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2.2.1. ADOS-2 | ADOS-2 is a standard, semistructured diagnosis assessment of a range of activities focusing on reciprocal social interactions, communication and language, play, and restricted and repetitive, stereotyped interests and behaviours [ | PMC9920098 |
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2.2.2. SRS-2 | repetitive behaviors | SRS-2 is a norm-referenced quantitative assessment measuring 65 items about children’s behaviour. Parents/caregivers rate five subdomains (social awareness, social cognition, social communication, social motivation subdomains, and restricted, repetitive behaviors) [ | PMC9920098 |
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2.2.3. ABC | irritability, hyperactivity/noncompliance, lethargy/social withdrawal | SECONDARY | ABC, a secondary rating scale, was originally developed to assess the effectiveness of psychotropic medication and measures the severity of a range of behaviour problems across five subscales. At each follow-up, parents/caregivers evaluated subdomains as follows: irritability, lethargy/social withdrawal, stereotypic behaviour, hyperactivity/noncompliance, and inappropriate speech. Summary scores were used for psychometric analysis. | PMC9920098 |
2.3. Preparation of Sulforaphane-Rich Broccoli Sprouts and Placebo Powder | A sulforaphane-rich broccoli sprout/red radish sprout powder mix was prepared using BroccoPhaneThe placebo powder was prepared using spinach puree (Agro Jesenice, Zlatníky-Hodkovice, Czech Republic). The spinach puree was divided into aluminium dishes, cooled to −18 °C, lyophilized, and powdered. The placebo powder was filled into PE/AL storage bags containing 1.2 ± 0.1 g of powder load each. | PMC9920098 |
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2.4. Statistics | All analyses were completed using MedCalc version 20.010 (MedCalc Software Ltd., Ostend, Belgium) and OriginPro 8.5.0 SR1 (OriginLab Corporation, Northampton, MA, USA). Descriptive statistics were used to characterize the variables. A one-way repeated measures analysis of variances (ANOVA) followed by a Tukey post hoc test was used to determine whether three group means within each study group were different. Student’s | PMC9920098 |
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2.5. Ethics | All information was accessed in accordance with the applicable laws and ethical requirements for the study period concerned, and was compliant with the Declaration of Helsinki, revised in 2000. All parents/caregivers were thoroughly educated and consented at the screening visit. The study was approved by the Institutional Review Board (IRB) of the General University Hospital in Prague (Ethics Committee Approval Number: 158/19). | PMC9920098 |
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3. Results | PMC9920098 |
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3.1. Study Population | A total of 40 children qualified for our study and were randomized ( | PMC9920098 |
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3.2. Changes in Symptoms | SRS | The changes in SRS and ABC scores over the study period are shown in Changes in the assessment of the ADOS-2 subscale scores are presented in Subjects’ scores at 18 or 36 weeks were subtracted from the same individual’s scores at the time of previous observation; differences were averaged and are presented as the means ± SEMs. Subjects’ scores at 18 or 36 weeks were subtracted from the same individual’s scores at the time of previous observation; differences were averaged and are presented as the means ± SEMs. | PMC9920098 |
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3.3. Comparison of Parental and Trained Professional Ratings of Children’s ASD Symptoms or Feature Development | REGRESSION | We attempted to compare concordance and assess the eventual interchangeability of parents’ ratings of therapeutic efficacy in their children and the assessment of therapeutic efficacy performed by a trained professional. The parents’ impression scale was classified as follows: −1, the child worsened; 0, no noticeable change; and 1, the child improved somewhat [Clinical psychologists evaluated the regression of behavioural symptoms in probands at the end of the study. Approximately 80% of the children in both groups did not show clinical improvement. In contrast, no children in the placebo group were classified as having no further improvement based on their parents’ impression scale ratings, whereas only one child within the SFN group was assessed as having no further improvement by their parent. We compared the two assessment techniques using the Bland–Altman plot and statistics. The line of equality is not within either the 95% CI of the mean difference or the 95% CI of the regression curve, and the bias indicates a lack of agreement between the two methods of assessment. The parents’ ratings of therapeutic efficacy and the clinical assessments of child regression indicated a significant systematic difference (H | PMC9920098 |
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4. Discussion | ADOS | No significant clinical improvement was demonstrated in the behavioural outcome measures evaluated in ASD children aged 3–7 years treated with sulforaphane (SFN) in our study. The mean total raw scores on ABC and SRS-2 improved in the SFN and placebo groups, but none of the changes reached statistical significance. Changes in the assessment of the ADOS subscale scores also did not differ between the two study cohorts. There were no significant differences between the SFN and placebo groups at any time point or with any of the methods used. Similar to the ABS and SRS-2 surveys, the mean summary subscale scores on both visits mostly showed improvement, but the changes were also not significant.Numerous studies have revealed that placebo effects can affect the information capability of rating scales assessed by parents or caregivers [Contradicting trial results provided mixed evidence of the effect of SFN [Previous studies have reported that parents’/caregivers’ beliefs about how a treatment will work are efficacious. Parents tend to give favourable ratings to treatments that much research has shown to be ineffective. This was also shown in the parents of our patients. The vast majority of parents reported some clinical improvement irrespective of taking the SFN or placebo in the first phase with a lesser effect in the second phase of the study ( | PMC9920098 |
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5. Conclusions | autistic spectrum disorders | This investigation aimed to assess the effects of SFN on the reduction of ASD symptom severity. We examined a paediatric cohort of ASD patients aged three to seven years. We found no significant clinical improvement in the behavioural outcome measures evaluated in ASD children aged 3–7 years treated with sulforaphane (SFN). The evidence from this study suggests that, despite the reasonable level of knowledge of the action and metabolic pathways of SFN and proposed SFN-elicited cellular response, the clinical effects of SFN in ASD patients must be prudently evaluated. More thoughtful research is needed to better understand the true nature of the clinical benefits of SFN in the supportive treatment of ASD. Avenues for future research include large and longer-duration randomized controlled trials also considering the susceptibility to placebo effects that could provide more definitive evidence. If the debate is to be moved forwards, a better understanding of autistic spectrum disorders’ aetiology and underlying factors needs to be developed to avoid the boundless but vain hope for a miraculous treatment. | PMC9920098 |
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Author Contributions | J.T. | M.M. had a leadership role in the preparation and organization of the clinical study, performed the clinical examinations, and wrote the first draft of the manuscript. K.T. was the leading psychologist; she provided the clinical evaluations, organized the data collection, and critically revised the draft together with V.Ž. and I.Š. co-wrote and edited the manuscript and performed the statistical analyses and data evaluation. M.H. initiated the study and participated in the sulforaphane preparation. P.N., J.T., N.V., I.S. and L.J. took part in the sulforaphane and placebo preparation development and edited the manuscript. All authors have read and agreed to the published version of the manuscript. | PMC9920098 |
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Institutional Review Board Statement | All information was accessed in accordance with the applicable laws and ethical requirements for the study period concerned, and was compliant with the Declaration of Helsinki, revised in 2000. The study was approved by the Institutional Review Board (IRB) of the General University Hospital in Prague (Ethics Committee Approval Number: 158/19). | PMC9920098 |
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Informed Consent Statement | All parents/caregivers were thoroughly educated and consented at the screening visit. Informed consent was obtained from all subjects involved in the study. | PMC9920098 |
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Data Availability Statement | The data are available upon reasonable request to the corresponding author. | PMC9920098 |
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Conflicts of Interest | Ladislav Jílek is a co-owner of the Pure Food Norway Company, a business focusing on food supplements. This ownership and the funders had no role in the design of the study; in the collection, analyses or interpretation of data; in the writing of the manuscript; or in the decision to publish the results. | PMC9920098 |
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References | Autism | Enrollment, follow-up, and analysis of the clinical study.Effect of sulforaphane treatment on Aberrant Behaviour Checklist (ABC, upper panels) and Social Responsiveness Scale (SRS-2, lower panels) scores. SFN, sulforaphane group. Red dots represent score means.Effect of sulforaphane treatment on Autism Diagnostic Observation Schedule-2 (ADOS-2) subscale scores. SFN, sulforaphane group. Red dots represent score means.Baseline characteristics of patients.M, male; F, female; SD, standard deviation.Effect of sulforaphane treatment on Social Responsiveness Scale (SRS-2) scores.Effect of sulforaphane treatment on Aberrant Behaviour Checklist (ABC) scores.Effect of sulforaphane treatment on Autism Diagnostic Observation Schedule-2 (ADOS-2) scores.Frequencies of parental ratings of children’s ASD symptoms or feature development. The parents’ impression scale was classified as follows: −1, the child worsened; 0, no noticeable change; and 1, the child improved somewhat. * | PMC9920098 |
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Subject terms | The most common BRAF mutation is thymine (T) to adenine (A) missense mutation in nucleotide 1796 (T1796A, V600E). The BRAF | PMC10400539 |
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Introduction | tumor | MALIGNANCIES, TUMOR, THYROID NODULES, PAPILLARY THYROID CANCER | The BRAFMore importantly, According to earlier research, BRAFWith the increasing popularity of tumor thermal ablation technology (microwave, radio frequency, and laser) in China, an increasing number of patients with PTC, particularly those with minimal papillary thyroid cancer (MPTC), are willing to accept thermal ablation as a minimally invasive procedure to maximize the preservation of thyroid function. As a result, proper preoperative detection of BRAFThe main imaging method for evaluating thyroid nodules is ultrasound (US)Radiomics analysis using US images has been used to forecast the molecular characteristics of several malignancies, which include PTC | PMC10400539 |
Materials and methods | PMC10400539 |
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Patients | PTC | PAPILLARY THYROID CARCINOMA | A retrospective analysis was performed on PTC patients who had undergone preoperative thyroid US elastography, BRAFSchematic diagram of the patient selection. PTC, papillary thyroid carcinoma. | PMC10400539 |
Strain elastography ultrasound examination | calcification | BLOOD, THYROID NODULES | There were two ultrasonic devices used: the Philips Q5 (both Healthcare, Eindhoven, Netherlands) and the GE LOGIC E20 (GE Medical Systems, American General) (L12-5 linear array probe, frequency: 10–14 MHz).To acquire longitudinal and transverse images of the thyroid nodules, continuous longitudinal and transverse scanning was done while the patients were supine. Blood flow in and around the nodule, strain elastic grading of the nodule, calcification, and CLNM were all visible on the coexisting diagram, which also included the nodule diameter, location, echo, and boundary.The cross-sectional image's position and size of the sampling frame were adjusted, and the strain elastic imaging mode was activated. With an ROI that was larger than the nodules (generally more than two times), the nodules were placed in the middle of the elastic imaging zone. Pressure was applied steadily (range 1–2 mm, 1–2 times/s) while the probe was perpendicular to the nodule. When the linear strain hint graph (green spring) suggested stability, the freeze key was pressed to get an elastic image; the ROI's color changed (green indicated soft; red indicated hard), and the nodule's hardness was determined based on elasticity. The elastic image was graded according to the following criteria: one point equals a nodular area that alternates between red, green, and blue; two points equal nodules that are partially red and partially green (mostly green, area > 90%); three points equal a nodule area that is primarily green, with surrounding tissues visible in red; four points equal a nodule area that is primarily red, with the red area > 90%; and five points equal a nodule area that is completely covered in red. | PMC10400539 |
Region of interests (ROIs) segmentation | One week prior to surgery, thyroid US exams were conducted. US image segmentation was done manually. Using the ITK-SNAP program (( | PMC10400539 |
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Radiomic feature extraction | Radiomic features were extracted using PyRadiomics ( | PMC10400539 |
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Radiomic feature selection | The retrieved features were normalized using a standard scalar to reduce bias and overfitting in the study. The dataset was divided into training and validation cohorts. To make each characteristic substantially independent, the row spatial dimension of the feature matrix was reduced using the Pearson correlation coefficient (PCC). Every pair of features with a PCC of more than 0.80 was deemed redundant.After PCC, recursive feature elimination (RFE) for feature selection was applied to the whole dataset using the Scikit-learn python module | PMC10400539 |
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Development of machine learning-based models | NB | The Support Vector Machine with the linear kernel (SVM_L), Support Vector Machine with radial basis function kernel (SVM_RBF), LogisticRegression (LR), Naïve Bayes (NB), K-nearest Neighbors (KNN), and Linear Discriminant Analysis (LDA) classifiers were used to build the prediction models using the RFE’s key features. All six algorithms were implemented using the Scikit-learn machine learning libraryThe same feature sets were chosen and fed into the model during the validation process. Standard clinical statistics like the area under the curve (AUC), sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), and accuracy (ACC) were used to evaluate the model's performance on the training and validation datasets. | PMC10400539 |
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Statistical analysis | Python (version 3.7, A two‐sided P < 0.05 indicated statistically significant differences. PyRadiomics (version 2.2.0, Medcalc Statistical Software was used to calculate the six models’ AUCs and evaluate the predictions. The DeLong method was used to compare the AUCs of the six machine learning classifiers. To create calibration curves, the sci-kit-learn version 1.2 | PMC10400539 |
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Institutional review board statement | The study was conducted in accordance with the Declaration of Helsinki and approved by the Jiangsu University-Affiliated People’s Hospital and traditional Chinese medicine hospital of Nanjing Lishui District Ethics Committee. | PMC10400539 |
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Informed consent | Patient consent was waived by the Jiangsu University-Affiliated People’s Hospital and traditional Chinese medicine hospital of Nanjing Lishui District ethics committee due to the retrospective nature of the study. | PMC10400539 |
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Results | PMC10400539 |
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Clinical characteristics | PTC, NB | REGRESSION, PAPILLARY THYROID CARCINOMA | There were 138 PTC patients in all, 87 of whom were women (mean age, 41.81 ± 11.23 [range, 25–57] years), and 51 of them were men (mean age, 43.82 ± 12.18 [range, 28–65] years). In Table Comparison of clinical and ultrasonic characteristics of the PTC patients in the training and validation dataset.The relationship between the BRAFPatient characteristics of the PTC with BRAFClinical characteristics, such as age and gender, did not differ significantly between the two groups (P > 0.05). There were no significant differences in mean nodule size between the two groups (BRAFPredictive performance comparison of machine learning algorithms in the training and validation cohorts.AUC, area under the curve; ACC, accuracy; SEN, sensitivity; SPEC, specificity; NPV, negative predictive value; PPV, positive predictive value; USR, ultrasound radiomic; PTC, papillary thyroid carcinoma; SVM-L, support vector machine with linear kernel;SVM-RBF, support vector machine with radial basis function; KNN, K-nearest neighbour; NB, naïve bayes; LDA, linear discriminant analysis;LR, logistic regression. | PMC10400539 |
Diagnostic performance of the machine learning models in the training and validation cohorts | NB | REGRESSION | After PCC and RFE with stratified tenfold cross-validation, 27 radiomic features were chosen in the training cohort (Figs. Boxplot of Selected features after RFE. Features were reduced to twenty-seven features during training of the machine learning models.Recursive feature elimination (RFE) with tenfold cross‐validation; number of features selected vs. cross‐validation score.The following features were chosen to develop the predictive models for BRAFRadiomics features selected after PCC and RFE analysis.In the training cohort, AUCs for KNN, LDA, LR, NB, SVM_L, and SVM_ RBF were 0.96 (95% confidence interval [CI]: 0.89–0.99), 1.00 (95% CI 0.96–1.00), 1.00 (95% CI 0.96–1.00), 0.96 (95% CI 0.89–0.99), 1.00 (95% CI 0.96–0.1.00), and 1.00 (95% CI 0.96–1.00), respectively (Table The mixed ROC curves of the six machine learning models in the training cohort. ROC: receiver operating characteristic; KNN: K-nearest neighbor; LDA: linear discriminant analysis; LR: logistic regression; NB: Naïve Bayes;SVM_L: support vector classifier with the linear kernel; SVM_RBF: support vector classifier with the radial basis function.In the validation cohort, AUCs for NB, KNN, LDA, LR, SVM_L, and SVM_RBF were 0.80 (95% confidence interval [CI]: 0.65–0.91), 0.87 (95% CI 0.73–0.95), 0.91(95% CI 0.79–0.98), 0.92 (95% CI 0.80–0.98), 0.93 (95% CI 0.80–0.98), and 0.98 (95% CI 0.88–1.00), respectively. The SVM_RBF model performed the best in the validation cohort, followed by the LR, SVM_L, LDA, KNN, and NB models, in that order (Fig. The mixed ROC curves of the six machine learning models in the validation cohort. ROC: receiver operating characteristic. KNN: K-nearest neighbor; LDA: linear discriminant analysis; LR: logistic regression; NB: Naïve Bayes; SVM_L: support vector classifier with the linear kernel; SVM_RBF: support vector classifier with the radial basis function.Furthermore, the DCA was used to evaluate the clinical utility of these models (Fig. Decision curve for predictive models based on machine learning models in the training cohort (Calibration curves of the machine learning ( | PMC10400539 |
Discussion | NB | REGRESSION, DISEASE, EVENT | The BRAF Real-time tissue strain elastography helps assess the anatomical structure and biological traits of PTC because it represents the relative hardness of the lesion and its surrounding tissues, whereas the hardness of PTC tissues is closely related to its internal pathological structure. Bojunga et al.In a previous studyMachine learning algorithms benefit from learning from input data and automatically recognizing patterns and trends in that data automatically. There have been numerous studiesIn order to determine whether US-based radiomics could perhaps assess the occurrence of BRAFThe higher AUCs and ACCs in the current study could be attributed to the US elastography radiomic features used, which provided more information than the grayscale US. Also in this study, machine learning algorithms were used in conjunction with radiomics, and several machine learning classifiers were used to build the models. To the best of our knowledge, this is the first study to develop models based on different machine-learning algorithms to predict BRAFComparing the current study results to our previous studyThe AUCs of the KNN (0.87), LDA (0.91), LR (0.92), and NB (0.80) classifiers were all lower than the logistic regression classifier (0.93) utilized in our previous study. The SVM_L AUC (0.93) score, on the other hand, was the same as the logistic regression algorithm (0.93) utilized in our previous work. When compared to the logistic regression classifier (ACC: 0.88 and AUC: 0.93) employed in our previous investigation, the SVM_RBF had higher ACC (0.93) and AUC (0.98) values. The disparity in performance could be attributed to the various feature preprocessing techniques and feature selection strategies used in the current investigation.On US examination, Kabaker et al.The calibration curve of the prediction model is an essential metric for evaluating the probability accuracy of a disease risk model in predicting an individual outcome event in the future. A high degree of calibration shows that the prediction model is accurate, whereas a low degree of calibration indicates that the model may exaggerate or underestimate the risk of illness. The blue line reflects the performance of the machine learning algorithms, while the diagonal dotted line represents an ideal prediction (Fig. Furthermore, the DCA was used to evaluate the clinical utility of these models (Fig. There are some limitations of the study, in the construction of the models to predict BRAF | PMC10400539 |
Conclusion | Finally, our study found that machine learning-based US elastography radiomic models performed well in predicting the potential of BRAF | PMC10400539 |
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Author contributions | Conceptualization, E.A.A. and X.Q.; methodology, E.A.A.; software, E.A.A. and D.A.; validation, Y.-G.W., J.O.T., and Y.-Z.R.; formal analysis, E.A.A.; investigation, E.A.A. and F.-J.X.; resources, E.A.A., and Y.-G.W.; data curation, E.A.A., X.W., and X.W.; writing—original draft preparation, E.A.A.; writing—review and editing, E.A.A., X.Q., and K.H.C.; visualization, E.A.A. and K.H.C.; supervision, X.Q., project administration, E.A.A., and X.Q; funding acquisition, X.Q. All authors have read and agreed to the published version of the manuscript. | PMC10400539 |
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Funding | This study was financially supported by the National Natural Science Foundation of China (Project No.: 81971629). Jiangsu Provincial Health Commission research project (Z2021071), 2023 Medical Education Collaborative Innovation Fund of Jiangsu University (JDYY2023015). | PMC10400539 |
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Data availability | The original contributions presented in the study are included in the article. Further inquiries can be directed to the corresponding authors. | PMC10400539 |
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Competing interests | The authors declare no competing interests. | PMC10400539 |
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References | PMC10400539 |
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1. Introduction | CVD | These authors contributed equally to this work.We hypothesized that consumption of high-fat (HF) ground beef (24% fat) would not affect plasma concentrations of high-density lipoprotein cholesterol (HDL-C) or low-density lipoprotein (LDL-C), whereas low-fat (LF) ground beef (5% fat) would decrease HDL-C and LDL-C concentrations. In a randomized 2-period crossover, controlled feeding trial, 25 men (mean age and body mass index, 40 years and 31.2) consumed 115-g HF or LF patties, 5/week for 5 weeks with a 4-week washout. The HF treatment increased % energy from fat (Beef is a popular food worldwide, and the United States (U.S.) consumes 21% of the world’s beef production, with China, the European Union, and Brazil consuming 16%, 13%, and 13%, respectively, of the world’s production (As indicated above, ground beef is a popular component in U.S. diet, and as such, ground beef constitutes one of the primary dietary sources of saturated fatty acids. In addition, the total fat and saturated fatty acid content can be changed readily and accurately during the formulation of ground beef preparations. Therefore, we conducted several randomized, controlled trials with men and/or postmenopausal women in which we tested the effects of ground beef differing in fatty acid composition on risk factors for CVD. Adams et al. [Our previous studies also demonstrated that ground beef interventions elicit differences in lipoprotein particle sizes. LDL particle diameter decreased in men following a 35% fat ground beef intervention [The primary outcome of the current randomized controlled trial was to document the effects of high-fat (HF) ground beef (27 g/patty, 24% fat by weight) and low-fat (LF) ground beef (6 g/patty, 5% fat by weight) on voluntary nutrient intake, and to establish if changes in major macronutrient intake were responsible for any changes we observed in lipoprotein cholesterol concentrations. We hypothesized that consumption of HF ground beef for 5 weeks would reduce the voluntary intake of carbohydrates but have no effect on HDL-C or LDL-C concentrations. Conversely, consumption of LF ground beef for 5 weeks would depress HDL-C and LDL-C concentrations. | PMC9861690 |
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2. Materials and Methods | PMC9861690 |
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2.1. Ethics Statements and Participant Recruitment | This randomized, controlled, 2-period crossover trial was conducted in accordance with the Declaration of Helsinki guidelines [Seventy-five healthy males between the ages of 25 and 60 years participated in one of two informational meetings ( | PMC9861690 |
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2.2. Inclusion Criteria | The participants had to be non-smoking males, not be on any restrictive diets or cholesterol-lowering medications, and not have a total cholesterol (TC) above 350 mg/dL. The participants were requested not to change their habitual diet or level of physical activity. Due to limited funding, we chose to recruit men only, and not women only or a combination of men and women. Statistical power calculations were based on changes in HDL-C concentration in normocholesterolemic men in response to a ground beef intervention ([ | PMC9861690 |
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2.3. Study Design | The study design was a two-period, randomized crossover design in which each participant completed two 5-week ground beef interventions in a randomly assigned order, with a 4-week washout period [ | PMC9861690 |
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2.4. Source of Ground Beef | vacuum-packaged patties | The source of raw materials for the production of LF and HF patties were the beef pectoralis muscle and 75:25 coarse ground beef, respectively, purchased from a local supplier (Readfield Meats, Bryan, TX, USA). The muscle raw materials were ground, and 4-ounce (115 g) patties were formed in a patty maker, individually vacuum-packaged, and stored at −20 °C. Prior to the initiation of each phase of the ground beef interventions, each participant received an unlabeled box containing 25 frozen, vacuum-packaged patties. Chemical analysis of the ground beef after patty formation indicated that raw LF patties contained 5% fat (6 g fat/patty) and HF patties contained 24% fat (27 g fat/patty) ( | PMC9861690 |
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2.5. Diet Records | The participants were required to complete a 3-day diet record before the diet interventions and once during each intervention to establish nutrient intakes and encourage compliance. Daily intake of major nutrients and dietary exchanges were analyzed by a registered dietitian nutritionist (RDN) using ESHA’s Food Processor Nutrition Analysis software (ESHA, Salem, OR, USA). The participants were trained in the use of myfitnesspal (myfitnesspal.com) to record daily intakes, which were forwarded to the RDN. All participants received instructions from the RDN for the preparation of the ground beef, including recipes, but the participants were not restricted to specific cooking methods for the test ground beef. The RDN also contacted the participants at regular intervals to encourage compliance and provide information about completing diet records. | PMC9861690 |
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2.6. Body Composition | The body composition of all subjects was assessed at the beginning and at the end of the study using dual-energy X-ray absorptiometry (DXA) (General Electric Lunar Prodigy Advance, Madison, WI, USA). Derived variables of interest from the DXA scans were total body mass, lean body mass, android fat, gynoid fat (all in kg), and percent fat mass. Body mass index (BMI) was calculated for each individual ( | PMC9861690 |
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2.7. General Blood Sampling and Analyses | BLOOD | Blood sampling and assay procedures were published previously [ | PMC9861690 |
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2.8. Lipoprotein Density Profiles | Density profiles for circulating lipoproteins were determined by imaging 6 μL serum following NBD-C6-ceramide labeling of lipoproteins, as described [The average percent relative standard deviation in AUC for different lipoprotein subfractions was 4.45% (within-day) and 7.37% (day-to-day). Data were also used to express HDL subfractions as percentages of total HDL AUC: | PMC9861690 |
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2.9. Statistics | Power calculations were conducted to estimate the required sample size based on HDL-C concentrations from our previous studies with normocholesterolemic men [Ground beef effects were analyzed using a repeated measures mixed model to assess the effects of diet (LF vs. HF), sequence (entry, first LF/HF intervention, washout, and second LF/HF intervention), and the diet-by-sequence interaction. Entry BMI and age were included as covariates in the initial model but were insignificant for all dependent variables and were dropped from the final model. The NORM.DIST model of Excel (Microsoft Excel of Mac version 16.16.27) was used to test for normality, and the data were normally distributed. Pairwise comparisons were assessed by Fisher’s Protected LSD method when there was a significant effect of diet or sequence. Associations among plasma lipids were assessed using Pearson’s correlations. Absolute change from baseline was calculated by subtracting measurements taken at entry from post-dietary intervention period values. Data are reported as means ± standard error of the mean (SEM) ( | PMC9861690 |
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3. Results | PMC9861690 |
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3.1. Ground Beef Composition and Participant Nutrient Intake | The LF patties did not lose a detectable amount of fat following pan frying, but the HF patties lost nearly 41% fat after frying. The drained, pan-fried HF patties contained more total SFA, MUFA, and polyunsaturated fatty acids (PUFA) than the pan-fried LF patties (Energy intake did not differ among treatment phases, although energy intake during the LF intervention tended (Protein intake (g/d) tended (There were significant ( | PMC9861690 |
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3.2. Plasma Lipid Concentrations | TG | As indicated above, plasma LDL-C concentration was calculated by the Friedwald equation, which is based primarily on TC (LDL-C = TC − HDL-C − TG/5). For this reason, there was a high correlation between TC and LDL-C concentration (rPlasma TG concentration tended ( | PMC9861690 |
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3.3. Lipoprotein Density Distributions | TRL AUC was greater following the LF intervention than at entry ( | PMC9861690 |
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3.4. Pearson Correlation Coefficients | Plasma HDL-C concentration was negatively correlated with TRL AUC (r = −0.383; | PMC9861690 |
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4. Discussion | PMC9861690 |
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4.1. Energy and Macronutrient Intake and Composition of Patties | The primary outcome of this study was to document which voluntary changes in macronutrient intake were responsible for any observed changes in lipoprotein cholesterol concentrations. The current study confirmed significant increases in % energy from total fat, saturated fatty acids, and monounsaturated fatty acids during the HF treatment. We also calculated absolute change from baseline as previously reported by others [The calculations of daily fat intake during the LF and HF interventions assumed that, regardless of the method of cooking, drippings were not included in the final food product. We previously reported that pan-broiled, 25% fat ground beef lost 44–49% fat, depending on the degree of doneness [Many randomized studies have provided set guidelines for nutrient intake during the treatment phases and/or provided baseline diets before initiating dietary interventions [Saturated fatty acid intake by participants in this study exceeded dietary recommendations of less than 10% energy intake from saturated fatty acids; approximately 73% of U.S. males exceed this recommendation [ | PMC9861690 |
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4.2. High-Density Lipoprotein Cholesterol Concentrations | HDL particles carry out reverse cholesterol transport and possess antioxidative and anti-inflammatory activities through associated proteins and bioactive lipids [Scott et al. [ | PMC9861690 |
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4.3. Low-Density Lipoprotein Cholesterol Abundance | Each LDL particle contains one apolipoprotein B (apoB), and the larger, less dense LDLWang et al. [ | PMC9861690 |
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4.4. Lipoprotein Area under the Curve | CVD | NBD-C6-ceramide labels the surface of lipoprotein particles and can be used to indicate particle diameter associated with a specific density interval [Wang et al. [Small, dense LDL particles have the strongest association with the risk for CVD [ | PMC9861690 |
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4.5. Nutrient Intake and Lipoprotein Cholesterol | The LF treatment increased % energy from protein, and the HF treatment increased % energy from fat and saturated fat, and decreased % energy from carbohydrate. However, the LF and HF treatments caused similar reductions in HDL-C and LDL-C concentrations from entry. This seemingly would rule out % energy from protein, fat, or carbohydrate as causative for the reductions in HDL-C and LDL-C concentrations. However, as indicated above, cholesterol intake during washout and the LF and HF treatments was lower than at entry, especially for the HF treatment. Dietary interventions designed to reduce saturated fat intake typically reduced cholesterol intake [ | PMC9861690 |
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4.6. Limitations | Several limitations of the present study should be considered. Because of the nature of the study treatments, the study staff were not blinded, which leads to the potential for bias associated with lack of blinding. The short duration of the intervention, 35 days, may also be considered a limitation, but previous research conducted by the authors has shown that changes in HDL-C and LDL-C concentrations were evident at 5 weeks of making dietary changes [ | PMC9861690 |
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Author Contributions | Conceptualization, S.B.S., R.L.W. and S.F.C.; methodology, J.R.L., T.P. and D.R.S.; formal analysis, S.B.S.; writing, S.B.S., R.L.W., J.R.L., T.P. and D.R.S.; funding acquisition, S.B.S. and R.L.W. All authors have read and agreed to the published version of the manuscript. | PMC9861690 |
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Institutional Review Board Statement | This study was conducted in accordance with the Guidelines of the Declaration of Helsinki guidelines and approved by the Texas A&M University Institutional Review Board for use of human participants in research (Protocol number IRB2018-0755). This trial was registered at | PMC9861690 |
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Informed Consent Statement | Informed consent was obtained from all subjects involved in the registered trial NCT04841460. | PMC9861690 |
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Data Availability Statement | The data presented in this study are available on request from the corresponding author. The data are not publicly available as no appropriate public database is available. | PMC9861690 |
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Conflicts of Interest | The authors declare no conflict of interest. | PMC9861690 |
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Abbreviations | CVD, CARDIOVASCULAR DISEASE | AUC, area under the curve; BMI, body mass index; CVD, cardiovascular disease; DXA, dual-energy X-ray adsorptiometry; HDL-C, high-density lipoprotein cholesterol; HF, high-fat; LDL-C, low-density lipoprotein cholesterol; LF, low-fat; MUFA, monounsaturated fatty acids; PUFA, polyunsaturated fatty acids; RDN, registered dietitian nutritionist; SFA, saturated fatty acids; TG, triglycerides; TFA, | PMC9861690 |
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Materials and methods | jaundice | This randomized controlled clinical trial was performed on 106 full-term neonates with jaundice who were admitted to the neonatal ward of 17 Shahrivar Hospital in Rasht, Iran. The neonates were randomly assigned to two groups of intervention (10 mg/kg UDCA+phototherapy) and control (phototherapy alone). Total serum bilirubin (TSB) was measured at the time of admission, during first 12, 24, and 48 hours after admission and at the time of discharge. The duration of hospitalization and side effects were also assessed in both groups. IBM SPSS Statistics for Windows, version 20 was used to analyze the data. | PMC10715657 |
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Results | Results showed that in the intervention group, 28 (52.8%) of neonates were boys with the mean age of 5.1±1.25 days. While, in the control group 29 (54.7%) of them were boys with the mean age of 5.19±2.26 days. Bilirubin levels in both groups decreased significantly after hospitalization (at 12, 24 and 48 hours) (P <0.001). The mean of bilirubin at 12, 24 and 48 hours in the intervention and control groups were 17.1, 13.2, 10.2 mg / dl and 17.1, 14.2 and 11.3 mg / dl, respectively. At the time of discharge, TSB in the former compared to the latter group was significantly reduced (7.74± 1.39 vs. 8.67±1.35) (P = 0.001). In addition, the duration of hospitalization was considerably shorter in the intervention compared to the control group (P = 0.038) and no side effects were observed. | PMC10715657 |
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Conclusions | NEONATAL HYPERBILIRUBINEMIA | Administering UDCA plus phototherapy reduced TSB and length of hospital stay with proper safety and efficacy. Therefore, it seems that this combination can be an appropriate treatment modality in neonatal hyperbilirubinemia. | PMC10715657 |
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Data Availability | “All data are available within the manuscript and/or | PMC10715657 |
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Introduction | primary bile acid chenodeoxycholic acid, Hyperbilirubinemia | NEONATAL DISORDERS, NEONATAL HYPERBILIRUBINEMIA, HYPERBILIRUBINEMIA | Hyperbilirubinemia is one of the most common neonatal disorders, especially in the first week after birth, which occurs in half of term and most preterm infants [Ursodeoxycholic Acid (UDCA) is a type of hydrophilic bile acid that accounts for about 4% of bile acids in humans and is synthesized by bacterial enzymes in the gallbladder from primary bile acid chenodeoxycholic acid. During oral administration, almost half of the drug, is absorbed in the intestine and enters hepatocytes through the portal circulation. UDCA significantly reduces the secretion of cholesterol into the bile [It is noteworthy that pediatricians have to be assured about the safety profile of drugs used for neonates. Although some previous studies mentioned the positive effect of administering UDCA on neonatal hyperbilirubinemia [ | PMC10715657 |
Materials and methods | PMC10715657 |
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Patients and settings | Gilbert’s syndromes, Crigler-Najjar, hyperbilirubinemia, sepsis, breast milk | HYPOTHYROIDISM, GLUCOSE 6 PHOSPHATE DEHYDROGENASE DEFICIENCY, MATERNAL DIABETES, CHRONIC DISEASES, LIVER DISEASE, DIRECT HYPERBILIRUBINEMIA, HYPERBILIRUBINEMIA, SEPSIS, DISEASES | The present study is a paralleled randomized single-blinded controlled clinical trial that was performed from 10 April 2021 to 10 October 2021 for 6 months. In this study, 106 term neonates were admitted for at least 48 hours due to indirect hyperbilirubinemia in the neonatal ward of 17 Shahrivar Hospital in Rasht, Iran.This study was approved by the ethics committee of the Vice-Chancellor of Research at Guilan University of Medical Sciences (Number: IR.GUMS.REC.1399.645, Date: 2021-03-03). The clinical trial was registered in the Iranian registry of clinical trials (Number: IRCT20210201050199N1, Date: 2021-04-03). The authors confirm that all ongoing and related trials for this drug/intervention are registered. Written Informed consent letter was obtained from parents or guardians.The inclusion criteria were 3 to 7 days of age, 2500 to 4000 grams birth weight, exclusive breastfeeding, 38 to 42 weeks of gestation, 14–20 mg/dL total serum bilirubin (TSB), and less than 1.5 mg/dL direct bilirubin. Neonates were excluded if there was ABO and Rh incompatibility, glucose 6 phosphate dehydrogenase deficiency (G6PDd), history of any neurological or chronic diseases, sepsis, diseases leading to hyperbilirubinemia (e.g., Crigler-Najjar and Gilbert’s syndromes, hypothyroidism, and liver disease) and a history of maternal diabetes as well as parental dissatisfaction.Eligible patients were randomly allocated by randomized blocking (or grouping). The following website “The intervention group received 10 mg/kg/day oral UDCA divided into two doses plus phototherapy, which was dissolved in breast milk (Amin Pharmaceutical Company, Iran). The control group received phototherapy alone. The method of phototherapy was the same in both groups. Based on the AAP guideline [Sample size was indicated based on Shahramian et al. [n10% drop rate = 5N = 53 in each group | PMC10715657 |
Data gathering | bloating, constipation, rash, nausea, vomiting | SECONDARY | Data were gathered by a checklist including baseline and post randomization variables. Baseline characteristics were age, sex, gestational age, and baseline blinrubin level. Also, bilirubin level at 12, 24, and 48 hours after admission and side effects including nausea, vomiting, constipation, bloating, and skin rash were assessed as post randomization variables in the two groups. To measure serum bilirubin, arterial blood samples were taken from the neonates and transferred to the single laboratory and was performed by colorimetric assay using 2 and 4-dichloroaniline (DCA) in a 3500BT device. We considered the change of TSB level from baseline as the primary outcome and the difference in length of hospitalization as the secondary outcome. | PMC10715657 |
Statistical analysis | Data were analyzed using IBM SPSS Statistics for Windows, version 20 (IBM Corp., Armonk, N.Y., USA). Data were reported by frequency, percent, mean, and standard deviation. Qualitative variables were also described based on number and percent. At first, the normality of the data was evaluated using the Kolmogorov-Smirnov test. Then, independent T and chi-square tests were used to compare the groups in terms of different variables. It is noteworthy that in case of non-normal data, Mann-Whitney U test and if data did not fulfill the necessary condition for chi-square, Fisher’s exact test was used. We used the Friedman test to compare the quantitative non-normal data. P-value less than 0.05 was considered significant. The investigation was performed based on the intention to treat analysis. | PMC10715657 |
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Results | In the present study, 198 admitted neonates were assessed for eligibility from 10 April 2021 to 10 October 2021 for 6 months. Among them, 106 were enrolled in two groups of 53 neonates ( | PMC10715657 |
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Flow chart of participants. | PMC10715657 |
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Baseline demographic characteristics in the intervention and control groups. | * Mann-Whitney U test.** Independent samples T-test.*** Chi-Squared test.According to the results, a statistically significant difference was observed between the total bilirubin levels at the time of admission and discharge in both groups (P <0.001).As | PMC10715657 |
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Comparing bilirubin level at admission and discharge in the intervention and control groups. | *Wilcoxon signed-rank test.** Mann-Whitney U test.In addition, bilirubin levels in both groups were measured during 12, 24, and 48 hours after admission, and the results were obtained by Friedman test. We intended to investigate the difference in bilirubin levels in these three time periods, the neonates studied at this stage were 49 in the intervention and 43 in the control group. Therefore, 14 participants were excluded due to loss to follow-up. The intragroup analysis indicated that TSB in both groups had significant decrease during 12, 24, and 48 hours after hospitalization (P <0.001). Although there was no significant difference between the two groups at 12 and 48 hours after hospitalization (P>0.05), significant difference was noticed at 48 hours after hospitalization (P = 0.009) ( | PMC10715657 |
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The trend of bilirubin levels of all, intervention, and control groups from baseline to discharge. | PMC10715657 |
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Inter and intra group analyses of bilirubin level in 12, 24, and 48 hours after hospitalization. | SECONDARY | *Friedman test.*** Mann-Whitney U test.Using the Mann-Whitney U test, the length of hospital stay as the secondary outcome was significantly reduced in the intervention compared to the control group (P = 0.038) ( | PMC10715657 |
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Comparing duration of hospitalization in the intervention and control groups. | bloating, constipation, rash, nausea, vomiting | * Mann-Whitney U test.No side effects including nausea, vomiting, constipation, bloating, and skin rash were observed in the two groups. | PMC10715657 |
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Discussion | diabetic mothers might, retinal damage, constipation, dehydration, skin rash, nausea, vomiting | DEHYDRATION, HYPOCALCEMIA, RETINAL DAMAGE | Phototherapy is a cheap, simple, non-invasive method with appropriate effectiveness. This treatment has side effects such as changes in circadian rhythm, dehydration, hypocalcemia, skin rash, and retinal damage [In the present study, we compared TSB at the beginning of hospitalization and at the time of discharge between two groups. TSB at discharge was significantly reduced in the UDCA group. Although TSB at admission in both groups was about 17.1 mg / dl, but at discharge, it was significantly lower in the intervention rather than the control group. In the previous studies, bilirubin levels have been measured at regular intervals with the same interventions. Although Jafari et al. who compared groups at 8, 12, 24, 36, and 48 hours of hospitalization showed decreased bilirubin level in both groups, the difference was statistically significant only at 8 [Based on the findings of our study, the mean duration of hospitalization in the UDCA group was significantly lower than the control group. Consistent with our results, previous studies mentioned a significant difference between mean duration of phototherapy between two groups as well [Gharehbaghi et al. also revealed that the length of hospital stay was reduced and more than 70% of infants receiving the dose of 7.5 mg / kg of UDCA were hospitalized for less than one day, but in the group receiving the dose of 5 mg / kg and the control group, 42.5% and 17.5% of infants were hospitalized less than one day [Also lack of any possible side effects including nausea, vomiting, constipation, and skin rash in the intervention group suggested an acceptable and safe profile of the drug. Consistent with these results, several human and animal studies have confirmed the safety and efficacy of UDCA in both adults and children [We have one main limitation that should be considered in further studies. It would be better if we could compare term neonates with preterm ones. Besides, comparing term neonates with and without risk factors such as ABO & Rh incompatibilities, G6PDd, and infants of diabetic mothers might be considerably informative. | PMC10715657 |
Conclusions | NEONATAL JAUNDICE, NEONATAL HYPERBILIRUBINEMIA | Based on the findings, administering UDCA plus phototherapy reduced TSB and length of hospital stay with appropriate safety and efficacy. Therefore, it seems that this combination can be an appropriate treatment modality in neonatal hyperbilirubinemia. Besides, further studies can be recommended to evaluate the efficacy of UDCA on outpatient management of prolonged neonatal jaundice. | PMC10715657 |
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Supporting information | PMC10715657 |
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Consort checklist: CONSORT 2010 Checklist dr aghili. | (DOC)Click here for additional data file. | PMC10715657 |
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Data set: Dr aghili–analysis. | (XLSX)Click here for additional data file. | PMC10715657 |
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Persian protocol: Trials persian dr aghili. | (PDF)Click here for additional data file. | PMC10715657 |
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English protocol: Trials english dr aghili. | (PDF)Click here for additional data file. | PMC10715657 |
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Persian and English protocol summary: Protocol dr aghili revised. | (DOCX)Click here for additional data file. | PMC10715657 |
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Consort flow diagram: CONSORT 2010 flow diagram dr aghili. | (DOC)Click here for additional data file.This was the proposal accepted by the Vice-Chancellor of Research at Guilan University of Medical Sciences. It was the thesis of the Dr. Safoora Aghili resident of pediatrics (third Author). We appreciate all colleagues and parents/guardians for their valuable cooperation. | PMC10715657 |
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Abstract | PMC10097047 |
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Introduction | PHN, Herpes zoster | POSTHERPETIC NEURALGIA, PHN, HERPES ZOSTER, COMPLICATIONS | Postherpetic neuralgia (PHN) is one of the most common complications of Herpes zoster (HZ), yet the mechanism and the treatment for PHN remains elusive. We first performed this feasibility study to verify the safety and efficiency of autologous fat grafting into the paravertebral space in early HZ to prevent PHN. | PMC10097047 |
Methods | PHN, rash, pain | PHN | Patients suffering from HZ with a rash in chest, back, or abdomen were arranged for autologous fat grafting to the paravertebral space. The primary endpoint was the incidence of PHN, which was defined as persistence pain in the affected dermal area in 12 weeks after fat grafting. Secondary endpoints including patient‐reported changes in pain intensity, assessed pain threshold and the quality of life during follow‐ups. | PMC10097047 |
Results | PHN, pain | ADVERSE EVENTS, EVENTS, PHN | Eight patients accept the intervention and completed all follow‐ups. Most patients report immediate pain relief after injection, one patient has a mild to moderate dizzy symptom after injection. No other short‐ or long‐term adverse events occurred. For primary outcome, all patients have a timely reduced pain intensity, with no PHN events occurred, as all patients report pain intensity ≤3 in the VAS scale in 3 months after treatment. For electrical pain threshold, we identify that fat grafting differentially increases sensation and pain threshold in HZ area and healthy skin of patients. Besides, our results indicate significant improvement in patients’ life quality decrease in analgesic consumption. | PMC10097047 |
Discussion | PHN, rash | PHN | Autologous fat transplantation to the paravertebral space is a safe and feasible technique in preventing PHN from HZ in a rash. Further randomized controlled trial to investigate the actual long‐term benefice of autologous fat grafting to the paravertebral space in preventing PHN is needed. | PMC10097047 |
Trial registration | ChiCTR, (ChiCTR1900025416); registered August 26, 2019.
Xiujuan Li, Ran Tao, and Xiaoyan Meng contributed equally to this work. | PMC10097047 |
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