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Meal challenge buffet energy intake
There was no significant difference in total energy intake (AL 2887 [194] kJ, SB 3185 [196] kJ; Proportion of total energy contributed by core and discretionary foods at buffet
PMC9614749
Discussion
appetite suppression, satiety
As rates of overweight and obesity continue to rise throughout the developed world, it is important to understand the mechanisms that regulate eating behaviours. Satiation and satiety are important factors in regulating food intake by suppressing hunger and hence food intake [Our study demonstrates that the consumption...
PMC9614749
Strengths and limitations
weight gain, adiposity, overweight or obesity
ADIPOSITY, BROWN
This study was conducted prior to and during the COVID-19 pandemic, and restrictions on clinical research which occurred once the pandemic began prevented the study team from continuing the food buffet protocol. Thus, only those participants who completed the study prior to the onset of the pandemic completed the buffe...
PMC9614749
Conclusion
obesity, weight loss, fullness, diabetes
OBESITY, DIABETES
Foods that promote satiety help to regulate energy balance and may assist with weight management. Future studies should consider test food dose and composition carefully as the volume of food, its sensory qualities, and the acceptance of the food respective of usual meal patterns, may be important in eliciting a feelin...
PMC9614749
Supplementary Information
Below is the link to the electronic supplementary material.Supplementary file1 (PDF 191 KB)We would like to thank the research staff, placement students and volunteers for their involvement in the study.
PMC9614749
Author contributions
RECRUITMENT
AMC was the principal investigator for the study. AMC, JDB, AMH, S-YT, GBR were co-investigators on the grant application and as such were involved with the original design. SC, AMH, JDB, AMC were involved with study coordination and were responsible for the day to day running of the trial, recruitment and sample colle...
PMC9614749
Funding
Open Access funding enabled and organized by CAUL and its Member Institutions. This work was funded by the Almond Board of California. This funding source had no role in the design of this study or the analysis and interpretation of the data.
PMC9614749
Declarations
PMC9614749
Conflict of interest
AMC has consulted for Nuts for Life (an initiative of the Australian Tree Nut Industry). S-YT has previously been involved in studies funded by the Californian Walnut Commission. AMC, JDB and S-YT have previously been involved in studies funded by International Nut and Dried Fruit Council.
PMC9614749
References
PMC9614749
Subject terms
SARS-COV-2 INFECTION
The efficacy of Hydroxychloroquine (HCQ) as post-exposure prophylaxis (PEP) for the prevention of COVID-19 was contentious. In this randomized control double-blind clinical trial, asymptomatic individuals with direct contact with laboratory-confirmed COVID-19 cases were randomized into PEP/HCQ (N = 574) and control/pla...
PMC9825075
Introduction
thrombotic eventsMany
MAY, VIRUS, SARS-COV-2 INFECTION, SECONDARY INFECTION
The novel corona virus (SARS-CoV-2) pandemic affected more than 575 million people worldwide with more than 6.3 million loss of life, as of 2nd August 2022When the study was carried out, there were no definitive therapeutic drugs available for the treatment of COVID-19. COVID-19 patients used to be managed with symptom...
PMC9825075
Methods
The methodology followed in this study was similar to our previously published institutional study, regarding HCQ prophylaxis for the prevention of COVID-19
PMC9825075
Aims of the study
To evaluate the efficacy of Hydroxychloroquine (HCQ) as post exposure prophylaxis (PEP) for the prevention of COVID-19 in asymptomatic high-risk household individuals in direct contact with the laboratory-confirmed COVID-19 cases.
PMC9825075
Site of study
Communicable disease
COMMUNICABLE DISEASE, EMERGENCY
It was a single center study. The individuals with history of high-risk direct contacts with COVID-19 case were screened and enrolled for the study in the COVID-19 screening clinic at Emergency medical outpatient department (EMOPD) and Communicable disease ward of the Post Graduate Institute of Medical Education and Re...
PMC9825075
Study design
BLIND
In this randomized control double blind clinical trial, asymptomatic individuals with direct contact with laboratory-confirmed COVID-19 cases were screened for enrolment according to the inclusion and exclusion criteria and randomized into PEP/HCQ and control/placebo group after getting written informed consent. The pa...
PMC9825075
Study duration
The clinical trial was executed from the month of March to July 2021 during the second wave of the COVID-19 pandemic. The enrollment period was from 22nd march 2021 to 17th June 2021. The Delta variant of COVID-19 was an emerging predominant variant during that time.
PMC9825075
Inclusion and exclusion criteria
Regardless of gender with age ≥ 18 years, all asymptomatic individuals with direct contact with laboratory-confirmed COVID-19 cases were included in the study
PMC9825075
Method and intervention
followsThe
DISEASE PROGRESSION, BLIND
In this randomized control double blind clinical trial, the participants were randomly assigned into either PEP/HCQ group or control/placebo group, after getting written informed consent. The PEP/HCQ group received tablet HCQ 400 mg q 12 hourly on day one, followed by 400 mg once weekly for 3 weeks (total 5 tablets and...
PMC9825075
Outcome
ADVERSE DRUG REACTION
Primary outcome was the incidence of COVID-19 cases, definite COVID-19 cases & probable COVID-19 cases. Secondary outcomes were 1.new onset symptoms of COVID-19, 2. Compliance to the advised therapy, 3. Incidence of adverse drug reaction (ADR).
PMC9825075
Sample size and statistical analysis
As per our institutional pilot study during the first wave of the COVID-19, the incidence of COVID-19 was considerably (P = 0.033) lower in the PEP group (10.6%) that received HCQ prophylaxis compared to the control group (19.5%) with absolute risk reduction of –8.9% pointsStudy design, screening and enrollment.
PMC9825075
Results
PMC9825075
Study population’s baseline characteristics
Diabetes mellitus, co-morbidity, bronchial asthma, hypothyroidism, hypertension
DIABETES MELLITUS, BRONCHIAL ASTHMA, HYPOTHYROIDISM, HYPERTENSION, CORONARY ARTERY DISEASE
Out of 1168 participants, majority of the participants were male 865 (74.1%) than female 303 (25.9%). Study population’s mean age was 35.0 (± 10.4) years, with majority of the participants were from 18 to 45 years age group (84.4%), followed by > 45–65 years age group (14.2%), and > 65 years of age group (1.4%). None o...
PMC9825075
Symptomatic COVID-19
Out of 51 COVID-19 cases majority of them were symptomatic 41 (80.4%) and only 10 (19.6%) participants were asymptomatic. The incidence of symptoms were comparable (p = 0.317) between the control group [N = 24 out of 594, 4.0%] and PEP [17 out of 574, 3.0%] groups (Table
PMC9825075
Secondary outcome
gastritis-related symptoms, nausea, anxiety, vomiting, palpitation, skin rash
ADVERSE EVENTS, RECURRENCE, SIDE EFFECT
Overall compliance to the therapy was very good. The compliance to therapy was inadequate in 4 (0.3%) participants (1 in control group and 3 in PEP group) who stopped taking medication after day one either due to side effect or the anxiety related to the possible side effect. The drug was well tolerated and no serious ...
PMC9825075
Discussion
retinopathy, G6PD-deficient, rheumatoid arthritis, systemic lupus erythematosusHCQ, SARS-CoV-2 infection, illness, palpitation, haemolysis
RETINOPATHY, RHEUMATOID ARTHRITIS, VIRUS, CARDIAC ARRHYTHMIAS, SARS-COV-2 INFECTION, RECURRENCE, DISEASE, EVENT, CARDIAC EVENTS, LOSS OF VISION, HYPOGLYCAEMIA
In this randomized, double-blind placebo-controlled clinical trial, 1168 asymptomatic individuals of high risk household direct contact with the laboratory-proven COVID-19 cases received PEP with either HCQ or Placebo and followed up for 4 weeks for the detection of new onset COVID-19. We found that PEP with HCQ was no...
PMC9825075
Supplementary Information
The online version contains supplementary material available at 10.1038/s41598-022-26053-w.
PMC9825075
Acknowledgements
We thank and acknowledge AKUMS Drugs & Pharmaceuticals LTD. Research & Development center Haridwar, Uttarakhand, for providing GMP-certified matching placebo tablets of Hydroxychloroquine (400 mg) free of cost. We are also grateful to all the participants for their voluntary participation in this clinical trial to crea...
PMC9825075
Author contributions
RECRUITMENT
D.P.D.: Concept, design, contact tracing, recruitment, data analysis, data interpretation, protocol & manuscript writing. N.A.: Plan Execution, screening, contact tracing, follow up, data collection, Case record form. D.C.: Plan Execution, screening, contact tracing, recruitment, data collection, Case record form. A.P....
PMC9825075
Data availability
All reasonable data requests should be submitted to the corresponding author (DPD) for consideration.
PMC9825075
Competing interests
The authors declare no competing interests.
PMC9825075
References
PMC9825075
Aim and background
autoimmune mucocutaneous disorder, OLP
ORAL LICHEN PLANUS
Oral lichen planus (OLP) is a chronic autoimmune mucocutaneous disorder of unknown etiology and treatment is targeted at alleviating symptoms. At present, corticosteroids are the mainstay treatment, and their side effects hamper their long-term use, demanding alternative therapy. This study intended to assess the effic...
PMC10507837
Materials and methods
thirty-four, OLP
After sample size determination, thirty-four subjects confirmed histopathologically with OLP were included in the study. They were divided into 3 groups, Group 1(Control) was treated with 0.1% triamcinolone acetonide, and Group 2(Case) and 3 (Case) were treated with topical purslane 5% and 10%, respectively. They were ...
PMC10507837
Results
The study was analyzed statistically and a
PMC10507837
Conclusion
Purslane, OLP
Purslane is a magical herb with a plethora of rich nutrients, ease in accessibility and devoid of side effects. It was concluded that its preparation is beneficial and can be a safer alternative long-term drug for the management of OLP.
PMC10507837
Clinical significance
With available literature evidence, our present study is the first of its kind to formulate a topical gel with purslane to treat symptomatic OLP. Our study had a longer follow-up of 3 months compared to other studies in the literature.
PMC10507837
Keywords
PMC10507837
Introduction
ulcerative, OLP [, chronic inflammatory disorder, OLP, plaque-type, malignant disorder, cardiac glycoside
DISORDER, REMISSIONS, ULCERATIVE, DISORDERS, AUTOIMMUNITY, PATHOGENESIS, ORAL CANCER, PLAQUE, ORAL LICHEN PLANUS, OXIDATIVE STRESS, CHRONIC INFLAMMATORY DISORDER, ATROPHIC, DESQUAMATIVE GINGIVITIS
The World Health Organization Collaborating Centre for Oral Cancer Workshop held in the United Kingdom (2020) confirmed oral lichen planus (OLP) as a potentially malignant disorder. OLP is defined as a “chronic inflammatory disorder of unknown etiology with characteristic relapses and remissions, displaying white retic...
PMC10507837
Aims and objectives
This study aims to assess and compare the therapeutic efficacy of topical purslane gel at two concentrations (5% and 10%) against topical triamcinolone acetonide 0.1% OLP management.
PMC10507837
Materials used
PMC10507837
Study design
Proper ethical clearance was obtained from the Institutional Review Board (SRMDC/IRB/2020/MDS/No.901), and the study was registered in the Clinical trial registry of India (CTRI/2021/09/036647) on 20/09/2021. A double blinded randomized controlled clinical trial was proposed and conducted in the Department of Oral Medi...
PMC10507837
Study samples
Based on the Agha Hosseini et al. (2010) study [
PMC10507837
Inclusion criteria
Patients clinically diagnosed with symptomatic OLP were further confirmed by histopathology.Patients who had not used systemic or topical glucocorticosteroids for at least the past 2 weeks.Patients who agreed not to use any other medication such as analgesics and anesthetics in either topical form or systemic form dur...
PMC10507837
Exclusion criteria
lichenoid lesions, allergic, ulcerative
HYPERSENSITIVITY REACTIONS, ULCERATIVE
Patients who are not willing to be a part of the study.Patients with lichenoid lesions are thought to develop hypersensitivity reactions to drugs and dental materials.Patients on long-term glucocorticosteroid therapy.Pregnant and lactating mothers.Patients who are allergic to purslane.Participants had a clinical appea...
PMC10507837
Methodology
PMC10507837
Preparation of purslane gel
Fresh leaves from Portulaca oleracea were collected from the local market in Tondiarpet, Chennai, Tamil Nadu washed with running water, shade dried, and powdered to granules. It was processed to obtain the ethanolic extract, which was formulated with the ora-base gel at 5% and 10% concentrations. The composition of the...
PMC10507837
Double-blinded randomized controlled trial
chief complaints of burning sensation, pain
ORAL LICHEN PLANUS, ATROPHIC
Participants with chief complaints of burning sensation or pain were selected for the study. Thirty-four participants with clinically diagnosed and histopathologically confirmed oral lichen planus were categorized into 3 groups by randomization. Participants were evaluated at baseline, 14 days, 30 days, 60 days, and 90...
PMC10507837
Statistical analysis
pain
The SPSS program (IBM SPSS Statistics, Version 20.0, Armonk, NY: IBM Corp.), the statistical analysis was carried out. “Shapiro Wilks test” was used to evaluate the normality of the data distribution of the study variables. Nonparametric tests were used to determine differences in significance between the comparison gr...
PMC10507837
Results
pain
REMISSION
The descriptive statistics pertaining to “demographic data” (mean age group, gender, and site) for both intervention groups showed that the mean age of the 3 groups was 45.60(Group 1), 42.17(Group 2), and 40.25(Group 3). The results on mean age in our study are in accordance with the literature. The male: female ratio ...
PMC10507837
Discussion
pain, OLP [, OLP
ORAL LICHEN PLANUS, RECURRENCE, RECURRENT APHTHOUS STOMATITIS
PK Mankapure et al., undertook a study to better understand the demographics and clinical characteristics of OLP in 108 patients. The findings revealed that 87.9% of cases involved the buccal mucosa, with females making up 70.4% of those affected [Kia et al., assessed the comparative efficacy of triamcinolone and curcu...
PMC10507837
Clinical significance
With available literature evidence, our present study is the first of its kind to formulate a topical gel with purslane to treat symptomatic OLP. Our study had a longer follow-up of 3 months compared to other studies in the literature. Additionally, the results were compared as intergroup and intragroup comparisons at ...
PMC10507837
Conclusion
OLP
RECURRENCES
Over the period, corticosteroids have been the mainstay treatment for OLP. Undesirable effects of steroids have made it possible for more herbal therapies to be used, and many studies are being focused on in search of safer alternatives. Purslane, a magical herb with a plethora of rich nutrients, easy availability, and...
PMC10507837
Acknowledgements
We are thankful for Dr. Dhamodaran Umapathy, Academic Co- Ordinator (Tamil Nadu Chapter, Educational Multimedia Research Centre (EMMRC), Anna University Campus, Guindy for helping out in the gel preparation.
PMC10507837
Clinical trial registry
The study was registered in Clinical trial registry of India (CTRI/2021/09/036647) registered on 20/09/2021.
PMC10507837
Authors’ contributions
Arul Jothi Murugan - is the primary investigator of the study, conceptualized, collected the sample and the data, interpreted, and worked on the manuscript. Anuradha Ganesan- helped in framing the concept and study design. Guided throughout the study and helped in drafting the manuscript. Yesoda K. Aniyan - helped in f...
PMC10507837
Funding
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. It is a self-funded study.
PMC10507837
Availability of data and materials
The datasets generated and/or analyzed during the current study are not publicly available as permission has to be obtained from the institution but are available from the corresponding author on reasonable request.
PMC10507837
Declarations
PMC10507837
Ethics approval and consent to participate
Proper ethical clearance obtained from Institutional Review Board (IRB) of SRM Dental College, Ramapuram, Chennai – 600089 (SRMDC/IRB/2020/MDS/No.901) and registered in Clinical trial registry of India (CTRI/2021/09/036647). Following the guidelines of the Helsinki declaration, participants who volunteered for the stud...
PMC10507837
Consent for publication
Proper consent is obtained from the participants for the publication of study results without revealing personal information.
PMC10507837
Competing interests
The authors declare no competing interests.
PMC10507837
References
PMC10507837
Background
malignancy, Neuroblastoma, NB
NEUROBLASTOMA
Neuroblastoma (NB) is a childhood malignancy with marked heterogeneity, resulting in highly variable outcomes among patients. This study aims to establish a novel nomogram and risk stratification system to predict the overall survival (OS) for patients with NB.
PMC10465685
Methods
neuroblastoma
REGRESSION, NEUROBLASTOMA
We analyzed neuroblastoma patients from the Surveillance, Epidemiology, and End Results (SEER) database between 2004 and 2015. The nomogram was constructed using independent risk factors for OS, identified through univariate and multivariate Cox regression analyses. The accuracy of this nomogram was evaluated with the ...
PMC10465685
Results
tumor, NB
BRAIN METASTASES, TUMOR
A total of 2185 patients were randomly assigned to the training group and the testing group. Six risk factors, including age, chemotherapy, brain metastases, primary site, tumor stage, and tumor size, were identified in the training group. Using these factors, a nomogram was constructed to predict 1-, 3-, and 5-year OS...
PMC10465685
Conclusion
This nomogram demonstrates excellent accuracy and reliability, offering more precise personalized prognostic predictions to clinical patients.
PMC10465685
Keywords
PMC10465685
Introduction
neuroblastoma, tumor, Neuroblastoma, malignancy, NB, intermediate-risk neuroblastoma
MALIGNANCIES, NEUROBLASTOMA, NEUROBLASTOMA, TUMOR
Neuroblastoma (NB) is a childhood malignancy that originates from the developing sympathetic nervous system (Maris Despite these advancements, the prognosis for patients with neuroblastoma still demonstrates substantial variability due to the considerable tumor heterogeneity. Patients with low- and intermediate-risk ne...
PMC10465685
Methods
PMC10465685
Patients and methods
PMC10465685
Data source
cancer, Cancer
CANCER, CANCER
The patient data were extracted from the SEER database of the National Cancer Institute (NCI). The SEER database, administered by the NCI, serves as the authoritative source of information that provides updated data on cancer incidence and patient survival rates from population-based cancer registries, covering approxi...
PMC10465685
Patients selection
neuroblastoma, death, neuroblastoma or, deaths, ganglioneuroblastoma
ONCOLOGY, DISEASES, NEUROBLASTOMA, GANGLIONEUROBLASTOMA
Patients with neuroblastoma between 2004 and 2015 were selected from the SEER database according to the International Classification of Diseases for Oncology 3rd Edition (ICD-O-3). Inclusion criteria were: (1) age equal to or below 18 years, and (2) diagnosed with neuroblastoma or ganglioneuroblastoma (GNB). Exclusion ...
PMC10465685
Clinical variables and outcomes
tumor, death, Tumor
TUMOR, METASTASES, TUMOR
The collected patient information included age, race, sex, histology, primary site, tumor number, tumor size, first malignant primary indicator, tumor grade, distant metastases, tumor stage, surgery, scope of regional lymph node surgery, regional nodes, surgical procedure of other sites, chemotherapy, and radiotherapy....
PMC10465685
Statistical analysis
Analyses were performed using SPSS 26.0 (IBM, Chicago, IL, USA) and R software (version 4.2.2). Statistical significance was defined as
PMC10465685
Prognostic nomogram construction
REGRESSION
Univariate and multivariate Cox regression analyses were carried out to identify independent prognostic factors. Significant factors (
PMC10465685
Prognostic nomogram validation
The concordance index (C-index) was used to measure the accuracy of model predictions. A value above 0.7 indicates that the predictive model has excellent discriminative ability. The receiver operating characteristic (ROC) curve was employed to evaluate the performance of classification models. An area under the ROC cu...
PMC10465685
Risk stratification based on nomogram
Patients were categorized into three groups according to their total scores on the nomogram using X-tile software: the low-risk group (total score ≤ 140), the intermediate-risk group (140 < total score < 223), and the high-risk group (total score ≥ 223). The differences in survival among these risk categories were comp...
PMC10465685
Dynamic nomogram construction
A web-based dynamic nomogram was constructed using the open source R Shiny Server, which allows clinicians to conveniently assess patient prognosis using the nomogram.
PMC10465685
Results
PMC10465685
Patient characteristics
neuroblastoma, ganglioneuroblastoma
NEUROBLASTOMA, GANGLIONEUROBLASTOMA
A total of 2,185 patients were diagnosed with neuroblastoma or ganglioneuroblastoma between 2004 and 2015. Of these, 1529 were assigned to the training group and 656 to the testing group. The demographic and clinical features of the patients are outlined in Table Demographics and clinical characteristics of patients wi...
PMC10465685
Nomograms validation
tumor
TUMOR
The accuracy and applicability of the nomogram were assessed using both the training and testing groups for internal and external validation. The C-index was first used for estimation, resulting in values of 0.790 (95% CI 0.768–0.812) and 0.781 (95% CI 0.750–0.812) for the training and testing groups, respectively. In ...
PMC10465685
Nomogram-Based risk stratification system
The overall prognostic score for each patient was calculated based on variables within the nomogram. Two optimal cutoff values were identified at 140 and 223 scores using X-tile software. Utilizing these thresholds, patients were stratified into low, intermediate, and high-risk groups, consisting of 1100 patients (50.3...
PMC10465685
Subgroup analysis based on the new risk stratification
PRIMARY TUMOR
To underscore the benefits of risk stratification, we conducted an analysis of primary tumor sites and surgical outcomes across the different risk groups. Intriguingly, we observed a poorer prognosis in the retroperitoneum for the intermediate-risk group, whereas a worse prognosis was noted in the adrenal gland for the...
PMC10465685
Web-based nomogram
NEUROBLASTOMA
We developed a web-based nomogram to predict patient outcomes (≤ 18 years) diagnosed with neuroblastoma. This accessible tool empowers physicians and patients alike to individually and visually appraise survival probability of each patient by selecting common clinical variables (
PMC10465685
Author contributions
XZ: Writing-Original draft preparation, Methodology, Software. LX: Data curation, Visualization, Investigation. WT: Conceptualization, Supervision. WH: Conceptualization, Writing-Reviewing and Editing.
PMC10465685
Data availability
The data supporting the findings of this study are sourced from the publicly available Surveillance, Epidemiology, and End Results (SEER) Program (
PMC10465685
Declarations
PMC10465685
Conflict of interest
On behalf of all authors, the corresponding author states that there is no conflict of interest.
PMC10465685
References:
PMC10465685
Background
anxiety
Test anxiety is a prevalent issue among students, including those in the medical field. The present study aims to examine the impact of auricular acupressure on reducing test anxiety specifically among medical students.
PMC10629063
Methods
Anxiety
In this single-blind randomized parallel-group trial, a total of 114 medical students from Kermanshah, Iran, were allocated into two groups: intervention and control. Each group consisted of 57 students. The data collection instruments included a demographic information form and the Sarason Anxiety Inventory. In the in...
PMC10629063
Results
anxiety
The mean test anxiety scores in the Shen Men acupressure group exhibited a significant reduction from 18.4 ± 5.3 before the intervention to 13.3 ± 4.8 after the intervention (P = 0.001). Conversely, in the Sham acupressure group, the mean test anxiety scores showed no significant change, with values of 16.36 ± 6.4 befo...
PMC10629063
Conclusion
anxiety
Shen Men auricular acupressure demonstrates efficacy in reducing test anxiety among medical students. However, to validate its effectiveness, further research using objective measures is warranted.
PMC10629063
Keywords
PMC10629063
Introduction
anxiety
One common source of anxiety among students is examinations [Severe cases of test anxiety may necessitate therapeutic interventions [The Shen Men point, located in the triangular fossa of the ear, is an acupressure point known for its relaxing and analgesic effects [Test anxiety is a widespread issue among students, kn...
PMC10629063
Methods
PMC10629063
Study design
The current study employed a randomized, single-blind, parallel-group trial design, adhering to the guidelines outlined in the Consolidated Standards of Reporting Trials (CONSORT) criteria [
PMC10629063
Sample and sampling method
anxiety
The study population consisted of medical students from Kermanshah University of Medical Sciences (KUMS), Iran. A total of 114 medical students were included in the study. Sample size estimation was conducted using the formula for comparing means between two independent groups. The sample size calculation was based on ...
PMC10629063
Study setting
The intervention was carried out in the examination hall of the Kermanshah School of Medicine, which serves as the venue for all medical students’ exams. The examination hall has a capacity to accommodate 200 students, providing a suitable environment for conducting the intervention in this study.
PMC10629063