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Trial status | RECRUITMENT | VISAGE trial has begun recruitment in March 2021. As of December 2022, 33/82 patients (40,2%) have been included. | PMC10084642 | |
Acknowledgements | We acknowledge all patients and therapists who support the study. | PMC10084642 | ||
Authors’ contributions | MB planned the study, wrote the grant application, and the protocol for the Ethics Committee for this project. MB is the principal investigator of this study. MB participated in data collection and drafted the manuscript. MB, EA and JMG contributed to developing the protocol, drafting the manuscript, and checked the fi... | PMC10084642 | ||
Authors’ information | Neurolocomotrice | MONDOR |
- Dr Marjolaine Baude, Hôpitaux Universitaires Henri Mondor, Service de Rééducation Neurolocomotrice, Créteil; marjolaine.baude@aphp.fr;- Dr Ludovic Bénichou, Hôpital Saint-Joseph, Service de Chirurgie Maxillo-faciale, Paris; lbenichou@hpsj.fr;- Pr André Coste, Intercommunal Centre de Créteil, Service d’Oto-Rhino-Lary... | PMC10084642 |
Availability of data and materials | MONDOR | The dataset supporting this article is available at Henri Mondor University Hospitals, at the Clinical Research Unit, 1 rue Gustave Eiffel, 94,000 Créteil, France.
Any substantial modification of the protocol by the coordinating investigator must be transmitted to the sponsor for approval. After this approval, the spon... | PMC10084642 | |
Declarations | PMC10084642 | |||
Ethics approval and consent to participate | This study is conducted in accordance with the ‘Helsinki Declaration’. Study protocol, patient information letter, and informed consent form were approved by an International Review Board Est-III (Nancy, Besançon, Dijon, Strasbourg, France) on October 3 | PMC10084642 | ||
Consent for publication | We will use our institutional consent form to confirm that we have obtained consent of the participant (or legal guardian) to report and publish individual patient data. We confirm that the images depicted in Figs. | PMC10084642 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10084642 | ||
References | PMC10084642 | |||
Background | COPD | DISEASE, COPD, VIRUS | Epstein-Barr virus (EBV) frequently is measured at high levels in COPD using sputum quantitative polymerase chain reaction, whereas airway immunohistochemistry analysis has shown EBV detection to be common in severe disease. | PMC10808072 |
Research Question | COPD, EBV suppression | COPD | Is valaciclovir safe and effective for EBV suppression in COPD? | PMC10808072 |
Study Design and Methods | COPD, Epstein-Barr Virus Suppression | ADVERSE REACTIONS, COPD | The Epstein-Barr Virus Suppression in COPD (EViSCO) trial was a randomized double-blind placebo-controlled trial conducted at the Mater Hospital Belfast, Northern Ireland. Eligible patients had stable moderate-to-severe COPD and sputum EBV (measured using quantitative polymerase chain reaction) and were assigned random... | PMC10808072 |
Results | EBV suppression | From November 2, 2018, through March 12, 2020, 84 patients were assigned randomly (n = 43 to valaciclovir). Eighty-one patients completed trial follow-up and were included in the intention-to-treat analysis of the primary outcome. A greater number of participants in the valaciclovir group achieved EBV suppression (n = ... | PMC10808072 | |
Interpretation | COPD, EBV suppression | INFILTRATE, COPD | Valaciclovir is safe and effective for EBV suppression in COPD and may attenuate the sputum inflammatory cell infiltrate. The findings from the current study provide support for a larger trial to evaluate long-term clinical outcomes. | PMC10808072 |
Trial Registry | ClinicalTrials.gov; No.: NCT03699904; URL: | PMC10808072 | ||
Graphical Abstract | PMC10808072 | |||
Key Words | PMC10808072 | |||
Abbreviations | adverse eventEpstein-Barr virusinterquartile rangeNorthern Ireland Clinical Trials Unitquantitative polymerase chain reactiontertiary lymphoid organ
FOR EDITORIAL COMMENT, SEE | PMC10808072 | ||
Study Design and Methods | PMC10808072 | |||
Study Design and Patients | This was a randomized double-blind placebo-controlled allocation-concealed clinical trial conducted at Mater Hospital Belfast, Northern Ireland. Trial management, statistical support, and data monitoring and management was facilitated by the Northern Ireland Clinical Trials Unit (NICTU). The trial was sponsored by Belf... | PMC10808072 | ||
Randomization and Masking | Eligible participants were enrolled by the study investigators and assigned randomly (1:1) to valaciclovir 1 g tid or matching placebo for 8 weeks according to a prespecified randomization schedule. Mixed block sizes and no stratification were used. The randomization schedule was generated by an independent NICTU stati... | PMC10808072 | ||
Procedures | exacerbations, COPD | ADVERSE EVENTS, CHRONIC OBSTRUCTIVE LUNG DISEASE, COPD | The trial involved a screening visit, a baseline visit (visit 1), and 8 weeks of double-blind treatment with valaciclovir (1 g tid for 8 weeks) or matching placebo with scheduled follow-up visits at week 4 (visit 2) and week 8 (visit 3). Participants continued with their allocated treatment schedule until they attended... | PMC10808072 |
Outcomes | ADVERSE REACTIONS, SECONDARY | The primary efficacy outcome was the suppression of EBV in the sputum measured using qPCR between baseline and week 8. EBV suppression was defined as a 90% reduction in the viral load at week 8. The primary safety outcome was the incidence of serious adverse reactions. Prespecified secondary outcomes included the chang... | PMC10808072 | |
Sputum EBV Quantification and Biomarker Analysis | Nucleic acid was extracted from sputum specimens according to Regional Virus Laboratory Standard Operating Procedures. Full details of the sputum EBV quantification and sputum processing methods are provided in | PMC10808072 | ||
Sample Size | Using a χ | PMC10808072 | ||
Statistical Analysis | The primary efficacy outcome was analyzed on an intention-to-treat basis using a χContinuous outcomes were reported using mean ± SD, or median (interquartile range [IQR]) if appropriate, and treatment groups were compared using independent samples | PMC10808072 | ||
Results | cardiovascular comorbidity, COPD | VIRUS, SUPPRESSION, LUNG, EVENT, COPD, ADVERSE EVENT, REGRESSION, EVENTS | Between October 2018 and March 2020, 171 patients underwent trial screening. In total, 84 patients were assigned randomly to receive either valaciclovir (n = 43) or placebo (n = 41) (Consolidated Standards of Reporting Trials flow diagram showing the Epstein-Barr Virus Suppression in COPD Study: a randomized double-bli... | PMC10808072 |
Discussion | herpes, COPD | INFILTRATE, HERPES, RECRUITMENT, ORAL HAIRY LEUKOPLAKIA, COPD, IDIOPATHIC PULMONARY FIBROSIS | In this randomized double-blind placebo-controlled trial of patients with moderate to severe COPD, valaciclovir was shown to be safe and effective for the suppression of EBV. We used valaciclovir at a dose of 1 g tid on the basis of a previous open-label study of oral hairy leukoplakia by Walling et al.This study was n... | PMC10808072 |
Interpretation | COPD, EBV suppression | INFILTRATE, COPD | Valaciclovir is safe and effective for EBV suppression in COPD and may attenuate the sputum inflammatory cell infiltrate. The findings from the current study provide support for a larger trial to evaluate long-term clinical outcomes. | PMC10808072 |
Funding/Support | NICHS, Stroke | HEART, STROKE | This study was funded by the Mater Hospital YP Trustee Fund (registered with The Charity Commission for Northern Ireland [Identifier: NIC100084]). D. A. L. has received salary and research costs from Mater Hospital YP Trustees. M. C. M. reports funding from Medical Research Council (MRC) for current post [Grant MR/T016... | PMC10808072 |
Financial/Nonfinancial Disclosures | The authors have reported to | PMC10808072 | ||
References | PMC10808072 | |||
Supplementary Data | PMC10808072 | |||
e-Online Data | PMC10808072 | |||
Abstract | Principal Investigator: Jodi Layton, MD, Tulane School of Medicine, New Orleans, LA, USA | PMC10020796 | ||
Background | prostate cancer death, mCRPC, castrate-resistant prostate cancer | METASTATIC PROSTATE CANCER, CASTRATE-RESISTANT PROSTATE CANCER | Black men are at higher risk for prostate cancer death. Previous studies showed a benefit of different therapies, including immune-based therapy, for Black men with metastatic prostate cancer. We sought to explore the efficacy of the PD-L1 inhibitor avelumab in Black men with metastatic castrate-resistant prostate canc... | PMC10020796 |
Methods | PROSTATE | This pilot phase II study enrolled self-identified Black patients who developed mCRPC on next-generation hormonal therapies (NHTs) abiraterone acetate or enzalutamide (NCT03770455). Enrolled patients received avelumab 10mg/kg IV every 2 weeks while remaining on the same NHTs. The primary endpoint of our study was ≥ 50%... | PMC10020796 | |
Results | A total of eight patients were enrolled. The median duration on NHTs prior to enrollment was 364 days (95% CI, 260.9-467.1). The median time to initiate avelumab was 8 days (3-14). With a median follow-up of 196 days, no patients achieved the primary endpoint. The median time to PSA progression was 35 days (95 CI%, 0-9... | PMC10020796 | ||
Conclusion | castrate-resistant prostate cancer | METASTATIC PROSTATE CANCER, CASTRATE-RESISTANT PROSTATE CANCER | In conclusion, the addition of avelumab to NHT did not demonstrate clinical activity in Black men with new mCRPC. The unexpected short interval between PSA and radiographic and/or clinical progression observed in this study has potential clinical implications.ClinicalTrials.gov Identifier: NCT03770455 (IND number 13955... | PMC10020796 |
Lessons Learned | mCRPC, castrate-resistant prostate cancer | CASTRATE-RESISTANT PROSTATE CANCER | The addition of avelumab did not demonstrate clinical activity in a cohort of Black men with metastatic castrate-resistant prostate cancer (mCRPC) that had progressed on abiraterone acetate or enzalutamide.Black men with mCRPC had a short interval between PSA and radiographic/clinical progression on this trial. | PMC10020796 |
Discussion | –10, tumor, prostatic tumors, prostate cancer | TUMOR, PROSTATE CANCER, MICROSATELLITE INSTABILITY | Our group and others have previously shown that immune checkpoint inhibitors are effective in specific prostatic tumors with microsatellite instability and high tumor mutational burden but their effect in the biology of prostate cancer is not entirely known.PSA kinetics of enrolled patients. The accelerated PSA progres... | PMC10020796 |
Assessment, Analysis, and Discussion | prostatic malignancies, prostate cancer death, tumors, mCRPC, prostate cancer | ADVERSE EVENTS, DISEASE, SOLID TUMORS, SOMATIC MUTATION, EVENTS, TUMOR GROWTH, TUMORS, PROSTATE CANCER | Black men are known to be at higher risk for prostate cancer death.Black patients are continually underrepresented in clinical trials and there are possible racial differences in the molecular profiling of tumors and outcomes of these patients that require further investigation of active therapies in this underrepresen... | PMC10020796 |
Funding | EMD | We acknowledge that this study was financially supported by EMD Serono, Inc., an affiliate of Merck KGaA, in alliance with Pfizer Pharmaceuticals. | PMC10020796 | |
Conflict of Interest | OI |
(C/A) Consulting/advisory relationship; (RF) Research funding; (E) Employment; (ET) Expert testimony; (H) Honoraria received; (OI) Ownership interests; (IP) Intellectual property rights/inventor/patent holder; (SAB) Scientific advisory board. | PMC10020796 | |
Data Availability | The data underlying this article will be shared on reasonable request to the corresponding author. | PMC10020796 | ||
References | PMC10020796 | |||
Aim | EVENTS | We compared effects of infant positioning and feed‐rate interventions on respiratory events and oximetry parameters in spontaneously breathing preterm infants born <32 weeks gestation managed in a neonatal unit. | PMC10092656 | |
Methods | A randomised triple crossover design was employed. | PMC10092656 | ||
Results | EVENTS | Propped/prone positioning significantly reduced events and improved percentage time SpO | PMC10092656 | |
Conclusions | Alternative infant positioning should be considered in preterm infants managed in the neonatal unit.Conflict of interest: None declared. | PMC10092656 | ||
What is already known on this topic | EVENTS |
Cardiorespiratory events are common in preterm infants and reducing such events is a cornerstone of neonatal care.Position and feed‐rate interventions are frequently utilised without a clear evidence base.To our knowledge no studies have evaluated such interventions during or after feeds in spontaneously breathing inf... | PMC10092656 | |
What this paper adds | bradycardia, cot, apnoea | EVENTS, EVENT, APNOEA OF PREMATURITY |
This study evaluates the impact of feeding interventions (positional and feed‐rate) on cardiorespiratory events in spontaneously breathing preterm infants born <32 weeks gestation.Propped/prone positioning reduces events and improves oximetry profile compared with both neutral position and continuous pump feeds.Positi... | PMC10092656 |
Methods | Randomised triple crossover design was employed whereby each infant underwent three test conditions in randomised sequence, each over a 24‐h period for three consecutive days without washout (Fig. (a) CONSORT flowchart and (b) conditions and sequences for randomised triple crossover design. | PMC10092656 | ||
Study population | congenital heart disease, congenital upper airway obstruction | EVENTS, RECRUITMENT, REFLUX | We recruited 68 preterm infants (birth gestation < 32 weeks) from an Australian tertiary neonatal unit. Eligible infants were: (i) self‐ventilating for at least 5 days prior to commencement; (ii) receiving full enteral feeds (>150 mL/kg/day) for at least 5 days and third‐hourly feeding for at least 48 h and (iii) not y... | PMC10092656 |
Outcome measures | EVENTS, EVENT, EVENTS | Primary study outcomes were: (i) number of respiratory events and (ii) percentage of time with SpOManual review of event triggers was undertaken by four investigators who were blinded to the condition sequence using standardised data collection sheets. Events were reconciled with dedicated nursing observation records a... | PMC10092656 | |
Position intervention | cot | Infants undertaking Condition A (‘supine and flat’) were placed supine with the cot in neutral (horizontal) position. The positional intervention, Condition B (‘propped and prone’), combined infant and cot position, with infants placed prone with head turned to one side and cot inclined at 15° (default cot elevation ac... | PMC10092656 | |
Infants in Conditions A and B received usual third‐hourly gravity bolus feeds via nasogastric tube, typically over 5–15 min. The feed‐rate intervention (Condition C) was defined by third‐hourly feed volume given over 45 min by pump, with usual supine/flat infant position. Pump feeds were administered via Vygon (Écouen,... | PMC10092656 | |||
Sample size | EVENTS | We aimed to recruit 90 infants to detect a 40% reduction in the log(number of events) and a 50% reduction in the log(percentage time with SpO | PMC10092656 | |
Statistical analysis | APPENDIX | Additional statistical methodology is provided in Appendix | PMC10092656 | |
Results | PMC10092656 | |||
Baseline participant characteristics | EVENTS | Of 68 infants included in the study, 23 (34%) were twins and 38 (56%) were male (Table Patient characteristics; overall and by treatment sequence (Pair of twins allocated to same condition sequence.Ten data points were missing for daily number of events (5%) and there were four missing data points each for time SpO | PMC10092656 | |
Outcomes | EVENTS, EVENT | Condition B (positional intervention) demonstrated lower number of events, smaller percentage time with SpOMarginal mean estimates for number of events, percentage of time spent with SpO
Back transformed estimates and 95% CIs.There was a statistically significant increase in percentage time with SpODescriptive statisti... | PMC10092656 | |
Summary | EVENTS | The positional intervention (Condition B) was superior compared to other conditions, significantly reducing number of events and percentage of time with SpO | PMC10092656 | |
Discussion | EVENTS, SECONDARY | ‘Propped and prone’ positioning is superior to both supine/flat positioning and continuous pump‐feeding in reducing respiratory events and percentage time with SpOThere were no differences in primary or secondary outcomes between feed‐rate intervention (continuous pump‐feeds) and care‐as‐usual (gravity bolus feeds). Th... | PMC10092656 | |
Limitations | cot | RECRUITMENT, SENSITIVITY, SECONDARY, SEPARATION, SUDDEN INFANT DEATH SYNDROME, EVENTS | There was <5% missing data for primary and secondary outcomes, some missing at random and some not. The sequence effect in the events model is thought to be due to patient characteristics. Sensitivity analysis showed results are robust and confirm Condition B as superior.Our position intervention combined both infant a... | PMC10092656 |
Conclusions | EVENTS | Propped and prone positioning should be considered by neonatal physicians and nurses caring for spontaneously breathing, late‐preterm infants with established enteral feeds, particularly those in whom respiratory events have been problematic. There does not appear to be evidence to support feed‐rate interventions in th... | PMC10092656 | |
Author Contributions | Conceptualization & Methodology: Christopher M Richmond and Pita Birch; Data Collection: Christopher M Richmond, Fabian Ring, Lacey Richmond, and Erika Rossouw, Formal Analysis: Christopher M Richmond and Emma Ballard; Validation: Christopher M Richmond, Emma Ballard, Pita Birch; Supervision: Pita Birch; Writing, origi... | PMC10092656 | ||
Ethics Statement | This project received Human Research Ethics Committee approval (HREC/15/QGC/297) and site‐specific approval (SSA/15/QGC/300) through Gold Coast Health (Southport, Queensland, Australia) in 2016. | PMC10092656 | ||
Supporting information |
Click here for additional data file. | PMC10092656 | ||
Acknowledgements | The authors wish to acknowledge and value the contributions of clinical staff who supported the trial within the Newborn Care Unit at Gold Coast University Hospital, Statisticians at Data Analysis Australia for initial advice on study design and families who contributed their time to this study. Open access publishing ... | PMC10092656 | ||
Data Availability Statement | Data analysed are supplied in Supporting Information and are also available upon request to the corresponding authors. | PMC10092656 | ||
References | PMC10092656 | |||
Objectives | ’ | Jumping ability has been identified as a key factor that influences the performance of badminton athletes. Autoregulatory progressive resistance exercise (APRE) and velocity-based resistance training (VBRT) are commonly used approaches to enhance muscle strength and have been shown to accurately monitor the development... | PMC10414022 | |
Methods | ± | Upon completing familiarization and pretesting, 18 badminton athletes were included and completed the training intervention (age, 21.4 ± 1.4 years; stature, 170.1 ± 7.3 cm; body mass, 65.9 ± 12 kg); they were randomly divided into the APRE group ( | PMC10414022 | |
Results | (1) The results of the within-group indicated that only the CMJ (pre: 41.56 ± 7.84 | PMC10414022 | ||
Conclusions | ’ lower limb explosive | The results showed that, compared to VBRT, APRE can effectively improve the performance of the reactive athletes’ lower limb explosive power in the CMJ in a shorter period of time. The findings indicate that APRE may be useful for coaches seeking to improve the CMJ performance of athletes in the short term. | PMC10414022 | |
Introduction | RPE | Badminton is a type of racquet sport that involves various explosive movements, such as jumping, quick changes of direction, net shots, and fast arm movements (Autoregulatory progressive resistance exercise (APRE), rating of perceived exertion (RPE), and velocity-based resistance training (VBRT) are three common method... | PMC10414022 | |
Materials and Methods | PMC10414022 | |||
Experimental approach to the problem | A randomized controlled trial was conducted to investigate the effects of APRE and VBRT on the explosive power of the lower limbs in athletes. After familiarization with the program and pretesting, participants were randomly assigned to the VBRT or APRE group. Participants volunteered to participate in the study from A... | PMC10414022 | ||
Participants | ±, injury or illness | Twenty-one participants (male = 11, female = 10) were originally recruited to take part in the research study. The inclusion criteria of the recruited athletes for the study were as follows: (1) absence of any significant physical health issues, (2) older than 18 years, (3) a minimum of 3 years of prior experience in p... | PMC10414022 | |
Physical characteristics of the participants (M ± SD). | PMC10414022 | |||
Procedures | Participants completed jumping performance testing in 1 day, including the CMJ, SJ, and DJ. Before all testing and training sessions, participants were supervised during a standardized warm-up, consisting of 5 min of jogging and dynamic stretching. After the completion of the final resistance training, testing for outc... | PMC10414022 | ||
Outcome measures | BEND | CMJ, SJ, and DJ tests were administered indoors using the SmartJump wireless portable jump test mat, which consists of a wireless mobile device terminal and a SmartJump vertical jump mat. The jumping test mat analyzes the jumping motion by pressure sensing. All the tests required participants to place their arms around... | PMC10414022 | |
Statistical analyses | Data analysis was completed using Jamovi 2.3.26. Mean and standard deviation (SD) values were calculated using standard statistical methods. The normality of all variables was tested using the Shapiro–Wilk test procedure. Levene’s test was used to determine the homogeneity of variance. Subsequently, repeated measures a... | PMC10414022 | ||
Results | ± | All data are expressed as means ± SD. The subject’s characteristics including age, weight, and height are listed in After 4 weeks of training, only the APRE group demonstrated greater improvement in the CMJ (pre: 41.56 ± 7.84 | PMC10414022 | |
Intra-group and inter-group change in CMJ, SJ, EUR, and RSI from 4 week for APRE and VBRT groups. | All data are presented as Mean ± SD. *Significant differences between pre- and post- for APRE or VBRT at the | PMC10414022 | ||
Changes in the variables of CMJ, SJ, EUR, and RSI between pre- and post-test after training in each of groups. | PMC10414022 | |||
Conclusion | RSI | Improving the jumping ability of badminton athletes is crucial for achieving excellent athletic performance and competition results. Therefore, coaches need to understand methods for enhancing the jumping ability of athletes during the season. This study found that using APRE can effectively improve the CMJ performance... | PMC10414022 | |
Supplemental Information | PMC10414022 | |||
Experimental program. | Click here for additional data file. | PMC10414022 | ||
Experimental data. | Click here for additional data file.We would like to thank the researchers and study participants for their contributions. | PMC10414022 | ||
Additional Information and Declarations | PMC10414022 | |||
Competing Interests | The authors declare that they have no competing interests. | PMC10414022 | ||
Human Ethics | The following information was supplied relating to ethical approvals (This study was approved by the Ethics Committee for Human Experiments (Approval number: 2022LCLL-38). | PMC10414022 | ||
Data Availability | The following information was supplied regarding data availability:Raw data are available in the | PMC10414022 | ||
References | PMC10414022 | |||
Introduction | death, urinary tract infections, bacterial infection, infections, bacteriuria, sepsis, UTIs | INFECTIOUS DISEASES, SYSTEMIC DISEASE, URINARY TRACT INFECTIONS, URINARY TRACT INFECTIONS, BACTERIAL INFECTION, INFECTIONS, NOSOCOMIAL INFECTIONS, UTI, SEPSIS | Urinary tract infections (UTIs) are among the most prevalent infectious diseases in both community and healthcare settings [Among hospital settings, UTIs account for almost 40% of all nosocomial infections, and represent a major burden, given the associated morbidity and mortality. A correlation between urinary tract i... | PMC10321614 |
Material and methods | PMC10321614 | |||
Study design | EMERGENCY, UTI | A total of 349 patients were enrolled in two open-label, monocentric, non-interventional clinical trials in collaboration with the Department of Emergency Medicine at Azienda Ospedaliera Sant’Andrea, Rome and the outpatient clinic at Istituto Dermopatico dell’Immacolata, Rome; 101 and 248 patients were enrolled in the ... | PMC10321614 |
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