scholarly journals Changes in Biomarkers of Exposure on Switching From a Conventional Cigarette to the glo Tobacco Heating Product: A Randomized, Controlled Ambulatory Study

2020 ◽  
Author(s):  
Nathan Gale ◽  
Michael McEwan ◽  
Oscar M Camacho ◽  
George Hardie ◽  
James Murphy ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Cigarette Smoking ◽  
Tobacco Product ◽  
Ambulatory Setting ◽  
Controlled Study ◽  
Control Group ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Biomarkers Of Exposure ◽  
Never Smokers

Abstract Introduction Tobacco heating products (THPs) generate lower machine yields of toxicants compared to those found in conventional cigarette smoke. During use, these products are likely to expose users to lower levels of particulate matter and harmful and potentially harmful compounds compared with smoking cigarettes. Aims and Methods This randomized, controlled study is investigating whether biomarkers of exposure (BoE) to smoke toxicants are reduced when smokers switch from smoking cigarettes to using the glo THP in a naturalistic, ambulatory setting. Control groups include smokers who are abstaining from cigarette smoking and never-smokers. At a baseline study visit, 24-hour urine samples and spot blood samples were taken for BoE analysis, and exhaled carbon monoxide was also measured. N-(2-cyanoethyl) valine (CEVal) was used as a marker of compliance in subjects asked to refrain from combustible cigarette smoking. Subjects are being followed up at periodic intervals for 360 days; this article presents data following a planned interim analysis at day 90. Results In continuing smokers, BoE remained stable between baseline (day 1) and day 90. In both per-protocol and CEVal-compliant analysis populations, reductions in BoE were observed in subjects switching to using glo or undergoing smoking cessation. These reductions were statistically significant for a number of BoE when switching to glo was compared with continued smoking. Furthermore, in both populations, reductions observed in subjects switching to using glo were comparable to those seen with smoking cessation and were also to levels similar to those seen in never-smokers. Conclusion glo is a reduced-exposure tobacco product. Implications This clinical study builds on a previous 5-day confinement study and demonstrates that when smokers switched from smoking combustible cigarettes to using the glo THP in a naturalistic, ambulatory setting, their exposure to tobacco smoke toxicants was significantly decreased. For most BoE examined, this was to the same extent as that seen when a control group of smokers ceased cigarette smoking, or even to levels seen in never-smoker controls. This indicates that glo is a reduced-exposure product with the potential to be a reduced-risk tobacco product, when used by smokers whose cigarette consumption is displaced completely. Clinical trial registration ISRCTN81075760.

scholarly journals Changes in biomarkers after 180 days of tobacco heating product use: a randomised trial

2021 ◽  
Author(s):  
Nathan Gale ◽  
Michael McEwan ◽  
Oscar M. Camacho ◽  
George Hardie ◽  
Christopher J. Proctor ◽  
...  
Keyword(s):  
Cigarette Smoking ◽  
Randomised Trial ◽  
Prostaglandin F2α ◽  
Health Impact ◽  
Ambulatory Setting ◽  
Controlled Study ◽  
Control Group ◽  
Biomarkers Of Exposure ◽  
Randomised Controlled Study ◽  
Randomised Controlled

AbstractThe aim of this study was to investigate whether biomarkers of exposure (BoE) and potential harm (BoPH) are modified when smokers switch from smoking cigarettes to exclusive use of a tobacco heating product (THP) in an ambulatory setting. Participants in this randomised, controlled study were healthy volunteer smokers assigned either to continue smoking or switch to a THP, and a control group of smokers who abstained from cigarette smoking. Various BoE and BoPH related to oxidative stress, cardiovascular and respiratory diseases, and cancer were assessed at baseline and up to 180 days. In continuing smokers, BoE and BoPH remained stable between baseline and day 180, while THP users’ levels of most BoE reduced significantly, becoming similar to those in controls abstaining from cigarette smoking. Also at 180 days, significant changes in numerous BoPH, including total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol, 8-epi-prostaglandin F2α type III, fractional concentration of exhaled nitric oxide and white blood cell count, were directionally consistent with lessened health impact. Our findings support the notion that the deleterious health impacts of cigarette smoking may be reduced in smokers who completely switch to using THPs.

scholarly journals A Randomized Controlled Study of Caudal Dexmedetomidine for the Prevention of Postoperative Agitation in Children Undergoing Urethroplasty

2021 ◽  
Vol 9 ◽  
Author(s):  
Weichao Zhu ◽  
Jie Sun ◽  
Jianhua He ◽  
Wangping Zhang ◽  
Meng Shi
Keyword(s):  
Controlled Study ◽  
Postanesthesia Care Unit ◽  
Control Group ◽  
Sedation Scale ◽  
Caudal Block ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Ramsay Sedation Scale ◽  
Group D ◽  
Excessive Sedation

Background: Postoperative agitation is a common complication in children undergoing general anesthesia. This study aimed to investigate the effect of caudal dexmedetomidine for the prevention of postoperative agitation in children undergoing urethroplasty.Materials and Methods: Eighty children were prospectively recruited to this study and randomized to two groups (40 cases in each group), specifically, a dexmedetomidine group (group D) who received 0.2% ropivacaine + 0.5 μg/kg dexmedetomidine for caudal block, and a control group who received 0.2% ropivacaine alone. The time to wake up, the time to discharge from the postanesthesia care unit (PACU), the duration of the caudal block, and the Ramsay sedation scale (RSS) were evaluated in the patients. Adverse events such as postoperative agitation, respiratory depression, bradycardia, hypotension, excessive sedation, nausea, and vomiting were also recorded during the first postoperative 24 h.Results: The incidence of postoperative agitation was lower in group D compared with patients in the control group (2.5 vs. 22.5%, p = 0.007). The time to wake up and the time to discharge from PACU were longer in group D than in the control group (15.2 ± 2.6 vs. 13.4 ± 1.3 min, 48.2 ± 7.7 vs. 41.5 ± 8.0 min, respectively, p < 0.001). However, the extubation times were similar between the two groups. The duration of the caudal block was longer in group D compared with the control group (8.8 ± 1.6 vs. 4.6 ± 0.7 h, p < 0.001).Conclusions: Caudal dexmedetomidine prolongs the duration of caudal block and decreases the incidence of postoperative agitation in children undergoing urethroplasty.Clinical Trial Registration: ChiCTR1800016828.

scholarly journals WhatsApp embedded in routine service delivery for smoking cessation: Effects on success rates in a randomized controlled study (Preprint)

2018 ◽  
Author(s):  
Seyfi Durmaz ◽  
Isil Ergin ◽  
Raika Durusoy ◽  
Hur Hassoy ◽  
S. Ayhan Çalışkan ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Service Delivery ◽  
Success Rate ◽  
Intervention Group ◽  
University Hospital ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Secondary Outcomes

BACKGROUND The demand for smoking cessation services has risen in Turkey, as those planning to quit, reached 35% in 2012. For quitting efforts, communication technologies are used widespread globally, yet service integration is rare. OBJECTIVE This study aims to assess the effect of a WhatsApp application embedded in the cessation service delivery, on success rate. METHODS Randomized controlled intervention study was conducted with 132 volunteers, followed up at Ege University Hospital, Smoking Cessation Clinic, March-July 2017. Intervention content based on Transtheoretic Model, was prepared and 60 WhatsApp messages were delivered to participants for 3 months, with 6 months follow up. Initial interview and follow up forms consisting sociodemographics, smoking status, medical condition and treatment, were used. The success rate at 1st and 3rd months were assessed by point-prevalence. Intention-to-treat analysis was used. As secondary outcomes; number of follow-ups, change in weight and continuity of medication were evaluated. RESULTS Success rate at 1st month was 65.9% for intervention group and 40.9% in control group; for the 3rd month it was 50.0% and 30.7%, consecutively. Being in the intervention group increased success rate by 3.50 (1.30-9.44) times in the 1st 2.50 (1.08-6.40) times in the 3rd and 2.31 (1.03- 5.16) times 6th month. The intervention was the only parameter effective in the two follow-up periods; all other factors were eliminated after adjustment for the intervention. As secondary outcomes, in the intervention group, number of follow-ups and face to face follow-ups increased for the 1st and 3rd months and continuity of medication was higher at 3rd month. CONCLUSIONS WhatsApp support embedded in cessation service delivery increases the success rate and has favorable effects on follow-up. Moreover, the equalizing effect of the intervention in terms of socioeconomic differences, positively contributes to the elimination of inequalities for successful smoking cessation in disadvantaged groups.

scholarly journals Effectiveness of Abdominal and Gluteus Medius Training in Lumbo-Pelvic Stability and Adductor Strength in Female Soccer Players. A Randomized Controlled Study

2021 ◽  
Vol 18 (4) ◽  
pp. 1528
Author(s):  
Héctor Guerrero-Tapia ◽  
Rodrigo Martín-Baeza ◽  
Rubén Cuesta-Barriuso
Keyword(s):  
Repeated Measures ◽  
Gluteus Medius ◽  
Soccer Players ◽  
Controlled Study ◽  
Control Group ◽  
Extrinsic Factors ◽  
Randomized Controlled ◽  
Limb Injuries ◽  
Experimental Group

Background. Abdominal and lumbo-pelvic stability alterations may be the origin of lower limb injuries, such as adductor pathology in soccer players. Imbalance can be caused by both intrinsic and extrinsic factors. Methods: In this randomized controlled trial over 8 weeks, 25 female footballers were randomly allocated to an experimental group (isometric abdominal training and gluteus medius-specific training) or a control group (isometric abdominal training). Evaluations were performed at baseline, at the end of the intervention and after a 4-week follow-up period. The exercise protocol in common for both groups included three exercises: Plank, Lateral plank and Bird dog. Specific exercises for the gluteus medius were: Pelvic drop and Stabilization of the gluteus medius in knee valgus. Outcome measures were lumbar-pelvic stability and adductor strength. Results: After the intervention, there was an increase in lumbo-pelvic stability in both groups, being greater in the control group than in the experimental group (mean differences [MD]: 4.84 vs. MD: 9.58; p < 0.01) with differences in the analysis of repeated measures (p < 0.001), but not in group interaction (p = 0.26). Changes were found in adductor strength in the experimental group (MD: −2.48; p < 0.001 in the left adductor; MD: −1.48; p < 0.01 in right adductor) and control group (MD: −1.68; p < 0.001 in the left adductor; MD: −2.05; p < 0.001 in the right adductor) after the intervention, with differences in the analysis of repeated measures in left (p < 0.001) and right (p < 0.001) adductor strength. Conclusions: An abdominal and gluteal training protocol shows no advantage over a protocol of abdominal training alone for lumbo-pelvic stability and adductor strength, while improvements in both variables are maintained at four weeks follow-up.

scholarly journals Efficacy of axial TheraTogs on gait pattern in children with dyskinetic cerebral palsy: a randomized controlled trial

2021 ◽  
Vol 26 (1) ◽  
Author(s):  
Shamekh Mohamed El-Shamy ◽  
Ehab Mohamed Abd El Kafy
Keyword(s):  
Cerebral Palsy ◽  
Physical Therapy ◽  
Muscle Tone ◽  
Controlled Trial ◽  
Gait Pattern ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Gait Parameters ◽  
Experimental Group

Abstract Background TheraTogs promotes proprioceptive sense of a child with cerebral palsy and improves abnormal muscle tone, posture alignment, balance, and gait. Therefore, the aim of this study was to investigate the efficacy of TheraTogs orthotic undergarment on gait pattern in children with dyskinetic cerebral palsy. Thirty children with dyskinetic cerebral palsy were selected for this randomized controlled study. They were randomly assigned to (1) an experimental group that received TheraTogs orthotic undergarment (12 h/day, 3 days/week) plus traditional physical therapy for 3 successive months and (2) a control group that received only traditional physical therapy program for the same time period. Gait parameters were measured at baseline and after 3 months of intervention using Pro-Reflex motion analysis. Results Children in both groups showed significant improvements in the gait parameters (P < 0.05), with significantly greater improvements in the experimental group than in the control group. Conclusions The use of TheraTogs may have a positive effect to improve gait pattern in children with dyskinetic cerebral palsy. Trial registration This trial was registered in the ClinicalTrial.gov PRS (NCT03037697).

Patterns of non-cigarette tobacco and nicotine use among current cigarette smokers and recent quitters: Findings from the 2020 ITC Four Country Smoking and Vaping Survey

2021 ◽  
Author(s):  
Lin Li ◽  
Ron Borland ◽  
K Michael Cummings ◽  
Shannon Gravely ◽  
Anne C K Quah ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Cigarette Smoking ◽  
Smoking Status ◽  
Tobacco Product ◽  
Cigarette Tobacco ◽  
Cigarette Smokers ◽  
Tobacco Products ◽  
Patterns Of Use ◽  
Levels Of Use ◽  
Current Cigarette

Abstract Introduction This study explores patterns of use of non-cigarette tobacco and nicotine products among adult cigarette smokers and recent ex-smokers. Along with cigarette smoking status we explore differences as a function of countries with different product regulations, gender and age. Methods Data came from the ITC Four Country Smoking and Vaping Wave 3 Survey conducted between February-June 2020. The analytic sample consisted of 9112 current cigarette smokers (at least monthly) and 1184 recent ex-smokers (quit cigarettes ≤ 2 years) from Australia, Canada, England, and the US. Respondents were asked about their cigarette smoking and current use of the following non-cigarette products: combustible tobacco (cigars, cigarillos, pipe, waterpipe); non-combustible tobacco (smokeless tobacco, and heated tobacco products (HTPs)); and non-tobacco nicotine products (nicotine vaping products (NVPs), nicotine replacement therapy (NRT), and nicotine pouches)). Results Overall, NVPs (13.7%) and NRT (10.9%) were the most reported nicotine products used, followed by cigars (5.3%), cigarillos (4.2%), and HTPs (3.5%). More than 21% current and recent ex-smokers of cigarettes reported using a non-tobacco nicotine product and non-combustible product, with respondents in England reporting the highest levels of use (&gt;26%). Males, younger respondents, and current non-daily cigarette smokers were more likely to use non-cigarette nicotine products. Notably, 11.6% of ex-cigarette smokers were using other combustible tobacco. Conclusion Considerable percentages of current cigarette smokers and ex-smokers use non-cigarette nicotine products, and there are unexpectedly high levels of use of other combustible products by those recent ex-smokers of cigarettes which is concerning and has important implications for definitions of smoking cessation. Implications The tobacco product market has evolved to include new products which add to existing non-cigarette tobacco products creating a much more diverse nicotine market. This brief report provides a snapshot of use of various combustible and non-combustible nicotine containing products among current cigarette smokers and recent ex-smokers in four western countries. Our results indicate that use of non-cigarette tobacco and nicotine products among these cigarette smokers and recent ex-smokers is not low, particularly among males, younger and non-daily cigarette smokers. Use of other combustible tobacco among respondents that recently quit cigarette smoking is concerning and has important implications for definitions of smoking cessation. Increased emphasis on researching non-cigarette nicotine product use is warranted in tobacco control generally and smoking cessation in particular.

scholarly journals The effect of therapeutic listening on anxiety and fear among surgical patients: randomized controlled trial

2018 ◽  
Vol 26 (0) ◽  
Author(s):  
Ana Cláudia Mesquita Garcia ◽  
Talita Prado Simão-Miranda ◽  
Ana Maria Pimenta Carvalho ◽  
Paula Condé Lamparelli Elias ◽  
Maria da Graça Pereira ◽  
...  
Keyword(s):  
Heart Rate ◽  
Randomized Controlled Trial ◽  
State Anxiety ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Clinical Trial Registration ◽  
Physiological Variables ◽  
Randomized Controlled ◽  
Therapeutic Listening

ABSTRACT Objective: To investigate the effect of therapeutic listening on state anxiety and surgical fears in preoperative colorectal cancer patients. Method: A randomized controlled trial with 50 patients randomly allocated in the intervention group (therapeutic listening) (n = 25) or in the control group (n = 25). The study evaluated the changes in the variables state anxiety, surgical fears and physiological variables (salivary alpha-amylase, salivary cortisol, heart rate, respiratory rate and blood pressure). Results: In the comparison of the variables in the control and intervention groups in pre- and post-intervention, differences between the two periods for the variables cortisol (p=0.043), heart rate (p=0.034) and surgical fears (p=0.030) were found in the control group, which presented reduction in the values of these variables. Conclusion: There was no reduction in the levels of the variables state anxiety and surgical fears resulting from the therapeutic listening intervention, either through the physiological or psychological indicators. However, the contact with the researcher during data collection, without stimulus to reflect on the situation, may have generated the results of the control group. Clinical Trial Registration: NCT02455128.

scholarly journals Biofeedback Intervention for Stress and Anxiety among Nursing Students: A Randomized Controlled Trial

ISRN Nursing ◽  
2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
Paul Ratanasiripong ◽  
Nop Ratanasiripong ◽  
Duangrat Kathalae
Keyword(s):  
Nursing Students ◽  
Stress Level ◽  
Clinical Training ◽  
Intervention Program ◽  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Moderate Increase ◽  
Randomized Controlled ◽  
The Impact

Purpose. It has been well documented that nursing students across the world experience stress and anxiety throughout their education and training. The purpose of this randomized controlled study is to investigate the impact of biofeedback intervention program on nursing students' levels of stress and anxiety during their first clinical training. Methods. Participants consisted of 60 second-year baccalaureate nursing students. The 30 participants in the biofeedback group received training on how to use the biofeedback device to assist in stress and anxiety management for 5 weeks while the 30 in the control group did not receive any training. Findings. Results indicated that the biofeedback group was able to maintain the stress level while the control group had a significant increase in the stress level over the 5-week period of clinical training. Additionally, the biofeedback group had a significant reduction in anxiety, while the control group had a moderate increase in anxiety. Conclusions. The better the nursing students can manage their stress and anxiety, the more successful they can be in their clinical training. Ultimately, the more psychologically healthy the nursing students are, the more likely they will flourish and graduate to become productive and contributing members of the nursing profession.

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