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Funding | The trAPP-study is funded by a grant from
| PMC10755994 | ||
Ethical approval | Erasmus | The local medical ethics committee of the Erasmus MC University Medical Center Rotterdam approved the study (MEC 2014-250). The trial was registered at the Dutch Trial Registration (NTR 4765). | PMC10755994 | |
Data | The data that support the findings of this study are available from the corresponding author on reasonable request. | PMC10755994 | ||
Provenance | Freely submitted; externally peer reviewed. | PMC10755994 | ||
Competing interests | The authors have declared no competing interests. | PMC10755994 | ||
Discuss this article: | PMC10755994 | |||
References | PMC10755994 | |||
Background | heart failure | HEART FAILURE | In a large randomized controlled trial (PARADIGM-HF), ARNI has been shown to significantly reduce cardiovascular mortality and hospitalization for patients with reduced ejection fraction in heart failure. This study analyzed the efficacy and safety of ARNI on the basis of various types of heart failure patients in sout... | PMC10334639 |
Methods | heart failure | HEART FAILURE | This study included patients with heart failure who were treated at the Affiliated Hospital of North Sichuan Medical College from July 2017 to June 2021. This study analyzed the efficacy and safety of ARNI in the treatment of heart failure, and analyzed the risk factors for readmission after ARNI treatment. | PMC10334639 |
Results | readmission, heart failure, HF | ADVERSE EVENTS, HEART FAILURE | After propensity score matching, a total of 778 patients were included in the study. The readmission rate for heart failure in patients treated with ARNI (8.7%) was significantly lower than that in the standard treatment group (14.5%) (P = 0.023). Both the proportion of patients with increased LVEF and with decreased L... | PMC10334639 |
Conclusion | readmission, heart failure, HF | HEART FAILURE | Patients with heart failure treated with ARNI can improve clinical symptoms and reduce the risk of readmitted hospital admission. Age > ~ 65 years and HFrEF were independent predictors of readmission in HF patients treated in ARNI group. | PMC10334639 |
Keywords | PMC10334639 | |||
Introduction | Heart failure, heart failure, HF | HEART FAILURE, HEART FAILURE | Heart failure (HF) is a major public health problem that imposes an enormous social and economic burden on the world, and about 64.3 million people in the world suffer from HF [In China, there is currently a lack of real-world studies analyzing drug therapy in patients with heart failure. To explore the efficacy and sa... | PMC10334639 |
Methods | PMC10334639 | |||
Patients | Heart Failure, heart failure | HEART FAILURE, HEART FAILURE | This study is a real-world study involving patients with heart failure who were treated at the Affiliated Hospital of North Sichuan Medical College from July 2017 to June 2021. Inclusion criteria include meeting the diagnosis and treatment standards for HF in the “Chinese Heart Failure Diagnosis and Treatment Guideline... | PMC10334639 |
Variables extraction | HEART | The data used in this study were extracted from a database constructed by combining information from multiple data sources, including the Hospital Information System, Laboratory Information Management System, Picture archiving and communication systems, and Electronic Medical Record of the Affiliated Hospital of North ... | PMC10334639 | |
Outcomes and definition | heart failure, hypotension | HEART FAILURE, RENAL IMPAIRMENT | The outcomes of interest in this study were readmission rate, hypotension, and renal impairment. The definition of heart failure refers to the description of heart failure in “Chinese guidelines for the diagnosis and treatment of heart failure 2018“ [ | PMC10334639 |
Statistical analysis | REGRESSION | Propensity score matching (PSM) was used to balance measurable confounders between standard treatment group and ARNI group. The propensity score was calculated by logistic regression model with the following covariates age, gender, height, weight, smoking, drinking, medical history, type of HF and NYHA classification. ... | PMC10334639 | |
Results | PMC10334639 | |||
Baseline characteristics of patients with heart failure | heart failure, CKD, chronic kidney disease, PAD | PERIPHERAL ARTERIAL DISEASE, MYOCARDIAL INFARCTION, HEART, PAD, HEART FAILURE | Before propensity score matching, a total of 2096 patients with heart failure met the criteria. Among them, 1826 patients received standard therapy and 270 patients received ARNI therapy. There were significant differences in age, sex, height, weight, smoking, drinking, PAD, type of HF, and NYHA classification between ... | PMC10334639 |
Compare adverse events between standard treatment group and ARNI treatment group | renal injury, hypotension | ADVERSE EVENTS | There were no significant differences in the overall incidence of adverse events (1.5%vs. 2.0%, P = 0.766) and the incidence of hypotension (1.3%vs. 1.6%, P = 0.755) and renal injury (0.2%vs. 0.4%, P = 0.545) between the standard-care and ARNI-treated patients (Table
Compare adverse events between two group | PMC10334639 |
Logistics regression analysis of risk factors for readmission in ARNI-treated patients | CKD, chronic kidney disease, PAD | PERIPHERAL ARTERIAL DISEASE, MYOCARDIAL INFARCTION, HEART, PAD, REGRESSION, HEART FAILURE | Univariate logistic regression analysis found that age (> 65 vs. ≤65 years), HFrEF, NYHA classification, serum creatinine (abnormal vs. normal), and eGFR (abnormal vs. normal) were all associated with readmissions in ARNI-treated patients (all P < 0.1) (Table
Factors association with readmission in ARNI groupOR, odds ... | PMC10334639 |
Acknowledgements | We thank Shanghai Synyi Medical Technology Co., Ltd. for providing the data analysis and statistical platform. | PMC10334639 | ||
Authors’ contributions | XB Wang J Pu and HX Hu mainly participated in literature search, study design, writing and critical revision，Figure 1; Tables 1, 2, 3, 4 and 5. J Pu, GX Wang, H Xu, LM Liu, Z Li, RJ Qin, XM Zhao, M Li and ZD Hao mainly participated in data collection, data analysis and data interpretation. All authors read and approved... | PMC10334639 | ||
Funding | The study was funded by Major Projects of Sichuan Provincial Health Commission (21ZD004), Science and Technology Department of Sichuan Province Project (2021YJ0208, 2021YJ0210), and Research Project Foundation of Affiliated Hospital of North Sichuan Medical College (2022LC009, 2021ZK002, 2021LC011). | PMC10334639 | ||
Data Availability | The data that support the findings of this study are available from Affiliated Hospital of North Sichuan Medical College but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the corresponding aut... | PMC10334639 | ||
Declarations | PMC10334639 | |||
Conflict of interest | The authors declared that there was no conflict of interest associated with the manuscript. | PMC10334639 | ||
Ethics approval and consent to participate | The study was approved by the Ethics Committee of the Affiliated Hospital of North Sichuan Medical College (2022ER291-1), all methods were performed in accordance with the Declarations of Helsinki, and since the study only involved retrospective analysis of previous clinical data, the requirement for informed consent w... | PMC10334639 | ||
Consent for publication | Not applicable. | PMC10334639 | ||
References | PMC10334639 | |||
1. Introduction | obesity, eating behavior, eating behaviors, Eating Behaviors, ’s eating behavior, disordered eating, diabetes, cancer | OBESITY, CHRONIC DISEASES | These authors contributed equally for this paper and should be considered co-first authors.Self-efficacy has a strong influence on children’s eating behavior. Feeling capable of regulating one’s eating behavior is especially relevant in situations of activation while facing temptations or experiencing negative emotions... | PMC9956400 |
2. Materials and Methods | PMC9956400 | |||
2.1. Participants | Children were recruited from 6 Portuguese public schools from different environments (i.e., rural and urban). A total of 827 elementary school children ( | PMC9956400 | ||
2.2. Procedure | The present study was part of a broader investigation approved by the University of Minho Ethics Committee for Research in Social and Human Sciences (CEICSH) (CEICSH 032/2019). Elementary school children and their parents or legal guardians were informed about the study’s aims and assured of the data’s confidentiality.... | PMC9956400 | ||
2.3. Instruments | PMC9956400 | |||
2.3.1. Self-Efficacy to Regulate Eating Behaviors Scale for Children (SEREB-C) | Bandura [SEREB-C was introduced with the following indication: “A number of situations are described below that can make it hard to stick to a healthy diet. For each sentence, please select the answer that best represents how certain you are that you can stick to a healthy diet on a regular basis” (see | PMC9956400 | ||
2.3.2. Self-Regulation Processes toward Healthy Eating | Self-regulation was assessed using the Self-Regulation Processes towards Healthy Eating Questionnaire [ | PMC9956400 | ||
2.3.3. Declarative Knowledge about Healthy Eating | Declarative knowledge about healthy eating was assessed using an adapted version of the Knowledge of Healthy Eating Questionnaire [ | PMC9956400 | ||
2.3.4. Attitudes and Perceptions towards Healthy Eating | Attitudes and perceptions towards healthy eating were assessed using an adapted version of the Students’ Attitudes and Perceptions on Healthy Eating Questionnaire [ | PMC9956400 | ||
2.4. Data Analysis | eating behaviors | REGRESSION | The data were analyzed in several phases, following the purposes of the present study. First, missing values for the 14 items of SEREB-C ranged from 0.1% to 1.0% (M = 0.55%) and were imputed using regression imputation. Second, to examine the SEREB-C’s factor structure, participants were randomly split into two groups ... | PMC9956400 |
3. Results | PMC9956400 | |||
3.1. Principal Component Analysis (PCA) | For Group 1 ( | PMC9956400 | ||
3.2. Confirmatory Factor Analysis (CFA) | For Group 2 (Each of the 14 items was specified to load on only one factor in the two-factor solution (i.e., either activation and temptation situations or negative emotional situations); therefore, the structure coefficients estimated indicator–construct correlations [ | PMC9956400 | ||
3.3. Reliability | The means of the scale for the two groups combined ( | PMC9956400 | ||
4. Discussion | eating behaviors | The present study aimed to validate the SEREB-C. Our preliminary results indicated that SEREB-C has good psychometric quality regarding reliability (i.e., exhibits good Cronbach’s alpha and omega coefficients) and validity evidence (e.g., positive relationship with external relevant measures). Moreover, the two-factor ... | PMC9956400 | |
5. Conclusions | eating behaviors | In the present study, the factor structure of the SEREB-C was examined using exploratory and confirmatory factor analysis. Our preliminary results showed that SEREB-C comprises two factors: activation and temptation situations and negative emotional situations. The two-factor model showed a good fit for Portuguese elem... | PMC9956400 | |
Author Contributions | Conceptualization, C.S., B.P. and P.M.; methodology, C.S., B.P. and G.F.; validation, B.P.; formal analysis, B.P. and J.C.N.; investigation, B.P. and G.F.; data curation, C.S., B.P. and G.F.; writing—original draft preparation, C.S. and B.P; writing—review and editing, G.F., P.R. and P.M.; supervision, P.R. and P.M.; p... | PMC9956400 | ||
Institutional Review Board Statement | The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the University of Minho Ethics Committee for Research in Social and Human Sciences (CEICSH 032/2019). | PMC9956400 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC9956400 | ||
Data Availability Statement | Data are available from the corresponding author upon reasonable request. | PMC9956400 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC9956400 | ||
Appendix A | A number of situations are described below that can make it hard to stick to healthy eating. Please, for each sentence, select the answer that best represents how certain you are that you can stick to a healthy eating diet on a regular basis. | PMC9956400 | ||
References | Eating Behaviors | Rotated Factor Pattern (Structure) Matrix for the SEREB-C *.Note: Group 1 (Model Comparison: Summary of Goodness-of-Fit Indices.Note: Group 2 (Standardized Coefficients for the Two-Factor CFA Model.Note: Group 2 (Pearson correlations between SEREB-C and the 3 external measures and mean, and standard deviation of the ex... | PMC9956400 | |
Purpose | weight gain | It is widely accepted that patients experience weight gain after total thyroidectomy, and preventive measures should be recommended. | PMC10293335 | |
Methods | weight gain | A prospective study was designed to assess the efficacy of a dietetic intervention to prevent post-thyroidectomy weight gain in patients undergoing surgery for both benign and malignant thyroid conditions. Patients undergoing total thyroidectomy were prospectively and randomly assigned to receive a personalized pre-sur... | PMC10293335 | |
Results | The final study group encompassed 30 patients in Group A and 58 patients in Group B. The two groups were similar in terms of age, sex, pre-surgery BMI, thyroid function and underlying thyroid condition. The evaluation of body weight variations showed that patients in Group A did not experience significant body weight c... | PMC10293335 | ||
Conclusions | weight gain | A dietician counseling is effective in preventing the post-thyroidectomy weight gain. Further studies in larger series of patients with a longer follow-up appear worthwhile. | PMC10293335 | |
Keywords | PMC10293335 | |||
Introduction | An increase in body weight is experienced by the majority of patients undergoing total thyroidectomy [ | PMC10293335 | ||
Materials and methods | Patients were enrolled among those undergoing thyroidectomy at the Surgery Unit of the Istituti Clinici Scientifici Maugeri, I.R.C.C.S. (Pavia, Italy), between February the 1Weight was measured on two different weight scales, which are periodically checked for their accuracy by an agency of standards, asking the partic... | PMC10293335 | ||
Dietic intervention | post-thyroidectomy | All the patients (Group A) received an individual nutritional counseling, performed by a registered clinical dietitian, within one week pre-surgery (T0). The dietitians analyzed the patient’s dietary pattern and habits, estimating intake frequencies of all the food groups throughout a validated questionnaire, the “QueM... | PMC10293335 | |
Endocrine follow-up | THYROID | All patients attended regular endocrinological follow-up at T1 and T2, according to standard clinical practices. After surgery all patients were treated with levothyroxine at replacement or mildly TSH-suppressive doses according to a benign or malignant histology. Thyroid function parameters were measured at 40–60 days... | PMC10293335 | |
Statistical analysis | Statistical analysis was performed using the SPSS software (SPSS, Inc., Evanston, IL). Between groups comparisons were performed by Student’s | PMC10293335 | ||
Body weight changes | GROUP B | We compared body weight changes from pre-surgery (T0) to T1 and T2 between the two groups. Patients in Group A did not experience significant body weight changes at either T1 or T2. In particular, mean body weight was 71.5 ± 14.1 kg at T0, 71.9 ± 14.2 kg at T1 (As shown in Fig. Percentage body weight variation between ... | PMC10293335 | |
Lifestyle, dietary pattern and habits changes | GROUP B | The analysis of lifestyle and QueMD MODV6 questionnaires throughout the study span failed to register any significant difference between the two groups, both at baseline (mean score 6.90 ± 1.32 in Group A vs 7.07 ± 1.25 in Group B, | PMC10293335 | |
Funding | This work was partially supported by the ‘Ricerca Corrente’ funding scheme of the Ministry of Health Italy. This work was partially funded under the National Recovery and Resilience Plan (NRRP), Mission 4 Component 2 Investment 1.3 - Call for proposals No. 341 of 15 March 2022 of Italian Ministry of University and Rese... | PMC10293335 | ||
Data availability | Some or all data used during the study are available from the corresponding author by request. | PMC10293335 | ||
Compliance with ethical standards | PMC10293335 | |||
Competing interests | The authors declare no competing interests. | PMC10293335 | ||
Informed consent | Informed consent was obtained from all individual participants included in the study. | PMC10293335 | ||
References | PMC10293335 | |||
Abstract | Sodium oxybate (γ-hydroxybutyrate, GHB) is an endogenous GHB/GABA | PMC10267648 | ||
Introduction | MRS | Sodium oxybate (γ-hydroxybutyrate, GHB) is an endogenous GHB/GABARecent neuropsychopharmacological approaches involve the assessment of cerebral resting-state functional connectivity (rsFC) to understand how psychoactive substances differentially modulate brain functioning. Here, an established model to analyze rsFC on... | PMC10267648 | |
Methods | PMC10267648 | |||
Permission | The study was approved by the Swiss Agency for Therapeutic Products (Swissmedic) as well as by the Ethics Committee of the Canton of Zurich and registered at | PMC10267648 | ||
Study design | rapid-eye movement sleep, sleep-related disorders, and reduced sleep efficiency | SLEEP APNEA, RESTLESS LEGS SYNDROME | The study followed a randomized, placebo-controlled, order-balanced, double-blind, cross-over design. Two experimental nights (GHB vs. placebo) were separated by a washout phase of 7 days. Prior to definitive enrollment into the study, all participants underwent a polysomnographic examination in the sleep laboratory of... | PMC10267648 |
Participants | In sum, 20 healthy, male volunteers completed the study, whereof 4 participants were excluded from the final data analysis due to technical issues with the MR scanner or insufficient MR data quality (mean age of included participants: 25.8 ± 5.1 years). The following criteria were required for inclusion: (i) male sex (... | PMC10267648 | ||
Urine immunoassay | Urine samples were taken on each test night, to ensure abstinence from illegal drug use (Drug-Screen Multi 12-AE, Nal von Minden GmbH, Regensburg, DE). | PMC10267648 | ||
Drug administration | At each experimental night, study participants were awoken at 02:30 a.m. to receive 50 mg/kg of GHB (Xyrem®) or placebo dissolved in 2 dL of orange juice, matched in appearance and taste (see Study design of the experimental nights. Sleep period (23:00–07:00), time point of drug administration (02:30) and MRS/MRI scan ... | PMC10267648 | ||
MRI data acquisition | BEST | The fMRI resting state scan was performed in the morning after both experimental nights on a Philips Achieva 3T whole-body MR-unit equipped with a 32-channel head coil (Philips Medical Systems, Best, The Netherlands). The session started at 09:00 a.m. with a T1-weighted anatomical brain scan and was followed by fMRI ac... | PMC10267648 | |
MRI data preprocessing | REGRESSION, BRAIN | Standard image data preparation and pre-processing as well as statistical analysis and visualization were performed in Matlab (The Mathworks Inc., United States) and BrainVoyager (Brain Innovation B.V., The Netherlands). Functional data preprocessing included a correction for slice scan timing acquisition, a 3D rigid b... | PMC10267648 | |
Statistical analysis of fMRI images | PMC10267648 | |||
Independent component analysis of resting-state fMRI networks | The independent component analysis (ICA) analysis of RSN networks followed the identical approach described in a previous study of ours ( | PMC10267648 | ||
Analysis of correlations between RSN-FC and single voxel MRS metabolites | To explore possible interactions between neurochemical brain balance and RSN-FC, we also investigated associations of FC alterations between conditions with the respective changes of metabolite signals measured by single voxel sv-MRS analysis. The change in metabolite spectral signals across experimental conditions was... | PMC10267648 | ||
Subjective state variables | Each participant’s post-awakening mental state was assessed at 10:00 a.m. using the self-report questionnaire EWL-60 (“Eigenschaftswörterliste”; Janke and Debus | PMC10267648 | ||
Results | PMC10267648 | |||
fMRI data and RSNs | For both conditions (GHB and placebo), the mean frame-wise displacement was below the critical threshold of 0.5 mm and did not differ between the conditions. Using the network template masks for extracting the homolog network best-fitting ICA components from each subject, we examined the differences between conditions ... | PMC10267648 | ||
Associations between RSN-rsFC and sv-MRS metabolite signals | MRS | MRS data have been reported in detail in a separate publication (Scatterplots showing associations between the GHB-induced changes in resting-state functional connectivity between the SN and rCEN connection (ΔrsFC SN-rCEN) and the GHB-induced changes of metabolite signals in the ACC (ΔGABA, ΔGlu). In the | PMC10267648 | |
Subjective drug effects | REGRESSION | Generalized linear regression models revealed no significant effects of condition (GHB vs. placebo) and experimental session order on morning EWL subscale scores (all | PMC10267648 | |
Discussion | MRS | The present study aimed at investigating the neuropsychopharmacological effects of a nocturnal dose of 50 mg/kg GHB p.o. on next mornings’ rsFC and its relationship to GABA and Glu alterations in the ACC. First, we observed a newly induced rCEN-SN coupling after a night with GHB, which was not present in the placebo co... | PMC10267648 | |
Supplementary material | PMC10267648 | |||
Supplementary Material | Click here for additional data file. | PMC10267648 | ||
Acknowledgments | Vinnie | All authors report no conflicts of interest, financial or otherwise. We thank Vinnie Kandra for supporting us with the data acquisition. | PMC10267648 | |
Author contributions | Francesco Bavato: data analysis and interpretation, drafting the article;Fabrizio Esposito: data analysis and interpretation; critical revision of the article; Dario A. Dornbierer: project conceptualization and planning; data collection; Niklaus Zölch: data collection, data analysis, and interpretation; Boris B. Quedno... | PMC10267648 | ||
Funding | The study was supported by grants from the Swiss National Science Foundation (SNSF) (grant # 320030_163439 to H.P.L.) and the Clinical Research Priority Program | PMC10267648 | ||
Data availability | Anonymized data will be shared by request with any qualified investigator with institutional review board approval for the purposes of validation and/or replication using our center’s established procedures for sharing data.
| PMC10267648 | ||
References | PMC10267648 | |||
Summary | Contributed equallyContributed equally | PMC10533414 | ||
Background | Tafenoquine, co-administered with chloroquine, is approved for the radical cure (prevention of relapse) of | PMC10533414 |
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