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Availability of data and materials {29}
It is planned to make anonymous trial data on which scientific publications are based and all anonymous primary data publicly available for re- and meta-analyses after completion of the trial in an appropriate repository.
PMC9890770
Declarations
PMC9890770
Ethics approval and consent to participate {24}
MAY, RECRUITMENT
According to § 15 of the Professional Code for Physicians in Germany (Berufsordnung für die in Deutschland tätigen Ärztinnen und Ärzte), the coordinating investigator has consulted the Ethics Committee (EC) of the University of Ulm before the start of the trial. Approval was granted on 23 May 2022 (Number 76/22). Also,...
PMC9890770
Consent for publication {32}
A model consent form is provided on request.
PMC9890770
Competing interests {28}
The authors declare that they have no competing interests.
PMC9890770
References
PMC9890770
Background
congenital heart disease, CHD
Esketamine is commonly used as a premedication for its sedation effect. However, the proper dosage for intranasal use in children with congenital heart disease (CHD) has not been determined. This study aimed to estimate the median effective dose (ED
PMC10114298
Methods
Anxiety
SEPARATION
Thirty-four children with CHD who needed premedication in March 2021 were enrolled. Intranasal esketamine was initiated at a dose of 1 mg/kg. Based on the outcome of sedation in the previous patient, the dose for the subsequent patient was either increased or reduced by 0.1 mg/kg, which was adjusted between each child....
PMC10114298
Results
The 34 children enrolled had a mean age of 22.5 ± 16.4 (4–54) months and a mean weight of 11.2 ± 3.6 (5.5–20.5) kg; American Society of Anesthesiologists classification I–III. The ED
PMC10114298
Conclusions
The ED
PMC10114298
Trial registration
: The trial was registered in the Chinese Clinical Trial Registry Network (ChiCTR2100044551) on 24/03/2021.
PMC10114298
Keywords
PMC10114298
Background
nausea, anxiety, hypoxia, intracardiac right-to-left shunting, allergy, vomiting, pain, cyanotic CHD
ADVERSE REACTIONS, SEPARATION, HYPOXIA, ALLERGY
Preoperative pediatric anxiety occurs in approximately 50–60% of children, especially those aged 1–5 years. This may have a negative psychological impact on children undergoing surgery [Preoperative sedation can alleviate perioperative anxiety of young children, thus creating a good condition for parental separation an...
PMC10114298
Methods
PMC10114298
Participants
liver/kidney dysfunction, airway abnormality, allergy
ALLERGY, OBSTRUCTIVE SLEEP APNEA SYNDROME
This prospective, randomized, single-blind study was approved by the ethics committee of by the Medical Ethics Committee of Shanghai Children’s Medical Center (SCMCIRB-K2020058-2) and registered in the Chinese Clinical Trial Registry Network (ChiCTR2100044551) on 24/03/2021. Inclusion of children with CHD was decided b...
PMC10114298
Methods
Before surgery, the parents/guardians of the participants were advised to routinely fast their children for 6 h, avoid breastfeeding for 4 h and feed them with light food for 2 h. The patients and their guardians were escorted to the operating room 60 min before surgery. The patient’s preoperative status was assessed b...
PMC10114298
Research Parameters
The primary endpoint of the present study was the ED
PMC10114298
Statistical analysis
Anxiety
REGRESSION, SEPARATION
Statistical data were analyzed by SPSS 20.0 (IBM Corp., Armonk, NY, USA) and Excel Software (Microsoft Corporation, Redmond, WA, USA). The normality test of measurement data was performed using the Kolmogorov-Smirnov method, and data for normal distribution are expressed as the mean ± standard deviation. Under homogene...
PMC10114298
Results
Anxiety, Tetralogy of Fallot, ductus arteriosus, coronary right ventricular fistula, ventricular septal defect, TOF, PVS, CHD, aortic stenosis, atrial septal defect
REGRESSION, PULMONARY VALVE STENOSIS, OBSTRUCTIVE SLEEP APNEA SYNDROME, AORTIC STENOSIS, SEPARATION, SEPARATION
Thirty-four patients were included in the study,, ASAI–III,21 boys and 13 girls, with a mean age of 22.5 ± 16.4 (4–54) months and a mean weight of 11.2 ± 3.6 (5.5–20.5) kg. The mean weight for successful and failed sedation was 11.0 ± 4.0 kg and 11.5 ± 3.1 kg, respectively. The CHD of the patients included ventricular ...
PMC10114298
Discussion
anxiety
DISEASE
We determined that the preoperative EDMidazolam, dexmedetomidine, and Ketamine are commonly used for preoperative sedation in children. An early in vitro animal experiment suggested that ketamine may be able to exert a potent diastolic effect on the intima of the pulmonary artery, thus reducing pulmonary circulation re...
PMC10114298
Acknowledgements
We thank all colleagues in the Department of Anesthesiology, Fujian Children’s Hospital, Shanghai Children’s Medical Center for their support in analyzing and collecting data for the paper, and for correcting the language and grammatical structure of the manuscript. We would like to thank Editage (
PMC10114298
Author Contributions
J.B.
H.B. G and J.J. H were the major contributors to the drafting of the manuscript. J.B. and D.Q. L were responsible for contacting the hospitals. D.Q. L analyzed and interpreted the data. The questionnaire was designed by H.B. G, J.J. H, J B, and D.Q. L. All authors read and approved the submitted version of the manuscri...
PMC10114298
Funding
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
PMC10114298
Data Availability
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
PMC10114298
Declarations
PMC10114298
Ethics approval and consent to participate
The studies involving human participants were reviewed and approved by the Medical Ethics Committee of Shanghai Children’s Medical Center. Written informed consent to participate in this study was provided by the participant’s legal guardian/next of kin. All methods were carried out in accordance with relevant guidelin...
PMC10114298
Consent for publication
Not applicable.
PMC10114298
Competing interests
The authors declare no competing interests.
PMC10114298
Abbreviations
Anxiety
SEPARATION
American Society of Anesthesiologistscongenital heart diseaseconfidence intervaleffective doseParental Separation Anxiety Scalesaturation of peripheral oxygenTetralogy of Fallot
PMC10114298
References
PMC10114298
1. Introduction
SECONDARY, TYPE 2 DIABETES
Among all tree nuts, walnuts contain the highest total polyphenols by weight. This secondary data analysis examined the effect of daily walnut supplementation on the total dietary polyphenols and subclasses and the urinary excretion of total polyphenols in a free-living elderly population. In this 2-year prospective, r...
PMC10005107
2. Materials and Methods
PMC10005107
2.1. Study Design and Participants
WAHA
The WAHA study was a 2-year parallel group, observer-blinded randomized controlled trial (RCT) examining the effect of the usual diet supplemented with walnuts at 15% (30–60 g/d) of energy compared to a walnut free habitual diet on the aging outcomes in elderly participants [Detailed information about the WAHA study ha...
PMC10005107
2.2. Sociodemographic, Anthropometric, and Biochemical Outcomes
Demographic data, anthropometric measurements, and dietary and lifestyle habits were collected from the participants at the baseline according to the study protocols [
PMC10005107
2.3. Estimation of Dietary Nutrient and Polyphenol Intake
Collection of dietary recall data and nutrient analysis was performed using the Nutrition Data System for Research (software version 2018) developed by the Nutrition Coordinating Center, University of Minnesota, Minneapolis, MN. The 24-h dietary recalls were obtained by telephone or face-to-face interviews using a mult...
PMC10005107
2.4. Urinary Total Polyphenols
Spot urine samples [
PMC10005107
2.5. Statistical Analyses
REGRESSION
From the LLU cohort, a total of In the descriptive analysis of urinary polyphenols, the means (SD) by treatment and time were determined. To compare the morning spot urine polyphenol excretion between treatment groups, linear regression mixed models fitted for both variables (mg GAE/L, mg GAE/g Cr) included the treatme...
PMC10005107
4. Discussion
WAHA
In this sub-study of the WAHA trial, we showed that the daily ingestion of walnuts for 2 years significantly increased the total dietary polyphenols and the subclasses of flavonoids, flavanols and phenolic acids in healthy elderly participants. To our knowledge, this is the first study to show that the inclusion of a s...
PMC10005107
5. Conclusions
age-related chronic diseases
CVD, DISEASE
A single food such as walnuts eaten daily can increase dietary polyphenol intake. This is important as we now know that polyphenols have significant health benefits, being powerful anti-inflammatory and antioxidant phytochemicals. To reduce the risk for age-related chronic diseases, it may be prudent to include nuts su...
PMC10005107
Author Contributions
Conceptualization, R.I.A., S.R., J.S. and E.R.; Methodology, R.I.A. and R.S.; Validation, R.S.; Formal analysis, K.O.; Writing—original draft preparation, R.I.A.; Writing—review and editing, R.I.A. and E.H.H.; Supervision, I.N., S.R. and R.S.; Project administration, R.S., I.N., M.C. and J.S.; Funding acquisition, J.S....
PMC10005107
Institutional Review Board Statement
The study protocol was conducted in accordance with the guidelines of the Declaration of Helsinki and approved by the institutional review boards of all centers.
PMC10005107
Informed Consent Statement
Informed consent was previously obtained from all subjects involved in the study.
PMC10005107
Data Availability Statement
Detailed data relating to the study are available upon request from the corresponding author.
PMC10005107
Conflicts of Interest
Rajaram, Sabaté, and Ros received research funding through their institutions from the California Walnut Commission. Sabaté and Ros were nonpaid members of the Scientific Advisory Council of the CWC. Dr Ros was a paid member of the CWC Health Research Advisory Group and has received personal money from the CWC for pres...
PMC10005107
2. Materials and Methods
PMC10305125
2.1. Study Design and Patients
diabetes mellitus, bone disorders
SYSTEMIC DISEASE, HEMORRHAGIC DISORDERS, DIABETES MELLITUS, OSTEOPOROSIS, BONE DISORDERS
This study was a prospective, randomized, and controlled clinical trial. Patients were recruited from the outpatient department of the Department of Periodontology, Krishnadevaraya College of Dental Sciences, Bengaluru.Patients over the age of 18 exhibiting a keratinized tissue width greater than 1.5 mm, Siebert’s clas...
PMC10305125
2.2. Clinical Measurement, Radiological Assessment, and Pre-Surgical Procedures
postoperative pain
HAND SWELLING
A preoperative clinical examination was carried out before the procedure. Study casts were prepared with dental stones for all the treated cases to plan the surgical procedure and estimate the amount of augmentation required.The clinical ridge height and width were measured preoperatively using a University of North Ca...
PMC10305125
2.3. Surgical Procedure
INFILTRATION
The area was anesthetized with lidocaine 2%, via a nerve block or infiltration. Disinfection with povidone-iodine was done followed by isolation of the area.
PMC10305125
2.3.1. Minimalistic Alveolar Ridge Augmentation Technique
A vertical incision of approximately 10 mm was performed mesial to the defect, away from the marginal gingiva and towards the MGJ using Bard-Parker #15 blade (The blood flowing out of the pouch was collected with a 5 mL syringe in order to manipulate the graft material to prepare the osseous coagulum. The graft materia...
PMC10305125
2.3.2. LLLT Test Sites
At the test sites, LLLT was performed prior to bone graft deposition. A diode laser was employed to deliver LLLT on the exposed bone surface inside the pouch (The length of the edentulous ridge was taken into consideration in order to determine the amount of laser radiation to be delivered. The parameters used were 100...
PMC10305125
2.4. Statistical Analysis
The clinical and radiological measurements were transferred into Microsoft Excel datasheets, and statistical analyses were carried out. All statistical tests were conducted using Statistical Package for Social Sciences (SPSS) version 20.0 (SPSS Inc., Chicago, IL, USA) software. The data’s normality was assessed using t...
PMC10305125
3. Results
Of the 20 patients (Data was analyzed, and statistical analyses were performed. The majority of the patients treated were males (
PMC10305125
3.1. Clinical Observation
swelling
The surgical procedure took less than one hour in both of the groups. At three months follow-up, all of the sites had healed completely, with graft bulk palpable in the treated area. At six months follow-up, all the sites manifested good visible alveolar ridge width and aesthetic harmony. A total of 70% of the subjects...
PMC10305125
3.2. Radiological Findings
±
Radiographic assessment with CBCT at six months post-surgery showed an increase in MRW for all the cases treated (The MBD for the test group and control group, at baseline and six months, was 1040.70 ± 490 to 904.30 ± 402.55 and 1138.20 ± 342.50 to 1093.9 ± 380.36, respectively. MBD was found to decrease at six months ...
PMC10305125
4. Discussion
postoperative pain, swelling, fibrous, tooth, ultra-conservative
SEQUELA, PERIOSTEUM, WOUND DEHISCENCE, HAND SWELLING, HYDROXYAPATITE, COMPLICATIONS
Most dental surgeries, such as guided bone regeneration and implant surgeries, require extensive soft and hard tissue manipulation, resulting in subsequent loss of the tissue volume. Over the years, surgical methods have been refined in order to take advantage of ultra-conservative approaches which cause the least poss...
PMC10305125
Author Contributions
A.M.L.
Conceptualization, K.P.A. and R.P.; methodology, K.P.A., R.P., M.L.V.P. and S.K.B.; software, K.P.A.; validation, R.P., M.L.V.P., S.K.B., R.T. and H.A.; formal analysis, K.P.A. and R.P.; investigation, K.P.A. and S.K.B.; resources, R.T., H.A., A.M.L., K.P.S. and G.K.B.; data curation, K.P.A.; writing—original draft pre...
PMC10305125
Institutional Review Board Statement
This study was conducted in accordance with the Declaration of Helsinki and was approved by the Institutional Review Board of Krishnadevaraya College of Dental Sciences for studies involving humans. (KCDS/110/PG 2017-18, 10/11/2017).
PMC10305125
Informed Consent Statement
Informed consent was obtained from all subjects involved in the study.
PMC10305125
Data Availability Statement
The dataset used in the current study is available upon reasonable request.
PMC10305125
Conflicts of Interest
The authors declare no conflict of interest.
PMC10305125
References
Consort flow diagram showing the randomization, follow-up, and analysis involved in the study.Surgical technique: (CBCT analysis of the ridge width and bone density. (Description of patients and graft sites.Patient reported outcomes for both the control and test groups.Radiographic measurements.* Significant according ...
PMC10305125
Study design
DILATION, REACTIVE HYPEREMIA
The study was a substudy of the RituxME trial, a national, multicenter, randomized, double-blind, placebo-controlled phase III study on the effect of rituximab vs. placebo in ME/CFS patients in Norway. Flow-mediated dilation (FMD) and post-occlusive reactive hyperemia (PORH) was measured at baseline and after 18 months...
PMC9894436
Results
ME/CFS patients had markedly reduced FMD compared to healthy controls at baseline (5.1% vs. 8.2%, p< 0.0001, adjusted for arterial diameter and sex), and significantly lower microvascular regulation measured by PORH than healthy controls (1354 PU vs. 2208 PU, p = 0.002). There were no differences between the treatment ...
PMC9894436
Conclusions
DISEASE
ME/CFS patients had reduced macro- and microvascular endothelial function, indicating that vascular homeostasis may play a role in the clinical presentation of this disease.
PMC9894436
Data Availability
All relevant data are within the paper and its
PMC9894436
Introduction
ME/CFS disease, orthostatic intolerance, post-exertional malaise
REACTIVE HYPEREMIA, DISEASE, SYNDROME, DILATION, ENDOTHELIAL DYSFUNCTION
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a disease with a massive negative impact on quality of life for affected patients [In previous studies, results indicated that a subgroup of ME/CFS patients experienced improvement of symptoms after therapeutic B-lymphocyte depletion using the monoclonal an...
PMC9894436
Materials and methods
PMC9894436
Study design
The present study was a substudy of the RituxME trial [
PMC9894436
Variables
DISEASE
The main outcomes were measures of endothelial function (FMD and PORH) at baseline and after 18 months. Measures of disease severity at baseline and symptom change/clinical response at 18 months were other important variables.
PMC9894436
Measures of symptoms and disease severity
The severity of ME/CFS was categorized into five groups (mild, mild-moderate, moderate, moderate/severe, severe). The categorization into different severity groups was based on thorough clinical assessment by the physician at the time of inclusion, and supported by patient-reported function level and questionnaires. Se...
PMC9894436
Statistical analyses
SPSS versions 25 and 27 were used for statistical analyses. Chi square tests were used to compare groups for categorical variables and t-tests (equal variances not assumed) for comparing means of continuous variables. Normality was tested using the Shapiro-Wilk´s test. FMD in ME/CFS patients and in healthy controls wer...
PMC9894436
Results
PMC9894436
Baseline characteristics
Baseline characteristics of the participants are reported in
PMC9894436
Vascular measures—baseline
mean flow-mediated dilation
DILATION
Among ME/CFS patients, mean diameter pre-occlusion was 3.00 mm (SD 0.50 mm); mean post-occlusion diameter at maximum dilation was 3.15 mm (SD 0.51 mm). For healthy women, mean diameter pre-occlusion was 2.94 mm (SD 0.42 mm); mean post-occlusion diameter at maximum dilation was 3.19 mm (SD 0.44 mm). Compared by unpaired...
PMC9894436
Flow-mediated dilation and post-occlusive reactive hyperemia in ME/CFS patients and healthy controls.
DILATION
After administration of glyceryl nitrate sublingually, mean diameter was 3.69 mm (SD 0.59) in ME/CFS patients, and mean dilation in per cent was 23.3%, similar to healthy women (mean diameter 3.60 mm (SD 0.47) and mean dilation 22.6%). Adjusted for sex and baseline arterial diameter in ANCOVA, the results were similar ...
PMC9894436
Associations between vascular measures and disease severity
DISEASE
Correlation analyses between vascular measures and measures of disease severity and function levels are illustrated in
PMC9894436
Associations between vascular measures and disease severity.
PMC9894436
18 months follow-up, changes in clinical status and vascular measures
The Bergen cohort of the RituxME trial with rituximab and placebo groups pooled, experienced a slight clinical improvement after 18 months (
PMC9894436
Vascular measures at baseline and 18 months.
PMC9894436
Discussion
vascular dysfunction, preload failure, cardiovascular disease, endothelial dysfunction
CARDIOVASCULAR DISEASE, ENDOTHELIAL DYSFUNCTION, DISEASE, VASCULAR DILATION, SECONDARY, ENDOTHELIAL DYSFUNCTION
The present study is one of the first studies to investigate vascular function in ME/CFS patients, and was a substudy of a multi-center, national, randomized and placebo-controlled trial that investigated the effect of B-cell depletion using the monoclonal antibody rituximab in this poorly understood disease. We found ...
PMC9894436
Conclusions
DISEASE
ME/CFS patients in this study had reduced endothelial function, indicating that vascular homeostasis is affected in at least some of these patients and may play a role in the clinical presentation of this disease. There is a pressing need for more studies to investigate this important issue, in order to better understa...
PMC9894436
Supporting information
PMC9894436
Study protocol.
(PDF)Click here for additional data file.
PMC9894436
GLM syntax.
(PDF)Click here for additional data file.
PMC9894436
Study file.
Patients and PORH controls.(XLSX)Click here for additional data file.
PMC9894436
Study file.
Patients and FMD controls.(XLSX)Click here for additional data file.
PMC9894436
Methods and finding
ADVERSE EVENTS
A literature search was performed in PubMed, EMBASE, Cochrane Library, Web of Science, and Open Grey databases from inception to October 28, 2022. Three randomized controlled trials (RCTs) and one non-randomized controlled trial (non-RCTs), including 358 patients met our inclusion criteria and were included in qualitat...
PMC10374120
Conclusion
RA
EVENTS
This Systematic review and meta-analysis showed a favorable safety profile, without life-threatening events in subjects with RA, and a trend toward clinical efficacy that must be confirmed through high-quality RCTs, considerable sample size, and extended follow-up in subjects with RA.
PMC10374120
Data Availability
All relevant data are within the manuscript and its
PMC10374120
Introduction
rheumatic diseases, synovitis, rheumatic, RA disease, arthropathy, Rheumatoid arthritis, RA, autoimmune disease
RHEUMATIC DISEASES, SYNOVITIS, PROLIFERATION, AUTOIMMUNE DISEASES, ARTHROPATHY, RHEUMATOID ARTHRITIS, DISEASES, AUTOIMMUNE DISEASE, COMPLICATIONS
Rheumatoid arthritis (RA) is a chronic, inflammatory, and progressive autoimmune disease characterized by synovitis, destructive arthropathy, and systemic complications [According to the evidence, the prevalence of rheumatic diseases such as RA has increased in the last decades, with a global prevalence of 460 per 100....
PMC10374120
Materials and methods
The review protocol was registered on PROSPERO 2022 [CRD42022372228], available from:
PMC10374120
Search strategy
rheumatoid, arthritis rheumatoid
RHEUMATOID ARTHRITIS
We searched PubMed, EMBASE, Cochrane Library, Web of Science databases, and the system for information on grey literature—Open Grey. The following parameters were used in the included medical electronic databases, these parameters and restrictions applied were the same in all databases: ((arthritis rheumatoid [title/ab...
PMC10374120
Article selection
First, duplicate records were removed before the screening. Two reviewers initially screened all articles by title and abstract to exclude articles unrelated to the main objective of this study. Then, two reviewers read the full manuscripts and selected the eligible ones; a third reviewer resolved any discrepancies tha...
PMC10374120
Inclusion and exclusion criteria
rheumatoid arthritis, RA
RHEUMATOID ARTHRITIS, RHEUMATISM
We selected all randomized controlled trials (RCTs) or non-randomized controlled trials (non-RCTs) that met the following criteria: (i) patients > 18 years with a diagnosis of rheumatoid arthritis (RA) according to the classification criteria ACR (American College of Rheumatology) or EULAR (European League Against Rheu...
PMC10374120
Data extraction and quality/risk of bias assessment tools
Two independent reviewers extracted the data from all the articles according to the following information: The first author, published year, location, trial registration number, study type, study phase, study population, age, sex, sample size, infusion route, intervention, control, follow-up, efficacy outcomes, safety ...
PMC10374120
Outcomes
PMC10374120
1. Primary outcomes
DISEASE
Primary outcomes were an assessment of clinical activity through DAS-28 (disease activity score 28), HAQ (health assessment questionnaire), a measure of response: measured by the ACR scale 20, 50, 70 (American College of Rheumatology 20/50/70 criteria), and serology such as anti-CCP (anti-citrullinated protein antibodi...
PMC10374120
2. Secondary outcomes
ADVERSE EVENTS
Secondary outcomes were the safety of treatment with MSCs: adverse events (AE), serious adverse events (SAE), and non-serious adverse events.
PMC10374120
Statistical analysis
A meta-analysis of the data from 3 included studies was performed by Stata 17—multivariate meta-analysis software (StataCorp, Texas, USA). Risk ratio with their corresponding 95% confidence intervals (CIs) was used for dichotomous outcome pooling. We chose a random effects model in the analysis using the DerSimonian-La...
PMC10374120
Results
PMC10374120