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Author contributions
This study was designed by P.C.C., O.K., D.S., and E.H. Data collection was carried out by P.C.C.. Data analysis was carried out by P.C.C.. Interpretation of data was done by P.C.C., O.K., D.S., and E.H. Writing of the paper was done by P.C.C. Supervision was done by O.K., D.S., and E.H. All authors read and approved t...
PMC10603062
Funding
DER
This work was funded by Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung (Grant no. P0GEP1_175061).
PMC10603062
Data availability
Data used in the present study is publicly available at
PMC10603062
Competing interests
The authors declare no competing interests.
PMC10603062
References
PMC10603062
1. Introduction
death
REGRESSION
People who smoke often make several quit attempts before successfully maintaining abstinence. Therefore, incorporating re-engagement for people who fail to initially quit could increase quit attempts and ultimately increase cessation rates. Within the context of quit line-based interventions, it remains unknown what ch...
PMC9859567
2. Materials and Methods
PMC9859567
2.1. Data and Study Population
SECONDARY
This is a secondary data analysis from a large clinical trial of 612 adults who smoke designed to determine the efficacy of three re-engagement strategies on long-term (12 months) smoking cessation [
PMC9859567
2.2. Measures
The primary outcome of interest was the participant’s decision to re-engage at three months (yes vs. no) based on responses to the three-month follow-up assessment, thereby making another quit line-facilitated quit attempt, or to decline the opportunity to re-engage, including overt decline to re-engage (Several indepe...
PMC9859567
2.3. Statistical Analyses
REGRESSION
All analyses were performed using SAS 9.4 (SAS, Cary, NC, USA). Continuous variables were summarized using median and interquartile range and compared between participants who re-engaged vs. did not re-engage a using Wilcoxon rank sum test. Categorical variables were summarized using frequency and percentages and compa...
PMC9859567
3. Results
Among participants who did not re-engage, the majority were male (56.7%), White (83.1%), married or partnered (65.6%), and active duty or retired military (63.9%, Primary Results: Multivariable results indicated that race, baseline confidence in quitting, and initial counseling sessions completed were associated with r...
PMC9859567
4. Discussion
SECONDARY
The purpose of this study was to identify interpersonal and intervention use characteristics associated with re-engagement among adults participating in a quit line intervention study. To our knowledge, this study is the first to consider personal, tobacco use, motivation, and initial intervention utilization factors t...
PMC9859567
5. Conclusions
This study identified predictors of re-engagement among adults enrolled in a cessation intervention who relapsed or failed to initially quit by three months after enrolling in a cessation quit line intervention study. We identified initial intervention use and personal characteristics associated with re-engagement, inc...
PMC9859567
Author Contributions
Conceptualization, K.P.W., R.C.K. and G.W.T.; methodology, K.P.W., X.-Q.W. and I.M.; formal analysis, X.-Q.W. and I.M.; writing—original draft preparation, K.P.W., C.A.A. and I.M.; writing—review and editing, X.-Q.W., D.G.C., M.A.P., M.A.L., G.W.T. and R.C.K.; funding acquisition, R.C.K., G.W.T. and M.A.L. All authors ...
PMC9859567
Institutional Review Board Statement
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
PMC9859567
Informed Consent Statement
The voluntary, fully informed consent of the subjects used in this research was obtained as required by 32 CFR 219 and DODI 3216.02_AFI 40-402.
PMC9859567
Data Availability Statement
This study was pre-registered at clinicaltrials.gov: NCT02201810. The analysis plan was not formally pre-registered. De-identified data from this study are not available in a public archive. De-identified data from this study will be made available (as allowable according to institutional IRB standards) by emailing the...
PMC9859567
Conflicts of Interest
The authors declare that they have no conflict of interest.
PMC9859567
References
Demographic, tobacco use, and initial intervention use overall and by three-month re-engagement.Note: Baseline confidence in quitting and reasons for quitting by three-month re-engagement.Note: Association between personal characteristics, and initial intervention engagement with re-engagement at three months.OR: odds ...
PMC9859567
Supplementary Information
thrombotic thrombocytopenia purpura, organ damage
ITTP, SECONDARY, RECURRENCE
Caplacizumab is an anti-von Willebrand factor humanized single-variable-domain immunoglobulin fragment whose efficacy and safety in immune-mediated thrombotic thrombocytopenia purpura (iTTP) have been demonstrated in international studies. This prospective, open-label phase 2/3 study evaluated caplacizumab 10 mg admini...
PMC9970947
Keywords
PMC9970947
Introduction
ischemia, hemolytic anemia, TTP, Thrombotic thrombocytopenia purpura
HEMOLYTIC ANEMIA, THROMBOCYTOPENIA, ISCHEMIA, ITTP, TTP
Thrombotic thrombocytopenia purpura (TTP) is an acute life-threatening condition characterized by thrombocytopenia, non-immune hemolytic anemia and organ ischemia [The acquired, or immune-mediated, form of TTP (iTTP) is rare, but more prevalent than the hereditary form [Approximately 18% of individuals with iTTP are re...
PMC9970947
Materials and methods
PMC9970947
Study design
ITTP, MAY, RECURRENCE
This was a prospective, single-arm, open-label study (NCT04074187) conducted at 11 centers in Japan between October 2019 and May 2021, and sponsored/funded by Sanofi. The primary objective of the study was to evaluate the ability of caplacizumab to prevent the recurrence of iTTP during the overall study period.The prot...
PMC9970947
Participants
thrombocytopenia, ADAMTS13, TTP
ITTP, THROMBOCYTOPENIA, TTP
The study included male or female Japanese individuals aged ≥ 18 years with a clinical diagnosis of iTTP (initial or recurrent) that required initiation of daily TPE treatment. A confirmed diagnosis of iTTP based on ADAMTS13 activity was not required for study enrollment. The TTP clinical diagnosis was defined as throm...
PMC9970947
Treatment
autoimmune disease
AUTOIMMUNE DISEASE
Eligible participants received caplacizumab 10 mg once daily, in addition to standard care, throughout the TPE treatment period and for 30 days after completion of TPE. The first caplacizumab dose was administered by intravenous injection at least 15 min prior to TPE, with subsequent doses administered subcutaneously a...
PMC9970947
Endpoints
thrombocytopenia, death
THROMBOEMBOLIC EVENT, RECURRENCE, RECURRENCE, THROMBOCYTOPENIA, ITTP
The primary endpoint of the study was the proportion of participants with a recurrence of iTTP during the overall study period and was assessed in the per-protocol (PP) population. Recurrence was defined as recurrent thrombocytopenia after initial recovery of platelet count (confirmed platelet count ≥ 150 × 10Secondary...
PMC9970947
Outcome assessments
bleeding, organ damage, ADAMTS13
EVENTS, BLEEDING
The use of TPE and other medications, as well as bleeding events, platelet count, and organ damage markers, were recorded daily until the end of TPE, weekly until the end of the study, and at the first and last follow-up visits. In addition, the Standardized Mini-Mental State Examination (SMMSE) [With regards to caplac...
PMC9970947
Statistical analysis
SE
ITTP, DISEASE, RECURRENCE
The planned sample size was 15 participants, based on feasibility considerations; no sample size calculation was performed. The success criterion for the study was ≤ 20% of evaluable participants (i.e., PP population) with a recurrence of iTTP during the overall study period. The PP population (the primary analysis pop...
PMC9970947
Results
PMC9970947
Efficacy
PMC9970947
Organ function parameters and cognitive function
SE, organ damage, cognitive impairment
In the PP population, 14 of 15 (93.3%) participants experienced normalization of all three organ damage maker levels, with the median time to normalization in these individuals occurring at 2.65 (95% CI: 0.98–4.98) days (Fig. Kaplan–Meier plot of time to normalization of all three markers of organ damage (lactate dehyd...
PMC9970947
TTP treatment course
The fresh-frozen plasma (absolute plasma volume) replaced in the PP population by TPE over 3–11 days (median 5 days) ranged between 13.4 and 50.0 L (median 24.6 L) in the overall treatment period. Median normalized plasma volume, which is TPE days multiplied by the ratio of absolute plasma volume by estimated plasma vo...
PMC9970947
Pharmacokinetics and pharmacodynamics
Plasma caplacizumab concentrations remained consistent throughout the treatment period (Supplementary Fig. S1). During the post-daily TPE period, mean plasma concentrations ranged from 611 ng/mL to 785 ng/mL.Mean levels of VWF:Ag (Supplementary Fig. S2) and FVIII:C (Supplementary Fig. S3) and VWF:RCo (Fig. Mean plasma ...
PMC9970947
ADAMTS13 activity
ADAMTS13
ITTP, EVENT, RECURRENCE
Mean ± SE ADAMTS13 activity increased steadily from 7.06 ± 6.12% at screening to 39.37 ± 7.80% at the end of Week 1, then dropped to 28.18 ± 6.76% at Week 2 (1 week after the end of TPE), and increased again to 49.5 ± 10.15% by the Week 5 visit. The participant who had iTTP recurrence had an ADAMTS13 activity level of ...
PMC9970947
Immunogenicity
Three participants (14.3%) developed anti-caplacizumab antibodies during treatment. Neither pre-existing antibodies nor anti-drug antibodies were found to have an influence on the time to platelet count response, plasma caplacizumab concentrations, VWF:RCo, or VWF:Ag levels.
PMC9970947
Discussion
ADAMTS13, exacerbations, cognitive impairment, initiation of caplacizumab., TTP
RECURRENCE, DISEASE, ITTP, SECONDARY, TTP
This study, the first to evaluate caplacizumab treatment in Japanese individuals with iTTP, indicates that adding caplacizumab to the standard protocol of TPE and immunosuppressive treatment results in a low rate of iTTP recurrence, and rapid normalization of platelet count and organ function parameters. It is notable ...
PMC9970947
Acknowledgements
The authors thank Catherine Rees of inScience Communications, Springer Healthcare, who wrote the outline of the manuscript and Andrea Bothwell who wrote the first draft on behalf of inScience Communications, Springer Healthcare. This medical writing assistance was funded by Sanofi K.K., Japan.
PMC9970947
Author contributions
MM
MM and YM contributed to conception and design of the work. YM, KI, SI, HU, YU, AY, SF, TM, HA, KN, KS, YO, and HM contributed to data acquisition. MM, YM, YH, TT, and ST contributed to data analysis or interpretation of data. All authors have agreed to take responsibility for the aspects of the work with which they we...
PMC9970947
Data availability
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to...
PMC9970947
Declarations
PMC9970947
Conflict of interest
MM
BLOOD
YM served as a consultant for Sanofi K.K. and Zenyakukogyo Co., Ltd., has participated in advisory boards for Sanofi K.K., and received research funding from Sanofi K.K. KI received honoraria from Celgene Co., Ltd., Bristol-Myers Squibb K.K., Astellas Pharma Inc., Chugai Pharmaceutical Co., Ltd., Sumitomo Dainippon Pha...
PMC9970947
References
PMC9970947
Methods
Forty-six young men were recruited (mean age: 20.65 years) and assigned randomly to aerobic exercise (n = 15), cognitive training (n = 15), or dual-task (n = 16) groups. Executive functions were assessed before, immediately after, and 30 min after intervention using Go/No-go, 2-back, and More-Odd-Shifting tests.
PMC10431647
Results
Working memory function improved after all three interventions (significant Time effect,
PMC10431647
Conclusion
Executive function was enhanced by single-task (acute aerobic exercise or cognitive training) and dual-task interventions. The effect continued for 30 min after both the single-task aerobic exercise and the dual-task intervention. For short-term intervention, the dual-task was not more effective than either of the sing...
PMC10431647
Data Availability
The data that support the findings of this study are available from figshare, DOI:
PMC10431647
1. Introduction
In daily life, people must often perform motor and cognitive tasks at same time, such as shopping, counting coins while queuing up, or walking while answering a mobile phone call. Poor dual-task performance can greatly impact activities of daily life [EF continues to change throughout life [Aerobic exercise is a good n...
PMC10431647
2. Methods
PMC10431647
2.1 Participants
cognitive impairments, musculoskeletal difficulties
COLOR BLINDNESS, CARDIOPULMONARY DISEASE, MOVEMENT DISORDERS
We estimated simple size (n) using a power analysis with the following parameters in G*power. We set effect size = 0.25; alpha err prob = 0.05; power (1—beta err prob) = 0.80; number of groups = 3; number of measurements = 3; corr among rep measures = 0.5; and nonsphericity correction ε = 0.5. The resulting sample size...
PMC10431647
2.2 Interventions
Participants were assigned to one of three groups: aerobic exercise, cognitive training, or dual-task (both aerobic exercise and cognitive training). Interventions lasted 30 min and were conducted in a quiet room.
PMC10431647
The intervention procedures.
PMC10431647
2.2.1 Aerobic exercise intervention
Based on the American College of Sports Medicine’s standard for grading the intensity of aerobic exercise for healthy adults, combined with the research results from other scholars, participant heart rate while exercising should range between 60% to 70% of the maximum heart rate [
PMC10431647
2.2.2 Cognitive intervention
Based on earlier studies [The calculation task was designed to help improve global EF. A simple 2-number addition or subtraction problem comprising 2-digit numbers was presented on the computer screen for 5 s (e.g., 28 + 14, 39–15), and participants had to provide their answer before the problem disappeared. There were...
PMC10431647
2.2.3 Dual-task intervention
Dual-task intervention combined aerobic exercise and cognitive intervention. The participants were required to pedal the cycle ergometer at a moderate intensity while doing the cognitive tasks.
PMC10431647
2.3 EF measurements
All EF measures were collected in a light and sound-attenuated room with participants seated in a comfortable chair. Before the intervention, global cognitive state was assessed using the MoCA. Three tests were used to measure the three aspects of EF before intervention, immediately after intervention, and 30 min after...
PMC10431647
2.3.1 Inhibition control
A Go/No-go task was used to measure inhibition control [
PMC10431647
2.3.2 Information updating
The ability to update information was evaluated using a 2-back task [
PMC10431647
2.4 Rule shifting
The more-odd-shifting task was used to measure shifting ability [
PMC10431647
2.5 Statistical analysis
For normally distributed data, continuous variables are reported as mean ± standard deviation. Tests of normality followed by analysis of variance (ANOVA) were used to examine all data. The effects of Time (before, immediately after, 30 min after) and Group (exercise, cognitive training, dual-task) on EF were assessed ...
PMC10431647
3. Results
PMC10431647
3.1 Participant characteristics
Fifty-one young men were recruited, and 46 ultimately agreed to participate in the study. They were assigned to the aerobic exercise (n = 15), cognitive training (n = 15), and dual-task (n = 16) groups.
PMC10431647
Baseline characteristics.
*p<0.05, **p≤0.01; MoCA: Montreal cognitive assessment.
PMC10431647
Results of executive function measurement across intervention groups at three time points.
Abbreviations: Values are presented as mean ± SD.Inhibition control was assessed using a Go/No-go task. The two-way ANOVA for performance on the Go/No-go task revealed a main effect of Time (The two-way ANOVA for Go/No-go response time did not find any differences among the three groups at any of the three time points ...
PMC10431647
3.3 Information updating
The 2-back task was used assess the ability to update working memory. On task accuracy we found a significant main effect of Time (
PMC10431647
3.4 Rule shifting
The ability to shift between rules was assessed using the more-odd-shifting task. We found a significant main effect of Time (
PMC10431647
4. Discussion
We examined the effects of aerobic exercise, cognitive training, and dual-task intervention on EF in young men. We found that 30-min of intervention improved some aspects of EF, regardless of the type of intervention. Specifically, both 30-min of single-task aerobic exercise intervention and 30-min of dual-task interve...
PMC10431647
The effect of acute aerobic training on EF
CORTEX
Our results showed a main effect of Time on accuracy for the shifting task. This is consistent with previous research showing that only 30 min of acute moderate-intensity aerobic exercise improved shifting ability in all age groups [In our study, we only assessed EF with cognitive tests. However, other studies have use...
PMC10431647
The effect of acute cognitive training on EF
CORTEX
Although we did not find significant differences in EF after a bout of cognitive training, we observed a trend for information updating and shifting to be improved. Cognitive training improves EF by activating the prefrontal cortex, which is important for EF [
PMC10431647
The effect of acute dual-task intervention on EF
The dual-task intervention led to improved EF in terms of shifting and working memory abilities, and the effect lasted for up to 30 minutes after the intervention. Similarly, Pellegrini-Laplagne et al. [However, as with acute aerobic exercise, we did not find any changes in inhibition control. Indeed, results regarding...
PMC10431647
Limitation
motor-cognitive dual-task training on EF
Limitations of the current study include its small sample size, which reduces the power to detect significant effects. Second, we only measured behavior. It will be important in future studies to investigate the dynamic changes in brain activity following motor-cognitive dual-task training. Although, short-term interve...
PMC10431647
5. Conclusion
The major conclusion that can be drawn from this study is that acute aerobic exercise, cognitive training, and dual-task intervention for 30 min can improve the EF performance for young men. Acute aerobic exercise and the dual-task promoted working memory and shifting ability. Moreover, the improvement after dual-task ...
PMC10431647
Background
lumbar medial branch block, pain, disability, LMBB, LFJ, facet joints
The aim of this multicenter randomized interventional prospective study was to compare the ultrasound (US)-guided lumbar medial branch block (LMBB) with the fluoroscopy (FS)-guided LMBB in terms of analgesic efficacy and disability in the setting of the treatment of pain arising from the lumbar facet joints (LFJ).
PMC10007783
Methods
Anxiety, Pain, Oswestry Disability, Depression, LFJ” syndrome
Fifty adults with a “LFJ” syndrome were randomized into two groups: in group FS, fluoroscopic-guidance was used to block the medial branch at three lumbar levels (L3-L4, L4-L5 and L5-S1); in group US, same blocks were performed under ultrasound. Needle transverse approach was used with both techniques. Effects of these...
PMC10007783
Results
LMBB
LMBB under US-guidance was not inferior to FS-guidance (
PMC10007783
Conclusions
pain, bundle branch block
BUNDLE BRANCH BLOCK
The medial lumbar bundle branch block under ultrasound-guidance is not inferior to the fluoroscopy-guidance procedure in effectively alleviating pain arising from the facet joints. Considering that this ultrasound technique has the benefit of an irradiation-free, real-time procedure, it can be considered as an effectiv...
PMC10007783
Keywords
PMC10007783
Introduction
lumbar medial branch block, Lumbar facet joints, pain, LMBB, LFJ, LBP
ARTHRITIC CHANGES, CHRONIC LOW BACK PAIN, DEGENERATIVE, INFLAMMATION, SYNDROME
Lumbar facet joints (LFJ) syndrome is a common source of spinal suffering affecting up to 45% of patients with a chronic low back pain (LBP) because of inflammation, degenerative or arthritic changes, overload of the posterior LFJ or muscle imbalance [In fact, it cannot be identified by imaging or physical examination ...
PMC10007783
Materials and methods
PMC10007783
Design and population
tumor, Pain, anxiety, stroke, allergy, psychiatric, neurological diseases, Depression, Anxiety, fracture, radiculitis, depressive disorders, Oswestry Disability, infection, LMBB, hematoma, LBP, scoliosis, pain, Parkinson’s disease, LFJ
TUMOR, INFILTRATION, NEUROLOGICAL DISEASE, ANKYLOSING SPONDYLITIS, SCOLIOSIS, ADVERSE EVENTS, STROKE, ALLERGY, DISORDERS, RADICULITIS, SPINAL INSTABILITY, INFECTION, SYSTEMIC INFECTION, SYNDROME, COAGULATION DISORDER, HEMATOMA, VASOVAGAL SYNCOPE
This prospective multicenter randomized controlled trial was conducted from 6 January 2021 until 10 March 2022 in three pain management centers in Brussels (Belgium); Saint-Pierre University Hospital (César de Paepe site), Erasme and Braine-l’Alleud Hospitals. This open label study was approved by the three Ethics Comm...
PMC10007783
US-guided and FS-guided infiltrations
TUNNEL VISION, LORDOSIS, INFILTRATION
Patients were positioned in prone position with a pillow under the stomach to facilitate the view of the structures by compensating the lumbar lordosis. After disinfection of the lumbo-sacral region with alcoholic chlorhexidine 0,5%, an infiltration was performed in three puncture points unilaterally (L3-L4, L4-L5 and ...
PMC10007783
Statistical analysis
LMBB
The primary endpoint was to investigate the non-inferiority of the US group, comparing to the FS group in regard to the evolution of the ODI measured 1 month after the LMBB. Power analysis was performed with a projected standard deviation of 7. If there was truly no difference between the standard and experimental trea...
PMC10007783
Discussion
Facet syndrome, Facet joints, anxiety, facet joints, LFJ syndrome, fibromyalgia, chronic pain, fibrous, pain, zygapophyseal joints, LMBB, depression, LFJ, LBP
RHEUMATOID ARTHRITIS, MUSCLE WEAKNESS, INFILTRATION, FIBROMYALGIA, LOCAL ANESTHETICS, CHRONIC PAIN, COMPLICATIONS
This prospective randomized study showed that the LMBB under US-guidance is not inferior to FS-guidance. It confirmed the retrospective results of Han et al. [Few patients are no longer taking medications and have psychological follow-up. The pain is not always treated optimally in the “bio-psycho-social” model require...
PMC10007783
Acknowledgements
We thank all participants for accepting the study and for taking the time to answer questions by phone.
PMC10007783
Significance
bundle branch block
OBESE, BUNDLE BRANCH BLOCK
Ultrasound-guided medial lumbar bundle branch block should be preferred to the fluoroscopy technique whenever it is possible in patients who are not morbidly obese. Indeed, fluoroscopy is considered as the gold standard but is irradiating and does not allow manipulations as precise as ultrasound.
PMC10007783
Authors’ contributions
Nisolle Marie-Laure
Dr. Nisolle Marie-Laure and Dr. Ghoundiwal Djamal designed the study protocol with the contribution of Prof. Tuna Turgay, Prof. Guntz Emmanuel and Prof. Kapessidou Panayota, Dr. Ghoundiwal Djamal, Dr. El Founas Walid and Dr. Gouwy Jonathan recruited the patients. Dr. Nisolle Marie-Laure phoned patients to collect answe...
PMC10007783
Funding
We did not need any funding and the participants did not pay any supplements.
PMC10007783
Availability of data and materials
The datasets used and analysed during the current study available from the corresponding author on reasonable request. The data will be anonymized.
PMC10007783
Declarations
PMC10007783
Ethics approval and consent to participate
INFILTRATION
We confirm that all methods were carried out in accordance with relevant guidelines and regulations. An informed consent was obtained for all participants before the infiltration including all the information about the procedure, the benefits and the possible risks. The trial was approved by the three Ethics Committees...
PMC10007783
Consent for publication
Not applicable.
PMC10007783
Competing interests
The authors declare no competing interests.
PMC10007783
References
PMC10007783
ABSTRACT
PMC9831626
BACKGROUND:
hernias
Robotic-assisted surgery research has grown dramatically in the past two decades and the advantages over traditional videolaparoscopy have been extensively debated. For hernias, the robotic system can increase intraoperative strategies, especially in complex hernias or incisional hernias.
PMC9831626
AIMS:
hernia
This study aimed to compare the direct cost differences between robotic and laparoscopic hernia repair and determine each source of expenditure that may be related to the increased costs in a robotic program from the perspective of a Brazilian public institution.
PMC9831626
METHODS:
hernia
This study investigated the differences in direct costs from the data generated from a trial protocol (ReBEC: RBR-5s6mnrf). Patients with incisional hernia were randomly assigned to receive laparoscopic ventral incisional hernia repair (LVIHR) or robotic ventral incisional hernia repair (RVIHR). The direct medical cost...
PMC9831626
RESULTS:
A total of 19 patients submitted to LVIHR were compared with 18 submitted to RVIHR. The amount spent on operation room time (RVIHR: 2,447.91±644.79; LVIHR: 1,989.67±763.00; p=0.030), inhaled medical gases in operating room (RVIHR: 270.57±211.51; LVIHR: 84.55±252.34; p=0.023), human resources in operating room (RVIHR: 3...
PMC9831626
CONCLUSION:
hernia
Robotic system adds a significant overall cost to traditional laparoscopic hernia repair. The cost of the medical and robotic devices and longer operative times are the main factors driving the difference in costs.
PMC9831626
RESUMO
PMC9831626