Categories
Nevin Manimala Statistics

The effect of bitter almond (Amygdalus communis L. var. Amara) gum as a functional food on metabolic profile, inflammatory markers, and mental health in type 2 diabetes women: a blinded randomized controlled trial protocol

Trials. 2023 Jan 17;24(1):35. doi: 10.1186/s13063-023-07085-7.

ABSTRACT

BACKGROUND: Using functional foods in the prevention and treatment of type 2 diabetes mellitus (T2DM) has increased across the world owing to their availability, cultural acceptability, and lower side effects. The present study will aim to examine the impact of bitter almond (Amygdalus communis L. var. Amara) gum as a functional food on metabolic profile, inflammatory markers, and mental health in women with T2DM.

METHODS: We will conduct a randomized, triple-blind, placebo-controlled trial. A total of 44 women with T2DM will be randomly allocated into two groups: an intervention group (n = 20) and a placebo group (n = 20). Patients will receive either 5 g/d of bitter melon gum or a placebo for 8 weeks. Clinical and biochemical outcome parameters which include glycemic indices, lipid profile, inflammatory markers, oxidative stress indices, tryptophan (Trp), kynurenine (KYN), cortisol, glucagon-like peptide 1 (GLP-1), leptin, adiponectin, ghrelin, peroxisome proliferator-activated receptor (PPAR) gene expression, brain-derived neurotrophic factor (BDNF), endothelial cell adhesion molecules, plasminogen, cluster deference 4 (CD4), cluster deference 8 (CD8), anthropometric indices, blood pressure, dietary intake, and mental health will be measured at the baseline and end of the study. Statistical analysis will be conducted using the SPSS software (version 24), and P value less than 0.05 will be considered statistically significant.

DISCUSSION: The present randomized controlled trial will aim to investigate any beneficial effects of bitter almond gum supplementation on the cardio-metabolic, immune-inflammatory, and oxidative stress biomarkers, as well as mental health in women with T2DM.

ETHICS AND DISSEMINATION: The study protocol was approved by the Ethical Committee of the Tabriz University of Medical Sciences (IR.TBZMED.REC.1399.726).

TRIAL REGISTRATION: Iranian Registry of Clinical Trials ( www.irct.ir/IRCT20150205020965N7 ).

PMID:36650599 | DOI:10.1186/s13063-023-07085-7

Categories
Nevin Manimala Statistics

Electric impedance tomography-guided PEEP titration reduces mechanical power in ARDS: a randomized crossover pilot trial

Crit Care. 2023 Jan 17;27(1):21. doi: 10.1186/s13054-023-04315-x.

ABSTRACT

BACKGROUND: In patients with acute respiratory distress syndrome undergoing mechanical ventilation, positive end-expiratory pressure (PEEP) can lead to recruitment or overdistension. Current strategies utilized for PEEP titration do not permit the distinction. Electric impedance tomography (EIT) detects and quantifies the presence of both collapse and overdistension. We investigated whether using EIT-guided PEEP titration leads to decreased mechanical power compared to high-PEEP/FiO2 tables.

METHODS: A single-center, randomized crossover pilot trial comparing EIT-guided PEEP selection versus PEEP selection using the High-PEEP/FiO2 table in patients with moderate-severe acute respiratory distress syndrome. The primary outcome was the change in mechanical power after each PEEP selection strategy. Secondary outcomes included changes in the 4 × driving pressure + respiratory rate (4 ΔP, + RR index) index, driving pressure, plateau pressure, PaO2/FiO2 ratio, and static compliance.

RESULTS: EIT was consistently associated with a decrease in mechanical power compared to PEEP/FiO2 tables (mean difference – 4.36 J/min, 95% CI – 6.7, – 1.95, p = 0.002) and led to lower values in the 4ΔP + RR index (- 11.42 J/min, 95% CI – 19.01, – 3.82, p = 0.007) mainly driven by a decrease in the elastic-dynamic power (- 1.61 J/min, – 2.99, – 0.22, p = 0.027). The elastic-static and resistive powers were unchanged. Similarly, EIT led to a statistically significant change in set PEEP (- 2 cmH2O, p = 0.046), driving pressure, (- 2.92 cmH2O, p = 0.003), peak pressure (- 6.25 cmH2O, p = 0.003), plateau pressure (- 4.53 cmH2O, p = 0.006), and static respiratory system compliance (+ 7.93 ml/cmH2O, p = 0.008).

CONCLUSIONS: In patients with moderate-severe acute respiratory distress syndrome, EIT-guided PEEP titration reduces mechanical power mainly through a reduction in elastic-dynamic power. Trial registration This trial was prospectively registered on Clinicaltrials.gov (NCT03793842) on January 4th, 2019.

PMID:36650593 | DOI:10.1186/s13054-023-04315-x

Categories
Nevin Manimala Statistics

Semiautomated pelvic lymph node treatment response evaluation for patients with advanced prostate cancer: based on MET-RADS-P guidelines

Cancer Imaging. 2023 Jan 17;23(1):7. doi: 10.1186/s40644-023-00523-4.

ABSTRACT

BACKGROUND: The evaluation of treatment response according to METastasis Reporting and Data System for Prostate Cancer (MET-RADS-P) criteria is an important but time-consuming task for patients with advanced prostate cancer (APC). A deep learning-based algorithm has the potential to assist with this assessment.

OBJECTIVE: To develop and evaluate a deep learning-based algorithm for semiautomated treatment response assessment of pelvic lymph nodes.

METHODS: A total of 162 patients who had undergone at least two scans for follow-up assessment after APC metastasis treatment were enrolled. A previously reported deep learning model was used to perform automated segmentation of pelvic lymph nodes. The performance of the deep learning algorithm was evaluated using the Dice similarity coefficient (DSC) and volumetric similarity (VS). The consistency of the short diameter measurement with the radiologist was evaluated using Bland-Altman plotting. Based on the segmentation of lymph nodes, the treatment response was assessed automatically with a rule-based program according to the MET-RADS-P criteria. Kappa statistics were used to assess the accuracy and consistency of the treatment response assessment by the deep learning model and two radiologists [attending radiologist (R1) and fellow radiologist (R2)].

RESULTS: The mean DSC and VS of the pelvic lymph node segmentation were 0.82 ± 0.09 and 0.88 ± 0.12, respectively. Bland-Altman plotting showed that most of the lymph node measurements were within the upper and lower limits of agreement (LOA). The accuracies of automated segmentation-based assessment were 0.92 (95% CI: 0.85-0.96), 0.91 (95% CI: 0.86-0.95) and 75% (95% CI: 0.46-0.92) for target lesions, nontarget lesions and nonpathological lesions, respectively. The consistency of treatment response assessment based on automated segmentation and manual segmentation was excellent for target lesions [K value: 0.92 (0.86-0.98)], good for nontarget lesions [0.82 (0.74-0.90)] and moderate for nonpathological lesions [0.71 (0.50-0.92)].

CONCLUSION: The deep learning-based semiautomated algorithm showed high accuracy for the treatment response assessment of pelvic lymph nodes and demonstrated comparable performance with radiologists.

PMID:36650584 | DOI:10.1186/s40644-023-00523-4

Categories
Nevin Manimala Statistics

The impact of different researchers to capture quality of life measures in a dementia randomised controlled trial

Trials. 2023 Jan 17;24(1):33. doi: 10.1186/s13063-022-07064-4.

ABSTRACT

BACKGROUND: Capturing changes in health and wellbeing within randomised controlled trials (RCTs) can be complex. The precision and accuracy of outcome scales to measure change is crucial, and therefore, consideration needs to be given to potential measurement errors when collecting these outcomes. Many RCTs use multiple researchers to collect data, which has the potential to introduce variation in measurements. This study aimed to identify if there was a measurable effect of using different researchers to collect repeated assessments of quality of life (QoL) at different time points.

METHODS: A previously conducted study assessing the impact of reminiscence therapy on participants with dementia and carer (PwD-carer) dyads, ‘REMCARE’ (Reminiscence groups for people with dementia and their family caregivers), provided the platform for this exploratory secondary analysis. Data was categorised into two broad groups: those where the same researcher attended all assessments and those where different researchers undertook the assessments. ANCOVA (analysis of covariance) models used in the original REMCARE analysis with the addition of the ‘researcher-continuity’ variable were run on two QoL measures, the QoL-AD (Quality of Life in Alzheimer’s Disease) and QCPR (Quality of the Caregiving Relationship).

RESULTS: Three hundred thirty PwD-carer dyads were included in the analysis. For the PwD, a statistically significant effect was found on the researcher continuity variable for the QoL-AD and QCPR outcome measures at follow-up 1 but not at follow-up 2 signifying an impact of researcher attendance at the first follow-up but not follow-up 2. For the carer data, analyses revealed no statistically significant effects at follow-up 1; however, the QoL-AD measure at follow-up 2 was found to be statistically significant.

CONCLUSIONS: These exploratory results indicate the possible impact of researcher continuity on QoL outcomes in dementia studies. Further research is required to explore this further and establish causality. If demonstrated, this would have implications for the planning of future empirical studies in dementia, in order to reduce this potential source of bias.

PMID:36650552 | DOI:10.1186/s13063-022-07064-4

Categories
Nevin Manimala Statistics

Frailty impacts immune responses to Moderna COVID-19 mRNA vaccine in older adults

Immun Ageing. 2023 Jan 17;20(1):4. doi: 10.1186/s12979-023-00327-x.

ABSTRACT

BACKGROUND: Immune responses to COVID-19 mRNA vaccines have not been well characterized in frail older adults. We postulated that frailty is associated with impaired antibody and cellular mRNA vaccine responses.

METHODS: We followed older adults in a retirement facility with longitudinal clinical and serological samples from the first Moderna mRNA-1273 vaccine dose starting in February 2021 through their 3rd (booster) vaccine dose. Outcomes were antibody titers, antibody avidity, and AIM+ T cell function and phenotype. Statistical analysis used linear regression with clustered error for antibody titers over multiple timepoints with clinical predictors including, age, sex, prior infection status, and clinical frailty scale (CFS) score. T cell function analysis used linear regression models with clinical predictors and cellular memory phenotype variables.

RESULTS: Participants (n = 15) had median age of 90 years and mild, moderate, or severe frailty scores (n = 3, 7, or 5 respectively). Over the study time course, anti-spike antibody titers were 10-fold higher in individuals with lower frailty status (p = 0.001 and p = 0.005, unadjusted and adjusted for prior COVID-19 infection). Following the booster, titers to spike protein improved regardless of COVID-19 infection or degree of frailty (p = 0.82 and p = 0.29, respectively). Antibody avidity significantly declined over 6 months in all participants following 2 vaccine doses (p < 0.001), which was further impaired with higher frailty (p = 0.001). Notably, avidity increased to peak levels after the booster (p < 0.001). Overall antibody response was inversely correlated with a phenotype of immune-senescent T cells, CD8 + CD28- TEMRA cells (p = 0.036, adjusted for COVID-19 infection). Furthermore, there was increased detection of CD8 + CD28- TEMRA cells in individuals with greater frailty (p = 0.056, adjusted for COVID-19).

CONCLUSIONS: We evaluated the immune responses to the Moderna COVID-19 mRNA vaccine in frail older adults in a retirement community. A higher degree of frailty was associated with diminished antibody quantity and quality. However, a booster vaccine dose at 6 months overcame these effects. Frailty was associated with an increased immune-senescence phenotype that may contribute to the observed changes in the vaccine response. While the strength of our conclusions was limited by a small cohort, these results are important for guiding further investigation of vaccine responses in frail older adults.

PMID:36650551 | DOI:10.1186/s12979-023-00327-x

Categories
Nevin Manimala Statistics

FASN multi-omic characterization reveals metabolic heterogeneity in pancreatic and prostate adenocarcinoma

J Transl Med. 2023 Jan 17;21(1):32. doi: 10.1186/s12967-023-03874-5.

ABSTRACT

BACKGROUND: Pancreatic ductal adenocarcinoma (PDAC) and prostate cancer (PCa) are among the most prevalent malignant tumors worldwide. There is now a comprehensive understanding of metabolic reprogramming as a hallmark of cancer. Fatty acid synthase (FASN) is a key regulator of the lipid metabolic network, providing energy to favor tumor proliferation and development. Whereas the biological role of FASN is known, its response and sensitivity to inhibition have not yet been fully established in these two cancer settings.

METHODS: To evaluate the association between FASN expression, methylation, prognosis, and mutational profile in PDAC and PCa, we interrogated public databases and surveyed online platforms using TCGA data. The STRING database was used to investigate FASN interactors, and the Gene Set Enrichment Analysis platform Reactome database was used to perform an enrichment analysis using data from RNA sequencing public databases of PDAC and PCa. In vitro models using PDAC and PCa cell lines were used to corroborate the expression of FASN, as shown by Western blot, and the effects of FASN inhibition on cell proliferation/cell cycle progression and mitochondrial respiration were investigated with MTT, colony formation assay, cell cycle analysis and MitoStress Test.

RESULTS: The expression of FASN was not modulated in PDAC compared to normal pancreatic tissues, while it was overexpressed in PCa, which also displayed a different level of promoter methylation. Based on tumor grade, FASN expression decreased in advanced stages of PDAC, but increased in PCa. A low incidence of FASN mutations was found for both tumors. FASN was overexpressed in PCa, despite not reaching statistical significance, and was associated with a worse prognosis than in PDAC. The biological role of FASN interactors correlated with lipid metabolism, and GSEA indicated that lipid-mediated mitochondrial respiration was enriched in PCa. Following validation of FASN overexpression in PCa compared to PDAC in vitro, we tested TVB-2640 as a FASN inhibitor. PCa proliferation arrest was modulated by FASN inhibition in a dose- and time-dependent manner, whereas PDAC proliferation was not altered. In line with this finding, mitochondrial respiration was found to be more affected in PCa than in PDAC. FASN inhibition interfered with metabolic signaling causing lipid accumulation and affecting cell viability with an impact on the replicative processes.

CONCLUSIONS: FASN exhibited differential expression patterns in PDAC and PCa, suggesting a different evolution during cancer progression. This was corroborated by the fact that both tumors responded differently to FASN inhibition in terms of proliferative potential and mitochondrial respiration, indicating that its use should reflect context specificity.

PMID:36650542 | DOI:10.1186/s12967-023-03874-5

Categories
Nevin Manimala Statistics

Evaluation of career planning group counseling and its effectiveness for intern male nursing students

BMC Med Educ. 2023 Jan 17;23(1):34. doi: 10.1186/s12909-022-03981-9.

ABSTRACT

OBJECTIVE: To investigate the influence of group counselling on the career planning and career maturity of male nursing students.

METHOD: Sixty male nursing students were randomly selected from a specific-level first-class hospital in Hunan Province from July to August 2020 by using the convenience sampling method and were subsequently divided into the control group and the experimental group using the random number table method. The control group received routine pre-job training, including aspects concerning the hospital profile, nurse etiquette, nursing core systems, professional ethics, nursing emergency treatment and career prospects and planning. In the experimental group, career planning group counselling was added after the regular pre-service training (once a week) with each session lasting 2 h for a total of six training sessions. At six weeks and three months after the intervention, the career status evaluation scale and the college students’ career maturity scale were used to compare the career planning and career maturity status of the two groups of male nursing students.

RESULTS: After six weeks and three months of intervention, all the dimensions and total scores of both the career status evaluation scale and the career maturity scale in the experimental group were superior to those in the control group with statistically significant differences (all P < 0.05). The repeated measures of variance analysis indicated that the differences in the total score for career planning and the four dimensions in terms of intergroup effect, time effect and interaction effect between the two groups were statistically significant (P < 0.05). The intergroup effect, time effect and interaction effect of the total score for vocational maturity, career goal, career confidence, career value, career freedom and career reference of the two groups were statistically significant (P < 0.05), while the time effect of the relative dependency dimension was also statistically significant (P < 0.05).

CONCLUSION: Group counselling can significantly improve the career planning and career maturity status of male nursing students and has a certain long-term effect.

PMID:36650532 | DOI:10.1186/s12909-022-03981-9

Categories
Nevin Manimala Statistics

Clinical outcomes of a novel porcine small intestinal submucosa patch for full-thickness hand skin defects: a retrospective investigation

J Orthop Surg Res. 2023 Jan 17;18(1):50. doi: 10.1186/s13018-023-03531-z.

ABSTRACT

OBJECTIVE: To investigate the clinical outcomes of a novel soft tissue repair patch (porcine small intestinal submucosa patch, SIS patch) in the treatment of full-thickness hand skin defects.

METHODS: From January 2017 to July 2019, 80 patients with hand soft tissue defects, who met the inclusion criteria, were retrospectively reviewed and divided into two groups. After debridement, patients in group A were treated with the novel SIS patch to cover the wound, and patients in group B were treated with autologous skin graft. The dimensions of skin defect area and healing outcome were evaluated and recorded. Scar assessment was carried out using Scar Cosmesis Assessment and Rating Scale (SCAR scale) at the last follow-up postoperation, and the recovery of wound sensation was assessed at the same time using British Medical Research Council (BMRC) grading of sensorimotor recovery. All the data were collected and statistically analyzed.

RESULTS: A total of 80 patients were enrolled in the study with 40 patients in each group. Four patients in group A and 5 patients in group B were excluded due to wound infection and lost to follow-up. There were 36 patients in group A and 35 patients in group B finally got follow-up postoperation with mean interval of 12.75 ± 5.61 months in group A and 14.11 ± 5.42 months in group B. The dimensions of skin defect area in group A ranged from 7.5 to 87.5 cm2 (mean 25.97 ± 18.66 cm2) and in group B ranged from 7.5 to 86.25 cm2 (mean 33.61 ± 19.27 cm2) which have no significant difference (P > 0.05). SCAR scale results of group A and group B were 10.98 ± 0.33 and 9.49 ± 0.35, respectively, and the difference was statistically significant (P < 0.05). BMRC grading results showed 6 cases of S4, 11 cases of S3+, 5 cases of S3, 6 cases of S2, 6 cases of S1 and 2 cases of S0 in group A, and 8 cases of S4, 10 cases of S3+, 7 cases of S3, 4 cases of S2, 5 cases of S1, and 1 case of S0 in group B, which had no significant difference between them (P > 0.05).

CONCLUSIONS: The novel SIS patch is an applicable biological material in the treatment of hand skin defect, which could achieve a better cosmetic appearance of the newborn skin tissue.

PMID:36650521 | DOI:10.1186/s13018-023-03531-z

Categories
Nevin Manimala Statistics

Prevalence of teenage pregnancy and its associated factors in high fertility sub-Saharan Africa countries: a multilevel analysis

BMC Womens Health. 2023 Jan 17;23(1):23. doi: 10.1186/s12905-023-02169-7.

ABSTRACT

BACKGROUND: Teenage pregnancies are persistently high among adolescent women in high fertility countries in sub-Saharan Africa. It has been attributed to the high unmet need for family planning in this population. The aim of this study was to determine the prevalence and factors associated with teenage pregnancy in high fertility countries in sub-Saharan Africa.

METHODS: Data for this study was obtained from the most recent Demographic and Health Surveys. A total weighted sample of 33,391 adolescent girls who had ever had sexual contact were included. A multilevel mixed-effect binary logistic regression model was fitted to identify the significant associated factors for teenage pregnancy. Finally, the Adjusted Odds Ratio (AOR) with a 95% confidence interval was used to declare as statistically significant.

RESULTS: The overall teenage pregnancy in sub-Saharan Africa high frtility countries was 24.88% (95% CI, 24.42, 25.35). Educational status; no formal education (AOR = 1.39, 95% CI, 1.23, 1.56) and primary education (AOR = 1.45, 95% CI, 1.30, 1.62), not working (AOR = 1.32, 95% CI, 1.21, 1.45), being married (AOR = 67.88, 95% CI, 61.33, 75.12), poor (AOR = 1.47, 95% CI, 1.32, 1.65) and middle wealth quantile (AOR = 1.21, 95% CI, 1.07, 1.35), knowledge about contracptives (AOR = 2.45, 95% CI, 2.19, 2.74), unmet need for family planning (AOR = 2.42, 95% CI, 2.14, 2.74), Angola (AOR = 9.59, 95% CI, 7.82, 11.77), Chad (AOR = 3.05, 95% CI, 2.49, 3.74), DR.Congo (AOR = 3.77, 95% CI, 3.06, 4.65), and Mali (AOR = 1.84, 95% CI, 1.47, 2.28) were factors significantly associated with teenage pregnancy.

CONCLUSIONS: This study found that teenage pregnancy remains a common public health problem in the study areas. Level of education, marital status, occupation, wealth index, unmet need for family planning, knowledge about contraceptives, and country were significantly associated with teenage pregnancy. Hence, for sustainable development goal 3 to be realized by 2030, there must be investment in policy implementation and evaluation, as well as engagement with stakeholders in adolescents’ sexual and reproductive health.

PMID:36650514 | DOI:10.1186/s12905-023-02169-7

Categories
Nevin Manimala Statistics

Potential factors that can affect the performance of undergraduate pharmacy research students: a descriptive study

BMC Med Educ. 2023 Jan 17;23(1):32. doi: 10.1186/s12909-023-04018-5.

ABSTRACT

OBJECTIVE: This descriptive study aimed to examine whether student past coursework performance, student or research supervisor characteristics, and the type of research project are related to the overall academic performance of a pharmacy student completing an honours research program.

METHODS: Data on undergraduate honours students who completed a Bachelor of Pharmacy degree at The University of Sydney, Sydney, Australia, between Jan 2015 and Dec 2020 was collected. This included socio-demographic characteristics, type of project undertaken, and academic outputs. Data was also collected on each supervisor’s academic role, level of experience, research area, and where they completed their PhD. Descriptive statistics were used to describe the study cohort and correlation analysis and unpaired t-tail analyses were conducted using SPSS software.

RESULTS: This five year study included 130 students of which 67% were female and 60% were domestic students. Each student was supervised by one of 48 individual academics who were a mix of early- (31%), mid-career (29%), and experienced researchers (40%) for pharmaceutical science (50%), clinical (45%), and education (5%) projects. Just less than half (49%) of students published one peer-reviewed journal article. Female students outperformed male students (p = 0.031) with female students also twice as likely (15%) to receive a university medal eligible mark compared with male students (7.0%). Similarly, domestic students were twice as likely (15%) to receive a university medal eligible mark when compared with international students (7.7%). Students who undertook a pharmaceutical science-based project outperformed education-based project students (p = 0.0235). Students who had published at least one peer-reviewed journal article outperformed those who had not published (p = 0.0014).

CONCLUSION: Factors that affected honours performance were student gender, residential status, type of project undertaken, and whether a student had published a peer-reviewed journal article.

PMID:36650513 | DOI:10.1186/s12909-023-04018-5