MO387CLINICAL PERFORMANCE, HEMOCOMPATIBILITY AND SAFETY OF A NEW DIALYZER WITH A MODIFIED POLYSULFONE MEMBRANE

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Manuela Kempkes-Koch ◽  
Manuela Stauss-Grabo ◽  
Ansgar Erlenkötter ◽  
Lena Rauber ◽  
James Kennedy ◽  
...  
Keyword(s):  
Removal Rate ◽  
Area Under The Curve ◽  
Side Surface ◽  
Good Tolerability ◽  
Polysulfone Membrane ◽  
Adequate Treatment ◽  
Middle Molecules ◽  
Comparable Performance ◽  
The Difference ◽  
Carry Over

Abstract Background and Aims Hemodialyzers containing membranes made from a blend of polysulfone and polyvinylpyrrolidone (PVP) are widely used. PVP makes the membrane material more hydrophilic to reduce interactions with plasma proteins and platelets. A modified spinning technique has been established to stabilize the PVP on the blood-side surface in the polysulfone dialysis membrane in the new dialyzer FX CorAL 600. The objective of the present study was to prove for this new dialyzer non-inferiority of performance in comparison to established dialyzers. Further, hemocompatibility and safety of the dialyzers were explored. Method In a multicenter, prospective, randomized, crossover study adult patients on online hemodiafiltration (HDF) were enrolled. They were treated for one week each with on-line HDF in post-dilution mode, and in randomized order with the dialyzers FX CorAL 600, FX 600, and FX CorDiax 600 (all Fresenius Medical Care, Bad Homburg, Germany). Blood samples were taken on the midweek session before start, at the end to analyze removal rate and at 60 min to determine clearance of ß2-microglobulin, myoglobin, urea, creatinine and phosphate. Further a pattern of hemocompatibility parameters and safety was evaluated. Assuming no carry over effect, linear mixed models were used for statistical analysis. Results The mean age of the 49 enrolled patients was 66.3±13.6 years, 76% were male. Treatments were performed in post-dilution mode with a mean blood flow > 300 mL/min and a substitution volume >19 L. The removal rate of ß2-microglobulin was 74.4, 70.4, and 73.1% for the FX CorAL 600, FX 600, and FX CorDiax 600 dialyzer, respectively. FX CorAL 600 proved to be statistically significantly non-inferior to FX 600 (p=0.0006) and to FX CorDiax 600 (p=0.036). The removal rate of FX CorAL 600 was by 4.0% (confidence interval 0.4 – 7.5%) significantly higher than with FX 600. The difference to FX CorDiax 600 was not significant. The clearance of ß2-microglobulin and myoglobin and the removal rate of myoglobin were significantly higher with the new dialyzer FX CorAL 600 than with the FX 600, and comparable to the FX CorDiax 600. Performance for small molecules was similar for all dialyzers. The complement factors C3a and C5a increased early in the treatment with a peak at 15 min, without differences between the three dialyzers for C3a, and for C5a with significantly lower increase at 15 min with FX CorAL 600 than for FX 600 (p=0.007); the difference of increase between FX CorAL 600 and FX CorDiax 600 was not significant (p=0.515). The course of sC5b9 was similar for all three dialyzers, with significantly lower increase at 15 min for both FX CorAL 600 (p=0.009) and FX CorDiax 600 (p=0.026) as compared to FX 600 and similar increase at 60 min for both FX CorAL 600 (p=0.573) and FX CorDiax 600 (p=0.386) as compared to FX 600. The area-under-the-curve for the course of sC5b-9 with FX CorAL 600 was significantly lower than with FX 600 (p=0.044) and comparable to FX CorDiax 600 (p=0.092). The leukocyte count showed a decrease in the first 15 min of the treatment, which recovered afterwards, similarly for all treatment phases with the different dialyzers. Further, the dialyzers did not differ with respect to adverse events. Conclusion All three dialyzers showed good performance, with higher removal rates for middle molecules with the new dialyzer FX CorAL 600 compared to the FX 600. Hemocompatibility profiles were mostly similar, with lower activation of C5a and of sC5b9 with FX CorAL 600 compared to FX 600. The new dialyzer provides comparable performance levels capable of delivering adequate treatment and good tolerability for the patient.

Development and Validation of Spectrophotometric and Liquid Chromatographic Methods for Estimation of Tigecycline in Injections

2020 ◽  
Vol 13 (5) ◽  
pp. 5148-5154
Author(s):  
Sagar Suman Panda ◽  
Ravi Kumar B.V.V.
Keyword(s):  
Area Under The Curve ◽  
Reversed Phase ◽  
Equal Concentration ◽  
Pharmaceutical Dosage Form ◽  
Liquid Chromatographic Method ◽  
Array Detection ◽  
The Difference ◽  
The One ◽  
Development And Validation ◽  
Liquid Chromatographic

Three new analytical methods were optimized and validated for the estimation of tigecycline (TGN) in its injection formulation. A difference UV spectroscopic, an area under the curve (AUC), and an ultrafast liquid chromatographic (UFLC) method were optimized for this purpose. The difference spectrophotometric method relied on the measurement of amplitude when equal concentration solutions of TGN in HCl are scanned against TGN in NaOH as reference. The measurements were done at 340 nm (maxima) and 410nm (minima). Further, the AUC under both the maxima and minima were measured at 335-345nm and 405-415nm, respectively. The liquid chromatographic method utilized a reversed-phase column (150mm×4.6mm, 5µm) with a mobile phase of methanol: 0.01M KH2PO4 buffer pH 3.5 (using orthophosphoric acid) in the ratio 80:20 %, v/v. The flow rate was 1.0ml/min, and diode array detection was done at 349nm. TGN eluted at 1.656min. All the methods were validated for linearity, precision, accuracy, stability, and robustness. The developed methods produced validation results within the satisfactory limits of ICH guidance. Further, these methods were applied to estimate the amount of TGN present in commercial lyophilized injection formulations, and the results were compared using the One-Way ANOVA test. Overall, the methods are rapid, simple, and reliable for routine quality control of TGN in the bulk and pharmaceutical dosage form. 

scholarly journals Heterotopic ossification in the post cruciate ligament of the knee: a case report and literature review

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Cun Li ◽  
Zonggui Huang ◽  
K. C. Anil ◽  
Chendeng Lao ◽  
Qianghua Wu ◽  
...  
Keyword(s):  
Literature Review ◽  
Heterotopic Ossification ◽  
Knee Pain ◽  
Cruciate Ligament ◽  
Complete Recovery ◽  
X Rays ◽  
Related Factors ◽  
Knee Motion ◽  
Adequate Treatment ◽  
The Difference

Abstract Background Heterotopic ossification (HO) is noted most frequently in periarticular muscles and has not yet been reported in the cruciate ligaments of the knee. We present a rare case of symptomatic ossification of the posterior cruciate ligament (PCL). Case presentation A 59-year-old woman had a 2-year history of knee pain that was getting worse during knee motion and had restricted knee motion for 1 year. X-rays could not show the lesion clearly. Multi-planar computed tomography demonstrated ossification within the PCL with mild osteoarthritic changes and excluded any other intra-articular pathology. The patient underwent arthroscopic debridement and then experienced immediate relief of pain and complete recovery of range of motion. Conclusion This is the first report of HO in the PCL as a possible cause of knee pain and restricted knee motion. On the basis of literature review, this case elaborates the difference between HO and calcification in the ligaments, the related factors inducing HO and the undefined pathogenesis, and favorable prognosis after adequate treatment.

scholarly journals A diabetes risk score for Qatar utilizing a novel mathematical modeling approach to identify individuals at high risk for diabetes

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Susanne F. Awad ◽  
Soha R. Dargham ◽  
Amine A. Toumi ◽  
Elsy M. Dumit ◽  
Katie G. El-Nahas ◽  
...  
Keyword(s):  
High Risk ◽  
Sensitivity And Specificity ◽  
Risk Score ◽  
Area Under The Curve ◽  
Diabetes Risk ◽  
Predictive Values ◽  
Predictive Variables ◽  
Comparable Performance ◽  
Representative Random Sample ◽  
Diabetes Risk Score

AbstractWe developed a diabetes risk score using a novel analytical approach and tested its diagnostic performance to detect individuals at high risk of diabetes, by applying it to the Qatari population. A representative random sample of 5,000 Qataris selected at different time points was simulated using a diabetes mathematical model. Logistic regression was used to derive the score using age, sex, obesity, smoking, and physical inactivity as predictive variables. Performance diagnostics, validity, and potential yields of a diabetes testing program were evaluated. In 2020, the area under the curve (AUC) was 0.79 and sensitivity and specificity were 79.0% and 66.8%, respectively. Positive and negative predictive values (PPV and NPV) were 36.1% and 93.0%, with 42.0% of Qataris being at high diabetes risk. In 2030, projected AUC was 0.78 and sensitivity and specificity were 77.5% and 65.8%. PPV and NPV were 36.8% and 92.0%, with 43.0% of Qataris being at high diabetes risk. In 2050, AUC was 0.76 and sensitivity and specificity were 74.4% and 64.5%. PPV and NPV were 40.4% and 88.7%, with 45.0% of Qataris being at high diabetes risk. This model-based score demonstrated comparable performance to a data-derived score. The derived self-complete risk score provides an effective tool for initial diabetes screening, and for targeted lifestyle counselling and prevention programs.

Taurine Improves the Absorption of a Fat Meal in Patients With Cystic Fibrosis

PEDIATRICS ◽  
1987 ◽  
Vol 80 (4) ◽  
pp. 517-523
Author(s):  
Dominique C. Belli ◽  
Emile Levy ◽  
Pauline Darling ◽  
Claudie Leroy ◽  
Guy Lepage ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Fatty Acid ◽  
Area Under The Curve ◽  
Enzyme Therapy ◽  
Taurine Supplementation ◽  
Control Subjects ◽  
Total Fatty Acids ◽  
The Difference ◽  
Fatty Acid Deficiency ◽  
Fat Meal

The effect of taurine supplementation on the absorption of a fat meal was evaluated in patients with cystic fibrosis. In a cross-over design study, five patients with cystic fibrosis (12.1 ± 2.6 years of age) and three control subjects received either placebo or taurine (30 mg/kg/d) for two 1-week periods, a month apart, followed by a fat meal test. Blood samples were drawn 0, 1, 2, 3, 5, 8 hours after the meal. Four patients with cystic fibrosis and severe steatorrhea despite appropriate enzyme therapy showed a significant (P < .05) improvement in the absorption of triglycerides, total fatty acids, and linoleic acid while receiving taurine supplements. Three control subjects and one child with cystic fibrosis and mild steatorrhea receiving enzyme therapy did not experience such an effect. The difference in triglyceride absorption, when calculated as the area under the curve, receiving and not receiving taurine was significantly (P < .05) correlated with the degree of steatorrhea. Furthermore, in contrast to control subjects, the fatty acid composition of chylomicrons in these four study patients showed important discrepancies with that of the fat meal and was corrected, in part, by taurine supplementation. These results suggest that taurine supplementation could be a useful adjunct in the management of patients with cystic fibrosis with ongoing fat malabsorption and essential fatty acid deficiency.

Performance of Abbreviated Protocols Versus Unenhanced MRI in Detecting Occult Breast Lesions of Mammography in Patients with Dense Breasts

2021 ◽  
Author(s):  
Suhong Zhao ◽  
Peipei Chen ◽  
Guangrui Shao ◽  
Baijie Li ◽  
Huikun Zhang ◽  
...  
Keyword(s):  
Reading Time ◽  
Area Under The Curve ◽  
Lesion Size ◽  
Lower Sensitivity ◽  
Chi Square ◽  
Dense Breast Tissue ◽  
Negative Findings ◽  
Chi Square Test ◽  
The Difference ◽  
Sensitivity Specificity

Abstract Objective: To assess the diagnostic ability of abbreviated protocols of MRI (AP-MRI) compared with unenhanced MRI (UE-MRI) in mammographically occult cancers in patients with dense breast tissue.Materials and Methods: The retrospective analysis consisted of 102 patients without positive findings on mammography who received preoperative MRI full diagnostic protocols (FDP) between January 2015 and December 2018. Two breast radiologists read the UE, AP, and FDP. The interpretation times were recorded. The comparisons of the sensitivity, specificity and area under the curve of each MRI protocol, and the sensitivity of these protocols in each subgroup of different size tumors used the Chi-square test. The paired sample t-test was used for evaluating the difference of reading time of the three protocols.Results: Among 102 women, there were 68 cancers and two benign lesions in 64 patients and 38 patients had benign or negative findings. Both readers found the sensitivity and specificity of AP and UE-MRI were similar (p>0.05), whereas compared with FDP, UE had lower sensitivity (Reader 1/Reader 2: p=0.023, 0.004). For different lesion size groups, one of the readers found that AP and FDP had higher sensitivities than UE-MRI for detecting the lesions ≤10 mm in diameter (p=0.041, p=0.023). Compared with FDP, the average reading time of UE-MRI and AP was remarkably reduced (p < 0.001).Conclusion: AP-MRI had more advantages than UE-MRI to detect mammographically occult cancers, especially for breast tumors ≤10 mm in diameter.

A stochastic airplane boarding model in a framework of ASEP with distinguishable particles

2018 ◽  
Vol 29 (10) ◽  
pp. 1850093
Author(s):  
ShengJie Qiang ◽  
Bin Jia ◽  
QingXia Huang
Keyword(s):  
Removal Rate ◽  
Exclusion Process ◽  
System Size ◽  
Nonequilibrium Systems ◽  
One Dimensional ◽  
Simple Exclusion Process ◽  
Maximum Current ◽  
Asymmetric Simple Exclusion ◽  
Simple Exclusion ◽  
The Difference

The asymmetric simple exclusion process (ASEP) is a paradigmatic model for nonequilibrium systems and has been used in many applications. Airplane boarding provides another interesting example where this framework can be applied. We propose a simple model for boarding process, in which a particle moves along a one-dimensional aisle after being injected, and finally is removed at a reserved site. Different from the typical ASEP model, particles are removed in a disorderly or a parallel way. Detailed calculations and discussions of some related characteristics, such as mean boarding time and parallelism indicator, are provided based on Monte-Carlo simulations. Results show that three phases exist in the boarding process: free-flow, jamming and maximum current. Transitions between these phases are governed by the difference between the injection and removal rate. Further analysis shows how the scaling behavior depends on the system size and the boarding conditions. Those results emphasize the importance of utilizing the whole length of the aisle to reduce the boarding time when designing an efficient boarding strategy.

scholarly journals Serum CYR61 As A Potential Biomarker for The Diagnosis of Esophagogastric Junction Tumor

2021 ◽  
Author(s):  
Ling-Yu Chu ◽  
Jian-Yuan Zhou ◽  
Yi-Xuan Zhao ◽  
Yan-Ting Ou ◽  
Tian Yang ◽  
...  
Keyword(s):  
Early Stage ◽  
Area Under The Curve ◽  
Serum Levels ◽  
Enzyme Linked Immunosorbent Assay ◽  
Operating Characteristics ◽  
Tumor Patients ◽  
Chi Square ◽  
Potential Biomarker ◽  
The Difference ◽  
Normal Controls

Background：Esophagogastric junction tumor (EGJ) is a rare but fatal disease with a rapid rising incidence worldwide in the late 20 years, and it lacks a convenient and safe method for diagnosis. This study aimed to evaluate the potential of serum CYR61 as a biomarker for the diagnosis of EGJ tumor. Methods: Enzyme-linked immunosorbent assay (ELISA) was used to estimate CYR61 levels in sera of 152 EGJ tumor patients and 137 normal controls. Receiver operating characteristics (ROC) was carried out to evaluate the diagnostic accuracy. The Mann–Whitney’s U test was used to compare the difference of serum levels of CYR61 between groups. And chi-square tests were employed to estimate the correlation of the positive rate of serum CYR61 between/among subgroups. Results: Serum CYR61 levels were statistically lower in EGJ tumor and early-stage EGJ tumor patients than those in normal controls (P&lt;0.0001). The sensitivity, specificity, and the area under the curve (AUC) of this biomarker in EGJ tumor were 88.2%, 43.8% and 0.691, respectively, and those for early stage of EGJ tumor were 80.0%, 66.4% and 0.722, respectively. Analyses showed that there was no correlation between the clinical data and the levels of CYR61 (P&gt;0.05). Conclusion: This study showed that CYR61 might be a potential biomarker to assist the diagnosis of EGJ tumor.

scholarly journals Distilling Deep Structural Facial Relationships for FAU Intensity Estimation

2021 ◽  
Author(s):  
Yingruo Fan ◽  
Jacqueline CK Lam ◽  
Victor On Kwok Li
Keyword(s):  
Structural Characteristics ◽  
Model Performance ◽  
Training Model ◽  
Model Parameters ◽  
Intensity Estimation ◽  
Structural Relationships ◽  
Proposed Model ◽  
Comparable Performance ◽  
Knowledge Distillation ◽  
The Difference

<div> <div> <div> <p>Facial emotions are expressed through a combination of facial muscle movements, namely, the Facial Action Units (FAUs). FAU intensity estimation aims to estimate the intensity of a set of structurally dependent FAUs. Contrary to the existing works that focus on improving FAU intensity estimation, this study investigates how knowledge distillation (KD) incorporated into a training model can improve FAU intensity estimation efficiency while achieving the same level of performance. Given the intrinsic structural characteristics of FAU, it is desirable to distill deep structural relationships, namely, DSR-FAU, using heatmap regression. Our methodology is as follows: First, a feature map-level distillation loss was applied to ensure that the student network and the teacher network share similar feature distributions. Second, the region-wise and channel-wise relationship distillation loss functions were introduced to penalize the difference in structural relationships. Specifically, the region-wise relationship can be represented by the structural correlations across the facial features, whereas the channel-wise relationship is represented by the implicit FAU co-occurrence dependencies. Third, we compared the model performance of DSR-FAU with the state-of-the-art models, based on two benchmarking datasets. Our proposed model achieves comparable performance with other baseline models, though requiring a lower number of model parameters and lower computation complexities. </p> </div> </div> </div>

The performance of neutron diffractometers at long and short pulse spallation sources: Comparison between ESS and J-PARC

2021 ◽  
pp. 1-18
Author(s):  
Masatoshi Arai ◽  
Ken H. Andersen ◽  
Dimitri N. Argyriou ◽  
Werner Schweika ◽  
Luca Zanini ◽  
...  
Keyword(s):  
Short Pulse ◽  
Source Power ◽  
Advantages And Disadvantages ◽  
Epithermal Neutrons ◽  
Pdf Analysis ◽  
Comparable Performance ◽  
Spallation Source ◽  
The Difference ◽  
Pulse Structure ◽  
Long Pulse

The general performance of diffractometers at the first long pulse spallation source ESS, is compared with their counterparts at J-PARC, a short pulse spallation source. The difference in the inherent pulse structure of these neutron sources presents opportunities for new concepts for instrumentation, where performance does not scale simply with source power. The article describes advantages and disadvantages of those diffractometers, adapting to the very different source characteristics. We find that the two sources offer comparable performance in flux and resolution when operating in high-resolution mode. ESS offers significant advantages in tunability and flexibility, notably in the ability to relax resolution in order to increase flux for a given experiment. The slow repetition rate of ESS favors long instruments. On the other hand, J-PARC instruments perform very well in spite of the lower source power and allow better access to epithermal neutrons, of particular interest for PDF analysis of diffraction data.

scholarly journals Advanced Quantification Methods To Improve the 18b Dormancy Model for Assessing the Activity of Tuberculosis Drugs In Vitro

2020 ◽  
Vol 64 (7) ◽  
Author(s):  
E. D. Pieterman ◽  
M. J. Sarink ◽  
C. Sala ◽  
S. T. Cole ◽  
J. E. M. de Steenwinkel ◽  
...  
Keyword(s):  
Drug Development ◽  
Area Under The Curve ◽  
High Dose ◽  
Current Form ◽  
Content Type ◽  
Solid Media ◽  
Development Pipeline ◽  
The Difference ◽  
Time Kill

ABSTRACT One of the reasons for the lengthy tuberculosis (TB) treatment is the difficulty to treat the nonmultiplying mycobacterial subpopulation. In order to assess the ability of (new) TB drugs to target this subpopulation, we need to incorporate dormancy models in our preclinical drug development pipeline. In most available dormancy models, it takes a long time to create a dormant state, and it is difficult to identify and quantify this nonmultiplying condition. The Mycobacterium tuberculosis 18b strain might overcome some of these problems, because it is dependent on streptomycin for growth and becomes nonmultiplying after 10 days of streptomycin starvation but still can be cultured on streptomycin-supplemented culture plates. We developed our 18b dormancy time-kill kinetics model to assess the difference in the activity of isoniazid, rifampin, moxifloxacin, and bedaquiline against log-phase growth compared to the nonmultiplying M. tuberculosis subpopulation by CFU counting, including a novel area under the curve (AUC)-based approach as well as time-to-positivity (TTP) measurements. We observed that isoniazid and moxifloxacin were relatively more potent against replicating bacteria, while rifampin and high-dose bedaquiline were equally effective against both subpopulations. Moreover, the TTP data suggest that including a liquid culture-based method could be of additional value, as it identifies a specific mycobacterial subpopulation that is nonculturable on solid media. In conclusion, the results of our study underline that the time-kill kinetics 18b dormancy model in its current form is a useful tool to assess TB drug potency and thus has its place in the TB drug development pipeline.

Sign in / Sign up

Export Citation Format

Share Document