bluuebunny/crossref_metadata_2025_split huggingface dataset:
Assessment of Gestational Diabetes Mellitus Outcomes for Hispanic Women Living in the Rio Grande Valley
Authors: Somohano-Mendiola Norma , Champion Jane Dimmitt , Vatcheva Kristina 
Published: March 2019

Introduction: Gestational diabetes mellitus (GDM) among women living along the U.S.–Mexico border are approximately twice that of the general population of pregnant U.S. women. This study compared outcomes for Hispanic pregnant women diagnosed and treated for GDM (i.e., two abnormal 3-hour oral glucose tolerance tests [OGTT]) with those who were screened but had only one abnormal 3-hour OGTT and therefore received no treatment. Methods: Retrospective chart review of pregnant Hispanic women of Mexican origin ( N = 95), with GDM ( N = 41) or one abnormal 3-hour OGTT value ( N = 54) who delivered between January 1, 2015, and December 31, 2017. Results: No significant differences were found between the two groups with regard to sociodemographic variables, hyperbilirubinemia, or other adverse neonatal outcomes. Comparisons identified differences between women with and without adverse neonatal outcomes concerned type of delivery; there were more C-sections among women with GDM. Conclusion: Pregnant women with one abnormal 3-hour OGTT value are at risk of giving birth to neonates with biomarkers similar to those diagnosed and treated for GDM. The treatment of hyperglycemia in Hispanic women of Mexican origin with one abnormal 3-hour OGTT value may improve the health outcomes and quality of life of the mother and the neonate. More research is warranted to clarify the risk of adverse outcomes of diverse pregnant women who do not meet guidelines for diagnosis of GDM.
Metameric spinal AVM: Long-term symptomatic relief achieved by embolization of the extradural component
Authors: Drake B , Patro S , Quateen A , Cora EA , Finitsis S , Sinclair J , Lesiuk H , Iancu D 
Published: March 2019

Background Metameric spinal cord arteriovenous malformations (AVMs) are rare lesions characterized by an intradural and extradural component. They are difficult to treat surgically by the endovascular route. We report a case in which symptomatic relief was achieved by embolization of the extradural component only. Case presentation A 35-year-old woman presented with acute worsening of back pain, weakness in the left leg and urinary retention. Spinal angiography showed a metameric spinal cord AVM with partial common venous drainage of the extradural and intradural components. Conclusions Targeted embolization of the extradural component led to dramatic improvement of the patient’s symptoms, probably by achieving venous decongestion. She remains neurologically stable at two years’ follow-up.
Balloon-assisted coiling of cerebral aneurysms with the dual-lumen Scepter XC balloon catheter: Experience at two high-volume centers
Authors: Wallace Adam N , Samaniego Edgar , Kayan Yasha , Derdeyn Colin P , Delgado Almandoz Josser E , Dandapat Sudeepta , Fease Jennifer L , Thomas Mary , Milner Anna M , Scholz Jill M , Ortega-Gutiérrez Santiago 
Published: March 2019

Background The Scepter XC is a dual-lumen balloon catheter that accommodates a 0.014-inch microwire and can be used for balloon-assisted coiling of cerebral aneurysms. We describe our experience with the use of this device. Methods Two high-volume institution neurointerventional databases were retrospectively reviewed for cerebral aneurysms treated with balloon-assisted coiling using the Scepter XC balloon catheter. Patient demographics, aneurysm characteristics, and procedural details were recorded. Major procedure-related neurologic complications were defined as events that caused an increase in modified Rankin Scale that persisted for more than 1 week after the procedure. Follow-up aneurysm occlusion was assessed using the Raymond-Roy classification. Results During the study period, 231 aneurysms were treated in 219 patients (152 women, 67 men) with a mean age of 58.4 ± 12.2 years. Mean aneurysm size was 6.1 ± 3.1 mm, with a mean neck diameter of 3.1 ± 1.3 mm. In total, 77.5% of aneurysms were wide necked, and 39.8% were treated in the setting of subarachnoid hemorrhage. The major complication rate was 0.9% (2/231) per treated aneurysm, including one stroke and one death related to intraoperative aneurysm rupture. Excluding patients who died, angiographic follow up was available for 85.3% (191/224) of aneurysms. During a mean follow up of 17.4 ± 13.0 months (range, 1.7–66.5 months), Raymond-Roy 1 and 2 occlusion rates were 56.5% (108/191) and 35.6% (68/191), respectively. The retreatment rate was 12.6% (24/191). Conclusion Our experience using the coaxial dual-lumen Scepter XC for balloon-assisted coiling demonstrates acceptable aneurysm occlusion and complication rates.
Globalization of clinical trials: Variation in estimated regional costs of pivotal trials, 2015–2016
Authors: Qiao Yao , Alexander G Caleb , Moore Thomas J 
Published: March 2019

Background/Aims Despite the increasing globalization of clinical trials, little is known regarding how the trial site costs vary around the world. We quantified the geographical distribution and regional cost differences for the clinical trials that established the benefits for new therapeutic drugs approved by the US Food and Drug Administration in 2015 and 2016. Methods We included all pivotal clinical trials for 59 new molecular entities approved by the US Food and Drug Administration in 2015 and 2016 that included at least one site in North America. We derived cost estimates from IQVIA’s CostPro, a global clinical trial cost-estimating tool used by pharmaceutical sponsors. We assessed the patient and site allocation of these trials across eight geographic regions. To quantify the region-specific cost differences, we conducted a within-trial comparison by expressing the estimated regional costs associated with the sites in each global region as a percent of the same costs in North America. We also estimated the percentage breakdown of regional cost components (pass-through, site management, regulatory, and study conduct costs) for each trial and for all endpoints reported the median and interquartile range. Results Overall, 127 pivotal clinical trials enrolled 91,415 patients from 13,264 sites. Most patients (60.3%) and sites (57.3%) were outside North America. A median of 66% of the total estimated trial costs (interquartile range: 60%–72%) were spent on regional tasks, with the largest share (53.3%) going directly to trial sites and the remainder going to other regional trial management tasks. Differences were greatest in four lower cost regions: Africa, with an estimated regional cost per site of 49% of North America (interquartile range: 44%–56%), Central Europe 50% (interquartile range: 41%–63%), Middle East 53% (interquartile range: 42%–64%) and Latin America 59% (interquartile range: 50%–70%). Overall, 90 (71%) of the 127 pivotal trials had a total of 3160 sites in these lower cost regions. In contrast, savings were more limited in Western Europe, Oceania, and Asia, where estimated regional costs were 78% of North America (interquartile range: 67%–89%). One-quarter of the trials with sites in Asia and Oceana did not achieve cost savings in those regions relative to North America. Conclusion Among this sample of pivotal trials for recently approved US Food and Drug Administration products, most patients and sites enrolled were outside of North America, with selection of regional sites having a significant impact on total trial costs.
The randomized study of endovascular therapy with versus without intravenous tissue plasminogen activator in acute stroke with ICA and M1 occlusion (SKIP study)
Authors: Suzuki Kentaro , Kimura Kazumi , Takeuchi Masataka , Morimoto Masafumi , Kanazawa Ryuzaburo , Kamiya Yuki , Shigeta Keigo , Ishii Norihiro , Takayama Yohei , Koguchi Yorio , Takigawa Tomoji , Hayakawa Mikito , Ota Takahiro , Okubo Seiji , Naito Hiromichi , Akaji Kazunori , Kato Noriyuki , Inoue Masato , Hirano Teruyuki , Miki Kazunori , Ueda Toshihiro , Iguchi Yasuyuki , Fujimoto Shigeru , Otsuka Toshiaki , Matsumaru Yuji 
Published: March 2019

Rationale Bridging therapy with endovascular therapy (EVT) and intravenous thrombolysis (IVT) has been reported to improve outcomes for acute stroke patients with large-vessel occlusion in the anterior circulation. While the IVT may increase the reperfusion rate, the risk of hemorrhagic complications increases. Whether EVT without IVT (direct EVT) is equally effective as bridging therapy in acute stroke remains unclear. Aim This randomized study of endovascular therapy with versus without intravenous tissue plasminogen activator for acute stroke with ICA and M1 occlusion aims to clarify the efficacy and safety of direct EVT compared with bridging therapy. Methods and design This is an investigator-initiated, multicenter, prospective, randomized, open-treatment, blinded-endpoint clinical trial. The target patient number is 200, comprising 100 patients receiving direct EVT and 100 receiving bridging therapy. Study outcome The primary efficacy endpoint is a modified Rankin Scale score of 0–2 at 90 days. Safety outcome measures are any intracranial hemorrhage at 24 h. Discussion This trial may help determine whether direct EVT should be recommended as a routine clinical strategy for ischemic stroke patients within 4.5 h from onset. Direct EVT would then become the choice of therapy in stroke centers with endovascular facilities. Trial registration UMIN000021488.
The potential risk of tumor progression after use of dehydrated human amnion/chorion membrane allograft in a positive margin resection model
Authors: Alvim Ricardo G. , Hughes Christopher , Somma Alexander , Nagar Karan K. , Wong Nathan C. , La Rosa Stephen , Monette Sebastien , Kim Kwanghee , Coleman Jonathan A. 
Published: March 2019

Objective: The objective of this study was to examine the impact of dehydrated human amnion/chorion membrane (dHACM) allografts on prostate and bladder cancer growth in the setting of residual disease and positive surgical margins. Materials and methods: A commercially available version of dHACM was used. Cytokines were identified and quantified, followed by comparative analysis of cell growth in two different human cell lines: prostate cancer (LNCaP) and bladder cancer (UM-UC-3), in vitro and in vivo. Tumor growth between the two groups, membrane versus no membrane implant, was compared and immunohistochemistry studies were conducted to quantify CD-31, Ki-67, and vimentin. A Student’s unpaired t-test was used to determine statistical significance. Results: The UM-UC-3 and LNCaP cells grew quicker in medium plus 10% serum and dHACM extract than in the other media ( p = 0.03). A total of 28 distinct cytokines were found in the extract, 11 of which had relatively high concentrations and are associated with prostate and bladder cancer tumor progression. In vivo LNCaP model, after 10 weeks, the median tumor volume in the membrane group was almost threefold larger than the partial resection alone ( p = 0.01). Two weeks after resection, in the UM-UC-3 model, the membrane group reached fourfold larger than the partial resection without membrane group ( p < 0.01). In both groups, the expression of CD-31 and Ki-67 markers were similar and showed no statistical significance ( p > 0.05). It was only in the LNCaP tumors that vimentin expression was significantly higher in the group without membrane compared with the membrane group ( p = 0.008). Conclusion: The use of dHACM after partial tumor resection is related to faster tumor relapse and growth in prostate and urothelial cancer in vivo models, showing a potential risk of rapid local recurrence in patients at high risk of positive margins.
The treatment of achalasia patients with esophageal varices: an international study
Authors: Pesce M , Magee C , Holloway RH , Gyawali CP , Roman S , Pioche M , Savarino E , Quader F , Sarnelli G , Sanagapalli S , Bredenoord AJ , Sweis R 
Published: March 2019

BackgroundTreatment options for achalasia include endoscopic and surgical techniques that carry the risk of esophageal bleeding and perforation. The rare coexistence of esophageal varices has only been anecdotally described and treatment is presumed to carry additional risk.MethodsExperience from physicians/surgeons treating this rare combination of disorders was sought through the International Manometry Working Group.ResultsFourteen patients with achalasia and varices from seven international centers were collected (mean age 61 ± 9 years). Five patients were treated with botulinum toxin injections (BTI), four had dilation, three received peroral endoscopic myotomy (POEM), one had POEM then dilation, and one patient underwent BTI followed by Heller's myotomy. Variceal eradication preceded achalasia treatment in three patients. All patients experienced a significant symptomatic improvement (median Eckardt score 7 vs 1; p < 0.0001) at 6 months follow‐up, with treatment outcomes resembling those of 20 non‐cirrhotic achalasia patients who underwent similar therapy. No patients had recorded complications of bleeding or perforation.ConclusionThis study shows an excellent short‐term symptomatic response in patients with esophageal achalasia and varices and demonstrates that the therapeutic outcomes and complications, other than transient encephalopathy in both patients who had a portosystemic shunt, did not differ to disease‐matched patients without varices.
Recurrence rate of hepatocellular carcinoma in patients with treated hepatocellular carcinoma and hepatitis C virus‐associated cirrhosis after ombitasvir/paritaprevir/ritonavir+dasabuvir+ribavirin therapy
Authors: Preda Carmen M , Baicus Cristian , Sandra Irina , Oproiu Alexandru , Manuc Teodora , Constantinescu Ileana , Gavrila Daniel , Diculescu Mircea , Dumitru Radu , Vasilescu Catalin , Tieranu Cristian , Istratescu Doina , Voiosu Theodor , Manuc Mircea 
Published: March 2019

IntroductionRecent studies have suggested a higher recurrence rate of hepatocellular carcinoma (HCC) in patients with a history of HCC and hepatitis C virus (HCV)‐associated cirrhosis treated with direct‐acting antiviral (DAA) agents.Material and methodsWe conducted a prospective analysis of 24 patients with HCV‐associated cirrhosis and treated HCC who received ombitasvir/paritaprevir/ritonavir+dasabuvir+ribavirin for 12 weeks. Prior therapies for HCC included resection (9/24 patients), radiofrequency ablation (RFA) (7/24) and trans‐arterial chemoembolization (TACE) (8/24). All patients were eligible for treatment if they had no HCC recurrence 6 months after their last procedure. A control group was defined. All patients were followed every 6 months, with dynamic computed tomography and/or magnetic resonance imaging.ResultsThe sustained virological response rate per protocol was 21/24 (87.5%). The study group included 14 (59%) males, median age 64 years (51–77), 50% with associated non‐alcoholic steatohepatitis and 24% with Child–Pugh A6 points. HCC recurrence rate/100 patient‐years was lower in the DAA‐HCC group versus control: 5.5 versus 24.6% patient‐years for the resection+RFA group (p = 0.044), respectively, and 18.6 versus 72.7% patient‐years for TACE group (p = 0.002). Survival without recurrence was higher in the resection+RFA group (45 compared to 18 months (p < 0.001)) and also in the TACE group (44 compared to 11.5 months (p = 0.002)).ConclusionsDAA therapy significantly reduced the recurrence rate of HCC and improved survival without recurrence in patients with treated HCV‐associated HCC.
Exploring changes in processing speed and intraindividual variability in youth following sports-related concussion
Authors: Green Stephanie L , Keightley Michelle L , Lobaugh Nancy J , Dawson Deirdre R , Mihailidis Alex 
Published: March 2019

Background Concussion represents a growing concern in sports participation for adults and youth alike. Studies exploring the neurocognitive sequelae of concussion, such as speed of processing typically compare mean reaction time scores to a control group. Intraindividual variability measures the consistency of reaction times between trials and has been previously explored in adults post-concussion. Some adult studies show increased variability following injury. Developmentally youth show higher intraindividual variability than adults, which may put them at higher risk of increased intraindividual variability change post-concussion. Exploring intraindividual variability may provide additional insight into fluctuating performance reported following injury. Despite preliminary findings of slowed reaction time in youth, a pre-/post-concussion comparison of intraindividual variability of reaction time has not been explored. Objective To describe and compare pre- and post-concussion measures of processing speed and intraindividual variability in youth. Methods A pre-/post-concussion design was used to compare mean reaction time and the coefficient of variation before and after sports-related concussion in 18 youth athletes aged 10–14 years using verbal and nonverbal working memory tasks. Pre-/post-concussion reaction time and coefficient of variation were compared using t-tests. Results The coefficient of variation for nonverbal working memory was significantly higher following concussion, but no changes in average reaction time were found. Conclusions Preliminary findings suggest that average response times are unchanged following concussion, but the fluctuation across response times is more variable during a nonverbal working memory task in youth. Increased variability in speed of reaction times could have implications for safe return to sports and reduced academic performance.
PEDIATRIC PATIENTS WITH FAI AND INFLAMMATORY COMORBIDITIES HAVE A CHARACTERISTIC CAM DEFORMITY: A PILOT STUDY
Authors: Carsen Sasha 
Published: March 2019

Background: Pediatric patients with inflammatory conditions often present with single or multifocal joint pain. Assessment of these patients at our institution revealed a possible association between femoroacetabular impingement (FAI) and inflammatory comorbidities. The purpose of this study was to investigate the prevalence and unique characteristic morphology of FAI in pediatric patients with inflammatory comorbidities. Methodology: A retrospective review was conducted on a consecutive series of 105 patients diagnosed with FAI in our institution’s adolescent hip clinic from January 2016 to March 2018. Patients with an inflammatory comorbidity were identified. Femoral head-neck junction morphology was assessed qualitatively and with standard radiographic measures for FAI. Results: Seven patients (6.7% of diagnosed patients), with eight symptomatic hips, were found to have FAI and an inflammatory comorbidity. These diagnoses included Crohn’s disease, Celiac disease, juvenile idiopathic arthritis, Type 1 diabetes mellitus and hypothyroidism. All seven patients had cam deformities. Qualitative assessment revealed that most patients had a characteristic head-neck morphology that was unique to this subset of patients, with a prominent and “sharp-edged” bump at the head-neck junction (See Figure 1). Radiographic analysis of the symptomatic hips revealed a mean alpha angle of 81.3o (±8.7 o), mean LCEA of 33.1o (±8.4 o) and mean femoral offset of 0.07 (±0.05). There was no significant difference in the radiographic measurements between symptomatic and asymptomatic hips in these patients. Conclusion: This is the first study to identify an association between FAI and inflammatory comorbidities in pediatric patients, with a prevalence of 6.7% at our institution. Given the relative rarity of inflammatory comorbidities in the general pediatric patient, this represents an unexpectedly high association. These patients presented with a unique head-neck morphology characterized by a more prominent and “sharp-edged” cam lesion than the typical morphology seen in patients without an inflammatory comorbidity. This study raises questions regarding the possible role of physeal inflammation in the development of cam deformities and indicates a need for further studies investigating the relationship between systemic inflammatory disorders and FAI. [Figure: see text]
DO ALTERATIONS IN PELVIC ROTATION ON THE FALSE PROFILE RADIOGRAPH EFFECT THE APPARENT AIIS MORPHOLOGY?
Authors: Khan Adam Z. , Putnam Sara , Minaie Arya , Clohisy John , Nepple Jeffrey J. 
Published: March 2019

Background: Prominence of the anterior inferior iliac spine (AIIS) may contribute to femoroacetabular impingement (FAI). Identification and classification of these morphologic variants are important to evaluation and treatment of symptomatic impingement. A standard hip radiographic series including false profile radiographs are commonly used for assessment of AIIS morphology, despite 3D-CT imaging being the gold standard. Yet, obtaining the accurate degree of rotation necessary for precise false profile radiographs in the office is difficult, often leaving the clinician to interpret radiographs with non-standard pelvic rotation. The purpose of this study is to investigate the effects of pelvic rotation of false profile radiographs on perceived AIIS morphology. Methods: Fifteen cadaveric hips (8 pelvises: 4 male, 4 females; 68-92 years of age) without evidence of prior surgery or osteoarthritis were obtained. Samples were fixed to a custom jig in neutral pelvic tilt and rotation. An AP pelvis and radiographic images from 450 to 850 of rotation at 50 intervals were taken, with 650 designated as a true false profile view. A single grader identified the morphology of the AIIS deformities on false profile views as well as measurement of the AIIS offset of each cadaver in 5 degree increments of rotation from 45 to 85 degrees (65 degree true false profile). Interobserver and intraobserver reliability was assessed in a random subset of 20 views. Paired t-test was used to evaluate significance of AIIS offset at varying degrees of pelvic rotation. Results: Significant increases (p < 0.05) in measured AIIS offset were observed with each subsequent increase of 50 of pelvic rotation (greater AIIS offset seen with increased pelvic rotation towards lateral). Mean AIIS offset values for each 50 of rotation are shown in Figure 1. Figure 2 shows examples of observed differences in AIIS offset at both extremes of rotation relative to a true false profile. There was strong inter- and intra-observer reliability for AIIS offset (0.920 and 0.965), especially compared to measured femoral head diameter (0.657 and 0.779). Conclusion: Significant variation in measurement of AIIS offset on false profile radiographs was observed based on degree of pelvic rotation. Increased prominence of AIIS (decreased AIIS offset) was noted with decreased pelvic rotation (away from true lateral view). These findings stress the importance of clinician caution and close attention to pelvic positioning with radiographic evaluation of AIIS prominence.