57 research outputs found
SAFETY PROFILES OF RANIBIZUMAB IN DIABETIC VERSUS NON-DIABETIC AMD PATIENTS FROM RANDOMISED CONTROLLED TRIALS
No full textOutcomes following three-line vision loss during treatment of neovascular age-related macular degeneration : subgroup analyses from MARINA and ANCHOR
No full textThis study aims to assess the impact of continued ranibizumab treatment for neovascular age-related macular degeneration on patients from the MARINA and ANCHOR randomised clinical studies who lost ? 3 lines of best-corrected visual acuity (BCVA) at any time during the first year of treatment
Natural history of diabetic macular edema and factors predicting outcomes in sham-treated patients (MEAD study)
No full textPurpose: To describe the natural history of diabetic macular edema (DME) with respect to best-corrected visual acuity (BCVA) and central retinal thickness (CRT) outcomes and to identify baseline patient characteristics and systemic factors associated with improvement or worsening of outcomes in sham-treated patients. Methods: The study population was sham-treated patients (n = 350) in the 3-year MEAD registration study of dexamethasone intravitreal implant for treatment of DME. Patients had center-involved DME and received sham intravitreal injections in the study eye at ≥ 6-month intervals. Potential prognostic factors for outcomes were evaluated using multiple linear regression analysis. Results: Visual and anatomic outcomes were poorer in patients who left the study early (n = 198) than in study completers (n = 152). Mean change in BCVA from baseline at the last visit with available data was + 0.9 letters; 37.5% of patients had no change in BCVA, 23.2% had gained > 10 letters, and 16.0% had lost > 10 letters. Older age and baseline diabetic retinopathy score > 6 were associated with worse BCVA outcomes; thicker baseline CRT and larger number of hypertension medications used were associated with larger reductions in CRT during the study. Conclusions: BCVA and CRT outcomes were variable in this population of DME patients with generally good glycemic control. In DME patients without active treatment, older age and baseline diabetic retinopathy score > 6 were associated with less improvement in BCVA; thicker baseline CRT and a larger number of antihypertensive medications used predicted better improvement in CRT. Trial registration: The MEAD study trials are registered at ClinicalTrials.gov with the identifiers NCT00168337 and NCT00168389
Derecho, diferencias y minorías étnicas en la constitución política de 1991
No full textThe first half of this research, along with the support of history and the various social and philosophicaltheories, attempted to reconstruct the way this contemporary world’s issue concerning the difference andminorities’ rights is perceived and interpreted. There are three thematic axes or tensions that serve as atheoretical and conceptual framework: globalization versus localization, modernity versus post modernity,and finally liberalism versus multiculturalism. The second half of this research focuses on exposing how thisdebate has influenced on the theory of law as well as the reception and development that such a problem hashad in Colombia’s regulatory and jurisprudential scope, especially that related to the indigenous minoritiesin Colombia.La primera parte de esta investigación trató de reconstruir, apoyado en la historia y las diversas teorías sociales y filosóficas, la manera como se percibe y se interpreta la problemática en torno a la diferencia y los derechos de las minorías en el mundo contemporáneo. Tres son los ejes temáticos o tensiones que nos sirven de marco teórico y conceptual: globalización versus localización, modernidad versus posmodernidad, y finalmente liberalismo versus multiculturalismo. La segunda parte de esta investigación está orientada a exponer la forma como este debate ha influido en la teoría del derecho y la recepción y el desarrollo que dicha problemática ha tenido en el ámbito normativo y jurisprudencial colombiano, especialmente, en relación a las minorías indígenas colombianas
Three-Year, Randomized, Sham-Controlled Trial of Dexamethasone Intravitreal Implant in Patients with Diabetic Macular Edema
No full textPurpose: To evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex, DEX implant) 0.7 and 0.35 mg in the treatment of patients with diabetic macular edema (DME). Design: Two randomized, multicenter, masked, sham-controlled, phase III clinical trials with identical protocols were conducted. Data were pooled for analysis. Participants: Patients (n = 1048) with DME, best-corrected visual acuity (BCVA) of 20/50 to 20/200 Snellen equivalent, and central retinal thickness (CRT) of >= 300 mu m by optical coherence tomography. Methods: Patients were randomized in a 1:1:1 ratio to study treatment with DEX implant 0.7 mg, DEX implant 0.35 mg, or sham procedure and followed for 3 years (or 39 months for patients treated at month 36) at = 15-letter improvement in BCVA from baseline at study end. Safety measures included adverse events and intraocular pressure (IOP). Results: Mean number of treatments received over 3 years was 4.1, 4.4, and 3.3 with DEX implant 0.7 mg, DEX implant 0.35 mg, and sham, respectively. The percentage of patients with >= 15-letter improvement in BCVA from baseline at study end was greater with DEX implant 0.7 mg (22.2%) and DEX implant 0.35 mg (18.4%) than sham (12.0%; P <= 0.018). Mean average reduction in CRT from baseline was greater with DEX implant 0.7 mg (-111.6 mu m) and DEX implant 0.35 mg (-107.9 mu m) than sham (-41.9 mu m; P < 0.001). Rates of cataract-related adverse events in phakic eyes were 67.9%, 64.1%, and 20.4% in the DEX implant 0.7 mg, DEX implant 0.35 mg, and sham groups, respectively. Increases in IOP were usually controlled with medication or no therapy; only 2 patients (0.6%) in the DEX implant 0.7 mg group and 1 (0.3%) in the DEX implant 0.35 mg group required trabeculectomy. Conclusions: The DEX implant 0.7 mg and 0.35 mg met the primary efficacy endpoint for improvement in BCVA. The safety profile was acceptable and consistent with previous reports. (C) 2014 by the American Academy of Ophthalmology
Additional stresses on buildings induced by vibration effects
No full textAbstractConstruction activities, blasting and traffic are the main sources of ground vibrations that may have a detrimental effect on buildings.The main objective of this research is to study the relationship between additional stresses on building induced by vibrations, vibration nature and building dynamic characteristics.Five numerical models were subjected to base excitation to represent different vibration sources and wave forms. These waves were scaled to the same peak acceleration.Experimental dynamic tests were carried out using five physical models with different characteristics. These models were subjected to different types of vibration. The vibration characteristics were identified and the models top acceleration responses were measured. Moreover, the models maximum stresses were measured due to each vibration load.The relationships between stress increasing, fundamental period and base excitation type were plotted; also the relationship between pseudo acceleration response at the top of the building and the frequency ratio between the model fundamental frequency and the base excitation predominant frequency was also plotted. These relations were analyzed and concluded to tangible results
Requisitos legales y jurisprudenciales para disfrutar del donante de la dotación.
No full textThere are conflicting opinions in jurisprudence and in Iranian legislation about the possibility or refusal to enjoy a donor's endowment. In recent years, the theory of possibility has prevailed, and researchers have been trying to open up ways to use the donor endowment. The beneficial enjoyment of the donor by the object of endowment with the concept of dedication and merely of benefit for others is not so conflicting and the license of use can be maximized. This good establishment of the legal system hashad a positive effect on the attitude of the people toward the endowment. This research explores and explains the jurisprudential and legal aspect of the subject.Hay opiniones contradictorias en la jurisprudencia y en la legislación iraní sobre la posibilidad o la negativa de disfrutar de un donante de la dotación. En los últimos años, la teoría de la posibilidad ha prevalecido, y los investigadores han estado tratando de abrir formas para utilizar al donante de la dotación. El disfrute beneficioso del donante por parte del objeto de dotación con el concepto de dedicación y meramente de beneficio para los demás no es tan conflictivo y la licencia de uso puede maximizarse. Este buen establecimiento del sistema legal ha tenido un efecto positivo en la actitud de la gente hacia la dotación. Esta investigación explora y explica el aspecto jurisprudencial y legal del tema. 
Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema: Subgroup analysis of the MEAD study
No full textBackground: Dexamethasone intravitreal implant 0.7 mg (DEX 0.7) was approved for treatment of diabetic macular edema (DME) after demonstration of its efficacy and safety in the MEAD registration trials. We performed subgroup analysis of MEAD study results to evaluate the efficacy and safety of DEX 0.7 treatment in patients with previously treated DME. Methods: Three-year, randomized, sham-controlled phase 3 study in patients with DME, best-corrected visual acuity (BCVA) of 34.68 Early Treatment Diabetic Retinopathy Study letters (20/200.20/50 Snellen equivalent), and central retinal thickness (CRT) ≥300 μm measured by time-domain optical coherence tomography. Patients were randomized to 1 of 2 doses of DEX (0.7 mg or 0.35 mg), or to sham procedure, with retreatment no more than every 6 months. The primary endpoint was ≥15-letter gain in BCVA at study end. Average change in BCVA and CRT from baseline during the study (area-under-the-curve approach) and adverse events were also evaluated. The present subgroup analysis evaluated outcomes in patients randomized to DEX 0.7 (marketed dose) or sham based on prior treatment for DME at study entry. Results: Baseline characteristics of previously treated DEX 0.7 (n = 247) and sham (n=261) patients were similar. In the previously treated subgroup, mean number of treatments over 3 years was 4.1 for DEX 0.7 and 3.2 for sham, 21.5 % of DEX 0.7 patients versus 11.1 % of sham had ≥15-letter BCVA gain from baseline at study end (P = 0.002), mean average BCVA change from baseline was +3.2 letters with DEX 0.7 versus +1.5 letters with sham (P = 0.024), and mean average CRT change from baseline was -126.1 μm with DEX 0.7 versus -39.0 μm with sham(P < 0.001). Cataract-related adverse events were reported in 70.3 % of baseline phakic patients in the previously treated DEX 0.7 subgroup; vision gains were restored following cataract surgery. Conclusions: DEX 0.7 significantly improved visual and anatomic outcomes in patients with DME previously treated with laser, intravitreal anti-vascular endothelial growth factor, intravitreal triamcinolone acetonide, or a combination of these therapies. The safety profile of DEX 0.7 in previously treated patients was similar to its safety profile in the total study population
Chemoenzymatic surface decoration of Nisin-shelled nanoemulsions: Novel targeted drug-nanocarriers for cancer applications
No full textNisin, a peptide used as a natural food preservative, is employed in this work for the development of a novel nanocarrier system. Stable and uniform nisin-shelled nanoemulsions (NSNE) with a diameter of 100 ± 20 nm were successfully prepared using 20 kHz flow-through ultrasonication technique. The NSNE showed limited toxicity, high bactericidal activity and high drug loading capacity (EE 65 % w/w). In addition, the nisin shell was exploited for the site-specific attachment of a recombinantly produced cancer targeting ligand (αHER2(LPETG) IgG). Employing a unique two phases (bio-click) approach which involved both Sortase A mediated Azide Bioconjugation (SMAB) and Strain Promoted Azide Alkyne Cycloaddition (SPAAC) reactions, targeted NSNE (NSNE(DOX)-αHER2 IgG) were successfully assembled and loaded with the chemotherapeutic drug Doxorubicin (DOX). Finally, NSNE(DOX)-αHER2 IgG showed cancer-specific binding and augmented cytotoxicity to HER2 expressing tumour cells
REFLEXIONS ENTORN DEL SISTEMA ELECTORAL DEL PARLAMENT DE CATALUNYA: EFECTES, PROPOSTES I LÍMITS
No full textThis article examines the particulareffects that the electoral systemapplicable to Catalonia have hashad on the last two elections (in1999 and in 2003). These effects,quite anomalous for a proportionalsystem, meant that the mostvotedpolitical party did not obtain,in turn, the largest numberof Parliamentaing seats. Moreover,these anomalous effects areone of the issues that have openedthe recent political debatefor establishing a new electoralsystem. From this starting point,the author firstly analyzes theconcrete electoral and politicalconsequences derived from thedifferent elements of the electoralsystem with one objective: to pinpointthose elements that couldbe subject to reform. Secondlyand in the light of this previousanalysis, the author presents anddiscusses the different electoralsystem proposals supported bythe main Catalan political parties.He finally provides some generalconclusions about a possible newelectoral system
- …
