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"Voskanyan, A"
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Long-Term Safety and Efficacy Evaluation of Travoprost Intracameral Implant Based on Pooled Analyses from Two Phase III Trials
by
Ang, Robert E.
,
Shen, Yannan
,
Berdahl, John P.
in
Adult
,
Aged
,
Antihypertensive Agents - administration & dosage
2024
Aim
The purpose of this study was to conduct and interpret a pooled 12-month analysis of two prospective, multi-center, randomized, double-masked, controlled trials designed to assess the efficacy and safety of the travoprost intracameral implant (slow-eluting [SE] implant in development as a new therapeutic and fast-eluting [FE] implant included for masking purposes) in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Methods
Subjects with OAG or OHT, on 0–3 intraocular pressure (IOP)-lowering medications, baseline unmedicated mean diurnal IOP of ≥ 21 mmHg, and IOP ≤ 36 mmHg at each baseline diurnal timepoint, received either a travoprost implant and twice-daily (BID) placebo eye drops or BID timolol 0.5% eye drops and a sham procedure. Subjects were followed through 12 months and assessed for IOP, reduction in topical IOP-lowering medications, and safety parameters including treatment-emergent adverse events (TEAEs). IOP at 8AM was prospectively collected at all study visits through 12 months and diurnal IOP, measured at 8AM, 10AM, and 4PM, was prospectively collected at baseline, day 10, week 6, and months 3 and 12.
Results
A total of 1150 subjects were randomized (385 FE implant, 380 SE implant, and 385 sham/timolol) across the two trials. Statistical non-inferiority to timolol and clinically relevant reductions in 8AM IOPs were demonstrated at month 12. In more detail, both implant groups demonstrated statistical non-inferiority to timolol and clinically relevant reductions from baseline in mean diurnal IOP at all visits over the 12-month evaluation period when diurnal IOP was collected. Additionally, both implant groups demonstrated robust treatment effect based on 8AM average IOP from day 10 through the specified visit which ranged from day 10 to month 12 from 6.9 to 8.5 mmHg in the FE implant group; 6.8 to 8.5 mmHg in the SE implant group; and 7.3 to 7.5 mmHg in the sham/timolol group. With regards to reduction in topical pharmacotherapy, at month 12, 77.6% of FE and 81.4% of SE implant eyes were completely free of all topical IOP-lowering medications and a significantly greater proportion of FE and SE implant eyes (89.9% and 93.0%) versus sham/timolol eyes (66.9%) were on the
same or fewer
topical IOP-lowering medications compared with pre-study (
p
< 0.0001). Furthermore, of subjects on topical IOP medications at screening, a significantly greater proportion of FE implant (80.2%) and SE implant (85.1%) eyes versus sham/timolol (22.8%) eyes were on
fewer
topical IOP-lowering medications at month 12 compared with pre-study (
p
< 0.0001). Lastly, of SE implant eyes on
same or fewer
topical IOP-lowering medications at month 12, the average through month 12 decreased by 0.9 medications, and of those SE implant eyes on
fewer
topical IOP-lowering medications compared with pre-study, the average through month 12 decreased by 1.4 medications. The most common TEAEs related to study treatment were hyperemia (conjunctival or ocular), iritis, and IOP increased.
Conclusion
The travoprost intracameral implant demonstrated robust IOP-lowering efficacy that was sustained and statistically non-inferior to timolol over the entire 12 months, resulting in a significant reduction in topical IOP-lowering medication use, with the majority of SE implant eyes remaining completely free of all topical IOP-lowering medications. In addition, the implant demonstrated a favorable safety and tolerability profile based on this pooled 12-month analysis of two pivotal trials.
Trial Registration
ClinicalTrials.gov identifiers NCT03519386 (registered May 09, 2018) and NCT03868124 (registered March 08, 2019).
Journal Article
Synthesis of ZnFe2O4 Nanospheres with Tunable Morphology for Lithium Storage
by
Tolstopjatova, Elena G.
,
Voskanyan, Lusine A.
,
Volkov, Filipp S.
in
anode materials
,
Anodes
,
Composite materials
2023
ZnFe2O4 (ZFO) nanospheres with complex structures have been synthesized by a one-step simple solvothermal method using two different types of precursors—metal chlorides and nitrates —and were fully characterized by XRD, SEM, XPS, and EDS. The ZFO nanospheres synthesized from chloride salts (ZFO_C) were loose with a size range of 100–200 nm, while the ZFO nanospheres synthesized from nitrate salts (ZFO_N) were dense with a size range of 300–500 nm but consisted of smaller nanoplates. The different morphologies may be caused by the different hydrolysis rates and different stabilizing effects of chloride and nitrate ions interacting with the facets of forming nanoparticles. Electrochemical tests of nitrate-based ZFO nanospheres as anode materials for lithium-ion batteries demonstrated their higher cyclic stability. The ZFO_C and ZFO_N samples have initial specific discharge/charge capacities of 1354/1020 and 1357/954 mAh∙g−1, respectively, with coulombic efficiencies of 75% and 71%. By the 100th cycle, ZFO_N has a capacity of 276 mAh∙g−1, and for ZFO_C, only 210 mAh∙g−1 remains after 100 cycles.
Journal Article
The impact of climate change on the forest ecosystems of Krasnodar Region
by
Kuznetsova, Yu.S.
,
Khekert, E.V.
,
Shkoda, V.V.
in
Anthropogenic factors
,
Climate change
,
Environmental impact
2024
Modern anthropogenic warming changes all climatic characteristics: temperature, precipitation, cloudiness, duration of snow cover, etc.The article analyzes the impact of global climate change on the forest ecosystems of Krasnodar region. The conclusion about the moderately negative contribution of the climatic factor to the forecast dynamics of forestry is substantiated.
Journal Article
Safety and efficacy of travoprost intracameral implant administered in combination with cataract surgery
2025
Background:
The travoprost intracameral implant and cataract surgery both lower intraocular pressure (IOP).
Objectives:
We evaluated the safety and IOP-lowering effect at 3 months following administration of travoprost intracameral implant in combination with cataract surgery.
Design:
Prospective, 12-month, open-label, single-arm trial.
Methods:
We enrolled patients with age-related cataracts and open-angle glaucoma or ocular hypertension in the same eye. At baseline, patients were required to have an unmedicated mean diurnal IOP (average of 8:00 am, 10:00 am, and 4:00 pm IOPs) of 24 mmHg or greater, and an IOP of 36 mmHg or less at each of these three timepoints. On the day of the combined procedure (day 1), patients who had uncomplicated phacoemulsification cataract surgery received a travoprost intracameral implant. Follow-up evaluations occurred on day 2–3, week 2, week 6, and month 3 visits.
Results:
Sixty patients had uncomplicated cataract surgery and received a travoprost intracameral implant. There were no serious adverse events. Study eye adverse events were reported in 8.3% of patients. The most frequently reported adverse event was dry eye (6.7%). At month 3, the mean diurnal IOP change from baseline was −10.6 mmHg (95% confidence interval: −11.2, −9.9; p < 0.0001) from an unmedicated baseline mean diurnal IOP of 25.2 mmHg. In addition, at month 3, 97% of eyes had a 20% or greater mean diurnal IOP reduction from baseline, and 91.0% of eyes had a mean diurnal IOP of 18 mmHg or less.
Conclusion:
Administration of a travoprost intracameral implant combined with routine cataract surgery was safe. The sizable −10.6 mmHg IOP change from baseline at month 3 was both statistically significant and clinically relevant.
Trial registration:
NCT06061718, Travoprost Intraocular Implant in Conjunction with Cataract Surgery, https://clinicaltrials.gov/study/NCT06061718.
Plain language summary
Study assessing the safety and the intraocular pressure lowering effect of administering a travoprost intracameral implant in combination with having cataract surgery in patients with open-angle glaucoma or ocular hypertension
Why was the study done? The travoprost intracameral implant is a drug delivery system that is placed directly in the eye to continuously release travoprost to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Cataract surgery also is known to lower intraocular pressure in normal eyes and to a greater extent in eyes with glaucoma or ocular hypertension. Placement of the implant in the anterior chamber angle of the eye and cataract surgery are both done through a small corneal incision. What did the researchers do? The researchers studied the safety and the reduction in intraocular pressure after administering a travoprost intracameral implant during the same procedure as removal of the cataractous lens and administration of an intraocular lens. Sixty patients with open-angle glaucoma had the combined procedure and were followed over a 3-month period to check their intraocular pressure and health of their eye.
What did the researchers find? There were no serious safety findings after the combined procedure, with less than 10% of patients having any ocular side effect. The most common side effect was dry eye. At month 3, mean intraocular pressure was reduced significantly from the untreated baseline pressure measured before the combined procedure. What do the findings mean? The study showed that it is safe to combine the placement of the travoprost intracameral implant in the eye during the same procedure as routine cataract surgery. The study also showed that there was a substantial lowering of intraocular pressure at 3 months in patients with open-angle glaucoma.
Journal Article
Ways to reduce harmful emissions from the operation of power plants in special environmental control areas
2021
The article examines the specifics of operating power plants in special environmental control areas, following the restrictions of the International Maritime Organization introduced in 2020. It focuses on innovative technologies such as the use of low-sulphur fuels, the implementation of SCR technology, the development of new logistical solutions and the use of new fuels. The method for controlling the emission of sulphur oxides into the atmosphere from power plants must be an integrated one, combining primary and secondary measures. Primary activities include purification of fuel from pollutants - improvement of fuel quality (enrichment of feedstock, use of alternative fuels); suppression of formation of harmful substances during combustion by improving fossil fuel combustion processes (by improving furnace designs, technological methods and regime measures, organization of mixture formation and combustion processes, improvement of fuel injection system). Secondary measures include technologies for capturing pollutants from flue gases, including methods designed for coarse and fine flue gas cleaning (flue gas recirculation, catalytic flue gas cleaning, wet methods, dry methods, absorbers for the cleaning of combustion products of sulphur oxides, cyclone-foam apparatus). The solution to the pollution of the World ocean, and in particular the special environmental control zones, by sulphur emissions from diesel engines primarily depends on the development of highly effective technologies to reduce its concentration at the diesel plant outlet.
Journal Article
Analyzing and Assessing Key Factors for High Rates of Economic Growth in Armenia in 2022–2023: Myth and Reality
by
Voskanyan, M. A
,
Sandoyan, E. M
,
Galstyan, A. G
in
Economic factors
,
Economic growth
,
Endogenous
2024
Abstract—This article is devoted to the analysis and assessment of the factors in economic growth in Armenia over the past two years and revising approaches to macroeconomic regulation in order to ensure sustainable economic growth in the long term. This study made it possible to identify the main reasons for economic growth in Armenia over 2022–2023 in terms of exogenous impact under the new geopolitical reality. The key conclusion of the study was the premise about the short-term nature of the double-digit growth in the last two years, which is more due to external factors, and the need to focus on the endogenous factors of economic growth in the long term.
Journal Article
Control by the accuracy of the results of studies for the cadmium content in samples applying the microwave laboratory system PLP-01M
by
Mikhaylova, T M
,
Rebezov, M B
,
Tretyak, L N
in
Absorption spectroscopy
,
Atomic absorption analysis
,
Cadmium
2021
The article states that in order to compare the results obtained while operating on the atomic absorption spectrometer \"Kvant-2AT\" applying the microwave laboratory system PLP-01M and during the sample preparation in accordance with GOST 26929 \"Raw materials and food products. Sample preparation. Mineralization to determine the content of toxic elements\", on operating samples, the products were selected that most fully cover the range of results obtained during the research. Some research results and data analysis were carried out within 30 operating days. The data were obtained while working on the Kvant-2AT atomic absorption spectrometer, taking into account the application of the PLP-01M microwave laboratory system and while the sample preparation in accordance with GOST 26929. The average values obtained under repeatability conditions were put in the table. The analyte cadmium was supplemented to assess the accuracy of the obtained values. The implementation of sample preparation methods taking into account the microwave decomposition of the sample in the case of using the microwave laboratory system PLP-01M and while sample preparation in accordance with GOST 26929-94 achieves the precision of the analysis results both under conditions of repeatability and under conditions of intermediate precision.
Journal Article
Assessment of imatinib as first-line treatment of chronic myeloid leukemia: 10-year survival results of the randomized CML study IV and impact of non-CML determinants
by
Beelen, D W
,
Gassmann, W
,
Lauseker, M
in
692/308/2779/777
,
692/699/1541/1990/283/1896
,
692/699/67/1059/99
2017
Chronic myeloid leukemia (CML)-study IV was designed to explore whether treatment with imatinib (IM) at 400 mg/day (
n
=400) could be optimized by doubling the dose (
n
=420), adding interferon (IFN) (
n
=430) or cytarabine (
n
=158) or using IM after IFN-failure (
n
=128). From July 2002 to March 2012, 1551 newly diagnosed patients in chronic phase were randomized into a 5-arm study. The study was powered to detect a survival difference of 5% at 5 years. After a median observation time of 9.5 years, 10-year overall survival was 82%, 10-year progression-free survival was 80% and 10-year relative survival was 92%. Survival between IM400 mg and any experimental arm was not different. In a multivariate analysis, risk group, major-route chromosomal aberrations, comorbidities, smoking and treatment center (academic vs other) influenced survival significantly, but not any form of treatment optimization. Patients reaching the molecular response milestones at 3, 6 and 12 months had a significant survival advantage. For responders, monotherapy with IM400 mg provides a close to normal life expectancy independent of the time to response. Survival is more determined by patients’ and disease factors than by initial treatment selection. Although improvements are also needed for refractory disease, more life-time can currently be gained by carefully addressing non-CML determinants of survival.
Journal Article
W and two-dimensional WO3/W nanocrystals produced by controlled self-sustaining reduction of sodium tungstate
by
Rouvimov, Sergei
,
Manukyan, Khachatur V.
,
Mukasyan, Alexander S.
in
Analysis
,
Applied and Technical Physics
,
Biomaterials
2013
The influence of calcium fluoride (CaF2) on combustion characteristics of Na2WO4 + 3 Mg system and microstructure of the produced W and WO3/W crystals is investigated. The results of thermodynamic analysis and experimental investigations show that CaF2 simultaneously enhances the conversion of Na2WO4 toward tungsten and binds sodium through the formation of NaF phase. The examination of the microstructure of quenched combustion products and differential scanning calorimetry analysis indicate that at early stages of combustion, a part of Na2WO4 is reduced by Mg to tungsten, whereas another part reacts with CaF2 forming CaWO4 and NaF. Subsequent magnesium reduction of CaWO4 significantly increases the overall temperature of the combustion process. Such modification in reaction mechanism coupled with postcombustion processing (e.g., acid/basic treatment) of the product allows us to produce either pure tungsten nanocrystals or tungsten oxide—tungsten nanostructures consisting of two-dimensional WO3 nanoflakes assembled on a W core. It is found that CaF2 does not influence the sizes of tungsten nanocrystals. However, since the addition of CaF2 leads to the increase of overall reaction temperature, it facilitates the formation of W particles with equilibrium crystal shape by faceting process.
Journal Article
Poverty and Uneven Distribution of Income and Wealth: World and Armenia
2020
Today, the world has a sharp contrast, from the world of high technology to the world of starving people. The uneven distribution of income and wealth in the world is observed not only in terms of the global north-south issue, when the capital is concentrated in high-income countries, but also at the level of different segments of the population, and even individuals. On the background of an oversupply of financial resources in the world stock exchanges, we observe a high mortality rate from hunger and diseases in countries with a low level of per capita income. This article is devoted to the analysis and assessment of the problem of poverty and the uneven distribution of income and wealth in the framework of modern realities, as well as the example of the Armenian economy.
Journal Article