Miracle-dz/UniFAR-FTUs huggingface dataset:
Immediate-Release Formulations Produced via Twin-Screw Melt Granulation: Systematic Evaluation of the Addition of Disintegrants

The current study evaluated the effect of location and amount of various superdisintegrants on the properties of tablets made by twin-screw melt granulation (TSMG). Sodium-croscarmellose (CCS), crospovidone (CPV), and sodium starch glycolate (SSG) were used in various proportions intra- and extra-granular. Tabletability, compactibility, compressibility as well as friability, disintegration, and dissolution performance were assessed. The extra-granular addition resulted in the fasted disintegration and dissolution. CPV performed superior to CCS and SSG. Even if the solid fraction (SF) of the granules was lower for CPV, only a minor decrease in tabletability was observed, due to the high plastic deformation of the melt granules. The intra-granular addition of CPV resulted in a more prolonged dissolution profile, which could be correlated to a loss in porosity during tableting. The 100% intra-granular addition of the CPV resulted in a distinct decrease of the disintegration efficiency, whereas the performance of SSG was unaffected by the granulation process. CCS was not suitable to be used for the production of an immediate-release formulation, when added in total proportion into the granulation phase, but its efficiency was less impaired compared to CPV. Shortest disintegration (78 s) and dissolution (Q80: 4.2 min) was achieved with CPV extra-granular. Using CPV and CCS intra-granular resulted in increased disintegration time and Q80. However, at a higher level of appx. 500 s and appx. 15 min, only SSG showed a process and location independent disintegration and dissolution performance.
Managing biological variation data: modern approaches for study design and clinical application

Abstract For more than one half-century, variability observed in clinical test result measurements has been ascribed to three major independent factors: (i) pre-analytical variation, occurring at sample collection and processing steps; (ii) analytical variation of the test method for which measurements are taken, and; (iii) biological variation (BV). Appreciation of this last source of variability is the major goal of this review article. Several recent advances have been made to generate, collate, and utilize BV data of biomarker tests within the clinical laboratory setting. Consideration of both prospective and retrospective study designs will be addressed. The prospective/direct study design will be described in accordance with recent recommendations discussed in the framework of a newly-developed system of checklist items. Potential value of retrospective/indirect study design, modeled on data mining from cohort studies or pathology laboratory information systems (LIS), offers an alternative approach to obtain BV estimates for clinical biomarkers. Moreover, updates to BV databases have made these data more current and widely accessible. Principal aims of this review are to provide the clinical laboratory scientist with a historical framework of BV concepts, to highlight useful applications of BV data within the clinical laboratory environment, and to discuss key terms and concepts related to statistical treatment of BV data.
Thiazolidinediones and Glucagon‐Like Peptide‐1 Receptor Agonists and the Risk of Nonalcoholic Fatty Liver Disease: A Cohort Study

Thiazolidinediones (TZDs) and glucagon‐like peptide‐1 (GLP‐1) receptor agonists are potential pharmacological treatment options for patients at risk of NAFLD. Therefore, we examined the association between the risk of NAFLD and the use of TZDs and GLP‐1 receptor agonists compared with the use of sulfonylureas (SUs) and insulins. Additionally, we calculated the incidence of HCC in users of TZDs and GLP‐1 receptor agonists.
Treatment of direct oral anticoagulants in patients with liver cirrhosis and portal vein thrombosis

Although patients with cirrhosis are known to be in a state of “rebalance” in that pro- and anticoagulant factors increase the risk for both bleeding and thrombosis, the prevalence of portal vein thrombosis (PVT) in patients with cirrhosis can be up to 26%. Therefore, physicians should consider anticoagulation for the prevention and management of PVT in patients with cirrhosis who are at high risk of PVT. Vitamin K antagonist or low molecular weight heparin is suggested as the standard treatment for PVT in cirrhosis. With the advent of new direct-acting oral anticoagulants (DOACs), there is a paradigm shift of switching to DOACs for the treatment of PVT in patients with cirrhosis. However, the safety and efficacy of DOACs in the treatment of PVT was not well-known in patients with cirrhosis. Therefore, this review focused on the current knowledge about the efficacy, safety concerns, and hepatic metabolism of DOACs in patients with cirrhosis and PVT.
Cement augmentation for trochanteric femur fractures: A meta-analysis of randomized clinical trials and observational studies

Introduction To date, it is unclear what the clinical benefit of cement augmentation in fixation for trochanteric fractures is. The aim of this meta-analysis is to compare cement augmentation to no augmentation in fixation of trochanteric femur fractures in the elderly patients (>65 years) following low energy trauma. Methods PubMed/Medline/Embase/CENTRAL/CINAHL were searched for both randomized clinical trials (RCT) and observational studies comparing both treatments. Effect estimates were pooled across studies using random effects models. Subgroup analysis was performed stratified by study design (RCTs and observational studies). The primary outcome is overall complication rate. Secondary outcomes include re-operation rate, mortality, operation duration, hospital stay, general quality of life, radiologic measures and functional hip scores. Results A total of four RCT’s (437 patients) and three observational studies (293 patients) were included. The effect estimates of RCTs were equal to those obtained from observational studies. Cement augmentation has a significantly lower overall complication rate (28.3% versus 47.2%) with an odds ratio (OR) of 0.3 (95%CI 0.1–0.7). The occurrence of device/fracture related complications was the largest contributing factor to this higher overall complication rate in the non-augmented group (19.9% versus 6.0%, OR 0.2, 95%CI 0.1–0.6). Cement augmentation also carries a lower risk for re-interventions (OR 0.2, 95%CI 0.1–0.7) and shortens the hospital stay with 2 days (95%CI -2.2 to -0.5 days). The mean operation time was 7 minutes longer in the augmented group (95%CI 1.3–12.9). Radiological scores (lag screw/blade sliding mean difference -3.1mm, 95%CI -4.6 to -1.7, varus deviation mean difference -6.15°, 95%CI; -7.4 to -4.9) and functional scores (standardized mean difference 0.31, 95%CI 0.0–0.6) were in favor of cement augmentation. Mortality was equal in both groups (OR 0.7, 95%CI 0.4–1.3) and cement related complications were rare. Conclusion Cement augmentation in fixation of trochanteric femoral fractures leads to fewer complications, re-operations and shorter hospital stay at the expense of a slightly longer operation duration. Cementation related complications occur rarely and mortality is equal between treatment groups. Based on these results, cement augmentation should be considered for trochanteric fractures in elderly patients.
Comparison of Bone Mineral Density and Markers of Bone Turnover in Osteoporotic Women after 6-Month Treatment with Alendronate or Bazedoxifene: A Randomized Controlled Trial

Background In a randomized controlled trial, we compared the bone mineral densities (BMDs) and blood markers of bone turnover during short-term treatment of osteoporotic women with bisphosphonate alendronate or bazedoxifene, a selective estrogen receptor modulator. Methods Ten and eleven patients were randomized to the alendronate and bazedoxifene groups, respectively. BMDs were measured before and after 6 months of treatment. Blood tests were used to measure the levels of osteocalcin (OC), C-terminal telopeptide of type I collagen (CTX), vitamin D3, and parathyroid hormone pretreatment and after 3 and 6 months of treatment. The variables were compared statistically. Results The alendronate group showed decreases in blood levels of both OC and CTX during the study period (P<0.001 and P=0.002, respectively), while the bazedoxifene group had a decrease only in OC levels (P=0.012). After 6 months of treatment, BMDs significantly increased in the alendronate group at multiple bone sites, including the L1–4 lumbar vertebrae, femur trochanter, and total femur. However, there was no significant increase in BMD in the bazedoxifene group. BMDs were not significantly different between the 2 groups. Conclusions Patients treated with alendronate showed more rapid suppression of markers of bone turnover and higher BMD than those treated with bazedoxifene during a short-term regime. Considering the effects and complications of each medication, the relationship between bone turnover rate and bone quality will need to be investigated in future studies.
Three-dimensional assessment of the spheno-occipital synchondrosis and clivus after tooth-borne and bone-borne rapid maxillary expansion.

OBJECTIVES To assess changes in spheno-occipital synchondrosis after rapid maxillary expansion (RME) performed with conventional tooth-borne (TB) and bone-borne (BB) appliances. MATERIALS AND METHODS This study included 40 subjects with transverse maxillary deficiency who received TB RME or BB RME. Cone-beam computed tomography images (CBCT) were taken before treatment (T0), and after a 6-month retention period (T1). Three-dimensional surface models of the spheno-occipital synchondrosis and basilar part of the occipital bone were generated. The CBCTs taken at T0 and T1 were registered at the anterior cranial fossa via voxel-based superimposition. Quantitative evaluation of Basion displacement was performed with linear measurements and Euclidean distances. The volume of the synchndrosis was also calculated for each time point as well as the Nasion-Sella-Basion angle (N-S-Ba°). All data were statistically analyzed to perform inter-timing and intergroup comparisons. RESULTS In both groups, there was a small increment of the volume of the synchondrosis and of N-S-Ba° (P < .05). Basion showed a posterosuperior pattern of displacement. However, no significant differences (P > .05) were found between the two groups. CONCLUSIONS Although TB and BB RME seemed to have some effects on the spheno-occipital synchondrosis, differences were very small and clinically negligible.
Peripheral glia diversity

Recent years have seen an evolving appreciation for the role of glial cells in the nervous system. As we move away from the typical neurocentric view of neuroscience, the complexity and variability of central nervous system glia is emerging, far beyond the three main subtypes: astrocytes, oligodendrocytes, and microglia. Yet the diversity of the glia found in the peripheral nervous system remains rarely discussed. In this review, we discuss the developmental origin, morphology, and function of the different populations of glia found in the peripheral nervous system, including: myelinating Schwann cells, Remak Schwann cells, repair Schwann cells, satellite glia, boundary cap‐derived glia, perineurial glia, terminal Schwann cells, glia found in the skin, olfactory ensheathing cells, and enteric glia. The morphological and functional heterogeneity of glia found in the periphery reflects the diverse roles the nervous system performs throughout the body. Further, it highlights a complexity that should be appreciated and considered when it comes to a complete understanding of the peripheral nervous system in health and disease.
The development of constitutive relationship for material behaviour at high rates of strain

Resume bref des donnees experimentales obtenues sur le comportement mecanique des materiaux metalliques a hautes et tres hautes vitesses de deformation. Revue des differentes relations analytiques utilisees pour decrire ces donnees experimentales et discussion de leurs bases theoriques. Demonstration de l'importance d'un parametre de structure interne dans une relation constitutive valable scientifiquement et description des differentes relations constitutives utilisees actuellement dans les programmes informatiques de modelisation de la reponse au choc des structures
Investigations into the chemical composition and nutritional value of single-cultivar rapeseed meals for broiler chickens

ABSTRACT A study was conducted to 1) investigate the influence of rapeseed cultivar on the range of variation in the chemical composition and feed value of rapeseed meals (RSM) for broilers and 2) to compare between single-cultivar RSM and a batch of UK-sourced proprietary rapeseed meal. Chemical composition was determined for a total of 10 single-cultivar RSM produced via prepressed solvent-extraction and a proprietary RSM. To investigate RSM digestibility a total of 360 birds were housed, six birds per pen, and between day 13 to 21 of age they received a diet containing per kg 250 g RSM and 750 g basal feed based on wheat and soybean meal. Titaniumdioxide (7 g/kg) was added as an inert marker. For the determination nitrogen-corrected metabolisable energy (AMEn) total excreta and feed intake were quantified over the last 4 d of the experiment. On the final day of the experiment ileal digesta were collected for determination of preceacal crude protein digestibility (pcCPD). With the exception of neutral detergent fibre (NDF), glucosinolates and soluble non-starch polysaccharides the coefficients of variation (CV%) for all major components were similar across all RSM (0.5 < CV% < 0.6). Glucosinolate contents were highest in the 10 single-cultivar RSM whereas NDF levels were greater in the proprietary RSM. Across the 10 single-cultivar RSM there was no significant effect of cultivar on AMEn or pcCPD. Pre-planned orthogonal contrasts indicated that the mean AMEn content and pcCPD of the proprietary RSM was significantly lower than the 10 single-cultivar RSM (p < 0.001). In view of the above, processing rather than cultivar appears to be the main driver of nutritional value in RSM fed to broilers.
Sexual harassment and assault predict sleep disturbances and is partly mediated by nightmares: Findings from a national survey of all university students in Norway

Sexual harassment and assault is common in most domains of society, and has been linked to several adverse outcomes, including reduced sleep quality. However, less is known about the possible impact of sexual harassment and assault on various sleep problems among university students. In a sample of 49,051 students in Norway (69.2% women), we examined i) the associations of varying extents of sexual harassment (unwanted sexual comments, looks or gestures, photographs, indecent exposure, and physical harassment) and sexual assault (attempted or completed rape), with meeting Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM‐5) diagnostic criteria of insomnia and with sleep duration, ii) the association of cumulative exposure to sexual harassment/assault with insomnia and sleep duration, and iii) to what extent nightmares could explain the association between sexual harassment and insomnia and sleep duration. For both genders, all forms of harassments with the exception of “indecent exposure” and “unwanted sexual photographs” for men were negatively associated with sleep duration, with the strongest associations being found for “rape” and “attempted rape”. For both genders, the odds of insomnia increased as a function of cumulative harassment exposure. Similarly, a graded, negative association was found between cumulative harassment and sleep duration for both genders. Mediation analyses showed that 28% of the observed association between cumulative harassment and insomnia, and 15% of the association between cumulative harassment and sleep duration, was mediated by frequency of nightmares.
Does clinically relevant psychopathology in adolescents necessarily require treatment or does it “grow out”?

ABSTRACT Objective: To determine the treatment effect of psychodynamic therapy for adolescents in comparison to normative developmental progression in two groups without treatment: healthy adolescents and adolescents with juvenile diabetes. Research Design and Methods: In a 3-wave longitudinal study, n = 531 adolescents (n = 303 treated adolescents, n = 119 healthy, n = 109 with diabetes) and their parents filled out psychopathology questionnaires (Youth Self-Report [YSR] and Child Behaviour Checklist [CBCL]). Growth curve modeling (GCM) was used to examine within-person change in psychopathology while controlling for stable between-person differences. Results: GCM analyses revealed significant within-person reductions in patients’ YSR and CBCL (d = 1.02–1.99) at the end of treatment. When accounted for the control groups’ developmental progression (d = .14–.94), patients’ within-person change remained significantly higher (d = .48-.82). In all three groups, parents rated the severity of psychopathology significantly lower, and within-person change significantly higher than the adolescents him/herself. Conclusions: Psychodynamic therapy led to a significant symptom reduction in treated adolescents and was superior to development-related symptom changes occurring in the two control groups. Hence, clinically relevant symptoms in adolescents do not “grow out”, but require psychotherapeutic treatment. Differences between adolescents and their parents in the evaluation of symptom severity and change require attention in psychotherapy treatment and research.
The effect of n-3 polyunsaturated fatty acids enriched hen eggs consumption on IgG and total plasma protein N-glycosylation in healthy individuals and cardiovascular patients.

OBJECTIVE This study determined the effect of n-3 PUFAs enriched hen eggs consumption on IgG and total plasma protein N-glycan profiles and inflammatory biomarkers level in healthy individuals (N = 33) and cardiovascular (CV) patients (N = 21). MATERIALS AND METHODS Subjects were divided to Control-Healthy and Control-CV subgroups (consumed three regular hens' eggs/daily (249 mg n-3 PUFAs/day)), and n-3-PUFAs-Healthy and n-3-PUFAs-CV subgroups (consumed three n-3 PUFAs enriched hen eggs/daily (1053 mg n-3 PUFAs/day)) for 3 weeks. Serum free fatty acids profile and high-sensitivity C reactive protein (hsCRP), interleukin 6 and 10 (IL-6, IL-10) and tumor necrosis factor alpha were measured. Total plasma protein and IgG N-glycome have been profiled before and after dietary protocols. RESULTS Serum n-3 PUFAs concentration significantly increased following n-3 PUFAs hen eggs consumption in both n-3-PUFAs-Healthy and n-3-PUFAs-CV. IL-10 significantly increased in both Healthy subgroups, while no change occurred in CV subgroups. Derived IgG N-glycan traits: bisecting GlcNAc (B) significantly decreased in n-3-PUFAs-Healthy, while agalactosylation (G0) and core fucosylation (CF) significantly increased in Control-Healthy. Derived total plasma protein N-glycan traits: high branching glycans (HB), trigalactosylation (G3), tetragalactosylation (G4), trisialylation (S3), tetrasialylation (S4) and antennary fucosylation (AF) significantly decreased, while G0, monogalactosylation (G1), neutral glycans (S0), B, CF and oligomannose structures (OM) significantly increased in n-3 PUFAs-CV. Digalactosylation (G2) significantly decreased, and G0, G1, S0, disialylation (S2), B and CF significantly increased in Control-CV. CONCLUSIONS n-3 PUFAs consumption alters IgG N-glycan traits and IL-10 in healthy individuals, and total plasma protein N-glycan traits in CV patients, by shifting them toward less inflammatory N-glycosylation profile.
Cyclic fatigue and torsional resistance evaluation of Reciproc R25 instruments after simulated clinical use.

BACKGROUND To assess the influence of multiple uses on the cyclic flexural fatigue and torsional resistance of Reciproc R25 (REC) instruments. METHODS 256 canals (2 for each mandibular molar) were prepared using Reciproc R25 instruments. A total of 96 25-mm-long Reciproc R25 instruments were divided in six groups (n=8) on the basis of different number of canal shaped: new instruments (control group), 1, 2, 3, 4 or 6 canals shaped during simulated clinical use for other groups respectively. Sixteen files were used for each of the six groups (8 instruments for cyclic fatigue test and 8 ones for torsional test). Times to fracture (TtF) for cyclic fatigue and ultimate torsional strength and angle of rotation to fracture for torsional resistance were recorded. Data were statistically evaluated by the analysis of variance (ANOVA) with P<. 05. RESULTS As for cyclic fatigue resistance, there was no significant difference between new REC and REC used in one, two and three canals respectively (P>.05). REC used in four and six canals showed significant lower times to fracture when compared with other groups (P<.05) with REC used in six canals showing the significant lowest times to fracture (P<.05). Considering torsional resistance parameters, no significant difference was observed between the new and used instruments (P>.05). CONCLUSIONS REC25 files showed a significant decrease in cyclic fatigue resistance only when used in four or more molar canals while their torsional behavior was not affected by multiple uses.
Incidence and Outcomes of Acute Kidney Injury in COVID-19: A Systematic Review

Background and Objectives: The recent worldwide pandemic of COVID-19 has been a serious, multidimensional problem that has left a detrimental worldwide impact on individuals of all ages and several organ systems. The typical manifestation of kidney involvement is acute kidney injury (AKI); however, there is a lack of consensus data regarding AKI epidemiology in COVID-19. This systematic literature review aims to bridge this knowledge gap. Design, Setting, Participants, and Measurements: MEDLINE and Cochrane library were systematically searched for the literature related to AKI in COVID-19 patients of all ages. MedRxIV was searched for relevant unpublished manuscripts. Two reviewers independently assessed the literature on the incidence of AKI and mortality, extracting the need for kidney replacement therapy (KRT). Results: Sixty studies (n = 43,871 patients) were included in this review. The pooled incidence of AKI among COVID-19 patients was 19.45% (95% confidence intervals [95% CI]: 14.63–24.77%), while the pooled incidence of AKI COVID-19 patients requiring KRT was 39.04% (16.38–64.57%). The pooled proportion of COVID+ patients was significantly lower at 8.83% (5.64% to 12/66%). The overall mortality of COVID-19 patients was calculated to be 17.71% (95% CI: 11.49–24.93%), while the mortality among patients with AKI was higher at 54.24% (95% CI: 44.70–63.63%). Conclusion: This comprehensive systematic review summarizes the available literature pertaining to AKI epidemiology in COVID-19 patients and highlights the incidence, associated mortality, and the need for KRT in this susceptible population.