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1907 citation(s) found for "Györi, Georg".

Trigeminal Nerve Schwannoma of the Cerebellopontine Angle
Peris‐Celda, Maria , Graffeo, Christopher S. , Perry, Avital , Link, Michael J. , Carlstrom, Lucas P.

Journal of Neurological Surgery Part B: Skull Base | September 25, 2018 | Volume: 79 | Issue: S 05 | Pages: S389-S390

10.1055/s-0038-1669966 | PMID 30456035 Get It

Introduction Large and even moderate sized, extra-axial cerebellopontine angle (CPA) tumors may fill this restricted space and distort the regional anatomy. It may be difficult to determine even with high resolution magnetic resonance imaging (MRI) if the tumor is dural-based, or what the nerve of origin is if a schwannoma. While clinical history and exam are helpful, they are not unequivocal, particularly since many patients present with a myriad of symptoms, or conversely an incidental finding. We present an atypical appearing, asymptomatic CPA tumor, ultimately identified at surgery to be a trigeminal schwannoma. Case History A 40-year-old man presented with new-onset seizure. MRI identified an incidental heterogeneously contrast-enhancing CPA lesion (Fig. 1A–D). The tumor was centered on the internal auditory canal (IAC) with no tumor extension into Meckel's cave, IAC or jugular foramen. Audiometry demonstrated 10db of relative left-sided hearing loss with 100% word recognition. Physical examination was negative for focal neurologic deficits. A retrosigmoid craniotomy was performed and an extra-axial, yellow-hued mass was encountered and resected, which was ultimately confirmed to originate from the trigeminal nerve (Video 1). Gross total resection was achieved, and the patient recovered from surgery with partial ipsilateral trigeminal sensory loss and no other new neurologic deficits. Conclusion Pure CPA trigeminal schwannomas are rare, but should be considered in the differential for enhancing CPA lesions. Although, Meckel's cave involvement is frequently observed, it is not universal, and pure CPA schwannomas of all cranial nerves IV–XII have been reported in the literature.The link to the video can be found at: https://youtu.be/AlodYCu70F8.
Scapholunate Ligament Internal Brace 360 Tenodesis (SLITT) Procedure: A Biomechanical Study
Greene, Ryan M. , Denbeigh, Janet M. , Wijnen, André J. van , Denbeigh, Janet, van Wijnen, Andre, van Wijnen, Andre J , Kakar, Sanjeev

Journal of Wrist Surgery | September 18, 2018 | Volume: 08 | Issue: 03 | Pages: 250-254

10.1055/s-0038-1670682 | PMID 31192049 Get It

Background Twelve paired fresh frozen cadaveric wrists were randomized to a 360-degree tenodesis repair group or the 360-degree tenodesis repair with an internal brace (suture tape) construct. Case Description The specimens were preloaded to 5 N and subsequently biomechanically loaded to failure, at a rate of 0.1 mm/s on a jig that allowed for axial load. The maximum load and mode of failure were recorded. Load to failure in the 360 tenodesis group with internal brace was 283.47 ± 100.25 N, compared with the 360 tenodesis group only, whose yield strength was 143.61 ± 90.54 N. The mode of failure within the internal brace construct was either through knot slippage, graft disruption, or bone separation from strength testing construct. The 360 tenodesis group tended to fail via graft slippage or graft rupture. Literature Review The management of scapholunate instability can be a difficult problem to treat. Traditionally, many of the surgical reconstructions have focused upon dorsal ligament reconstruction with Kirschner (K) wire fixation. This results in prolonged immobilization of the wrist with varied outcomes, in part due to the multiaxial instability that may persist due to concomitant volar ligament disruption. To address this instability, surgical techniques have been devised that address both the volar and dorsal ligament injuries. Clinical Relevance Scapholunate reconstruction with a 360-degree tenodesis and internal brace augmentation (SLITT procedure) provided superior biomechanical stability than tenodesis alone.
Emergency Physicians' Perceived Influence of EHR Use on Clinical Workflow and Performance Metrics
Denton, Courtney A., Soni, Hiral , Kannampallil, Thomas , Serrichio, Anna, Shapiro, Jason S. , Traub, Stephen J., Patel, Vimla Lodhia

Applied Clinical Informatics | September 12, 2018 | Volume: 09 | Issue: 03 | Pages: 725-733

10.1055/s-0038-1668553 | PMID 30208497 Get It

Objective Over the last decade, electronic health records (EHRs) have shaped clinical practice. In this article, we investigated the perceived effects of EHR use on clinical workflow and meaningful use (MU) performance metrics. Materials and Methods Semistructured interviews were conducted with 20 (n = 20) physicians at two urban emergency departments. Interview questions focused on time spent on EHR use, changes in clinical practices with EHR use, and the effect of MU performance metrics on clinical workflow. Qualitative coding using grounded theory and descriptive analyses were performed to provide descriptive insights. Results Physicians reported that EHRs improved their clinical workflow, especially on MU-related activities including door-to-doctor time and admit decision time. EHR use also affected physicians work efficiency, quality of care provided, and overall patient safety. Conclusion Physicians' perception of EHRs is likely to influence their practices. With negative perceptions of EHR usability problems, positive aspects of EHR use, including the influence on MU performance metrics, may be overridden.
Cochlear Implantation: An Overview
Deep, Nicholas L. , Dowling, Eric M. , Jethanamest, Daniel , Carlson, Matthew L. , Dowling, Eric

Journal of Neurological Surgery Part B: Skull Base | September 6, 2018 | Volume: 80 | Issue: 02 | Pages: 169-177

10.1055/s-0038-1669411 | PMID 30931225 Get It

AbstractA cochlear implant (CI) is a surgically implanted device for the treatment of severe to profound sensorineural hearing loss in children and adults. It works by transducing acoustic energy into an electrical signal, which is used to stimulate surviving spiral ganglion cells of the auditory nerve. The past 2 decades have witnessed an exponential rise in the number of CI surgeries performed. Continual developments in programming strategies, device design, and minimally traumatic surgical technique have demonstrated the safety and efficacy of CI surgery. As a result, candidacy guidelines have expanded to include both pre and postlingually deaf children as young as 1 year of age, and those with greater degrees of residual hearing. A growing proportion of patients are undergoing CI for off-label or nontraditional indications including single-sided deafness, retrocochlear hearing loss, asymmetrical sensorineural hearing loss (SNHL) in adults and children with at least 1 ear that is better than performance cut-off for age, and children less than 12 months of age. Herein, we review CI design, clinical evaluation, indications, operative technique, and outcomes. We also discuss the expanding indications for CI surgery as it relates to lateral skull base pathology, comparing CI to auditory brainstem implants, and address the concerns with obtaining magnetic resonance imaging (MRI) in CI recipients.
Biomechanical Evaluation of Suture Anchor versus Transosseous Tunnel Patellar Tendon Repair Techniques
Sherman, Seth L. , Black, Brandee S., Mooberry, Matthew A., Freeman, Katie L., Gulbrandsen, Trevor R. , Milles, Jeffrey L., Evans, Laura , Flood, David, Mooberry, Matthew, Evans, Laura, Pfeiffer, Ferris M.

The Journal of Knee Surgery | September 6, 2018 | Volume: 32 | Issue: 08 | Pages: 825-832

10.1055/s-0038-1669790 | PMID 30189438 Get It

Abstract The objective of this study is to compare the cyclic loading strength and ultimate failure load in suture anchor repair versus transosseous tunnel repair of patellar tendons using a cadaver model. Twelve cadaveric patella specimens were used (six matched pairs). Dual-energy X-ray absorptiometry (DXA) measurements were performed to ensure equal bone quality among groups. All right knees were assigned to the suture anchor repair group (n = 6), whereas all left knees were assigned to the transosseous bone tunnel group (n = 6). Suture type and repair configuration were equivalent. After the respective procedures were performed, each patella was mounted into a gripping jig. Tensile load was applied at a rate of 1 Hz between magnitudes of 50 and 150 N, 50 and 200 N, 50 and 250 N, and tensile load at a rate of 0.1 mm/s until failure. Failure was defined as a sharp deviation in the linear load versus displacement curve, and failure mode was recorded. DXA measurements demonstrated equivalence of bone quality between the two groups (p > 0.05). During cyclic load testing, there was only a statistically significant difference between the groups with regard to cyclic loading at the 50 to 200 N loading cycle (p = 0.010). There was no statistically significant difference between the groups with regard to ultimate load to failure (p = 0.43). Failure mode within the suture anchor cohort occurred through anchor pullout except for one, which failed through the tendon. All specimens within the transosseous cohort failed through the midsubstance of the tendon except for one, which failed through suture breakage. Suture anchor repair demonstrated a similar biomechanical profile regarding cyclic loading and ultimate load to failure when compared with “gold standard” transosseous tunnel patellar tendon repair with a trend toward less gapping in the suture anchor group. Using suture anchors for repair of the patella tendon has similar biomechanical properties to transpatellar tunnels but may provide other clinical advantages.
Phase 1b/3 study of avelumab-based combination regimens in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).
Chen, Robert W., Ansell, Stephen M. , Vacirca, Jeffrey, López‐Guillermo, Armando , Hutchings, Martin , Offner, Fritz , Santoro, Armando , Salles, Gilles , Stypinski, Daria, Laird, Douglas, Pavlov, Dmitri, Andreola, Giovanna, Fly, Kolette D., Woolfson, Adrian , Salles, Gilles A , Santoro, Armando , Zinzani, Pier Luigi , Jurczak, Wojciech , Heß, Georg , Gouill, Steven Le , Collins, Graham P.

Journal of Clinical Oncology | September 6, 2018 | Volume: 35 | Issue: 15_suppl | Pages: TPS7575-TPS7575

10.1200/jco.2017.35.15_suppl.tps7575 Get It

TPS7575 Background: Approximately 50% of patients (pts) with advanced DLBCL are refractory to or relapse following first line R-CHOP therapy. Pts with R/R DLBCL have limited treatment options and a poor prognosis. This study assesses immunotherapy-based regimens containing avelumab (a fully human IgG1 anti–PD-L1 antibody) in combination with utomilumab (a novel 4-1BB agonist), azacitidine, rituximab, and/or conventional chemotherapy (CT; bendamustine) in pts with R/R DLBCL. Methods: JAVELIN DLBCL (NCT02951156) is a global, multicenter, randomized, open-label, 2-component(phase 1b followed by phase 3) study of avelumab-based combination regimens in R/R DLBCL. In phase 1b, up to 84 pts will be randomized 1:1:1 to receive avelumab/rituximab/utomilumab, or avelumab/azacitidine/utomilumab, or avelumab/rituximab/bendamustine. The primary phase 1b objectives are preliminary assessments of dose-limiting toxicities (n = 6 per arm) and efficacy (objective response [OR]; n = 28 per arm). One regimen from phase 1b will be selected for phase 3 evaluation in 220 additional pts randomized 1:1 to the chosen regimen or investigator’s choice CT (rituximab/bendamustine or rituximab/gemcitabine/oxaliplatin). The primary phase 3 objective is to demonstrate progression-free survival (PFS) superiority of the avelumab-based regimen over CT. Overall survival is a key secondary endpoint. Eligible pts have completed up to 4 lines of prior rituximab/multiagent CT, and/or have failed autologous stem cell transplantation (ASCT), or are not eligible for intensive CT or ASCT. Other eligibility criteria include ECOG PS ≤1 and no prior therapy with a checkpoint inhibitor. Treatment with avelumab, utomilumab, and azacitidine will be continued until the pt no longer receives clinical benefit; rituximab and bendamustine are limited to 8 and 6 cycles, respectively. OR and PFS will be assessed per Lugano disease classification criteria. Other secondary efficacy endpoints include disease control, duration of response, time to response, and minimal residual disease burden. Safety, PK, immunogenicity, pt-reported outcomes, and biomarkers will also be evaluated. Clinical trial information: NCT02951156.
B-MIND: MOR208 plus bendamustine (BEN) versus rituximab (RTX) plus BEN in patients with relapsed or refractory (R-R) diffuse large B-cell lymphoma (DLBCL): An open-label, randomized phase II/III trial.
Nowakowski, Grzegorz S. , Molina, Lysianne, Kopečková, Kateřina , Laribi, Kamel , García, R. del Campo, Coiffier, Bertrand , Rummel, Mathias , Rosenwald, Andreas , Winderlich, Mark, Korolkiewicz, Roman , Belada, David , Laribi, Kamel , Jurczak, Wojciech , Heß, Georg , Zinzani, Pier Luigi

Journal of Clinical Oncology | September 6, 2018 | Volume: 35 | Issue: 15_suppl | Pages: TPS7571-TPS7571

10.1200/jco.2017.35.15_suppl.tps7571 Get It

TPS7571 Background: Patients ineligible for stem cell transplantation (SCT) or who relapse after SCT, and those who fail to respond to second-line or salvage chemotherapy, represent an unmet medical need for which new therapeutic strategies are required. MOR208 is a novel Fc-enhanced, humanized, monoclonal antibody directed against CD19. Significant single-agent activity of MOR208 in patients with R-R DLBCL (Jurczak et al., J Clin Oncol 34, 2016 [suppl; abstr 7545]) and enhancement of MOR208-mediated cytotoxicity by BEN in preclinical studies, provide a strong rationale to study MOR208 + BEN in patients with R-R DLBCL. Methods: B-MIND is a randomized (1:1), two-arm, multicenter, open-label, adaptive design, phase II/III study of MOR208 + BEN vs RTX + BEN in adult patients with histologically confirmed DLBCL who have relapsed after or are refractory to 1 to 3 prior lines of therapy and who are not candidates for high-dose chemotherapy and autologous SCT. At least 1 prior therapy line must have included a CD20-targeted therapy. Other key inclusion criteria: age ≥18 years; measurable disease; availability of tumor tissue for central pathology review; ECOG 0–2, and adequate major organ systems function. Key exclusion criteria: primary refractory DLBCL; central nervous system involvement, and known double/triple hit DLBCL genetics. The safety of the combination will be assessed in an initial phase II evaluation. Treatment will comprise 6 cycles of MOR208 (12 mg/kg IV) + BEN (90 mg/m2 IV) or RTX 375 mg/m2 IV + BEN. Patients achieving a response after cycle 6 will continue to receive antibody treatment for up to 18 additional cycles. Primary endpoint: progression-free survival (PFS); secondary endpoints include: best overall response, overall survival, safety, quality of life, immunogenicity and pharmacokinetics. Enrollment of 330 patients is anticipated in Europe, US and Asia-Pacific countries. Fourteen patients have been randomized to date. Clinical trial information: NCT02763319.
Maternal Obesity Affects Cardiac Remodeling and Recovery in Women with Peripartum Cardiomyopathy
Davis, Esa M. , Ewald, Gregory A. , Givertz, Michael M. , Rajagopalan, Navin , Cooper, Leslie T. , Felker, G. Michael , Bozkurt, Biykem , Hanley‐Yanez, Karen , Halder, Indrani, McTiernan, Charles F. , McNamara, Dennis M. , Investigators, on behalf of the IPAC, Kleet, Audrey , Cooper, Leslie T , Briller, Joan Ellen , Drazner, Mark H. , Investigators, on behalf of the IPAC

American Journal of Perinatology | September 5, 2018 | Volume: 36 | Issue: 05 | Pages: 476-483

10.1055/s-0038-1669439 | PMID 30184556 Get It

Objective To examine the association between maternal obesity on left ventricular (LV) size and recovery in women with peripartum cardiomyopathy (PPCM). Study Design This was a prospective analysis of 100 women enrolled within 13 weeks of PPCM diagnosis and followed for a year in the Investigation of Pregnancy Associated Cardiomyopathy study. Adiposity was defined by standard body mass index (BMI) definitions for under/normal weight, overweight, and obesity. Demographic, clinical, and biomarker variables were compared across weight categories. Outcomes LV end-diastolic diameter (LVEDD) and ejection fraction were measured at entry, 6, and 12 months postpartum. Multivariable regression models examined the relationship between adiposity, LV size, and leptin levels with cardiac recovery at 6 and 12 months postpartum. Results Obese and nonobese women had similar LV dysfunction at entry. Obese women had greater LV size and less LV recovery at 6 and 12 months postpartum. BMI was positively associated with leptin and ventricular diameter. Greater BMI at entry remained associated with less ventricular recovery at 6 months (p = 0.02) in adjusted race-stratified models. LVEDD at entry predicted lower ejection fraction at 6 months (p < 0.001) and similarly at 12 months. Conclusion Obese women with PPCM had greater cardiac remodeling, higher leptin levels, and diminished cardiac recovery.
Evaluation of genotoxicity related to oral methylene blue chromoendoscopy
Repici, Alessandro , Ciscato, Camilla , Wallace, Michael B. , Anderloni, Andrea , Carrara, Silvia , Leo, Milena Di , Hassan, Cesare , Hassan, Cesare , Wallace, Michael B , Sharma, Prateek

Endoscopy | August 29, 2018 | Volume: 50 | Issue: 10 | Pages: 1027-1032

10.1055/a-0630-1004 | PMID 29906809 Get It

Abstract Background An oral formulation of methylene blue with colonic delivery (MB-MMX) has been developed to increase detection of colorectal polys during colonoscopy. Traditionally, there have been safety concerns regarding DNA damage when methylene blue is exposed to white light. The aim of this study was to evaluate DNA damage in colonic mucosa after MB-MMX chromoendoscopy. Methods This was an open-label phase II safety study to assess for genotoxicity on colorectal biopsies of patients undergoing two sequential colonoscopies before and after an oral dose of 200 mg MB-MMX added to their bowel prep. Analysis of a biomarker of double-stranded DNA breaks, γH2AX, was performed on biopsy specimens. Results Ten patients were included in the study. The mean expression of γH2AX ± 95 % confidence intervals of the 50 biopsies before and after MB-MMX administration were 0.58 ± 0.08 and 0.62 ± 0.09, respectively (P = 0.24). None of the analyzed samples showed excess positive γH2AX expression, confirming the absence of DNA damage on biopsies after methylene blue exposure. No deaths or serious adverse events occurred. Conclusions An oral dose of 200 mg of MB-MMX did not result in any detectable DNA damage.
The Turnover in Normal Dogs of Prothrombin and Its Fragments; Effect of Induced Intravascular Coagulation
Owen, Charles A., Mann, Kenneth G. , McDuffie, Frederic C.

Thrombosis and Haemostasis | August 23, 2018 | Volume: 42 | Issue: 02 | Pages: 548-555

10.1055/s-0038-1666892 Get It

SummaryWhen 125I-labeled canine prothrombin was given to normal adult dogs intravenously, it was calculated that 240% of the plasma prothrombin crossed the capillary barrier per day, 410% of the interstitial prothrombin returned to the blood stream daily, and 79% of the plasmatic prothrombin was catabolized per day. These data are in close agreement with those observed for bovine prothrombin in calves by Takeda (1970).When derived from normal dog prothrombin, prethrombin-1 is a mixture of 2 polypeptides, one larger than the other, and both present in about equal amounts. The longer peptide, “prethrombin-1-long,” was catabolized twice as fast as prothrombin, and the shorter, “prethrombin-1-short,” 4 times faster. Prothrombin fragment-1 was catabolized by the normal dog still more rapidly.The catabolism of prothrombin was not accelerated in 3 dogs receiving continuous infusions of a thromboplastic emulsion of dog brain. Nor was the level of prothrombin in their plasma remarkably altered.