32 research outputs found

    Phase III study of pasireotide long-acting release in patients with metastatic neuroendocrine tumors and carcinoid symptoms refractory to available somatostatin analogues

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    In a randomized, double-blind, Phase III study, we compared pasireotide long-acting release (pasireotide LAR) with octreotide long-acting repeatable (octreotide LAR) in managing carcinoid symptoms refractory to first-generation somatostatin analogues. Adults with carcinoid tumors of the digestive tract were randomly assigned (1:1) to receive pasireotide LAR (60 mg) or octreotide LAR (40 mg) every 28 days. Primary outcome was symptom control based on frequency of bowel movements and flushing episodes. Objective tumor response was a secondary outcome. Progression-free survival (PFS) was calculated in a post hoc analysis. Adverse events were recorded. At the time of a planned interim analysis, the data monitoring committee recommended halting the study because of a low predictive probability of showing superiority of pasireotide over octreotide for symptom control (n=43 pasireotide LAR, 20.9%; n=45 octreotide LAR, 26.7%; odds ratio, 0.73; 95% confidence interval [CI], 0.27–1.97; P=0.53). Tumor control rate at month 6 was 62.7% with pasireotide and 46.2% with octreotide (odds ratio, 1.96; 95% CI, 0.89–4.32; P=0.09). Median (95% CI) PFS was 11.8 months (11.0 – not reached) with pasireotide versus 6.8 months (5.6 – not reached) with octreotide (hazard ratio, 0.46; 95% CI, 0.20–0.98; P=0.045). The most frequent drug-related adverse events (pasireotide vs octreotide) included hyperglycemia (28.3% vs 5.3%), fatigue (11.3% vs 3.5%), and nausea (9.4% vs 0%). We conclude that, among patients with carcinoid symptoms refractory to available somatostatin analogues, similar proportions of patients receiving pasireotide LAR or octreotide LAR achieved symptom control at month 6. Pasireotide LAR showed a trend toward higher tumor control rate at month 6, although it was statistically not significant, and was associated with a longer PFS than octreotide LAR

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    Not AvailableHeavy mortality in cage farmed cobia in the southeast coast of Tamil Nadu occurred during the summer of 2016 was investigated. About 60 per cent of the fish died following a few days of high temperature and low wind in the coastal region. The fish had an average size of 27.5 cm length and 200 g weight. The affected fish had focal erythematous lesions on the ventral distended abdomen, peritoneal serosanguinous fluid accumulation, splenomegaly and swollen kidney. Bacteriological examination of the peritoneal fluid, kidney and spleen revealed the presence of Gram negative short rods in large numbers. The bacteria grew as green colonies on thiosulphate citrate bile salt sucrose agar. The tissues were also screened for the presence of nervous necrosis nodavirus by PCR and cell culture but did not yield positive result. The bacterial strains isolated from the tissues were identified as Photobacterium damselae sub sp. damselae using API 20 E microbial identification kit. The species was confirmed by multiplex PCR for 16S rRNA and urease gene. Sequence analysis of 16S rRNA showed 99 per cent homogeneity with P. damselae subsp. damselae. One of the isolates was used for the pathogenicity study in sea bass fingerlings. The experimental infection was done by intraperitoneal administration of 50 micro liters of two dilutions of the culture at 4.2 ×10 raised to the power 5 and 4.2×103 cfu per fish. The experiment revealed that the bacteria were highly pathogenic to seabass and could induce 100 per cent mortality in 36 h. The same bacteria were re-isolated from kidney sample of moribund fish and were confirmed as Pdd with API test kits and 16S rRNA sequencing. The isolates were also screened for the presence of virulence genes.Not Availabl

    Performance investigation of ZnO/PVA nanocomposite film for organic solar cell

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    Organic solar cells are gaining popularity in the field of photovoltaics due to their solution processability, flexibility, low temperature fabrication, ease of integration, and environmental friendliness. Despite these characteristics, its energy conversion efficiency is still lower than other solar cells. It is therefore inevita- ble that the focus will be on improving the efficiency of organic solar cells. With this in mind, we have tried to improve its efficiency by developing and integrating ZnO/PVA nanocomposite film. The nano films were created using a solution casting method with varying concentrations of ZnO nanoparticles in a PVA matrix. Each nanocomposite sample was tested individually with the organic solar cell. Significant changes are observed in the efficiency of organic solar cells before and after applying the ZnO/PVA nanocomposite film. The film with an optimum weight percentage of 14.25% (ZnO) and 85.75% (PVA matrix) shows significant efficiency enhancement when applied to organic solar cells having an architecture of [Carbon Fiber)/(ZnO/Epoxy Resin)/(CuO/Epoxy Resin)/Carbon Fiber]. The optimum effi- ciency of solar cell before and after applying the nanocomposite film was found to be 10.07% and 13.57% respectively. The increase in efficiency of organic solar cells showed that the ZnO/PVA nanocomposite film possesses significant potential to be applied on organic solar cells for its efficiency enhancement. The solution casting method has been discovered to be a cost-effective and hassle-free method for devel- oping nanocomposite films. Low temperature processing and good conductivity of ZnO/PVA nanocom- posite film makes it a suitable candidate for potential application in organic solar cells. ! 2021 Elsevier Ltd. All rights reserved

    Renal function trajectories and clinical outcomes in acute heart failure

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    Background—Prior studies have demonstrated adverse risk associated with baseline and worsening renal function in acute heart failure, but none has modeled the trajectories of change in renal function and their impact on outcomes. Methods and Results—We used linear mixed models of serial measurements of blood urea nitrogen and creatinine to describe trajectories of renal function in 1962 patients with acute heart failure and renal dysfunction enrolled in the Placebo-Controlled Randomized Study of the Selective A1 Adenosine Receptor Antagonist Rolofylline for Patients Hospitalized with Acute Decompensated Heart Failure and Volume Overload to Assess Treatment Effect on Congestion and Renal Function study. We assessed risk of 180-day mortality and 60-day cardiovascular or renal readmission and used Cox regression to determine association between renal trajectories and outcomes. Compared with patients alive at 180 days, patients who died were older, had lower blood pressure and ejection fraction, and higher creatinine levels at baseline. On average for the entire cohort, creatinine rose from days 1 to 3 and increased further after discharge, with the trajectory dependent on the day of discharge. Blood urea nitrogen, creatinine, and the rate of change in creatinine from baseline were the strongest independent predictors of 180-day mortality and 60-day readmission, whereas the rate of change of blood urea nitrogen from baseline was not predictive of outcomes. Baseline blood urea nitrogen >35 mg/dL and increase in creatinine >0.1 mg/dL per day increased the risk of mortality, whereas stable or decreasing creatinine was associated with reduced risk. Conclusions—Patients with acute heart failure and renal dysfunction demonstrate variable rise and fall in renal indices during and immediately after hospitalization. Risk of morbidity and mortality can be predicted based on baseline renal function and creatinine trajectory during the first 7 days. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00328692 and NCT00354458

    Radiation-Induced Fibrosis: Mechanisms and Opportunities to Mitigate. Report of an NCI Workshop,

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    A workshop entitled "Radiation-Induced Fibrosis: Mechanisms and Opportunities to Mitigate" (held in Rockville, MD, September 19, 2016) was organized by the Radiation Research Program and Radiation Oncology Branch of the Center for Cancer Research (CCR) of the National Cancer Institute (NCI), to identify critical research areas and directions that will advance the understanding of radiation-induced fibrosis (RIF) and accelerate the development of strategies to mitigate or treat it. Experts in radiation biology, radiation oncology and related fields met to identify and prioritize the key areas for future research and clinical translation. The consensus was that several known and newly identified targets can prevent or mitigate RIF in pre-clinical models. Further, basic and translational research and focused clinical trials are needed to identify optimal agents and strategies for therapeutic use. It was felt that optimally designed preclinical models are needed to better study biomarkers that predict for development of RIF, as well as to understand when effective therapies need to be initiated in relationship to manifestation of injury. Integrating appropriate endpoints and defining efficacy in clinical trials testing treatment of RIF were felt to be critical to demonstrating efficacy. The objective of this meeting report is to (a) highlight the significance of RIF in a global context, (b) summarize recent advances in our understanding of mechanisms of RIF, (c) discuss opportunities for pharmacological mitigation, intervention and modulation of specific molecular pathways, (d) consider the design of optimal clinical trials for mitigation and treatment and (e) outline key regulatory nonprescriptive frameworks for approval
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