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Reporting summary | Further information on research design is available in the | PMC10011554 | ||
Supplementary information |
Supplementary InformationReporting Summary | PMC10011554 | ||
Supplementary information | The online version contains supplementary material available at 10.1038/s41467-023-36976-1. | PMC10011554 | ||
Acknowledgements | The authors thank the patients and their families who made this study possible and the clinical study teams who participated in the study. The authors also thank Olga Ferrero, the primary research nurse for the study, and Esther Chan for assistance with pharmacodynamic analyses. This study was sponsored by Celgene, a B... | PMC10011554 | ||
Author contributions | RECRUITMENT | R.S., B.A., X.W., Z.N., V.M., and I.B. contributed to the study design. V.M., M.V., J.M.S., V.G., T.H.-G., B.D., O.S., C.C.-S., J.-M.M., A.I., M.M., C.C., A.P., and I.B. contributed to patient recruitment. B.H. contributed to PK data analysis and interpretation. I.A. and E.F. contributed to | PMC10011554 | |
Peer review | PMC10011554 | |||
Data availability | Anonymized participant-level data cannot be shared due to an increased risk of patient reidentification. Bristol Myers Squibb will consider requests to share anonymized clinical trial data from interventional trials in patients that have completed on or after January 1, 2008. In addition, primary results from these tri... | PMC10011554 | ||
Competing interests | ONCOLOGY, EMD | V.M. has received consulting fees from Bristol Myers Squibb, Basilea, Bayer, Janssen, Nanobiotix, Pieris Pharmaceuticals, Regeneron/Sanofi, and Roche, and honoraria from Bristol Myers Squibb and Bayer. M.V. has received personal fees from Roche, EMD Serono, and TFS. J.M.S. has received personal fees and non-financial s... | PMC10011554 | |
References | PMC10011554 | |||
Methods | PMC9979657 | |||
Study Design | We used a randomized,
double-blind, placebo-controlled cross-over design ( | PMC9979657 | ||
Randomization | We randomly assigned
participants to travel in one of two minivans on each study day. One
vehicle was randomly selected to employ cabin air filtration using
an electrostatic air filter while the other had a placebo air filter
(i.e., unfiltered air). Following a 1-week washout period participants
“crossed over” to the o... | PMC9979657 | ||
Air Filter Selection | Commercially
available electrostatic cabin air filters designed to fit Chrysler
and Dodge branded minivans were used in this study. These filters
were selected based on pilot testing conducted in an Environment and
Climate Change Canada laboratory prior to starting the field study,
as described in a separate publicatio... | PMC9979657 | ||
Study Population | cardiac or cognitive
conditions on the study | ASTHMA | Study participants
(Healthy young participants
were recruited to minimize impacts of pre-existing cardiac or cognitive
conditions on the study results. Our interest was in acute subclinical
impacts. Pregnant women, subjects with self-reported respiratory (other
than asthma) or cardiovascular illnesses, and people with ... | PMC9979657 |
Health
Outcomes | PMC9979657 | |||
Heart Rate Variability | HEART | Heart rate
variability (HRV) was monitored before, during, and after the commute
using an ambulatory ECG (Holter) monitor (GE Seer Light or SEER Light
Extend recorders). Measures of HRV were calculated as outlined by
the Task Force of the European Society of Cardiology and the North
American Society of Pacing and Elect... | PMC9979657 | |
Saliva
Cortisol | Salivary cortisol
was measured before, during, and after the commute on each study day
(10 min prior to the commute; 45 min into the commute; 10 min postcommute;
and 80 min postcommute). The timing of measurements was consistent
across days for each participant to control for diurnal patterns.
Participants could not ea... | PMC9979657 | ||
Cognitive Function | RTI | The CANTAB testing
battery is a cognitive assessment system administered by touch screen.
Participants were introduced to the CANTAB tasks during an introductory
visit before the study commenced to minimize any learning effects.
The CANTAB battery was administered on each study day before and after
the commute and incl... | PMC9979657 | |
Exposure
Assessment | The following
air pollutants were simultaneously monitored inside the vehicle and
outside the vehicle using instruments mounted on the roof-top: UFPs,
PM | PMC9979657 | ||
Statistical Analysis | REGRESSION | Linear regression
models were used to estimate the impact of air filter use (as a dichotomous
variable) on in-vehicle pollutant concentrations, adjusting for concurrent
rooftop concentrations. Linear mixed models with random intercepts
for subject were used for all health analyses to account for repeated
measurements w... | PMC9979657 | |
Results | PMC9979657 | |||
Impact of Cabin Air Filter
on In-Vehicle Exposures | In-vehicle and rooftop pollutant
concentrations were measured during
48 vehicle commutes over 24 weekdays in October and November 2015
(mean duration 94 [SD 10] min) ( | PMC9979657 | ||
Mean In-Vehicle Environmental Conditions
with and without a Cabin Air Filter | Adjusted for outdoor-rooftop measurement,
except CORegardless of the presence of a cabin air filter,
concentrations
of UFPs, PMParticulate concentrations
increased considerably when passing
through vehicle tunnels. | PMC9979657 | ||
Study Population | Mean BMI and baseline
systolic and diastolic blood pressure measurements in our participants
(53% female; mean age 26 (range 29–49) years) are indicative
of a population in good health ( | PMC9979657 | ||
Saliva
Cortisol | After 45 min in-vehicle,
IQR increases in UFPs associated with 18% increases to cortisol levels
in women, whereas in men, PM | PMC9979657 | ||
Percent Change in Saliva Cortisol
per IQR Increase in Pollutant or Filter Presence | In-vehicle exposures preceding saliva
collection used for PM2.5, UFP, and BC analyses.Adjusted for baseline cortisol measurement,
sickness reported in
the past week, and indoor temperature. Percent changes in saliva cortisol
are per IQR change in pollutant: PM | PMC9979657 | ||
Cognitive
Function | decrements to neurocognitive function | In-vehicle exposures
were associated with decrements to neurocognitive function, most frequently
for BC ( | PMC9979657 | |
Percentage Change in Neurocognitive
Outcome Score per IQR Increase in Pollutants or by Filter Presence | RTI | AST = attention switching task;
RTI = reaction time; RVP = rapid visual processing; SWM = spatial
working memory. Adjusted for sickness reported in the past week and
indoor temperature. Statistically significant results in bold (On the rapid visual processing task,
BC was associated with small
decreases in A’ prime, in... | PMC9979657 | |
Discussion | PMC9979657 | |||
Exposure | Although
Canadians and Americans
only spend an average of five to six percent of their time in vehicles,Because of considerable daily
variability in TRAP concentrations during the study, filter presence
itself was not a perfect indicator of in-vehicle pollutant exposure;
indeed, some participants were exposed to higher... | PMC9979657 | ||
Heart Rate Variability | HEART | Heart rate
variability is used to evaluate the health and balance of the autonomic
nervous system, with both increased and decreased HRV identified as
risk factors for cardiac mortality. | PMC9979657 | |
Saliva Cortisol | Saliva cortisol is
a noninvasive indicator of active free cortisol, a glucocorticoid
used as a biomarker of stress, and HPA axis activation.Our study found that common TRAP pollutant exposures
were associated with marked changes to saliva cortisol, indicating
that commuter exposures may impact acute stress responses, p... | PMC9979657 | ||
Cognitive Function | Alzheimer’s disease, dementia, cognitive impairment | Air pollution
exposure may reduce cognitive function, with associated effects ranging
from mild cognitive impairment to Alzheimer’s disease and dementia. | PMC9979657 | |
Strengths and Limitations | Strengths
of this study include the use of a double-blind cross-over design
where neither the study participants nor the study staff (apart from
the lead investigator responsible for installing filters in the vehicles)
were aware of which vehicle had the cabin air filter in place on a
given day. As a cross-over study, ... | PMC9979657 | ||
Supporting Information Available | The Supporting Information is
available free of charge at Cross-over study design;
driving route in Montreal,
QC; in-vehicle, rooftop, and ambient environmental conditions during
filtered and unfiltered periods; effect of air filtration on indoor–outdoor
ratios of measured air pollutants and descriptive statistics; tim... | PMC9979657 | ||
Supplementary Material | es2c06556_si_001.pdfThe authors declare no
competing financial interest. | PMC9979657 | ||
Acknowledgments | This study was funded by Health Canada. | PMC9979657 | ||
References | PMC9979657 | |||
Introduction | xerostomia, HNC, head and neck cancer | ADVERSE EFFECTS, SECONDARY, XEROSTOMIA, HEAD AND NECK CANCER | Radiotherapy-induced xerostomia (RIX) is one of the most common adverse effects of radiotherapy (RT) in head and neck cancer patients (HNC) and a major determinant of survivors’ quality of life. The primary objective was to evaluate the reduction of patients’ xerostomia symptoms after the utilisation of a sodium-hyalur... | PMC10584731 |
Methods | The protocol was approved by the ethical committee (Ref. 50,053/19) and registered at ClinicalTrials.gov (ID: NCT05103124). The study was a double-blind randomised clinical trial (RCT) with a crossover design and was conducted at the Fondazione Policlinico Universitario A. Gemelli, Rome. | PMC10584731 | ||
Results | Xerostomia | XEROSTOMIA | Thirty-two patients completed the study protocol. Lower values of the modified Xerostomia Questionnaire (XQ) were retrieved when comparing the baseline scores to the ones after the treatment, when compared with placebo (Mann–Whitney | PMC10584731 |
Conclusions | ADVERSE EVENTS | This RCT highlights the advantages of treating RIX with the sodium-hyaluronate mouthwash since it seems to be clinically effective in reducing its symptoms, without any reported adverse events.ClinicalTrials.gov: NCT05103124 in 17/10/2021. | PMC10584731 | |
Supplementary Information | The online version contains supplementary material available at 10.1007/s00520-023-08090-x. | PMC10584731 | ||
Keywords | DEL | Open access funding provided by Università Cattolica del Sacro Cuore within the CRUI-CARE Agreement. | PMC10584731 | |
Introduction | xerostomia, Head and neck cancers, Xerostomia, HNC, Cancer | XEROSTOMIA, XEROSTOMIA, ADVERSE EFFECTS, SECONDARY, HEAD AND NECK CANCER, CANCER | Head and neck cancers (HNC) have a reported incidence of more than 900,000 new cases per year [RT-induced xerostomia (RIX) is one of the most common adverse effects of RT in patients with HNC and a major determinant of survivors’ quality of life (QoL) [The above-mentioned agent has already been tested in retrospective ... | PMC10584731 |
Materials and methods | DEL | The protocol was approved by the ethics committee of the ‘Università Cattolica del Sacro Cuore’ (Ref. 50,053/19) and is registered at ClinicalTrials.gov (ID: NCT05103124). This study has been reported according to the CONSORT guidelines (Supplementary files, | PMC10584731 | |
Trial design | The present study was conducted as a double-blind RCT with a crossover design; thus, the whole population received both the sodium-hyaluronate mouthwash and placebo. | PMC10584731 | ||
Participants | xerostomia, Tumour, HNC, psychiatric, Sjogren’s syndrome | XEROSTOMIA, TUMOUR | Patients with HNC who visited the Oral Medicine, Head and Neck Department – Fondazione Policlinico Universitario A. Gemelli—IRCSS between October 2020 and March 2022 were screened for inclusion. Patients were assessed during their routine follow-up within the context of the multidisciplinary Tumour Board.The following ... | PMC10584731 |
Interventions | xerostomia | XEROSTOMIA | A baseline visit (T0) was conducted 3 months after the end of RT. Demographic data and a thorough medical history were recorded with particular attention to oncologic history (i.e. chemotherapy, oncologic surgery, and RT dose) and smoking habits.The basal and stimulated salivary flow rates were measured, and patients w... | PMC10584731 |
Outcome measures | xerostomia | HYPOSALIVATION, XEROSTOMIA | The primary objective of this RCT was to evaluate the reduction in patients’ xerostomia symptoms due to RT in contrast to hyposalivation, which can be objectively evaluated using sialometry. The measurement of xerostomia is problematic because it comprises a set of symptoms, and therefore can be assessed only by direct... | PMC10584731 |
Randomisation sequence, allocation concealment, and blinding | The statistician and principal investigator (C.L.) generated the allocation sequence using a simple computer-generated random list. Allocation concealment was performed using sequentially numbered opaque sealed envelopes (SNOSE) [ | PMC10584731 | ||
Sample size and statistical methods | cancer, xerostomia | REGRESSION, CANCER, XEROSTOMIA | Assuming that sodium-hyaluronate mouthwash can cause a 20% reduction in the XQ scores when compared with the placebo, setting a bilateral 95% confidence interval and a study power of 80% in a crossover design, a minimum sample of 32 is required. Assuming a dropout rate of 20%, a sample size of 40 patients was required.... | PMC10584731 |
Results | PMC10584731 | |||
Participant flow and recruitment | GROUP B | The patients participating in this study were recruited between October 2020 and March 2022; the last follow-up consultation was conducted 3 months later, in June 2022. Thirty-nine patients were recruited. Of these, seven patients dropped out during the treatment because of cancer recurrence and the need for chemothera... | PMC10584731 | |
Baseline data and numbers analysed | GROUP B | The final sample included 32 patients (13 women and 19 men), with a mean age of 54.6 years (SD: 10.7; range: 24–72). The general patient characteristics are shown in Table General characteristics of the included sample. No statistically significant differences were found between the groupsThe main results, as well as t... | PMC10584731 | |
Discussion | dysphagia, xerostomia, caries, hyposalivation, dysgeusia, trismus | DYSPHAGIA, XEROSTOMIA, ADVERSE EVENTS, FUNGAL INFECTIONS, CARIES, HYPOSALIVATION, OSTEORADIONECROSIS, CAVITY, TRISMUS | RT may cause significant adverse events in the oral cavity of patients with HNC (i.e. osteoradionecrosis, dysphagia, dysgeusia, caries, and trismus) [No differences were found in the other variables. Probably, RT has a significant damaging effect on the salivary glands, making the effect of smoking negligible. The same... | PMC10584731 |
Conclusions | ADVERSE EVENTS | The results of this double-blind RCT highlight the advantages of treating RIX with sodium-hyaluronate mouthwash, as it seems to be clinically effective in offering relief of RIX symptoms in the majority of the patients, without any reported adverse events. | PMC10584731 | |
Author contribution | Conceptualisation, C.R. and C.L.; methodology, C.L.; software, C.R.; validation, R.P., A.L., F.M., and M.M.; formal analysis, C.L.; investigation, A.B., C.R., and G.G.; resources, C.L.; data curation, C.L.; writing—original draft preparation, C.R.; writing—review and editing, C.L.; visualization, R.P.; supervision, A.L... | PMC10584731 | ||
Funding | DEL | Open access funding provided by Università Cattolica del Sacro Cuore within the CRUI-CARE Agreement. This research was funded by Sunstar Europe S.A., Route de Pallatex 11, P.O. Box 32, 1163 Etoy, Switzerland (prot. CA-19–0888). | PMC10584731 | |
Data Availability | Data are available upon request to the authors. | PMC10584731 | ||
Declarations | PMC10584731 | |||
Conflict of interest | This research was funded by Sunstar Europe S.A., Route de Pallatex 11, P.O. Box 32, 1163 Etoy, Switzerland. (prot. CA-19-0888). The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results. | PMC10584731 | ||
Ethics approval and consent to participate | DEL | The protocol was approved by the ethics committee of the ‘Università Cattolica del Sacro Cuore’ (Ref. 50053/19) and is registered at ClinicalTrials.gov (ID: NCT05103124). The informed consent was carried out in line with the Declaration of Helsinki and was obtained from all subjects involved in the study. Written infor... | PMC10584731 | |
References | PMC10584731 | |||
Introduction | anxiety, coronavirus infectious disease, infection, depression, humor | INFECTION | The emergence of the novel coronavirus infectious disease (COVID-19) has put the health and life quality of the global populace at risk. The fear of infection, coupled with prolonged isolation because of quarantine restrictions and social distancing mandates led to a range of detrimental outcomes, including financial i... | PMC10348554 |
Method | PMC10348554 | |||
Participants | This study was a mixed method, parallel, pilot randomized controlled trial (RCT) aiming to examine the feasibility and effectiveness of DLT among women with young children aged under 6 years. Participants’ inclusion criteria were as follows: women who 1) had at least one child under 6 years; 2) had no acute mental heal... | PMC10348554 | ||
Contents of the distance laughter therapy. | HuLA | Opening (Self introduction and greetings)Facial stretching and raising mouth cornerExpressing oneself with laughter “This is me” (1Reinforcing the positivity with laughter “I thank to…” (2Increasing self-esteem with laughter “I like me because…” (3Complimenting each other with laughter “Yes, I hear that a lot” (4Relaxi... | PMC10348554 | |
Conditions for control group | The control group was asked to watch a popular South Korean 50-minute entertainment TV show titled “Infinite Challenge” via their personal computers, while the experimental group participated in four sessions of group-based laughter therapy. The treatment provided to the control group was the same in length and frequen... | PMC10348554 | ||
Study procedure | RA | One research assistant (RA), who was not involved in this study, randomly divided the 22 participants into two groups: an experimental group (n = 11) and a control group (n = 11), using a research randomizer site (Before the intervention, the RA sent a URL to participants as well as the participation schedule (date and... | PMC10348554 | |
Flow diagram of study procedure. | PMC10348554 | |||
Measurement | PMC10348554 | |||
Depression | depression, Depression | To assess the depression, the Korean version of the CES-D (Center of Epidemiologic Studies Depression Scale) was used [ | PMC10348554 | |
State/Trait anxiety | Anxiety, anxiety | State and trait anxiety was measured based on the Korean-version of the State-Trait Anxiety Inventory [ | PMC10348554 | |
Parental stress | Parental stress was assessed using Korean Parenting Stress Scale, a Korean cultural-specific tool developed by Kim and Kang [ | PMC10348554 | ||
Data analysis | Quantitative data were analyzed using SPSS version 26. A Shapiro-Wilk test, which is recognized for its power in detecting non-normality in continuous data with a small sample size (n < 50), was performed [Qualitative data were analyzed using a conventional content analysis [ | PMC10348554 | ||
Ethical consideration | The current research was conducted and reported by following the CONSORT 2010 [ | PMC10348554 | ||
Results | PMC10348554 | |||
Demographic characteristics of participants | The mean age of the participants was 35.41 years old (SD: 4.67), and the average number of children was 1.64 (SD: .58). All participants were married, and the majority of them identified as non-religious (72.7%). Moreover, 54.5% were housewives and 31.8% reported that they were taking time off from their work at the ti... | PMC10348554 | ||
Findings from the exit interview data | The themes and categories from the exit interview are listed in | PMC10348554 | ||
Themes and categories from the exit interview data. | PMC10348554 | |||
Perceived changes | depressive emotions | MUSCLE RELAXATION | After participating in DLT, participants reported numerous changes, encompassing physical, emotional, social, self-perception, and stress-coping domains. Under the physical changes category, two sub-categories, “feeling relaxed and energized” and “transition from awkward to natural smile,” emerged. Participants reporte... | PMC10348554 |
Program feedbacks | Participants provided feedback on their experiences with DLT. One key aspect they discussed involved the advantages and drawbacks of the web-based distance approach. All participants expressed high satisfaction with this method because of its convenience and comfort—they appreciated not needing to dress up, arrange chi... | PMC10348554 | ||
Discussion | depression, ’ parental stress, anxiety, self-induced | DER, MUSCLE RELAXATION | We developed and applied DLT using a virtual meeting technology for mothers caring for their young children during the pandemic. We evaluated its impact on reducing levels of depression, anxiety, and parental stress and assessed its application feasibility. We found that parental stress levels during the pandemic were ... | PMC10348554 |
Supporting information | PMC10348554 | |||
CONSORT 2010 checklist of information to include when reporting a randomised trial*. | (DOC)Click here for additional data file.(PDF)Click here for additional data file.(PDF)Click here for additional data file. | PMC10348554 | ||
References | PMC10348554 | |||
2. Methods | PMC9961050 | |||
2.1. Study Design | RECRUITMENT | This study was a randomized, prospective study assessing the effect of an exercise-based injury-prevention program on MSI incidence, motor performance and psychosocial status. The recruitment period was 15 December 2019 to 1 March 2020. The study period was 6 months (2 March 2020 to 16 August 2020). Outcome variables w... | PMC9961050 | |
2.2. Participants | injuries | The participants in this study were Estonian Military Academy cadets. Potential participants were briefed on the study objectives. All participants provided written informed consent prior to enrollment. Participants were included in the study if they had no current injuries causing limited duty days or inability to par... | PMC9961050 | |
2.3. Injury Incidence | musculoskeletal injury, injuries | The primary outcome of interest in our study was incidence of musculoskeletal injury during the 6-month study period. Injury tracking was performed through the Estonian Defence Forces medical database. Since participants receive health care through the military health care system, any musculoskeletal condition severe e... | PMC9961050 | |
2.4. Motor Performance Testing | Prior to motor performance testing, baseline body mass (kg) and height (cm) were measured. Based on these, body mass index (BMI) was calculated (BMI = weight (kg)/height (m) | PMC9961050 | ||
2.5. Isokinetic Muscle Strength Testing | Strength parameters of the knee flexor and extensor muscles were recorded using a computerized dynamometer (CON-TREX | PMC9961050 | ||
2.6. Postural Sway Measurement | A force platform (Kistler 9286A, Switzerland, dimensions 40 × 60 cm) and biomechanical movement analysis system Elite Clinic with Sway software | PMC9961050 | ||
2.7. Physical Fitness Test | EVENT | Participant physical fitness was assessed with a test consisting of a 2-min maximal-effort push-up event, a 2-min maximal-effort sit-up event and a 3.2 km timed run. | PMC9961050 | |
2.8. Psychosocial Status | pain | To assess participant psychosocial status, the RAND 36-item Health Survey 1.0 was used. All items in this survey are scored on a scale from 0 to 100, with a high score defining a more favorable health state. For analysis, the following subscales were used: physical functioning, role limitations due to physical health p... | PMC9961050 | |
2.9. Exercise Intervention | Participants in the INT group were asked to follow a prescribed injury-prevention program (PP) during warm-up before physical training for 6 months, 4 times per week. The PP was a structured warm-up routine, taking 20 min to finish. It was divided into 3 sequential parts: (1) whole-body range of motion and bodyweight s... | PMC9961050 | ||
2.10. Statistical Analysis | Descriptive statistics (mean, SD) in both groups were calculated. Differences between INT and CON groups were analyzed using an independent sample Student’s | PMC9961050 | ||
3. Results | musculoskeletal injury | There were no significant group differences between the INT and CON groups at baseline. During the 6-month study period, the musculoskeletal injury incidence was lower in the INT group compared with the CON group. The noted 20% risk reduction was not statistically significant ( | PMC9961050 | |
4. Discussion | Based on the results in our study, we were unable to detect any effect of an exercise-based injury-prevention program on MSI incidence in the military cadet population. One of the reasons why significant differences in injury incidence were not detected might be related to the prevention program specifics. This study, ... | PMC9961050 |
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