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Mesa R.A.,Mayo Medical School | Silver R.T.,Cornell Weill Medical Center | Verstovsek S.,University of Texas M. D. Anderson Cancer Center | Kessler C.M.,Georgetown University | And 3 more authors.
Haematologica | Year: 2013

The myeloproliferative neoplasm, myelofibrosis, is a morbid and frequently fatal illness encompassing primary myelofibrosis, and end-stage essential thrombocythemia and polycythemia. Bevacizumab (15 mg/kg intravenous (i.v.) every 21 days) was tested in a phase II international trial conducted by the Myeloproliferative Disorders Research Consortium. Thirteen patients were enrolled in the first stage of this 2-stage trial. Among the 11 patients who received therapy, only 3 received more than 4 cycles of therapy; none of the patients achieved an objective response. Furthermore, significant toxicity, not directly related to the vascular or gastrointestinal events typically associated with the anti-VEGF monoclonal antibody preparation in other disease states, was observed. Lack of objective responses coupled with toxicity led to the decision to terminate the study early. If future studies incorporate bevacizumab in combination therapy for myelofibrosis, more modest doses should be considered. © 2013 Ferrata Storti Foundation.


Malec J.F.,Indiana University | Beveridge S.,UPMC Mercy Hospital Rehabilitation Institute | Reddy C.C.,UPMC Mercy Hospital Rehabilitation Institute | Huffman T.,Ohio State University | And 2 more authors.
Brain Injury | Year: 2016

Primary objective: To develop and provide initial validation of a measure for accurately determining the need for Constant Visual Observation (CVO) in patients with traumatic brain injury (TBI) admitted to inpatient rehabilitation. Research design: Rating scale development and evaluation through Rasch analysis and assessment of concurrent validity. Methods and procedures: One hundred and thirty-four individuals with moderate–severe TBI were studied in seven inpatient brain rehabilitation units associated with the National Institute for Disability, Independent Living and Rehabilitation Research (NIDILRR) TBI Model System. Participants were rated on the preliminary version of the CVO Needs Assessment scale (CVONA) and, by independent raters, on the Levels of Risk (LoR) and Supervision Rating Scale (SRS) at four time points during inpatient rehabilitation: admission, Days 2–3, Days 5–6 and Days 8–9. Outcomes and results: After pruning misfitting items, the CVONA showed satisfactory internal consistency (Person Reliability = 0.85–0.88) across time points. With reference to the LoR and SRS, low false negative rates (sensitivity > 90%) were associated with moderate-to-high false positive rates (29–56%). Conclusions: The CVONA may be a useful objective metric to complement clinical judgement regarding the need for CVO; however, further prospective study is desirable to further assess its utility in identifying at-risk patients, reducing adverse events and decreasing CVO costs. © 2016 Taylor & Francis Group, LLC


Kawut S.M.,University of Pennsylvania | Bagiella E.,Columbia University | Shimbo D.,Columbia University | Lederer D.J.,Columbia University | And 7 more authors.
Contemporary Clinical Trials | Year: 2011

Background: Pulmonary arterial hypertension (PAH) is a progressive disease which causes exercise limitation, heart failure, and death. Aspirin and simvastatin are highly effective and safe therapies for other cardiovascular diseases characterized by platelet activation and endothelial dysfunction, but have not been formally studied in PAH. Methods: ASA-STAT is a phase II, randomized, double-blind, placebo-controlled 2×2 factorial clinical trial of aspirin and simvastatin in patients with PAH. A total of 92 subjects were to be randomized to aspirin or aspirin placebo and simvastatin or simvastatin placebo. The primary outcome is the distance walked in 6 min at 6 months after randomization. Secondary measures include brachial artery flow-mediated dilation, circulating biomarkers of platelet and endothelial function, functional class, quality-of-life, and time to clinical end points. The incidence of adverse events will be compared between treatment groups. Screening and enrollment: We screened a total of 712 individuals with PAH. Sixty-five subjects were enrolled when the trial was terminated for futility in reaching the primary end point for simvastatin. Conclusions: This study aims to determine whether aspirin or simvastatin have beneficial biologic or clinical effects in patients with PAH. The safety and side effects of these commonly prescribed cardiovascular drugs will also be assessed. © 2010 Elsevier Inc.


Shih G.,Cornell Weill Medical Center | Lakhani P.,University of Pennsylvania | Nagy P.,University of Maryland, Baltimore
Journal of Digital Imaging | Year: 2010

It is clear that ubiquitous mobile computing platforms will be a disruptive technology in the delivery of healthcare in the near future. While radiologists are fairly sedentary, their customers, the referring physicians, and the patients are not. The need for closer collaboration and interaction with referring physicians is seen as a key to maintaining relationships and integrating tightly with the patient management team. While today, patients have to settle for their images on a CD, in short time, they will be taking them home on their cell phone. As PACS vendors are moving ever outward in the enterprise, they are already actively developing clients on mobile platforms. Two major contenders are the Apple's iPhone and the Android platform developed by Google. These two designs represent two entirely different architectures and business models. © 2008 Society for Imaging Informatics in Medicine.


Friedberg J.W.,University of Rochester | Vose J.M.,University of Nebraska Medical Center | Kelly J.L.,University of Rochester | Young F.,University of Rochester | And 10 more authors.
Blood | Year: 2011

Given the significant activity and tolerability of bendamustine, rituximab, and bortezomib in patients with relapsed indolent and mantle cell non-Hodgkin lymphoma, and laboratory studies suggesting synergistic activity, we conducted a multicenter phase 2 study of the bendamustine/bortezomib/rituximab combination. Patients with relapsed or refractory indolent and mantle cell lymphoma with adequate organ function were treated with bendamustine 90 mg/m2 days 1 and 4; rituximab 375 mg/m2 day 1, and bortezomib 1.3 mg/m 2 days 1, 4, 8, 11. Six 28-day cycles were planned. Thirty patients (7 with mantle cell lymphoma) were enrolled and treated. Eight patients experienced serious adverse events, including one event of grade 5 sepsis. Common nonhematologic adverse events were generally grade 1 or grade 2 and included nausea (50%), neuropathy (47%), fatigue (47%), constipation (40%), and fever (40%). Of 29 patients evaluable for efficacy, 24 (83%) achieved an objective response (including 15 with complete response). With median follow-up of 24 months, 2-year progression-free survival is 47% (95% confidence interval, 25%-69%). On the basis of these promising results, the US cooperative groups have initiated randomized trials to evaluate this regimen in follicular and mantle cell lymphoma. This trial was registered at www.clinicaltrials.gov as #NCT00547534. © 2011 by The American Society of Hematology.


Kasari C.,University of California at Los Angeles | Brady N.,University of Kansas | Lord C.,Cornell Weill Medical Center | Tager-Flusberg H.,Boston University
Autism Research | Year: 2013

This paper addresses the issue of assessing communication, language, and associated cognitive and behavioral abilities of minimally verbal children with autism spectrum disorder (ASD), presenting a summary of a year-long series of meetings held by a group of experts in the field of ASD and National Institutes of Health staff. In this paper, our goals were to first define the population and then present general guidelines for optimizing assessment sessions for this challenging population. We then summarize the available measures that can be used across a variety of behavioral domains that are most directly relevant to developing language skills, including oral motor skills, vocal repertoire, receptive and expressive language, imitation, intentional communication, play, social behavior, repetitive and sensory behaviors, and nonverbal cognition. We conclude with a discussion of some of the limitations in the available measures and highlight recommendations for future research in this area. © 2013 International Society for Autism Research, Wiley Periodicals, Inc.


Lapidus K.A.B.,Mount Sinai School of Medicine | Gabbay V.,Mount Sinai School of Medicine | Mao X.,Cornell Weill Medical Center | Johnson A.,Mount Sinai School of Medicine | And 4 more authors.
Neuroscience Letters | Year: 2014

Inflammation and oxidative stress are important mechanisms that have been implicated in the pathophysiology of major depressive disorder (MDD). Glutathione (GSH) is the most abundant antioxidant in human tissue, and a key index of antioxidant capacity and, hence, of oxidative stress. The aims of this investigation were to examine possible relationships between occipital GSH and dimensional measures of depressive symptom severity, including anhedonia - the reduced capacity to experience pleasure - and fatigue. We hypothesized that the magnitude of anhedonia and fatigue will be negatively correlated with occipital GSH levels in subjects with MDD and healthy controls (HC). Data for eleven adults with MDD and ten age- and sex-matched HC subjects were included in this secondary analysis of data from a previously published study. In vivo levels of GSH in a 3cm×3cm×2cm voxel of occipital cortex were obtained by proton magnetic resonance spectroscopy (1H MRS) on a 3T MR system, using the standard J-edited spin-echo difference technique. Anhedonia was assessed by combining interest items from depression and fatigue rating scales, and fatigue by use of the multidimensional fatigue inventory. Across the full sample of participants, anhedonia severity and occipital GSH levels were negatively correlated (r=-0.55, p=0.01). No associations were found between fatigue severity and GSH in this sample. These preliminary findings are potentially consistent with a pathophysiological role for GSH and oxidative stress in anhedonia and MDD. Larger studies in anhedonic depressed patients are indicated. © 2014 Elsevier Ireland Ltd.


PubMed | Cornell Weill Medical Center
Type: Journal Article | Journal: Journal of digital imaging | Year: 2010

It is clear that ubiquitous mobile computing platforms will be a disruptive technology in the delivery of healthcare in the near future. While radiologists are fairly sedentary, their customers, the referring physicians, and the patients are not. The need for closer collaboration and interaction with referring physicians is seen as a key to maintaining relationships and integrating tightly with the patient management team. While today, patients have to settle for their images on a CD, in short time, they will be taking them home on their cell phone. As PACS vendors are moving ever outward in the enterprise, they are already actively developing clients on mobile platforms. Two major contenders are the Apples iPhone and the Android platform developed by Google. These two designs represent two entirely different architectures and business models.

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