Finkl C.W.,Coastal Education and Research Foundation CERF |
Vollmer H.M.,Boca Research
Journal of Coastal Research | Year: 2017
Laser Airborne Depth Sounding (LADS) bathymetric surveys conducted in 2001 and 2008 bracket two hurricane landfalls (Hurricane Ivan in 2004 and Hurricane Katrina in 2005) in Broward County, southeast Florida, thus providing an opportunity to investigate changes in bottom topography as a result of wave and current action. The seafloor in this region is characterized by a wide range of sedimentary features that are normally stabilized (held in place) by outcrops of carbonate bedrock and coral reefs. During high-energy events, however, the sedimentary deposits are partially mobilized by waves and currents. This methodological study used the two LADS bathymetric surveys to construct triangulated irregular networks (TINs, which are a digital means of representing surface morphology) surfaces using the ESRI® ArcGIS 3D Analyst extension. The two bathymetric TIN surfaces were compared to ascertain spatial gains and losses by landform. Comparison of TIN surfaces provides a means to estimate changes in sediment volume and infer variability in cross-shore sediment transport. Application of this methodological procedure is constrained to locations where seafloor features have been interpreted from the LADS bathymetry so that sediment volume changes can be related to specific landform units. © Coastal Education and Research Foundation, Inc. 2017.
Kingsberg S.A.,Boca Research
Menopause | Year: 2017
OBJECTIVE:: TX-004HR is an investigational, muco-adhesive, vaginal, softgel capsule containing low-dose, solubilized, 17β-estradiol designed to treat postmenopausal vulvar and vaginal atrophy (VVA) and improve user experience without an applicator and less mess. METHODS:: As part of the 12-week, placebo-controlled, double-blind, phase 3 REJOICE trial evaluating the efficacy/safety of 4-, 10-, and 25-μg TX-004HR in 764 postmenopausal women with VVA, a five-question product survey was administered. Pearson correlation coefficients were used to evaluate correlations between clinical endpoints (vaginal physiology, dyspareunia, and vaginal dryness) and patient acceptability and satisfaction. RESULTS:: Majority of the women receiving TX-004HR or placebo reported that the product was easy to use (85.4%-92.1%) and rated ease of capsule insertion as “good” to “excellent” (75.0%-82.6%). A significantly greater percentage of women reported being “very satisfied” or “satisfied” with TX-004HR (68.6%-76.3%) than with placebo (56.8%, P?0.05 for all). A greater percentage of women “somewhat” or “very much” preferred TX-004HR over their previous treatment versus those taking placebo (P?0.05). Significantly more women receiving TX-004HR (72.8%-80.5%) versus placebo (62.5%, P?0.05) would “probably” or “definitely” consider using the product again. Dyspareunia and vaginal dryness reductions were correlated with higher product satisfaction and the percentage of women who would consider re-using TX-004HR. CONCLUSIONS:: TX-004HR had a high level of product acceptability, and more women were satisfied with TX-004HR, preferred it over their previous treatment, and would consider using it again versus placebo. Women may find TX-004HR to be a more acceptable product than current options to treat their dyspareunia associated with postmenopausal VVA.This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0 © 2017 by The North American Menopause Society.
Gregory S.A.,Rush University |
Schwartzberg L.S.,The West Clinic |
Mo M.,Amgen Inc. |
Sierra J.,Hospital Of La Santa Creu I Sant Pau |
Vogel C.,Boca Research
Community Oncology | Year: 2010
Bone pain associated with pegfilgrastim has been perceived to occur at higher frequency and with greater severity than bone pain associated with filgrastim. This retrospective study analyzed patient-level data from randomized controlled trials (RCTs) conducted by Amgen to compare bone pain incidence in patients receiving: (1) once-per-chemotherapy-cycle pegfilgrastim (100 μg/kg or 6-mg fixed dose) versus daily filgrastim (5 μg/kg) in seven studies, and (2) once-per-chemotherapy- cycle pegfilgrastim (100 μg/kg or 6 mg) versus no granulocyte colony-stimulating factor (G-CSF) in five studies. An exploratory analysis that included patients who received once-per-chemotherapy-cycle pegfilgrastim (100 μg/kg or 6 mg) in 23 RCTs, non-RCTs, or single-arm interventional trials was also performed. In RCTs that compared pegfilgrastim versus filgrastim, the incidence (95% CI) of any grade and grade 3/4 bone pain was similar in the pegfilgrastim and filgrastim groups for the first four chemotherapy cycles: any grade, 62% (57%, 67%) and 66% (61%, 71%); grade 3/4, 7% (4%, 10%) and 8% (5%, 11%), respectively. In RCTs that compared pegfilgrastim versus no G-CSF, patients receiving pegfilgrastim appeared to have experienced more bone pain of any grade in the first chemotherapy cycle than patients not receiving G-CSF: 33% (30%, 36%) versus 23% (21%, 26%). Grade 3/4 bone pain was infrequently reported in the first cycle for both treatment arms: 3% (2%, 5%) versus 2% (1%, 3%). Results from subgroup analyses suggest that bone pain may be associated with age, tumor type, and chemotherapy regimen. In this retrospective analysis, bone pain associated with pegfilgrastim did not occur at higher frequency or with greater severity than bone pain associated with filgrastim. © 2010 Elsevier Inc.
PubMed | University of Houston, University of Colorado at Denver, Instituto Nacional Of Cancerologia Mexico, Clinical and Translational Oncology Group and 8 more.
Type: | Journal: Clinical lung cancer | Year: 2016
Lung cancer, the deadliest cancer worldwide, is of particular concern in Latin America. The rising incidence poses a myriad of challenges for the region, which struggles with limited resources to meet the health care needs of its low- and middle-income populations. In this environment, we are concerned that governments are relatively unaware of the pressing need to implement effective strategies for screening, diagnosis, and treatment of lung cancer. The region has also been slow in adopting molecularly-based therapies in the treatment of advanced disease: testing for epidermal growth factor receptor mutations and anaplastic lymphoma kinase rearrangements are not routine, and access to targeted agents such as monoclonal antibodies and tyrosine kinase inhibitors is problematic. In this paper, we review the current situation in the management of lung cancer in Latin America, hoping that this initiative will help physicians, patient associations, industry, governments, and other stakeholders better face this epidemic in the near future.
Weinreb N.J.,Boca Research |
Finegold D.N.,Childrens Hospital of Pittsburgh |
Feingold E.,University of Pittsburgh |
Zeng Z.,University of Pittsburgh |
And 3 more authors.
Orphanet Journal of Rare Diseases | Year: 2015
Background: GD1-DS3 is an integrated assessment of type 1 Gaucher disease (GD1) burden based on bone, hematologic and visceral domains. We investigated this disease severity scoring system (DS3) methodology for initial assessment, long-term follow-up and evaluation of treatment responses. Methods: We enrolled 133 treated adult GD1 patients. Baseline DS3 scores were calculated near the initial treatment date and patients stratified by severity as marked (DS3 6.00-19.00), moderate (DS3 3.00-5.99), mild (DS3 < 3.00). Follow-up scores were calculated annually. Minimal clinically important improvement (MCII), is defined as ΔDS3 of -3.1. Results: Patient characteristics: N370S was the most common allele (118 patients had at least one), 52 were N370S/N370S (48/52 were Ashkenazi Jews), N370S/L444P was the most common genotype among non-Jews. Median age of treatment: 45 years; median follow-up: 14 years. Baseline DS3 scores: Patients with marked disease (N = 58; median 7.84) were least likely to be N370S homozygous (19 %) and most likely to have had splenectomy (53 %), early age at diagnosis (median 18 years) and major pre-treatment bone pathology (76 %). Among patients with moderate disease (N = 53; median 4.33), 49 % were N370S/N370S, 15.1 % had splenectomy and 17 % had major bone disease. Median age at diagnosis: 32 years. No patient with mild disease (N = 22; median 2.4) had splenectomy or major skeletal disease. Median age at diagnosis: 40 years. 68 % were N370S homozygous. Response to treatment: Health-state transitions occurred primarily during the early treatment years. At Year 5, among 48 evaluable patients with marked baseline disease, eight were unchanged in severity status whereas 40 had MCII of varying degrees with 11 scored as mild. Among 42 evaluable moderate patients, none worsened, 16 remained moderate and 26 improved to mild. Among 16 evaluable mild patients, 14 remained so and 2 had DS3 scores in the low moderate range. Conclusions: DS3 is effective for assessing disease burden in GD1 and for monitoring response. ERT was associated with MCII in DS3 scores in patients with high severity. Nevertheless, despite better DS3 scores with treatment, GD1 patients especially those with splenectomy and pre-treatment bone pathology, continued to have bone complications. © 2015 Weinreb et al.
Weinreb N.J.,Boca Research |
Weinreb N.J.,University of Miami |
Lee R.E.,University of Pittsburgh
Critical Reviews in Oncogenesis | Year: 2013
Patients with type 1 Gaucher disease (GD1) have increased risk of developing myeloma, other hematological cancers, hepatocellular carcinoma, and other solid tumors. Patient awareness of the GD1-cancer association causes anxiety and fear. Little is known about cancer as a cause of death in GD1, especially in patients never treated with GD1-specific therapies. Consequently, the effect of treatment on cancer mortality in GD1 patients is difficult to evaluate. In this review, starting with a population of 184 GD1 cases never treated, we annotate and analyze the causes of death of 57 GD1 patients who died of cancer. The proportional mortality ratio (PMR) for all malignancies in patients with GD1 is 1.57 (p=0.0002), but it is much higher for myeloma (PMR = 9.66) and other hematological cancers, hepatocellular carcinoma, and kidney cancer (PMR = ~4). However, deaths from colorectal and pancreatic cancers were not more frequent than expected, and deaths from lung, breast, gynecological, and prostate cancer occurred less than anticipated. Herein, we discuss whether GD1 is truly a hereditary cancer syndrome and the problem of comorbidities and cancer risk assessment, and we speculate as to whether the variability in death by cancer type might be attributable to biochemical sequelae of tumor cell and macrophage/stromal cell GBA1 mutation affecting signals for metastasis, the process most closely associated with cancer mortality. © 2013 by Begell House, Inc.
Rendon M.I.,Boca Research |
Rendon M.I.,University of Miami |
Cardona L.M.,Boca Research |
Pinzon-Plazas M.,Boca Research
Journal of Cosmetic and Laser Therapy | Year: 2010
We report the use of injectable poly-l-lactic acid (PLLA) for volume restoration in a 45-year-old white female who was concerned about the appearance of her hands. The patient expressed a desire for long-term restoration, and selected injectable PLLA because of its known 2-year duration of effect, although she was informed that injectable PLLA is not FDA-approved for use in the hands. After reconstitution with 8 ml of diluent plus lidocaine, 0.10.2-ml aliquots of injectable PLLA were injected into selected sites, up to 5 ml per hand. The patient underwent three identical treatments, followed by postinjection use of moisturizing cream and massage; improvement in appearance was noted by the patient between the second and third treatments. Correction was maintained for at least 18 months, with no adverse events. We have also briefly reviewed the literature on the use of injectable PLLA for volume restoration in the hand. © 2010 Informa UK, Ltd.
Rendon M.I.,Boca Research |
Rendon M.I.,University of Miami
Journal of Cosmetic Dermatology | Year: 2012
Background Facial rejuvenation techniques have evolved in recent decades driven by a paradigm shift to restoration of lost volume, and an increase in the number of available products. As clinical experience has increased, practitioners have further refined the use of these products. Objectives To share observations and practical recommendations based on clinical experience with the aesthetic use of injectable poly-l-lactic acid (PLLA) in patients followed for up to 5years. Methods Literature review and retrospective case history review of the first 100 patients treated with injectable PLLA, many of whom have been followed for over 5years. Results Use of injectable PLLA, alone or in combination with other products, has provided excellent and long-lasting (up to 5years) aesthetic results for most of the reviewed patients. Typically, patients have received one or two touch-up sessions between years 2 and 4 after initial full correction. There were minimal adverse events of papule formation; these eventually resolved. Conclusions Injectable PLLA is a safe and effective option for achieving long-term patient satisfaction with soft-tissue augmentation. © 2012 Wiley Periodicals, Inc.
Dakic I.,Florida Atlantic University |
Stevanovic J.,Boca Research |
Stevanovic A.,Florida Atlantic University
IEEE Conference on Intelligent Transportation Systems, Proceedings, ITSC | Year: 2015
Traffic signal control is one of the most common means of traffic management in urban areas. To create an efficient urban transportation network, the optimization of signal control strategy is required. Various methods and tools can be used for that purpose. This study proposes two signal control algorithms that are based on backpressure model, which is originally developed to maximize the throughput in communication networks. Thus, one of the goals was to determine if such control strategies can lead to maximum throughput through an urban traffic network. In addition, the evaluation of the two algorithms included comparison of their performances with the performances of the conventional signal control strategies in microsimulation software. Evaluation results, in terms of various performance measures, demonstrate that backpressure control models are outperformed by conventional (fixed and actuated) signal timings optimized by a genetic algorithm. © 2015 IEEE.