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Nevin Manimala Statistics

Versatile TLC-Densitometric Methods for the Synchronous Estimation of Cinnarizine and Acefylline Heptaminol in The Presence of Potential Impurity and Their Reported Degradation Products

J Chromatogr Sci. 2021 Dec 8:bmab129. doi: 10.1093/chromsci/bmab129. Online ahead of print.

ABSTRACT

From evolution, thin-layer chromatography (TLC) attracts attention as a versatile technique for efficient separation and identification of many drug substances and chemicals. Owing to its simplicity and other outstanding advantages, TLC is extensively used by chromatographers in quantification and purity profiling objectives. In the present study two TLC-Densitometric methods are established and validated for the synchronous estimation of Cinnarizine (Cinn) and Acefyline Heptaminol (Acef) in the presence of Cinn/Acef reported degradation products and Thoephylline (Theo) as Acef potential impurity. The proposed methods are based on densitometric measurements of the spots of Cinn and Acef after separation from their degradation products. Separation is attained on silica gel sheet with dichloromethane: methanol: formic acid as a developing system in ratio: (15, 1, 0.5, by volume) and (15, 0.75, 0.4, by volume) for Cinn (method 1) and Acef (method 2) degradation, consecutively. Quantification is done at 254 nm over concentration ranges of 0.2-1.8 and 2-18 μg/spot for Cinn and Acef; respectively, with mean percentage recoveries of 99.18 ± 0.60/99.84 ± 0.53 and 99.19 ± 0.93/99.66 ± 0.58 for method 1 and method 2; consecutively. The two methods are fully validated and proven to be selective, robust and retained their accuracy in up to 50% of Cinn/Acef reported degradation products and Theo. Moreover, the two methods are applied to a coformulated drug product comprising Cinn and Acef showing satisfactory results. Comparison of the obtained results by the proposed methods with that of the reference ones statistically shows no significant differences.

PMID:34875682 | DOI:10.1093/chromsci/bmab129

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Nevin Manimala Statistics

Effect of a multimodal prehabilitation program on postoperative recovery and morbidity in patients undergoing a totally minimally invasive esophagectomy

Dis Esophagus. 2021 Dec 8:doab082. doi: 10.1093/dote/doab082. Online ahead of print.

ABSTRACT

Postoperative morbidity following esophagectomy remains substantial. Studies in major abdominal surgery have shown that prehabilitation can improve postoperative outcomes. This single-center study investigated the influence of prehabilitation on postoperative outcomes in patients undergoing minimally invasive Ivor-Lewis esophagectomy (MIE-IL). Data were collected on patients that underwent a MIE-IL and received a fully standardized enhanced recovery after surgery (ERAS) program, between October 2015 and February 2020. The intervention group comprised patients enrolled in the PREPARE prehabilitation program. The control group comprised a retrospective cohort with similar ERAS care, prior to implementation of PREPARE. Postoperative outcomes included (functional) recovery, length of hospital stay (LOHS), cardiopulmonary complications (CPC) and other predefined outcomes. The PREPARE group comprised 52 and control group 43 patients. Median time to functional recovery was 6 vs. 7 days (P = 0.074) and LOHS 7 vs. 8 days (P = 0.039) in PREPARE and control patients, respectively. Hospital readmission rate was 9.6 vs. 14.3% (P = 0.484). A 17% reduction in thirty-day overall postoperative complication rate was observed in PREPARE patients, but this was not statistically significant (P = 0.106). Similarly, a clinically relevant reduction of 14% in CPC rate was observed (P = 0.190). Anastomotic leakage rate was similar (9.6 vs 14.0%; P = 0.511). Despite no difference in severity (Clavien-Dindo) of complications (P = 0.311), ICU readmission rate was lower in PREPARE patients (3.8 vs. 16.3%, P = 0.039). Prehabilitation prior to MIE-IL led to a shorter LOHS and reduced ICU readmission rate. Additionally, a clinically relevant improvement in postoperative recovery and reduced morbidity rate was observed in prehabilitated patient.

PMID:34875680 | DOI:10.1093/dote/doab082

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Post-Progression Treatments after Palbociclib plus Endocrine Therapy in HR+/HER2- Metastatic Breast Cancer Patients: What Is the Better Choice?

Oncology. 2021 Dec 7. doi: 10.1159/000521252. Online ahead of print.

ABSTRACT

BACKGROUND: To date, a consensus has not yet been reached about the therapy sequence after disease progression (PD) on CDK4/6 inhibitors in patients with HR+/HER2- metastatic breast cancer (MBC).

OBJECTIVES: The present study assesses, in a real-world setting, the activity of different subsequent therapies in patients who experienced a PD on palbociclib (P) + endocrine therapy (ET), to evaluate the best therapy sequence.

METHODS: This is a multicenter retrospective observational study. Records of consecutive HR+/HER2- MBC patients from January 2017 to May 2019 were reviewed. The primary endpoint was the evaluation of progression-free survival (PFS) according to subsequent treatment lines after progression on P+ET. Toxicity data were also collected.

RESULTS: The outcomes were analyzed in 89 MBC patients that had progressed on previous P+ET: 17 patients were on hormone therapy (HT) and 31 patients on chemotherapy (CT) as second-line treatments; seven patients were on HT and 34 on CT as third-line therapies. PFS of patients treated with HT as second-line therapy is significantly improved when compared with patients treated with CT (p=0.01). Considering third-line settings, the difference in PFS was not statistically different between HT and CT. A better outcome in terms of toxicity is observed among HT patients for both second- and third-line therapies.

CONCLUSIONS: patients who were progressive on P+ET could still benefit from a subsequent ET. In patients who experienced a good efficacy from prior ET, without visceral metastatic sites, HT seems the most suitable option, when compared to CT, also in terms of safety.

PMID:34875670 | DOI:10.1159/000521252

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Nevin Manimala Statistics

Being a Cancer Patient during the Time of COVID-19: Impact of the Pandemic on the Anxiety and the Sleeping Quality of Oncology Patients

Chemotherapy. 2021 Dec 7:1-8. doi: 10.1159/000520483. Online ahead of print.

ABSTRACT

OBJECTIVE: In this study, we aimed to assess anxiety and sleep quality in cancer patients treated or followed up at our clinic at the time of the outbreak of the COVID-19 pandemic.

METHODS: Seven hundred and sixty-one patients who were either treated or followed up at our oncology clinic between April 2020 and May 2020 were included. Patients were assessed with the State-Trait Anxiety Inventory (STAI) and the Pittsburgh Sleep Quality Index (PSQI).

RESULTS: Mean scores of the 761 participants were STAI, 43.45 ± 9.34 (range, 23-75), and PSQI, 5.67 ± 4.24 (range, 0-19). Quality of sleep was found bad in 447 (58.7%) (global score ≥5). Univariate analyses demonstrated statistical differences by stage of cancer, status of treatment, subgroup of treatment, monthly income, and levels of education in anxiety and sleep quality levels. Multivariate analyses showed active treatment (OR: 21.4; 95% CI: 9.08-50.4; p < 0.001) as the major independent variable that affected sleep quality; the major independent variable associated with anxiety was low income (OR: 4.43; 95% CI: 1.69-11.5; p = 0.002).

CONCLUSION: Anxiety and sleep quality levels were found comparable to pre-pandemic reports, and the pandemic was not observed to have additional negative impact on cancer patients. Also, universal basal anxiety and sleep disorder that accompany cancer or active treatment were observed in our study. The accurate effects of the pandemic can be analyzed in further studies using repeated data obtained from the same patient group.

PMID:34875660 | DOI:10.1159/000520483

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Numerical study of silicon vacancy color centers in silicon carbide by helium ion implantation and subsequent annealing

Nanotechnology. 2021 Dec 7. doi: 10.1088/1361-6528/ac40c1. Online ahead of print.

ABSTRACT

Molecular dynamics (MD) simulation is adopted to discover the underlying mechanism of silicon vacancy color center and damage evolution during helium ions implanted four-hexagonal silicon carbide (4H-SiC) and subsequent annealing. The atomic-scale mechanism of silicon vacancy color centers in the process of He ion implantation into 4H-SiC can be described more accurately by incorporating electron stopping power for He ion implantation. We present a new method for calculating the silicon vacancy color center numerically, which considers the structure around the color center and makes the statistical results more accurate than the Wigner-Seitz defect analysis method. At the same time, photoluminescence (PL) spectroscopy of silicon vacancy color center under different helium ion doses is also characterized for validating the numerical analysis. The MD simulation of the optimal annealing temperature of silicon vacancy color center is predicted by the proposed new method.

PMID:34875640 | DOI:10.1088/1361-6528/ac40c1

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Real-world effectiveness of antipsychotic treatments in 1011 acutely hospitalized patients with schizophrenia: A one-year follow-up study

Asian J Psychiatr. 2021 Nov 6;67:102917. doi: 10.1016/j.ajp.2021.102917. Online ahead of print.

ABSTRACT

PURPOSE: To compare the real-world effectiveness of antipsychotic treatments focusing on long-acting injectable antipsychotic medications (LAIs) and antipsychotic polytherapies except polytherapy involving clozapine (APEC) for patients with schizophrenia.

METHODS: This prospective study was conducted over a 19-month period in 12 psychiatric emergency hospitals in Japan. Patients who were newly admitted to psychiatric emergency wards between September 2019 and March 2020 because of acute onset or exacerbation of Schizophrenia and Other Psychotic Disorders as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, were included. All patients were followed for one-year after discharge or until March 31, 2021. The primary outcome was the risk of treatment failure defined as psychiatric rehospitalization, discontinuation of medication, death, or continuation of hospitalization for one year. Cox proportional hazards multivariate regression was used for analyses.

RESULTS: A total of 1011 patients were enrolled (women, 53.7%; mean [SD] age, 47.5 [14.8] years). During follow-up, 588 patients (58.2%) experienced treatment failure including rehospitalization (513 patients), discontinuation of medication (17 patients), death (11 patients), and continuation of hospitalization for one-year (47 patients). Switching to LAIs (hazard ratio [HR] 0.810, 95%CI 0.659-0.996) and APEC (HR 0.829, 95%CI 0.695-0.990) were significantly associated with a low rate of treatment failure.

CONCLUSIONS: Switching to LAIs and APEC in early non-responders seems to be beneficial for the prevention of treatment failure in acutely admitted patients with schizophrenia. The risk of treatment failure was about 19% and 17% lower in patients treated with LAIs and APEC, respectively, than in patients treated without them.

PMID:34875558 | DOI:10.1016/j.ajp.2021.102917

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Novel InDel variations of the Cry2 gene are associated with litter size in Australian White sheep

Theriogenology. 2021 Nov 29;179:155-161. doi: 10.1016/j.theriogenology.2021.11.023. Online ahead of print.

ABSTRACT

Cryptochrome 2 (Cry2) gene regulates circadian rhythm and affects reproduction and pregnancy. Therefore, this study aimed to explore polymorphisms of the Cry2 gene and their associations with litter size at different parity in Australian White (AuW) ewes. Five putative insertion or deletion mutations within the Cry2 gene were selected to study their association with litter size. Two novel deletion mutations were identified in intronic region of Cry2 gene and were genotyped by agarose gel electrophoresis and DNA sequencing. The polymorphism information content (PIC) indicated that both mutations were low polymorphism in tested groups. Statistical analysis revealed that the P1-Del-6-bp was significantly correlated with litter size at third parity (P = 0.010), in which individuals with insertion/deletion (ID) genotype had larger litter size than insertion/insertion (II) genotype (P < 0.05). Whereas, the P2-Del-6-bp was significantly correlated with litter size at first parity (P = 0.036), in which individuals with insertion/insertion (II) genotype had larger litter size than insertion/deletion (ID) genotype (P < 0.05). Collectively, these findings may provide new insights to expedite molecular breeding in sheep through marker-assisted selection strategies (MAS).

PMID:34875538 | DOI:10.1016/j.theriogenology.2021.11.023

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The occurrence of geogenic fluoride in shallow aquifers of Kenya Rift Valley and its implications in groundwater management

Ecotoxicol Environ Saf. 2021 Dec 4;229:113046. doi: 10.1016/j.ecoenv.2021.113046. Online ahead of print.

ABSTRACT

Widespread concerns about high-fluoride groundwater and their health risks have been raised worldwide. Weathering of volcanic minerals is regarded as a principal source of groundwater fluoride in regions with volcanic bedrocks. However, how does the volcanic minerals control fluoride occurrence, if it induces other hydrogeochemical processes participating in and how this relates to human health still remain unclear. This study takes Kenya Rift Valley, which has volcanic geological formations, as an example to delineate the occurrence and origins of high-fluoride shallow groundwater with analysis of hydrochemistry, graphical and multivariate statistical methods. Over 40% of shallow groundwater (F: up to 23.5 mg/L) show elevated fluoride values over the WHO standards of 1.5 mg/L. High fluoride groundwater are generally Na-rich and Ca-poor with high pH and HCO3¯ concentrations. Hydrogeochemical and principal component analysis indicate that weathering of hyper-alkaline volcanic rocks could release accumulated fluoride in melts and volatile fractions, as well as in clay minerals. Alkaline condition and high HCO3 contents lead to the competitive desorption of F from clay minerals and Fe-hydroxides into groundwater. Clay minerals also provide abundant exchange sites where cation exchange happens and promotes the release of F from the sediments by controlling the dissolution/precipitation of calcite and fluorite. Health risk assessment results show that chronic health risks by groundwater geogenic fluoride ingestion are identified to various individuals, with highest threats in children. Finally, a conceptual model has been developed to demonstrate the formations of high geogenic fluoride groundwater in regions with volcanic bedrocks and its relation with human health.

PMID:34875514 | DOI:10.1016/j.ecoenv.2021.113046

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Effect of processing methods on the chipping resistance of veneered zirconia

J Mech Behav Biomed Mater. 2021 Nov 24;126:104995. doi: 10.1016/j.jmbbm.2021.104995. Online ahead of print.

ABSTRACT

OBJECTIVES: To evaluate the edge chipping resistance (ReA) and the fracture toughness (KC) of 3Y-TZP bilayers produced with the following materials/processing combinations: fluorapatite glass-ceramic applied on zirconia using the traditional layering and hot-pressing (press-on) techniques; feldspathic porcelain using rapid layer technology (RLT); and lithium disilicate glass-ceramic using CAD-on method. The influence of the cooling rate (slow and fast) was analyzed for layering and hot-pressing.

METHODS: Bilayer bars (25x4x2 mm) were made following manufacturers’ instructions. The edge chipping test was performed in an universal testing machine, using a coupled Vickers indenter. ReA was calculated dividing the critical load at fracture by the edge distance. Fracture toughness was calculated by a regression fit with a fixed slope of 1.5 correlating the critical chipping load regarding edge distance and also with indentation fracture (IF) method. Data were statistically analyzed using ANOVA and Tukey’s test (α = 5%).

RESULTS: ReA and KC was significantly higher for the CAD-on bilayers. RLT showed intermediate ReA means, and layering and hot-pressing techniques showed the lowest ReA values. For both processing methods there was no effect of the cooling protocol on the ReA and fracture toughness.

CONCLUSIONS: There is a significant effect of the material/processing association on the edge chipping resistance and fracture toughness of the bilayers. There was no effect of the cooling protocol on the edge chipping resistance and fracture toughness for the specimens processed by both the layering and hot-pressing techniques.

PMID:34875502 | DOI:10.1016/j.jmbbm.2021.104995

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Effect of different tightening protocols on the probability of survival of screw-retained implant-supported crowns

J Mech Behav Biomed Mater. 2021 Dec 2;126:105019. doi: 10.1016/j.jmbbm.2021.105019. Online ahead of print.

ABSTRACT

PURPOSE: This study evaluated the effect of different tightening protocols on the probability of survival of screw-retained implant-supported anterior crowns.

MATERIALS AND METHODS: Seventy-two implants with internal conical connections (4.0 × 10mm, Ti-6Al-4V, Colosso, Emfils) were divided into four groups (n = 18 each): 1) Manufacturer’s recommendations torque (25 N.cm for abutment’s screw and 30 N.cm for crown’s screw) (MaT); 2) Retightening after 10 min (ReT); 3) Torque 16% below recommended to simulate an uncalibrated wrench (AgT), and; 4) Temporary crown simulation (TeT), where crowns were torqued to 13 N.cm to simulate manual tightening, subjected to 11,200 cycles to simulate temporary crown treatment time (190 N), and then retightened to manufacturer torque (TeT). All specimens were subjected to cyclic fatigue in distilled water with a load of 190 N until 250,000 cycles or failure. The probability of survival (reliability) to complete a mission of 50,000 cycles was calculated and plotted using the Weibull 2-Parameter analysis. Weibull modulus and number of cycles at which 62.3% of the specimens would fail were also calculated and plotted. The failure mode was characterized in stereo and scanning electron microscopes (SEM).

RESULTS: The probability of survival was 69.3% for MaT, 70% for ReT, 54.8% for AgT, and 40.3% for TeT, all with no statistically significant difference. Weibull modulus was approximately 1.0 for all groups. The characteristic number of cycles for failure was 105,000 cycles for MaT, 123,000 for ReT, 82,000 cycles for AgT, and 54,900 cycles for TeT, with no significant difference between groups. The chief failure mode for MaT, ReT, AgT groups was crown screw fracture, whereas abutment screw fracture was the chief failure mode for the TeT group.

CONCLUSION: Tightening protocol did not influence the probability of survival of the screw-retained anterior crowns supported by internal conical implants (Ti-6Al-4V, Colosso, Emfils).

PMID:34875501 | DOI:10.1016/j.jmbbm.2021.105019