Repository of Research and Investigative Information Isfahan University of Medical Sciences
Not a member yet
23244 research outputs found
Sort by
A randomized, two-armed, double-blind, single-dose, cross-over, bioequivalence clinical trial to compare pharmacokinetic parameters and safety of recombinant human factor VIII with Fc fusion produced by AryoGen Pharmed Company versus Elocta® (reference product) in previously treated patients with severe haemophilia A
No full textThis clinical study evaluates the bioequivalence of recombinant factor VIII with Fc fusion protein (rFVIII-Fc) developed by AryoGen Pharmed Company compared to the reference product, Elocta (R) by Sobi Co., in severe haemophilia A patients. Fc-fused recombinant factor VIII represents a significant advancement in haemophilia A treatment, offering extended half-life and reduced infusion frequency, thus improving patients' adherence to treatment and quality of life. In a randomized, double-blind, single-dose crossover trial, 50 Iranian patients were assigned to treatment groups in a 1:1 ratio. Subjects received both the test and the reference product with a 7-day washout period between treatments. Pharmacokinetic assessments were conducted over five days post-administration to evaluate the primary outcome, the dose-normalized area under the curve (DNAUC). The results established bioequivalence between rFVIII-Fc (AryoGen Pharmed Company) and Elocta (R), based on the DNAUC as the primary outcome, in which the ratio of test and reference products was calculated to be 108.56 (90 confidence interval 104.88 to 112.37), falling within the pre-defined equivalence margin of 80-125. Secondary outcomes, including area under the curve (AUCinf), maximum concentration (Cmax), and half-life, further supported bioequivalence. Safety profiles were comparable, with adverse events mainly related to haemophilia A rather than the intervention. In conclusion, the rFVIII-Fc product is bioequivalent to Elocta (R) with a similar safety profile, offering an effective alternative for severe haemophilia A patients. This trial was registered in ClinicalTrials.gov (NCT06137092)
Association between diffusion tensor imaging measurements and cognitive performances in people with multiple sclerosis: A systematic review and meta-analysis
No full textBackground: Alterations in structural connectivity of brain networks have been linked to complex cognitive functions in people with multiple sclerosis (PwMS). However, a definitive consensus on the optimal diffusion tensor imaging (DTI) markers as indicators of cognitive performance remains incomplete and inconclusive. This systematic review and meta-analysis aimed to explore the evidence on the correlation between DTI metrics and cognitive functions in PwMS. Methods: A comprehensive literature search was conducted across PubMed/MEDLINE, Embase, Scopus, and the Web of Science up to March 2024 to identify studies reporting the correlation between DTI metrics and cognitive functions. Cognitive function was assessed using the Symbol Digit Modalities Test (SDMT), California Verbal Learning Test (CVLT), and Brief Visuospatial Memory Test-Revised (BVMT-R). The pooled correlation coefficients were estimated using R software version 4.4.0 with the random effect model. Results: Out of 1952 studies, 38 studies on 2055 PwMS fulfilled the inclusion criteria. The meta-analysis indicated that the SDMT exhibited the greatest correlation with corpus callosum fractional anisotropy (FA) (r = 0.54, 95 CI: 0.4 to 0.66, p-value < 0.001, I-2 = 34.1 , p-heterogeneity = 0.19) and mean diffusivity (MD) (r = -0.48, 95 CI: 0.61 to -0.33, p-value < 0.001, I-2 = 0 , p-heterogeneity = 0.77), white matter FA (r = 0.39, 95 CI: 0.24 to 0.52, p-value < 0.001, I-2 = 0 , p-heterogeneity = 0.1), and fornix FA (r = 0.35, 95 CI: 0.12 to 0.54, p-value = 0.003, I-2 = 50.7 , p-heterogeneity = 0.18) and MD (r = -0.35, 95 CI: 0.49 to -0.19, p-value < 0.001, I-2 = 0 , p-heterogeneity = 0.5). Conclusion: DTI measurements, including corpus callosum FA and MD, white matter FA, and fornix FA and MD, represent the indicators of cognitive performance in PwMS. Nonetheless, these findings warrant cautious interpretation due to the restricted kinds of cognitive tests and methodological variability across studies
The Role of Nurse Social Support in Hospital Readmission in Patients With Heart Failure: A Cross-Sectional Study
No full textBackground and Aims: Hospitalizations and hospital readmissions account for 75-80 of the economic burden related to heart failure (HF). This study aims to determine the relationship between perceived social support from nurses and hospital readmission rates in HF patients and to identify potential factors associated with hospital readmission, including sociodemographic and clinical variables, perceived social support, and country. Method: We recruited 380 HF patients from two countries (Iceland 92 and Iran 288) from October 2018 to May 2020. We used the social support scale of the Family Functioning, Health, and Social Support (FAFHES) questionnaire for data collection. The hospital readmission rates were collected from patients' hospital records. We performed a general linear model (GLM) to explore the significant factors associated with readmission. Results: A total of 125 (33) patients were readmitted within 6 months. Among them, 17 were readmitted once, 15 were readmitted twice, and 1 were readmitted three times. The strongest factor associated with the hospital readmission rate was perceived social support. Other significant factors included unemployment, age, and country of residence. Conclusion: This study underlines the important role of perceived social support in hospital readmission among HF patients. Our findings may be useful for better tailoring social support for HF patients to reduce hospital readmission. Moreover, it is recommended to investigate the effects of system-related factors, such as the strategy of healthcare systems in managing HF, on hospital readmissions
The diagnostic value of prolactin adjustment in bilateral inferior petrosal sinus sampling for differentiating Cushing's disease from the ectopic ACTH syndrome: a systematic review and meta-analysis
No full textBackground Adrenocorticotropin (ACTH)-dependent Cushing's syndrome can arise from a pituitary tumour (Cushing's disease) or an ectopic ACTH-secreting tumour, making precise differentiation essential for effective treatment. Bilateral inferior petrosal sinus sampling (BIPSS) is the gold standard for this differentiation, but false-negative results can limit its accuracy. Adding prolactin (PRL) measurement to BIPSS has been proposed to improve diagnostic precision. This meta-analysis evaluates how correction for prolactin levels ('prolactin adjustment') affects the diagnostic value of BIPSS in distinguishing Cushing's disease from ectopic ACTH syndrome. Methods A systematic literature search was conducted in PubMed, Scopus, EMBASE, Web of Science, and Google Scholar up to July 2024. Studies were included if they provided data on BIPSS with and without PRL adjustment for ACTH-dependent Cushing's syndrome. Data extraction and quality assessment were performed, and diagnostic accuracy metrics were analysed using bivariate generalised linear mixed modelling. Results A total of 10 studies with 310 participants were included. The pooled sensitivity and specificity of BIPSS with PRL adjustment were 0.96 (95 CI: 0.93-0.98) and 0.68 (95 CI: 0.52-0.81), respectively. The diagnostic odds ratio (DOR) was 48.0 (95 CI: 19.0-123.0), with a positive likelihood ratio (LR) of 3.00 (95 CI: 1.9-4.7) and a negative LR of 0.06 (95 CI: 0.03-0.12). The area under the summary receiver operating characteristic (SROC) curve was 0.95 (95 CI: 0.93-0.97). For BIPSS without PRL adjustment, the pooled sensitivity was 0.90 (95 CI: 0.86-0.93) and specificity was 0.74 (95 CI: 0.59-0.85), with a DOR of 27.0 (95 CI: 13.0-59.0). The SROC curve area was 0.92 (95 CI: 0.89-0.94). Prolactin adjustment improved sensitivity (P < 0.01) without a significant change in specificity (P = 0.13). Conclusions Prolactin adjustment in BIPSS slightly improves sensitivity for diagnosing Cushing's disease but does not enhance specificity for ectopic ACTH syndrome. This highlights the value of PRL measurement in improving diagnostic accuracy and reducing false negatives, while BIPSS remains crucial for ruling out EAS in clinical practice
Investigating treatment alternatives for fingolimod in patients with multiple sclerosis developed refractory fingolimod-related genital Human Papilloma Virus (HPV) infection
No full textIntroduction: Genital human papillomavirus (HPV) infection is a rare skin complication in patients with relapseremitting multiples sclerosis (RRMS) treated with fingolimod. Herein, we aimed to report a case series of 23 MS patients who had to discontinue fingolimod due to persistent HPV infection. Materials and methods: This retrospective case series was conducted between September 2023 to September 2024 in six MS centers in Iran to identify the outcome of HPV infection who discontinued fingolimod. Results: 23 patients with a mean age of 36.34 + 6.90 -year-old. The majority of patients were female (78.3 ) with a mean disease duration of 3.83 + 3.02 years, and a mean EDSS score of 1.26 + 1.10 at the time of fingolimod initiation. Most patients (39.1) were treatment na & iuml;ve. They developed genital HPV infection after a mean 32.21+ 25.15 months of using fingolimod. Most patients (78.3) were affected by low risk HPV infection and received a mean 1.96+ 1.43 cycles of cryotherapy. After a mean 14.30+11.05 months, all patients had to discontinue treatment, mainly switched to anti-CD20 agents (78.3). The lesions were resolved after a mean 4.52+ 3.11 months. In addition, except for two patients developing a rebound after fingolimod cessations, others were stable with no evidence of disease activity or progression over a one-year follow-up. Conclusion: Our preliminary results revealed that anti-CD20s agents could be considered safe in patients treated with fingolimod who had to discontinue treatment due to persistent HPV infection. Larger studies are needed to warrant our data
Ozone-Based Oxidation Treatment to Enhance Food Drying Rate and Quality: Mechanisms, Current Knowledge, and Future Outlook
No full textAgriculture is a significant part of the gross domestic product of almost all nations. Food production is a priority to sustain ever-increasing populations. Since food production is seasonal, long-term storage is imperative. Drying is a predominant processing technique for effective storage, used in the agri-food sector for moisture reduction, hence inactivating the numerous microorganisms (both spoilage and pathogenic) in food products and increasing shelf life. This technique, however, is known to cause significant changes in the natural quality of treated products. Ozone processing is a potential pretreatment technique that can drive the drying process affirmatively in terms of processing factors and overall keeping quality without leaving any trace residues. This review covers recent research and applications and focuses on the effectiveness, pros and cons, challenges, and limitations of ozone pretreatment on the drying of agricultural products. Alongside the numerous mathematical models demonstrating the behavior of pretreated products during the drying process, it is shown how ozonation can enhance drying, save energy, and shorten the drying time. It extends the shelf life and improves textural properties, antioxidant activity, phenolic content, nutritional, and color profile of dehydrated products. However, excessive ozone concentration and prolonged treatment time can have detrimental effects. Overall, it is an efficient hurdle technology for preserving products with better retention of natural properties. However, the challenges to scaling up ozonation need to be addressed to bring this technology to commercial implementation
Effects of Spirulina (Arthrospira) platensis supplementation on intestinal permeability, antioxidant and inflammatory markers, quality of life and disease severity in patients with constipated-predominant irritable bowel syndrome: a randomized double‑blind, placebo‑controlled trial
No full textBACKGROUND: Irritable bowel syndrome (IBS) is a chronic, functional gastrointestinal disorder (FGID) which is characterized by chronic pain related to defecation and alteration in GI motility. Recent findings indicated that intestinal barrier dysfunction, hyperpermeability, oxidative stress, and inflammation play a role in IBS pathogenesis. Considering the antioxidant properties of Spirulina (Arthrospira) platensis (SP), this study aimed to investigate the effect of SP supplementation on Quality of life (QoL), disease severity, antioxidant capacity, oxidative stress index and intestinal permeability in constipation-dominant IBS (IBS-C) patients. METHODS: This study was a parallel randomized, double-blind, placebo-controlled clinical trial involving 60 IBS-C patients aged 18-50 years. The patients were given either 1 g SP (two capsules/day; each capsule contained 500 mg of SP) or placebo for 12 weeks. IBS-QoL, IBS-Severity system score (IBS-SSS), plasma total antioxidant capacity (TAC), malondialdehyde (MDA), and zonulin levels were measured at baseline and the end of the intervention. Univariate comparison and intention-to-treat (ITT) were used for analysis. RESULTS: SP supplementation compared to placebo resulted in a significant increase in QoL score (7.05 +/- 2.02 vs. - 1.57 +/- 2.49; p = 0.008), TAC (145.27 +/- 30.77 vs. -54.90 +/- 45.72; p < 0.001) and decrease in IBS-SSS (-32.17 +/- 8.96 vs. 1.07 +/- 8.49; p = 0.002), MDA level (- 11.61 +/- 2.57 vs. - 2.00 +/- 2.24; p < 0.001) and zonulin level (- 0.22 +/- 0.05 vs. 0.12 +/- 0.07; p = 0.001). These results remained significant after adjusting for baseline values. CONCLUSIONS: SP supplementation demonstrated a promising effect in the management of IBS. However, larger trials with a dose-dependent approach in IBS-C and other subtypes of IBS are warranted. TRIAL REGISTRATION: The study protocol was approved by the ethical committee at the Isfahan University of Medical Sciences (Registration No. IR.MUI. RESEARCH: REC.1401.370) and registered online at http://www.IRCT.ir (code: IRCT20140208016529N8, approved date 25.04.2023)
Enhancing adhesive performance with N, N, N', N'-tetrakis (2-pyridyl methyl) ethylenediamine matrix metalloproteinase inhibitors: A comprehensive study of degree of conversion, microleakage, and micro-tensile bond strength in dental adhesives
No full textAIM: Matrix metalloproteinases (MMPs) play a significant role in the degradation of dentin collagen within hybrid layers, affecting the longevity of resin-bonded restorations. The incorporation of MMP inhibitors into dental adhesives has been explored to address this issue. This study aimed to assess the impact of the MMP inhibitor, N, N, N', N'-Tetrakis (2-pyridyl methyl) ethylenediamine (TPEN), on key adhesive properties, including the degree of conversion (DC), microleakage, and micro-tensile bond strength, shedding light on their potential in enhancing bond durability. SUBJECTS AND METHODS: Microleakage evaluations were conducted on 24 premolar specimens, while micro-tensile bond strength measurements were performed on the buccal surface of dentin samples. The DC was determined using Fourier Transform Infrared spectroscopy (FTIR) spectroscopy. RESULTS: The findings revealed no significant difference in DC between the adhesive with MMP inhibitors and the control group (P = 0.998). Remarkably, the adhesive containing the MMP inhibitor, TPEN, exhibited significantly higher micro-tensile bond strength than the control group (P = 0.008). However, there was no notable distinction between the two groups concerning microleakage (P = 0.085). CONCLUSION: The results suggest that including TPEN can effectively enhance micro-tensile bond strength in dental adhesives without compromising DC or exacerbating microleakage. This highlights the potential of MMP inhibitors in improving bond durability in restorative dentistry
Evaluating the anti-neuropathic effects of the thymol-loaded nanofibrous scaffold in a rat model of spinal cord injury
No full textBACKGROUND: Spinal cord injury (SCI) is a debilitating condition characterized by partial or complete loss of motor and sensory function caused by mechanical trauma to the spinal cord. Novel therapeutic approaches are continuously explored to enhance spinal cord regeneration and functional recovery. PURPOSE: In this study, we investigated the efficacy of the poly(vinyl alcohol) and chitosan (PVA/CS) scaffold loaded with different thymol concentrations (5, 10, and 15 wt) in a rat compression model for SCI treatment compare to other (e.g., thymol and scaffold) control groups. RESULTS AND DISCUSSION: The thymol-loaded scaffold exhibited a smooth surface and a three-dimensional nanofibrous structure with nanoscale diameter. The conducted analyses verified the successful incorporation of thymol into the scaffold and its high water absorption, porosity, and wettability attributes. Behavioral assessment of functional recovery showed improving sensory and locomotor impairment. Furthermore, histopathological examinations indicated the regenerative potential of the thymol-loaded nanofiber scaffold, by neuronal survival. CONCLUSION: Therefore, these findings suggest that the thymol-loaded nanofibrous scaffolds have promising pharmacological activities for alleviating neuropathic pain and addressing complications induced by SCI
Impact of platform switching implants on crestal bone level: A systematic review and meta-analysis
No full textSTATEMENT OF PROBLEM: Despite the widespread success of dental implants, crestal bone loss (CBL) remains a significant challenge, compromising long-term stability and esthetics. PURPOSE: The purpose of this systematic review and meta-analysis was to evaluate the effectiveness of platform switching in reducing CBL compared with conventional implant designs. MATERIAL AND METHODS: This systematic review and meta-analysis used primary and alternate search terms (identified through MeSH searching) to retrieve relevant studies published up to April 2024 from global databases, including PubMed (Medline), Scopus, Embase, Web of Science, Cochrane Library, and ClinicalTrials.gov. The random-effects model was applied to calculate the weighted mean differences (WMD) and 95 confidence interval (95 CI) of the CBL for the meta-analysis. The quality of the included studies was assessed with the Cochrane Risk of Bias Tool (RoB 2). RESULTS: The meta-analysis revealed that the platform-switching technique significantly reduced CBL compared with conventional implant designs. On average, implants with platform switching showed a 0.22-mm reduction in CBL (WMD=-0.22; 95 CI=-0.39, -0.05; I(2)=58.18; P(heterogeneity)=.069). Subgroup analyses indicated that this reduction was most pronounced for single implants (WMD=-0.42; 95 CI=-0.49, -0.35) and at the posterior mandible site (WMD=-0.48; 95 CI=-1.11, -0.15). Conventional loading restorations also showed a greater decrease in CBL compared with immediate and functional loading (WMD=-0.33 versus -0.06 and -0.08). Additionally, longer follow-up periods beyond 36 months resulted in a more substantial reduction in CBL (WMD=-0.50; 95 CI=-0.55, -0.45). CONCLUSIONS: These findings support the use of platform switching as a strategy to enhance implant stability and long-term outcomes, highlighting its potential for improving clinical practices in implant dentistry. Further research is recommended to confirm these benefits and explore the underlying mechanisms