title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Outcome measures |
Maximum inspiratory pressure (MIP)—was measured using a portable MicroRPM (Respiratory Pressure Meter)6-min walk distance (6-MWD)—a 30 m-long indoor walking corridor was used for this test.Pulmonary function tests—performed using a computerized PFT machine (RMS Helios 401). Under PFT, forced vital capacity (FVC), forc... | PMC9925741 | ||
Study protocol |
Pre-intervention assessment: Most data were collected after breakfast and lunch (3–5 pm).Maximum inspiratory pressure (MIP): The MIP was measured using a portable MicroRPM machine. The participants were asked to sit comfortably on a chair, hold the instrument with both hands, and close their lips around the mouthpiece... | PMC9925741 | ||
Data analysis | Data from 18 participants, with 9 participants in each group, were analyzed. SPSS statistical software, version 26 (SPSS Inc., Chicago, IL, USA), was used to analyze data. The normal distribution of baseline values of dependent variables (MIP, FVC, FEV | PMC9925741 | ||
Ethics approval and consent to participate | Ethical approval was obtained from the institutional ethics committee of B.J. Medical & College Hospital (File id: GSITESC/24/16). Before initiating any intervention, the risks and benefits of participation were discussed with all participants, who agreed voluntarily and signed the informed consent form. | PMC9925741 | ||
Results | The demographic characteristics and mean values of the dependent variables are presented in Table | PMC9925741 | ||
IS group | Participants in this group showed a statistically significant ( | PMC9925741 | ||
TIMT group | Participants in this group also showed a statistically significant increase ( | PMC9925741 | ||
Discussion | PD, muscle fatigue | RECRUITMENT | The present study aimed to compare the effectiveness of IS versus TIMT, when used for IMT, on lung functions in patients with PD. The results of the present study showed that MIP and 6-MWD improved with both IS and TIMT. No significant differences were observed with any of the techniques for PFT (FVC, FEV1, and PEFR). ... | PMC9925741 |
Limitations | PD | DISEASE | The present study is not without limitations. Since recruited participants belonged to stages 1–3 of the Hoehn and Yahr modified scale and stages 4–5 were excluded, the results of this study cannot be generalized to patients with advanced PD because often more impaired lung functions are observed in later stages of thi... | PMC9925741 |
Conclusions | PD | Inspiratory muscle training with IS or TIMT for six weeks improved MIP and 6-MWD in patients with early stages of PD. TIMT was more effective than IS in this population of patients. IS and TIMT did not show improvements in lung function tests (FVC, FEV1, and PEFR). | PMC9925741 | |
Acknowledgements | The authors extend their appreciation to the Deanship of Scientific Research, King Saud University for funding through Vice Deanship of Scientific Research Chairs; Rehabilitation Research Chair. | PMC9925741 | ||
Author contributions | S.F.M.Y. and A.B. conceptualized the study. S.N., A.H.A., and M.K. were involved in supervision. S.F.M.Y. and M.K. wrote the original draft. S.F.M.Y., M.K., and S.N. were involved in data curation, analysis, and final draft review. All authors read and approved the final manuscript. | PMC9925741 | ||
Funding | This study was funded by King Saud University, Deanship of Scientific Research, Vice Deanship of Scientific Research Chairs; Rehabilitation Research Chair. | PMC9925741 | ||
Data availability | The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request. | PMC9925741 | ||
Competing interests | The authors declare no competing interests. | PMC9925741 | ||
References | PMC9925741 | |||
Methods | In this online randomised controlled trial, adult participants received one of four intervention messages or a control message. The control message provided information about booster dose eligibility. Intervention messages added to the control message, each using a different persuasive strategy, including: emphasising ... | PMC10237633 | ||
Results | Of the 487 consenting and randomised participants, 442 (90.8%) completed the experiment and were included in the analysis. Participants viewing messages emphasising non-health benefits had the highest intention compared to those who viewed the control message (percentage point diff: 9.0, 95% CI -0.8, 18.8, | PMC10237633 | ||
Data Availability | The data files are available from the Open Science Framework at | PMC10237633 | ||
Introduction | DISEASE | COVID-19 vaccination has been critical for controlling the COVID-19 pandemic by protecting vulnerable individuals from severe disease, safeguarding health systems and helping return society to normal functioning [Suboptimal uptake of COVID-19 booster doses has occurred globally. In Australia, completion of a primary co... | PMC10237633 | |
Methods | PMC10237633 | |||
Experimental design | This was a parallel group, randomised, controlled, online experiment comparing intention to receive a COVID-19 vaccine booster dose and beliefs about COVID-19 vaccine booster doses between subjects after receiving persuasive message interventions. This study obtained ethics approval from the Sydney Children’s Hospitals... | PMC10237633 | ||
Participants | RECRUITMENT | Participants were adults 18 years or older residing in Australia who had received at least one primary dose of a COVID-19 vaccine but had not yet received a booster (third) dose and had access to the internet. Research company Quality Online Research (QOR) recruited a random sample of participants via email invitation ... | PMC10237633 | |
Pre-intervention survey items | After consenting, participants provided demographic information (age, gender, education, and state of residence). They were asked to respond to screening items about their COVID-19 vaccination status (‘Have you received a first/second/third dose of a COVID-19 vaccine?’, response options = yes/no). Participants were ask... | PMC10237633 | ||
Intervention | Participants received one of four intervention messages according to their randomised group. The intervention was a short piece of written material (a message of approximately 70–140 words) designed to encourage uptake of booster doses of COVID-19 vaccines. The material was modified from a public email communication ca... | PMC10237633 | ||
Intervention messages. | PMC10237633 | |||
Post-intervention outcome measures | Immediately after the intervention, participants responded to items measuring outcomes. The primary outcome measure was intention to receive a COVID-19 vaccine booster dose. This was assessed with a single item (‘How likely is it that you will get a booster dose of COVID-19 vaccine?’, with 5 response options: definitel... | PMC10237633 | ||
Sample size | The study aimed to recruit 480 participants to ensure a sample size of 430 participants, allowing for a drop-out/poor quality response rate of approximately 10%. The sample size was calculated using G*Power (an a priori power analysis tool) to estimate an effect size of Cohen’s d = 0.2 (the difference between two indep... | PMC10237633 | ||
Randomisation | RECRUITMENT | Participants were randomly assigned at recruitment via a randomisation sequence embedded within the online system to receive one of the four intervention messages or the control message. Because some participants were excluded after randomisation (they either failed the attention check or did not complete the experimen... | PMC10237633 | |
Flow diagram showing progress of participants through the online experiment. | PMC10237633 | |||
Statistical methods | The difference in proportion of participants intending to receive a COVID-19 vaccine and agreeing with COVID-19 vaccine booster dose belief statements was compared between the control group and each of the four intervention groups using tests of two proportions (z test). A subgroup analysis included data from vaccine h... | PMC10237633 | ||
Role of the funding source | This research was funded by a grant from NSW Health. The sponsor had no role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the article for publication. | PMC10237633 | ||
Results | Of the 487 participants who consented and were randomised, 442 (90.8%) completed the experiment, answered the attention check question correctly, and were included in the analysis. Participants had a mean age of 51.14 years ( | PMC10237633 | ||
Participant characteristics at baseline. | PMC10237633 | |||
Primary outcome (Intention to vaccinate) | Most participants (84.6%, 374/442) indicated a positive intention to get a booster dose of COVID-19 vaccine. | PMC10237633 | ||
Difference in intention to vaccinate in each intervention group compared to the control group. | PMC10237633 | |||
Difference in intention to vaccinate in each intervention group compared to the control group in hesitant participants (sub-analysis). | PMC10237633 | |||
Discussion | fatigue | WEDDINGS, INFLUENZA | This experiment found some evidence that messages emphasising non-health benefits of getting a COVID-19 booster dose, like travelling, enjoying family occasions like weddings, and seeing family and friends, may increase intention to vaccinate, especially in hesitant populations. In this study, intention was qualitative... | PMC10237633 |
Conclusions | DISEASE | Health authorities should consider emphasising the broader benefits of vaccination beyond prevention of severe disease to encourage uptake of COVID-19 vaccine booster doses, as well as benefits to people’s personal health and the health of the community. Communication using personal agency should be used with caution. ... | PMC10237633 | |
Supporting information | PMC10237633 | |||
CONSORT 2010 checklist of information to include when reporting a randomised trial*. | (DOC)Click here for additional data file. | PMC10237633 | ||
Supporting information. | (DOCX)Click here for additional data file. | PMC10237633 | ||
Protocol for persuasive COVID-19 vaccination message testing. | (DOCX)Click here for additional data file. | PMC10237633 | ||
Key Points | PMC9857635 | |||
Question | death, organ dysfunction | Does high-dose selenium therapy impact outcomes in patients at high risk of organ dysfunction and death after cardiac surgery? | PMC9857635 | |
Findings | In this randomized clinical trial of 1416 adult cardiac surgery patients, a high dose of sodium selenite compared with placebo did not result in a significant different morbidity or mortality. | PMC9857635 | ||
Meaning | death, organ dysfunction | High-dose sodium selenite was not effective in reducing the development of organ dysfunction and death in high-risk cardiac surgery patients. | PMC9857635 | |
Importance | Selenium contributes to antioxidative, anti-inflammatory, and immunomodulatory pathways, which may improve outcomes in patients at high risk of organ dysfunctions after cardiac surgery. | PMC9857635 | ||
Objective | postoperative organ dysfunction | To assess the ability of high-dose intravenous sodium selenite treatment to reduce postoperative organ dysfunction and mortality in cardiac surgery patients. | PMC9857635 | |
Design, Setting, and Participants | This multicenter, randomized, double-blind, placebo-controlled trial took place at 23 sites in Germany and Canada from January 2015 to January 2021. Adult cardiac surgery patients with a European System for Cardiac Operative Risk Evaluation II score–predicted mortality of 5% or more or planned combined surgical procedu... | PMC9857635 | ||
Interventions | Patients were randomly assigned (1:1) by a web-based system to receive either perioperative intravenous high-dose selenium supplementation of 2000 μg/L of sodium selenite prior to cardiopulmonary bypass, 2000 μg/L immediately postoperatively, and 1000 μg/L each day in intensive care for a maximum of 10 days or placebo. | PMC9857635 | ||
Main Outcomes and Measures | organ dysfunction | The primary end point was a composite of the numbers of days alive and free from organ dysfunction during the first 30 days following cardiac surgery. | PMC9857635 | |
Results | organ dysfunction | A total of 1416 adult cardiac surgery patients were analyzed (mean [SD] age, 68.2 [10.4] years; 1043 [74.8%] male). The median (IQR) predicted 30-day mortality by European System for Cardiac Operative Risk Evaluation II score was 8.7% (5.6%-14.9%), and most patients had combined coronary revascularization and valvular ... | PMC9857635 | |
Conclusions and Relevance | In high-risk cardiac surgery patients, perioperative administration of high-dose intravenous sodium selenite did not reduce morbidity or mortality. The present data do not support the routine perioperative use of selenium for patients undergoing cardiac surgery. | PMC9857635 | ||
Trial Registration | ClinicalTrials.gov Identifier: | PMC9857635 | ||
Introduction | organ dysfunction | Cardiac surgery is performed worldwide in an estimated 1 million patients per year.A potential way to reduce organ dysfunction is supplementation with the essential trace element selenium, which contributes to anti-inflammatory and immunomodulatory pathways and is a constituent of the active site of multiple antioxidan... | PMC9857635 | |
Methods | PMC9857635 | |||
Trial Design and Participants | congenital anomalies, arrest, cardiocirculatory arrest, neuropsychiatric disorders, hypersensitivity | HYPERSENSITIVITY, ARREST | We conducted an international, double-blind, randomized placebo-controlled trial, the Sodium Selenite Administration in Cardiac Surgery Trial (SUSTAIN CSX) trial, at 23 sites in Canada and Germany.Patients 18 years or older were eligible if they were scheduled to undergo elective or urgent cardiac surgery with the use ... | PMC9857635 |
Randomization and Masking | BLIND | The participants were randomly assigned in a 1:1 ratio to the intervention and placebo groups, respectively. Randomization was performed through a central, password-protected, web-based system with an audit trail that has been used for several prior international studies. Randomization was stratified by site in permute... | PMC9857635 | |
Procedures | hospital-acquired infections, arrhythmias, Frailty, sternal wound infection, stroke/cerebral vascular accident | ARRHYTHMIAS, MYOCARDIAL INFARCTION, CARDIOVASCULAR COMPLICATIONS | According to the group allocation, patients either received 2000 μg/L (to convert to micromoles per liter, multiply by 0.0127) of intravenous selenium (sodium selenite; Selenase) within 30 minutes after induction of anesthesia and prior to initiation of CPB, then 2000 μg/L of intravenous selenium immediately on admissi... | PMC9857635 |
Outcome Measures | organ dysfunction | The primary outcome was the number of days alive and free of persistent organ dysfunction within the first 30 days after surgery. | PMC9857635 | |
Statistical Analysis | organ dysfunction | We estimated that a total sample size of 1400 participants followed up for 30 days would provide 90% power at a 2-sided α = .05 to detect a difference in persistent organ dysfunction–free days following selenium supplementation if the intervention caused a 20% relative increase in the daily rate of liberation from life... | PMC9857635 | |
Results | PMC9857635 | |||
Participants | A total of 3791 patients were screened for eligibility; 1416 patients provided written consent and were randomized. Twenty-two randomized patients were excluded without ever receiving the allocated intervention; the majority of these were because the planned surgery was canceled or changed to a procedure not eligible p... | PMC9857635 | ||
Baseline Characteristics | The characteristics of patients at baseline were similar in the selenium and placebo group ( | PMC9857635 | ||
Baseline Demographics and Operative Characteristics | kidney disease | S; HEMOGLOBIN, KIDNEY DISEASE | Abbreviations: ACE, angiotensin-converting enzyme; BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); CABG, coronary artery bypass grafting; CBC, complete blood cell count; EF, ejection fraction; EuroSCORE, European System for Cardiac Operative Risk Evaluation; LVEF, left vent... | PMC9857635 |
Compliance With Study Protocol | Only 228 doses of investigational product were missed of 7173 doses indicated by protocol, giving an overall compliance rate of 96.8%. There was no meaningful difference in compliance with dosing as per protocol between the selenium and placebo groups (eTable 1 in | PMC9857635 | ||
Trial Outcomes | death, organ dysfunction | The overall daily frequency of the components of persistent organ dysfunction and occurrence of death are shown in eTable 3 in | PMC9857635 | |
Primary and Secondary Outcomes | Delirium, Confusion | Abbreviations: HR, hazard ratio; ICU, intensive care unit; OR, odds ratio; WBC, white blood cell count.SI conversion factors: To convert albumin to grams per liter, multiply by 10; blood lactate to millimoles per liter, multiply by 0.111; creatinine to micromoles per liter, multiply by 88.4; creatine kinase–MB fraction... | PMC9857635 | |
Primary Outcome (Persistent Organ Dysfunction–Free Days in 30 Days) by Subgroups | CKD, chronic kidney disease, cardiac disorders | ADVERSE EVENTS, ADVERSE EVENT, CARDIAC DISORDERS | CKD indicates chronic kidney disease; EuroSCORE, European System for Cardiac Operative Risk Evaluation.The observed 30-day mortality rate was 4.2% (n = 29) in the selenium and 5.0% (n = 35) in the placebo group (odds ratio, 0.82; 95% CI, 0.50-1.36; The overall median (IQR) time to discharge alive from the ICU and hospi... | PMC9857635 |
Laboratory Subanalysis: Selenium, Selenoprotein, and Glutathione Peroxidase Levels | SEPARATION | The measurement of selenium blood levels in a subgroup of patients showed a clear separation of treatment groups and selenium levels were significantly higher in the treatment group over the observation period when compared with the placebo group ( | PMC9857635 | |
Perioperative Selenium Levels and Perioperative Activity of Glutathione Peroxidase 3 | SELENIUM DEFICIENCY | A, Perioperative selenium levels are compared by treatment and time points. The dotted lines indicate the reference range of selenium. Selenium concentrations below 70 μg/L indicate a selenium deficiency and selenium levels below 45.9 μg/L a severe selenium deficiency. | PMC9857635 | |
Discussion | myocardial injury, organ dysfunction | SECONDARY, MYOCARDIAL ISCHEMIA | In this rigorous, international trial of high-risk cardiac surgical patients undergoing complex procedures, high-dose selenium supplementation compared with placebo did not increase the number of days alive and without persistent organ dysfunction over the 30 days after cardiac surgery. No differences between groups we... | PMC9857635 |
Limitations and Strengths | POSTOPERATIVE COMPLICATIONS | One limitation of the trial is the use of the EuroSCORE II as part of the inclusion criteria to identify patients at increased risk for postoperative complications. The inaccuracy of the EuroSCORE II for cardiac surgery preoperative risk assessment is demonstrated in the discordance between the observed and predicted E... | PMC9857635 | |
Conclusions | postoperative organ dysfunctions | In conclusion, the results of our trial in high-risk cardiac surgery patients show that perioperative high-dose selenium administration is safe but did not impact postoperative organ dysfunctions or mortality following surgery (eFigure 3 in | PMC9857635 | |
References | Trial protocol and statistical analysis plan.Click here for additional data file.eMethods.eFigure 1. Intervention SchemeeFigure 2. Six-month Kaplan-Meier Survival CurveeFigure 3. Product-Limit Survival EstimateseAppendix. Supplemental Data to Figure 3A and 3BeTable 1. Compliance with Study Investigational ProducteTable... | PMC9857635 | ||
1. Introduction | obesity, metabolic inflexibility, HIT | OBESITY, INSULIN RESISTANCE, CARDIOVASCULAR DISEASES, TYPE II DIABETES | Women of childbearing age have variations in substrate oxidation rates that can lead to overweight, type II diabetes, and other conditions that may be associated with metabolic inflexibility and the variations in estrogen concentrations observed during the monthly ovarian cycle. Purpose: This study aimed to verify and ... | PMC9964010 |
2. Materials and Methods | PMC9964010 | |||
2.1. Trial Design, Setting and Ethics | This is a pre-post pilot study on the effects of the same intervention (exercise) in two groups (women at different stages of the menstrual cycle, called follicular and luteal; FL and LT, respectively), comparing pre-training with post-training variables. The study was not randomized and did not have a placebo or contr... | PMC9964010 | ||
2.2. Inclusion and Exclusion Criteria | We included in this study all women aged 18–35 years with a body mass index (BMI) of 18.5–24.9 kg/m | PMC9964010 | ||
2.3. Outcomes Evaluations | After the interview, clinical evaluation, and anthropometric measurements, the women were conveniently assigned to the follicular or luteal phase after entering the data in the Flo application. Then, they were tested to determine peak oxygen consumption (VO2peak), peak velocity (Vpeak), and ventilatory anaerobic thresh... | PMC9964010 | ||
2.4. Body Composition | fat-free mass, FM | DECUBITUS | Body composition was determined using a bioimpedance device (Bio-dynamics 310), according to the manufacturer’s instructions, to analyze body fat percentage (%BF), fat mass (FM), fat-free mass (FFM), and basal metabolic rate (BMR). The distance of 5 cm between the electrodes was respected, and the participant was posit... | PMC9964010 |
2.5. Cardiopulmonary Test | HEART | The test protocol consisted of running on a treadmill (Model ATL, Inbrasport Ltd., Porto Alegre, Brazil) with an initial speed of 6 km/h followed by increments of 1 km/h every minute until the participants’ voluntary exhaustion. Ventilatory parameters were collected throughout the tests at each respiratory cycle and an... | PMC9964010 | |
2.6. Indirect Calorimetry (SWRE) | The balance of energy substrates was calculated by indirect calorimetry during submaximal work-rate running exercise for 45 min (SWRE), performed after six hours of fasting, before and after the training period. The dietary restriction before the SWRE session aimed to prevent the oxidation of exogenous carbohydrates am... | PMC9964010 | ||
2.7. Training Sessions | HIT | Participants performed eight HIT sessions, with a 48h interval between sessions. The treadmill HIT protocol consisted of two initial warm-up periods of 2 min each at 25% and 50% V | PMC9964010 | |
2.8. Statistical Analysis | The results are presented as the mean values ± standard error. The homogeneity and normality of the variables were verified using the Bartlett’s test and Shapiro–Wilk test, respectively. When appropriate, participants’ characteristics, ventilatory parameters, HR, and running speed were compared using Student’s The subs... | PMC9964010 | ||
3. Results | Initially, the anthropometry and body fat percentage (%BF) of 19 women were evaluated, of which 16 had BMI and %BF according to the inclusion criteria. Among these, eight were directed to the follicular group (FL) and eight to the luteal group (LT). Participants were allocated according to their menstrual cycle phase, ... | PMC9964010 | ||
3.1. Characterization of Participants | Anthropometric, body composition, resting blood glucose, and ventilatory data are presented in | PMC9964010 | ||
3.2. Max Tests and Exercise Intensity | The absolute mean values of peak effort and VATs for VOThe VAT means values relative to peak effort for VO | PMC9964010 | ||
3.3. Training Sessions | During training sessions, V | PMC9964010 | ||
3.4. Oxidation of Substrates | The indirect calorimetry data are presented in The relative energy derived from CHO after the training period was 18.89% higher in the FL group and 25.50% higher in the LT group. Consequently, the relative energy derived from LIP after training was 8.45% and 3.46% lower in FL and LT groups, respectively ( | PMC9964010 | ||
4. Discussion | incongruity, HIT | Our purpose was to examine the substrate oxidation rates of reproductive-age eumenorrheic women by indirect calorimetry during SWRE at two hormonally distinctive menstrual cycle phases, pre- and post-HIT. The present substrate metabolism finding indicated a greater dependency upon lipid versus carbohydrate in the menst... | PMC9964010 | |
5. Conclusions | The phases of the menstrual cycle promote significant changes in substrate oxidation rates, leading to a decrease in CHOox and an increase in LIPox in the follicular phase, possibly due to the higher concentration of estrogen, which favors changes in metabolism and performance during submaximal work rate exercise. High... | PMC9964010 | ||
Author Contributions | Individual author contributions are as follows: conceptualization, C.S.F.; methodology, C.S.F., M.L.M. and J.M.L.A.; software, M.L.M.; formal analysis, M.L.M.; investigation, C.S.F., J.M.L.A. and M.S.C.; data curation, M.L.M.; writing—preparation of original draft, C.S.F.; writing—proofreading and editing, C.S.F., M.L.... | PMC9964010 | ||
Institutional Review Board Statement | The study was conducted and approved by the Institutional Review Board of University City of Sao Paulo (UNICID), n° (31998914.8.0000.0064) for studies involving humans. | PMC9964010 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. Written informed consent has been obtained from the patient(s) to publish this paper. | PMC9964010 | ||
Data Availability Statement | The data presented in this study are available on request from the corresponding author. The data are not publicly available due to privacy. | PMC9964010 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC9964010 | ||
Abbreviations | PMC9964010 | |||
References | ± | Intervention.Flowchart of the inclusion, allocation, and follow-up process of the 11 study participants. Follicular (FL) and luteal (LT) groups.Relative energy derived from carbohydrates (CHOkc) and lipids (LIPkc) pre- and post-training. Mean values ± standard error; follicular (FL, Baseline data of groups follicular (... | PMC9964010 |
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