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Discussion
cardiovascular disease, inflammation, asthma, typically impaired, airway inflammation
INFLAMMATORY RESPONSES, CARDIOVASCULAR DISEASE, INFLAMMATION, ASTHMA, ARTERIAL STIFFNESS
We investigated the link between asthma and cardiovascular disease risk in a controlled laboratory environment by assessing the impact of the mannitol and methacholine airway challenges on systemic inflammation and vascular function in young people with confirmed asthma and in controls. Despite sufficiently reducing FE...
PMC10351735
Conclusion
inflammation, asthma exacerbations, airway inflammation
INFLAMMATION
Airway challenges that induce bronchoconstriction (methacholine) or inflammation and bronchoconstriction (mannitol) did not result in immediate measurable or clinically meaningful acute changes in systemic inflammation or vascular function. These findings suggest that airway inflammation and bronchoconstriction immedia...
PMC10351735
Supporting information
PMC10351735
CONSORT 2010 checklist of information to include when reporting a randomised trial*.
(DOC)Click here for additional data file.
PMC10351735
Study dataset with anonymized data necessary to replicate study findings.
(XLSX)Click here for additional data file.
PMC10351735
Study protocol.
(DOCX)Click here for additional data file.The authors of this study would like to thank Karishma Kapoor, Shelby Henry, Samira Roland, and Jenna Bertoncini at the University of Alberta for their assistance in data collection for this study. The authors thank Silvia Ortiz, MSc, at the University of Alberta for assistance...
PMC10351735
References
PMC10351735
Abstract
PMC10338851
Purpose
To refine the currently used, weight‐grouped protocol for coronary computed tomography angiography (CCTA), in terms of the radiation and contrast medium dose, through clinical evaluation.
PMC10338851
Methods
coronary artery disease
CORONARY ARTERY DISEASE
Following the current routine setting that varies between three weight groups (group A: 55–65 kg, group B: 66–75 kg, group C: 76–85 kg), three additional reduction protocols were proposed to each group, with different combinations of lowered tube voltage (70–100 kVp), tube current (100–220 mAs), and iodine delivery rat...
PMC10338851
Results
For all three groups, no significant difference was noticed in objective images quality between subgroups of dose settings (all
PMC10338851
Conclusion
It is feasible to refine the currently used, weight‐grouped protocol for CCTA in terms of radiation and contrast medium dose, by use of an optimization strategy where the balance between dose and image quality can be improved in a routine clinical setting. Yan Zhang and Ying Wang contributed equally to this study.
PMC10338851
INTRODUCTION
coronary artery disease
CORONARY ARTERY DISEASE
Coronary computed tomography angiography (CCTA) is a non‐invasive imaging modality that is of great value for diagnosing coronary artery disease (CAD).Efforts have also been made in optimizing the vessel enhancement in order to improve the image quality of CCTA.The purpose of this study was to refine the currently used...
PMC10338851
METHODS
PMC10338851
Study design and participants
CAD
CORONARY ARTERY DISEASE, CAD
As illustrated in Figure Flowchart of the study design. CAD, coronary artery disease; CCTA, coronary computed tomography angiography.Radiation and Contrast medium dose parameters.This prospective study received ethical approval from the Institutional Ethics Committee. Patients scheduled for CCTA from February to Decemb...
PMC10338851
CT image acquisition
All CT examinations were performed on a 320‐row CT scanner (uCT 960+; United Imaging Healthcare; Shanghai; China) with prospective electrocardiography (ECG)‐gating in axial scan mode, where the acquisition was completed in one single heartbeat. As in the majority of routine cases, beta‐blockers were not used. All patie...
PMC10338851
Objective image quality
One radiologist with over 7 years of experience in cardiovascular radiology sketched the ROIs for evaluating the objective image quality. The mean CT number and the noise were measured on the proximal segment of the left anterior descending (LAD) artery, the distal segment of the right coronary artery (RCA), as well as...
PMC10338851
Subjective image quality
BLIND
Two radiologists, one with 5 years and the other with 10 years of experience in CCTA diagnosis, were asked to assess the subjective image quality independently, where the cases were randomized and the observers were kept blind to the scanning protocol. The evaluation was performed for vessels with a diameter > 1.5 mm o...
PMC10338851
Statistical analysis
±, SD
Statistical analysis was performed using the SPSS software Version 26.0 (IBM Corp., Armonk, New York, USA). All data were expressed as means ± SD. The SNR, CNR, CTDI
PMC10338851
RESULTS
PMC10338851
Patient characteristics
A total of 321 patients (female/male: 126/195) were enrolled in the study, with 108, 108, and 105 cases in groups A, B, and C, respectively. Detailed information for each group i shown in Table Patient characteristics for three weight groups.
PMC10338851
Objective image quality
The results of objective image quality scores are shown in Figure Comparison of objective image quality. SNRs, signal‐to‐noise ratios; CNRs, contrast‐to‐noise ratios; LAD, left anterior descending; RCA, right coronary artery.
PMC10338851
Subjective image quality
Table Subjective image quality scores for each subgroup.
PMC10338851
Determination of the optimal setting
All other subgroups of protocols SNR and CNR measurement have no difference in image quality from conventional scanning protocols (Subgroups A(a‐c) VR and CPR images of a 73‐year woman (weight, 60 kg; BMI, 22.58 kg/m
PMC10338851
DISCUSSION
coronary artery stenosis
CORONARY ARTERY STENOSIS
In this study, we refined the currently used weight grouped protocol for CCTA in terms of the radiation and contrast medium dose through clinical evaluation. Given that no significant difference was found in objective image quality between subgroups, the optimal setting for each weight group was determined by the subje...
PMC10338851
CONCLUSION
It is feasible to refine the currently used, weight‐grouped protocol for CCTA in terms of radiation and contrast medium dose, by use of an optimization strategy where the balance between dose and image quality can be improved in a routine clinical setting. Apart from the optimal protocol as found for each of the weight...
PMC10338851
AUTHOR CONTRIBUTION
Conceptualization and study design: Huishu Yuan and Guozhi Zhang; Data collection, analysis, and interpretation: Yan Zhang, Ying Wang, Jing Li, and Aihui Di; Manuscript preparation: Yan Zhang, Jing Li, and Guozhi Zhang; All authors contributed to the work and approved the submitted version.
PMC10338851
CONFLICT OF INTEREST STATEMENT
The authors report no conflicts of interest.
PMC10338851
ACKNOWLEDGMENTS
To the anonymous reviewers.
PMC10338851
REFERENCES
PMC10338851
Background
hyper-inflammatory, hypoxic respiratory illness
SARS-COV-2 INFECTION
SARS-CoV-2 infections caused mild-to-moderate illness. However, a sizable portion of infected people experience a rapid progression of hyper-inflammatory and hypoxic respiratory illness that necessitates an effective and safer remedy to combat COVID-19.
PMC10696694
Methods
A total of 150 COVID-19-positive patients with no to mild symptoms, between the age groups 19–65 years were enrolled in this randomized, open-labeled three-armed clinical trial. Among them, 136 patients completed the study with RT-PCR negative reports. The patients received herbal drugs orally (Group A (
PMC10696694
Results
hypoxia
HYPOXIA, GROUP B
We found that the mean viral clearance time was 13.92 days (95% confidence interval [CI] 12.85–14.99) in Group A, 13.44 days (95% confidence interval [CI] 12.14–14.74) in Group B, and 11.86 days (95% confidence interval [CI] 10.62–13.11) days in Group C. Over a period of 14 days, the mean temperature in Groups A, and B...
PMC10696694
Graphical Abstract
PMC10696694
Supplementary Information
The online version contains supplementary material available at 10.1186/s40001-023-01507-7.
PMC10696694
Keywords
PMC10696694
Methods
PMC10696694
Study design, participants, and ethics
ARI, OPD
ACUTE RESPIRATORY INFECTION, RECRUITMENT, DELHI, GROUP B
A three-armed, open-labeled, randomized clinical trial was undertaken from November 2020 to September 2021. A total of 150 patients were recruited at the screening OPD and COVID health centre of All India Institute of Ayurveda (AIIA), New Delhi and ARI (acute respiratory infection) OPD and Corona Ward, ESIC Medical Col...
PMC10696694
Outcomes
PMC10696694
Primary outcomes
sore throat, myalgia, dyspnea, fever, fatigue, diarrhea, pain, cough, nasal congestion, headache, nausea,
SORE THROAT
The amount of time taken for RT-PCR to turn negative served as a primary outcome of viral clearance. Clinical symptoms such as fever, cough, difficulty breathing, dyspnea, sore throat, headache, joint pain, fatigue, running nose, nasal congestion, loss of sense of smell, loss of sense of taste, myalgia, nausea, vomitin...
PMC10696694
Secondary outcomes
Tecan
DISEASE PROGRESSION, DISEASE, PULMONARY INVOLVEMENT, SECONDARY, BLOOD
Blood tests planned to be conducted in the study were mainly of two types: (1) for assessment, monitoring the disease progression markers (PT-INR, Hs CRP, D-dimer, ferritin, cytokines, and other molecular markers) and observing the effect of trial medicines on them; (2) for identifying systemic effects of the disease a...
PMC10696694
Statistical analysis
The data processing and statistical analysis were performed using IBM Statistical Package for Social Sciences Software (SPSS) for Windows, version 26 and R software (v.4.1.2). The data distribution was examined for each parameter using the Shapiro–Wilk test (
PMC10696694
Results
A total of 150 patients diagnosed with COVID-19 using a RAT or RT-PCR positive test were enrolled among them 101 were males and 49 females with mean age 38.59 ± 11.74 years. Fourteen patients were considered to drop out of the trial. Among 136 patients, 50 patients were in Group A (All the groups had similar demographi...
PMC10696694
Viral clearance
Patients were mostly home quarantined and opted to come for follow-up RT-PCR at their convenience. Hence this is more indicative of the confirmation date rather than the actual time to negativity which could be earlier. The mean time taken to become COVID-19 negative was 13.92 days (95% confidence interval [CI] 12.85–1...
PMC10696694
Time to normal body temperature
RECRUITMENT, GROUP B
At the time of recruitment, 40% of patients had a temperature ≤ 98.6°F (normal body temperature) in Group A and < 50% of patients in Group B and C. Patients had higher body temperature recovered with the median day of 4 (95% confidence interval [CI] 3.86–6.72), 3 (95% confidence interval [CI] 2.66–4.41), 4 (95% confide...
PMC10696694
Primary clinical outcome
The average morning and evening data of each individual were assessed to compare the trend in their vital parameters for 14 consecutive days. There was a significant decline in mean temperature over 14 days from 98.92 ± 1.28 to 98.04 ± .80 in Group A; Trend in mean clinical symptoms in three study Groups over 14 days o...
PMC10696694
Secondary clinical outcome
PMC10696694
Pro-inflammatory and anti-inflammatory cytokines
GROUP B
A total of 15 pro-inflammatory and anti-inflammatory cytokines levels were examined using their serum samples. The cytokine levels in Group A (On the other hand, in Group B (In Group C (
PMC10696694
Molecular biomarkers for hypoxia and thrombosis
thrombosis, hypoxia
THROMBOSIS, HYPOXIA, GROUP B
The levels of hypoxia and thrombosis biomarkers, HIF-1α and vWF were tested. The level of HIF-1α significantly decreased in Group A after treatment (AT) (Table vWF, a molecular marker of thrombosis induced by HIF-1α, was undetectable in a large number of patients either before and/or after the treatment. The samples in...
PMC10696694
Management of complication
diabetes
GROUP B, DIABETES
One patient from Group A and another from Group B with diabetes were on oxygen supplementation for 4 days since their condition deteriorated from mild to moderate stage, antipyretic, and antibiotics were also given along with intervention drugs. One of them continued with the trial medication and hence included in the ...
PMC10696694
Discussion
dyspnea, SARS-CoV-2 infection, hyper-inflammatory, infection, hypoxemia, systemic disorder
SARS-COV-2 INFECTION, GROUP B, SILENT HYPOXIA, INFLAMMATORY RESPONSES, DISEASE, HYPOXIC, INFECTION, INFLAMMATORY RESPONSE
The majority of SARS-CoV-2 infections had either no or mild symptoms. But there is also a significant proportion of infected individuals who suffer from a severe hyper-inflammatory and hypoxic response that entails the development of a potent and effective treatment for COVID-19. The result of this clinical trial demon...
PMC10696694
Conclusions
hyper-inflammatory, viral pneumonia, AV herbal extract
VIRAL PNEUMONIA
Even though the alarmingly high number of SARS-CoV-2 cases are asymptomatic or mild, they can also manifest as severe viral pneumonia with hyper-inflammatory response, demanding the use of powerful and effective medication. We present the first clinical evidence of HIF-1 reduction in COVID-19 patients receiving AV herb...
PMC10696694
Acknowledgements
DELHI
The authors thank the Covid Health Centers of AIIA, ESIC, and the testing and research facilities of IGIB for their steadfast assistance. The authors also acknowledge the patients for their participation in the study. J.L.N. Shastri, and National Medicinal Plants Board, R. Galib AIIA, New Delhi, acknowledged for helpin...
PMC10696694
Author contributions
MP
RECRUITMENT
BP, TN, and AA conceived and designed the study. BP, TN, AKP, MB, SR, MP, and RT prepared the protocol and implemented the study. TN did trial drug procurement. MV, NR, AT, SKr, MB, SR, MP, and AKP performed patient recruitment and clinical monitoring. MF, RT, MP, MK, and SA did COVID RT-PCR testing. SR, RT, MP, and SK...
PMC10696694
Funding
The work is supported by a Grant (GAP0183) from M/o AYUSH for CoE Applied development in Ayurveda,
PMC10696694
Availability of data and materials
The data sets used and analyzed during the current study are available from the corresponding author upon reasonable request.
PMC10696694
Declarations
PMC10696694
Ethics approval and consent to participate
DELHI
This study was carried out in accordance with the recommendations of the Indian Council of Medical Research, India guidelines for biomedical research, with written informed consent from all subjects. All subjects gave written informed consent in accordance with the Declaration of Helsinki. The study protocols were revi...
PMC10696694
Consent for publication
A consent for publication was obtained from all study participants at the time of consenting for participation in the study.
PMC10696694
Competing interests
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
PMC10696694
References
PMC10696694
1. Introduction
RA
These authors contributed equally to this work.Background: Preschool children are in a period of rapid physical and psychological development, and improving their level of physical fitness is important for their health. To better develop the physical fitness of preschool children, it is very important to understand the...
PMC10002293
2. Methods
PMC10002293
2.1. Study Design and Participants
RA
This study was a single-blind, cluster-RCT study, with the kindergarten class as the cluster for the intervention. The data were sourced from the Physical Exercise on Fundamental Movement Skills and Physical Fitness of preschoolers (PEFP) project [In this study, a total of 309 preschool children aged 4 to 5 years were ...
PMC10002293
2.2. Intervention Procedures
RA, Preschool
The present study comprised four intervention groups: the BM, RA, BG, and MA groups. Preschool children in the control group participated in unorganized PA, and the details of the interventions have been described elsewhere [The intervention program consisted of structured lessons with a duration of 30 min performed th...
PMC10002293
2.3. Measurement Procedures
Physical fitness and descriptive data (e.g., age, sex, height, and weight) of preschool children were tested at baseline and at the end of the interventions, and each test was completed within a week. The physical fitness assessment was primarily based on the PREFIT battery, which has demonstrated satisfactory reliabil...
PMC10002293
2.4. Statistical Analysis
RA
The data were first tested for normality using standardized skewness and kurtosis values. Normally distributed data were presented as the mean and standard deviation, while non-normally distributed data were presented as the interquartile range. One-way analysis of variance (ANOVA) and the Kruskal–Wallis H test were us...
PMC10002293
3. Results
PMC10002293
4. Discussion
RA
Preschool children undergo a period of rapid physical growth and maturation of the nervous system, requiring the development of corresponding physical fitness, such as agility, strength, and reaction speed [In terms of cardiorespiratory fitness, pre-post effect sizes exhibited significant improvements in the 20 m shutt...
PMC10002293
5. Conclusions
Physical exercise programs designed for preschool physical education have positive effects on the physical fitness of preschool children. Compared with the exercise programs with a single project and action form, comprehensive exercise programs with multiple action forms can better improve the physical fitness of presc...
PMC10002293
Author Contributions
G.W. and D.Z. (Dan Zeng) had full access to all the data in the study, and they take responsibility for the integrity of the data and are responsible for the data analysis. D.Z. (Danqing Zhang) and S.Z. supervised the study data collection and analysis. G.W. and D.Z. (Dan Zeng) wrote the first draft of the manuscript a...
PMC10002293
Institutional Review Board Statement
The study was approved by the Ethics Committee at the Shanghai University of Sport (102772019RT034), with informed consent.
PMC10002293
Informed Consent Statement
The parents or guardians of the participants have signed a written informed consent form, which is kept by the Physical Exercise on Fundamental Movement Skills and Physical Fitness of preschoolers (PEFP) project data manager.
PMC10002293
Data Availability Statement
Data is unavailable due to privacy and ethical restrictions.
PMC10002293
Conflicts of Interest
The authors declare that they have no competing interests.
PMC10002293
References
Flow chart of research method.The results of the generalized linear mixed-model analyses for physical fitness tests after intervention. CG, Control group; BM, Basic movements group; RA, Rhythm activities group; BG, Ball games group; MA, Multiple activities group. The 20 m shuttle run test (Participant characteristics a...
PMC10002293
Background
chronic neck pain
This study aimed to evaluate the cost utility of pharmacopuncture in comparison with usual care for patients with chronic neck pain.
PMC10666315
Methods
chronic neck pain
A 12-week, multicenter, pragmatic randomized controlled trial was conducted, and 101 patients suffering from chronic neck pain for more than six months were randomly placed into the pharmacopuncture and usual care groups to receive four weeks of treatment and 12 weeks of follow-up observations. The quality-adjusted lif...
PMC10666315
Results
Compared to usual care, pharmacopuncture was superior as it showed a slightly higher QALY and a lower incremental cost of $1,157 from a societal perspective. The probability that pharmacopuncture would be more cost-effective at a willingness-to-pay (WTP) of $26,374 was 100%. Pharmacopuncture was also superior from a he...
PMC10666315
Conclusions
neck pain, chronic neck pain
Overall, pharmacopuncture for chronic neck pain was found to be more cost-effective compared to usual care, implying that clinicians and policy makers should consider new treatment options for neck pain.
PMC10666315
Trial registration
Number NCT04035018 (29/07/2019) Clinicaltrials.gov; Number KCT0004243 (26/08/2019) Clinical Research Information Service.
PMC10666315
Supplementary Information
The online version contains supplementary material available at 10.1186/s12913-023-10325-w.
PMC10666315
Keywords
PMC10666315
Background
neck pain, musculoskeletal disorder, pain
MUSCULOSKELETAL DISORDER, CERVICAL SPONDYLOSIS, DYSFUNCTION
Neck pain is a common musculoskeletal disorder among the general population, with a one-year prevalence of 15.8% [Despite various treatment options for neck pain, many patients seek complementary and alternative medicine (CAM) treatment approaches [However, high-quality evidence of the efficacy of pharmacopuncture is ...
PMC10666315
Methods
PMC10666315
Design
A cost-effectiveness analysis was conducted with a 12-week pragmatic RCT [Schedule of the participants is shown in Supplementary Table A1 (see Additional file
PMC10666315
Participants
cancer, rheumatoid arthritis, neurologic deficits, stroke, cancer metastasis or fracture, neck pain
STROKE, DISORDERS
Eligible patients were aged 17–70, had been experiencing neck pain for more than six months, and had a VAS score of more than five for their neck pain. The exclusion criteria for participation were as follows: having cancer metastasis or fracture in the spine; having progressive or severe neurologic deficits or other d...
PMC10666315
Intervention
HEAT
The general rule for pharmacopuncture treatment was undergoing two sessions per week for four weeks; however, one to three sessions per week were permitted depending on the patient’s condition and the physician’s determination. The type of pharmacopuncture solution and treatment points were determined by the physician....
PMC10666315
Randomization and blinding
Participants who were determined to be eligible based on the inclusion and exclusion criteria and signed the Informed consent form for this clinical study were assigned to two groups at a ratio of 1:1 using a randomization table. The randomization table was created in advance by a statistician using R studio 1.1.463 (©...
PMC10666315
Tools
Both EQ-5D and SF-12 scores were measured at baseline and at intervals of 5, 8, and 12 weeks after randomization. The Korean version of the EQ-5D with verified validity was used, and utility was calculated by applying the tariffs used by Kim et al. [
PMC10666315
Unit costs
Supplementary Table A2 (see Additional file
PMC10666315
Resource use measurement
neck pain, cervicalgia
DISEASES
In addition to the intervention used in the trial, healthcare services used personally by the patients for neck pain were investigated at baseline and at 5, 8, and 12 weeks using a questionnaire. The questionnaire was used to survey the non-reimbursement and copayments made by the patients as well as the frequency of u...
PMC10666315
Economic perspective
neck pain, pain
Two perspectives were considered, and the primary analysis was conducted from a societal perspective, reflecting productivity loss due to neck pain. The societal perspective includes direct medical costs, direct non-medical costs, and costs associated with productivity loss. The analysis from a healthcare perspective i...
PMC10666315
Data analysis
A primary analysis examining incremental cost utility from a societal perspective was performed to calculate the incremental cost-effectiveness ratio (ICER) by comparing the differential mean costs and QALY between the pharmacopuncture and usual care groups. ICERs were calculated by dividing the difference in total cos...
PMC10666315
Uncertainty
neck pain, Neck Disability, pain
The uncertainty of ICER and costs was estimated using the bootstrap residual technique [Three sensitivity analyses were conducted. First, a per-protocol analysis was performed only on patients who had received six or more treatments. Second, the method for calculating the productivity loss was altered. In the primary a...
PMC10666315
Results
PMC10666315
Participants
Between September 2019 and June 2020, 263 patients were screened, of which 101 were randomly allocated to the pharmacopuncture and usual care groups. One participant from each group withdrew their consent before receiving the treatment; moreover, one participant from the PT group was dismissed by the investigator due t...
PMC10666315
QALY
REGRESSION
The pharmacopuncture group showed a significantly lower EQ-5D-5 L score at baseline; however, the score was similar to those of the control group after 12 weeks. There were no significant differences between the two groups’ SF6D scores. The QALY was calculated using regression analyses adjusted for baseline values (Tab...
PMC10666315
Costs
From a healthcare perspective, the combination of medical costs and direct non-medical costs were similar between the pharmacopuncture and control groups during the treatment period, whereas the cost was lower by $26 (95% CI, -123 to 64) in the pharmacopuncture group during the entire period. Regarding direct non-medic...
PMC10666315
Cost-utility analysis
chronic neck pain, NRS, includedSensitivity
SENSITIVITY
From a societal perspective, pharmacopuncture was superior as it showed a slightly higher QALY and a lower cost of $1,157 compared to usual care. Based on $26,375 as the WTP among the Korean public, the probability of being cost-effective from a societal perspective was 100% based on both EQ-5D and SF-6D (Table  Cost-e...
PMC10666315