneurysm even in the young age in the absence of any other predisposing factors. The presentation and treatment of such retinal artery macroaneurysm, however, may remain the same to those that occur in older patients.
Feedback Simulation for Acupressure Training and Skill Assessment
Authors: Noll Eric , Romeiser Jamie , Shodhan Shivam , Madariaga Maria Cecilia , Guo Xiaojun , Rizwan Sabeen , Al-Bizri Ehab , Bennett-Guerrero Elliott 
Published: June 2017

IntroductionPrevious acupressure studies have yielded varying results. This could be due to differences in the amount of pressure applied to the acupressure point (acupoint) by study personnel within a study as well as between studies. Standardizing the level of pressure applied at an acupoint could improve clinical care and future research.MethodsAs part of an ongoing randomized clinical trial of postoperative acupressure, five trainees were asked to perform 2 minutes of acupressure and light touch sessions on a simulator. The applied weight was recorded every minute. Individual skill assessment was performed using cumulative sum analysis. Six pretraining and 20 posttraining measurements in each acupressure and light touch group were compared with an expert's simulation values.ResultsBefore training (baseline), there was significant difference in applied weight (grams) between the expert [5705 (636)] and five trainees [2998 (798),P= 0.004]. Four of the five trainees crossed the lower decision limit assessing proficiency in the acupressure group, and all five trainees were successful in the light touch group. The trainees' average number of measurements needed to cross the lower decision limit (H0), that is, defining that an individual failure rate does not statistically differ from the acceptable failure rate, was 21.3 measurements for acupressure. After this feedback simulation, trainees' scores showed no significant difference (P> 0.05) when assessed against the expert.ConclusionsFeedback simulation for acupressure training and skill assessment, evaluated by cumulative sum analysis, may help in improving the standardization of acupressure therapy performed during clinical practice or research.
The Role of Extracorporeal Membrane Oxygenation Simulation Training at Extracorporeal Life Support Organization Centers in the United States
Authors: Weems Mark F. , Friedlich Philippe S. , Nelson Lara P. , Rake Alyssa J. , Klee Laura , Stein James E. , Stavroudis Theodora A. 
Published: June 2017

Introduction
Extracorporeal membrane oxygenation (ECMO) requires a multidisciplinary healthcare team. The Extracorporeal Life Support Organization publishes training guidelines but leaves specific requirements up to each institution. Simulation training has shown promise, but it is unclear how many institutions have incorporated simulation techniques into ECMO training to date.

Methods
We sent an electronic survey to ECMO coordinators at Extracorporeal Life Support Organization sites in the United States. Participants were asked about training practices and the use of simulation for ECMO training. Descriptive results were reported as the percentage of total responses for each question. Logistic regression was used to identify characteristics associated with simulation use.

Results
Of 94 responses (62% response rate), 46% had an ECMO simulation program, whereas 26% report a program is in development. Most (61%) have been in operation for 2 to 5 years. Sixty-three percent use simulation for summative assessment, and 76% have multidisciplinary training. Access to a simulation center [odds ratio (OR) = 4.7, 95% confidence interval (CI) = 1.7–12.5], annual ECMO caseload of greater than 20 (OR = 2.5, 95% CI = 1.5–5.8), and having a pediatric cardiothoracic intensive care unit (OR = 2.8, 95% CI = 1.2–6.7) are each associated with increased likelihood of mannequin-based ECMO simulation. Common scenarios include pump failure (93%), oxygenator failure (90%), and circuit rupture (76%).

Discussion
Extracorporeal membrane oxygenation simulation is growing but remains in its infancy. Centers with access to a simulation center, higher caseloads, and pediatric cardiothoracic intensive care units are more likely to have ECMO simulation programs. Extracorporeal membrane oxygenation simulation is felt to be beneficial, and further work is needed to delineate best training practices for ECMO providers.
Glove Port Transanal Excision of Rectal Tumors an Alternative Method for Rectal Tumor Excision: Single Center Experience
Authors: Dharamavaram Sridhar , Sapre Dimple , Mohammed Ahmed M.A. , Badrinath Krishnamurthy 
Published: June 2017

Aim:
Transanal minimal invasive surgery has been practiced for several years for excision of rectal tumors however there is no standard consensus about its applications. This minimally invasive approach helps in avoiding major rectal resections and its associated risk of mortality and morbidity.
The aim of this study is to describe a single center experience with transanal glove port excision of rectal tumors which are not amenable to colonoscopic excision.

Materials and Methods:
Between the years 2011 and 2014, 9 patients underwent glove port excision of rectal tumors located within 15 cm from the anal verge. Glove port was constructed using circular anal dilator, standard surgical glove and a wound protector retractor; regular laparoscopic instruments were used. The median follow-up period was for 18 months (range, 9 to 27 mo) and all patients had flexible sigmoidoscopy for follow-up to look for any recurrence of the tumors.

Results:
All patients underwent transanal excision of rectal tumors successfully using glove port device and laparoscopic instruments. Full thickness excision of the tumor was performed in all patients and there was no significant postoperative morbidity. The final histology of 6 patients was benign and the remaining 3 patients had malignancy reported in the specimen. During the follow-up period between 12 and 18 months 3 patients had a recurrence of the polyp which was removed endoscopically without the need for any further surgical intervention.

Conclusions:
Glove port excision of rectal tumors is a feasible alternative to conventional surgical treatment for large benign rectal tumors.
What does this paper add to the literature?
This article demonstrates that performing local excision of rectal tumors can be achieved safely at a lower cost using simple platforms that are constructed locally like the glove ports. It also highlights the benefits of using the available laparoscopic kits to perform the procedure while making use of the previously acquired skills
The Role Safety Steps in Success and Complication Rate of Endoscopic Retrograde Cholangiopancreatography
Authors: Sevinç Bariş , Karahan Ömer 
Published: June 2017

Background:
Endoscopic retrograde cholangiopancreatography (ERCP) is widely used for treatment of biliary disorders. There are several studies to increase the success rate and decrease the complication rate of ERCP. In this study we aimed to evaluate the affect of safety steps in success and complication rate of ERCP.

Materials and Methods:
In this cohort study patients were evaluated under 2 groups divided as before the introduction of safety steps and after. Successful cannulation rate, difficult cannulations, and complications of the procedure were recorded.

Result:
Failed ampullary cannulation rates were 8.2% in group 1 and 4% in group 2. In terms of postprocedural complications; in group 2 complication rates significantly decreased from 10.7% to 4.3%. Moreover, post-ERCP pancreatitis rate decreased from 9.1% in group 1 to 4% in group 2.

Conclusions:
Introduction of safety steps, significantly increase the cannulation rate and decrease both overall complication rate and pancreatitis risk.
Minimally Invasive Cholecystolithotomy to Treat Cholecystolithiasis in Children: A Single-center Experience With 23 Cases
Authors: Lin Xiaokun , Cai Jingli , Wang Jisheng , Chen Congde , He Guorong , Han Yijiang 
Published: June 2017

Objective:
Minimally invasive cholecystolithotomy is recently popularized treatment that may offer advantages over laparoscopic cholecystectomy, especially in China. However, there are few reports concerning the use of this technique in the pediatric population. This report describes our initial experience with minimally invasive cholecystolithotomy using laparoscopy combined with choledochoscopy to treat cholecystolithiasis in children.

Materials and Methods:
A retrospective review of 23 pediatric patients with cholecystolithiasis who underwent minimally invasive cholecystolithotomy using laparoscopy combined with choledochoscopy from January 2009 to December 2015 was performed.

Results:
The operations were successful in all 23 cases. None required conversion to conventional laparoscopic cholecystectomy. The average operative time was 68 minutes (range, 45 to 97 min). The average bleeding volume during surgery was 30 mL (range, 10 to 55 mL). The average length of hospital stay was 5.2 days (range, 3 to 7 d). There were no perioperative complications. All patients were followed for 9 to 12 months without any obvious gastrointestinal symptoms. None had a recurrence of stones in the gall bladder.

Conclusions:
Minimally invasive cholecystolithotomy using laparoscopy combined with choledochoscopy is a safe and viable technique that may be used successfully in pediatric surgery.
Reexamining the Association of Body Mass Index With Overall Survival Outcomes After Liver Transplantation
Authors: Chang Su-Hsin , Liu Xiaoyan , Carlsson Nils P. , Park Yikyung , Colditz Graham A. , Garonzik-Wang Jacqueline M. , Chapman William C. , Wellen Jason R. , Doyle Maria B. , Alhamad Tarek 
Published: June 2017

Background
Several studies have shown that obese patients undergoing liver transplantation (LT) have an increased risk of mortality regardless of Model of End Stage Liver Disease (MELD) scores. The purpose of this study is to identify the range of body mass index (BMI) at LT associated with the lowest risks of posttransplant mortality by MELD category.

Methods
A retrospective cohort of patients aged 18 years or older from the Organ Procurement and Transplantation Network database undergoing LT between February 27, 2002, and December 31, 2013, was identified and followed up through March 14, 2014. Patients' MELD score at the time of transplantation was categorized into 10 or lower (MELD1), 11 to 18 (MELD2), 19 to 24 (MELD3), and 25 or higher (MELD4). Multivariable adjusted Cox proportional hazard analyses were conducted.

Results
Among 48 226 patients in the analytic cohort (14.8% were in MELD1, 33.7% were in MELD2, 19.6% were in MELD3, and 32.0% were in MELD4), 25% died with mean follow-up of 1371 days. For MELD1, patient BMI ranging from 30 to 33 was associated with a better survival outcome than BMI less than 30 or 33 or greater; for MELD2, BMI ranging from 28 to 37 had a better survival outcome than BMI less than 28 or 37 or greater; for MELD3, the survival outcome improved with an increasing BMI; for MELD4, the survival outcome was not associated with patient BMI.

Conclusions
This study provides evidence that obesity in LT patients is not necessarily associated with higher posttransplantation mortality and highlights the importance of the interaction between BMI and MELD category to determine their survival likelihood.
A review of cohesive zone modelling as an approach for numerically assessing hydrogen embrittlement of steel structures
Authors: Jemblie L. , Olden V. , Akselsen O. M. 
Published: June 2017

Simulation of hydrogen embrittlement (HE) requires a coupled approach; on one side, the models describing hydrogen transport must account for local mechanical fields, while, on the other side, the effect of hydrogen on the accelerated material damage must be implemented into the model describing crack initiation and growth. This study presents a review of coupled diffusion and cohesive zone modelling as a method for numerically assessing HE of a steel structure. While the model is able to reproduce single experimental results by appropriate fitting of the cohesive parameters, there appears to be limitations in transferring these results to other hydrogen systems. Agreement may be improved by appropriately identifying the required input parameters for the particular system under study.This article is part of the themed issue ‘The challenges of hydrogen and metals’.