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Christopher Proctor - One of the best experts on this subject based on the ideXlab platform.
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Statistical analysis plan for "A randomised, controlled study to evaluate the Effects of switching from cigarette smoking to using a tobacco heating product on Health Effect indicators in Healthy subjects".
Contemporary clinical trials communications, 2020Co-Authors: Oscar M. Camacho, Andrew Hedge, Frazer Lowe, Nik Newland, Nathan Gale, Mike Mcewan, Christopher ProctorAbstract:Abstract Tobacco harm reduction strategies aim to substitute smoking with potentially reduced risk products (PRRPs) such as e-cigarettes and tobacco-heating products (THPs). The Health benefits of switching from smoking to PRRPs is unknown. A randomised controlled trial is being conducted to increase understanding of the Health Effects of switching from smoking to a THP in a 12-month long ambulatory study (ISRCTN81075760). Here we describe the study endpoints and the statistical analysis plan. Endpoints are divided into biomarkers of exposure (BoE) to tobacco smoke constituents and Health Effect indicators related to risk of lung cancer, cardiovascular and obstructive lung disease. These have been selected on the basis of extensive literature evidence. Three primary endpoints, augmentation index (risk factor for cardiovascular disease), total NNAL (linked to lung cancer) and 8-Epi-PGF2α type III (indicator of oxidative stress linked to various diseases), and multiple secondary endpoints will be analysed at 90, 180, and 360 days. Changes from baseline will be compared between study arms by specific contrasts in mixed models. Study wise multiple comparisons adjustments will be performed to account for multiplicity of timepoints and comparisons within timepoints. Generalisability of outcomes will be tested by a sensitivity analysis adjusting for age and gender. Importantly, an ancillary analysis will be performed to assess product compliance during the study based on plasma levels of CEVal, a surrogate marker for acrylonitrile exposure. The rationale underlying the selection of BoEs and Health Effect indicators, coupled with the statistical analysis plan will be central to understanding the potential Health Effects of replacing smoking with THP use for one year.
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Evaluating the Effects of switching from cigarette smoking to using a heated tobacco product on Health Effect indicators in Healthy subjects: study protocol for a randomized controlled trial
Internal and Emergency Medicine, 2019Co-Authors: Nik Newland, Oscar M. Camacho, Nathan Gale, Mike Mcewan, James Ebajemito, George Hardie, James Murphy, Frazer John Lowe, Christopher ProctorAbstract:Tobacco heating products (THPs) are a potentially safer alternative to combustible cigarette smoking. Through continued use, THPs may reduce smoking-related disease risk, whilst maintaining the sensorial experience and nicotine delivery sought by smokers. While literature evidence of the biological Effects of THP aerosol exposure is increasing, there remains a knowledge gap with respect to substantiation of THP reduced risk potential in longer term real-life use. This randomized, multi-centre, controlled clinical study will test the hypotheses that following a switch from combustible cigarettes to a THP for 1 year, participants will experience a sustained reduction in exposure to tobacco-related toxicants that will lead to favourable changes in Health Effect indicators associated with smoking-related disease development. Changes in such indicators will be contextualized against smoking cessation and never-smoker cohorts. Up to 280 participants who do not intend to quit smoking will be randomized to continued combustible smoking (arm A, up to n = 80) or a commercially available THP (arm B n = 200). Furthermore, up to 190 participants with a high intent to quit smoking will undergo smoking cessation (arm D), and 40 never smokers will serve as a control group (arm E). Recruitment numbers were determined to be sufficient to achieve n = 50 in arms A, B and D, at study end. Enrolment started in March 2018 and the trial is scheduled to be completed in March 2020. Data from this study will be a valuable addition to the growing body of evidence in the field of understanding the individual and public Health impact of THPs. Clinical Trial Registration: https://www.isrctn.com/ISRCTN81075760
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Evaluating the Effects of switching from cigarette smoking to using a heated tobacco product on Health Effect indicators in Healthy subjects: study protocol for a randomized controlled trial.
Internal and Emergency Medicine, 2019Co-Authors: Nik Newland, Oscar M. Camacho, Frazer Lowe, Nathan Gale, Mike Mcewan, James Ebajemito, George Hardie, James Murphy, Christopher ProctorAbstract:Tobacco heating products (THPs) are a potentially safer alternative to combustible cigarette smoking. Through continued use, THPs may reduce smoking-related disease risk, whilst maintaining the sensorial experience and nicotine delivery sought by smokers. While literature evidence of the biological Effects of THP aerosol exposure is increasing, there remains a knowledge gap with respect to substantiation of THP reduced risk potential in longer term real-life use. This randomized, multi-centre, controlled clinical study will test the hypotheses that following a switch from combustible cigarettes to a THP for 1 year, participants will experience a sustained reduction in exposure to tobacco-related toxicants that will lead to favourable changes in Health Effect indicators associated with smoking-related disease development. Changes in such indicators will be contextualized against smoking cessation and never-smoker cohorts. Up to 280 participants who do not intend to quit smoking will be randomized to continued combustible smoking (arm A, up to n = 80) or a commercially available THP (arm B n = 200). Furthermore, up to 190 participants with a high intent to quit smoking will undergo smoking cessation (arm D), and 40 never smokers will serve as a control group (arm E). Recruitment numbers were determined to be sufficient to achieve n = 50 in arms A, B and D, at study end. Enrolment started in March 2018 and the trial is scheduled to be completed in March 2020. Data from this study will be a valuable addition to the growing body of evidence in the field of understanding the individual and public Health impact of THPs.
Ananda S Prasad - One of the best experts on this subject based on the ideXlab platform.
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zinc in human Health Effect of zinc on immune cells
Molecular Medicine, 2008Co-Authors: Ananda S PrasadAbstract:Although the essentiality of zinc for plants and animals has been known for many decades, the essentiality of zinc for humans was recognized only 40 years ago in the Middle East. The zinc-deficient patients had severe immune dysfunctions, inasmuch as they died of intercurrent infections by the time they were 25 years of age. In our studies in an experimental human model of zinc deficiency, we documented decreased serum testosterone level, oligospermia, severe immune dysfunctions mainly affecting T helper cells, hyperammonemia, neurosensory disorders, and decreased lean body mass. It appears that zinc deficiency is prevalent in the developing world and as many as two billion subjects may be growth retarded due to zinc deficiency. Besides growth retardation and immune dysfunctions, cognitive impairment due to zinc deficiency also has been reported recently. Our studies in the cell culture models showed that the activation of many zinc-dependent enzymes and transcription factors were adversely affected due to zinc deficiency. In HUT-78 (T helper 0 (Th0) cell line), we showed that a decrease in gene expression of interleukin-2 (IL-2) and IL-2 receptor α (IL-2Rα) were due to decreased activation of nuclear factor-κB (NF-κB) in zinc deficient cells. Decreased NF-κB activation in HUT-78 due to zinc deficiency was due to decreased binding of NF-κB to DNA, decreased level of NF-κB p105 (the precursor of NF-κB p50) mRNA, decreased κB inhibitory protein (IκB) phosphorylation, and decreased Iκκ. These Effects of zinc were cell specific. Zinc also is an antioxidant and has anti-inflammatory actions. The therapeutic roles of zinc in acute infantile diarrhea, acrodermatitis enteropathica, prevention of blindness in patients with age-related macular degeneration, and treatment of common cold with zinc have been reported. In HL-60 cells (promyelocytic leukemia cell line), zinc enhances the up-regulation of A20 mRNA, which, via TRAF pathway, decreases NF-κB activation, leading to decreased gene expression and generation of tumor necrosis factor-α (TNF-α), IL-1β, and IL-8. We have reported recently that in both young adults and elderly subjects, zinc supplementation decreased oxidative stress markers and generation of inflammatory cytokines.
Nik Newland - One of the best experts on this subject based on the ideXlab platform.
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Statistical analysis plan for "A randomised, controlled study to evaluate the Effects of switching from cigarette smoking to using a tobacco heating product on Health Effect indicators in Healthy subjects".
Contemporary clinical trials communications, 2020Co-Authors: Oscar M. Camacho, Andrew Hedge, Frazer Lowe, Nik Newland, Nathan Gale, Mike Mcewan, Christopher ProctorAbstract:Abstract Tobacco harm reduction strategies aim to substitute smoking with potentially reduced risk products (PRRPs) such as e-cigarettes and tobacco-heating products (THPs). The Health benefits of switching from smoking to PRRPs is unknown. A randomised controlled trial is being conducted to increase understanding of the Health Effects of switching from smoking to a THP in a 12-month long ambulatory study (ISRCTN81075760). Here we describe the study endpoints and the statistical analysis plan. Endpoints are divided into biomarkers of exposure (BoE) to tobacco smoke constituents and Health Effect indicators related to risk of lung cancer, cardiovascular and obstructive lung disease. These have been selected on the basis of extensive literature evidence. Three primary endpoints, augmentation index (risk factor for cardiovascular disease), total NNAL (linked to lung cancer) and 8-Epi-PGF2α type III (indicator of oxidative stress linked to various diseases), and multiple secondary endpoints will be analysed at 90, 180, and 360 days. Changes from baseline will be compared between study arms by specific contrasts in mixed models. Study wise multiple comparisons adjustments will be performed to account for multiplicity of timepoints and comparisons within timepoints. Generalisability of outcomes will be tested by a sensitivity analysis adjusting for age and gender. Importantly, an ancillary analysis will be performed to assess product compliance during the study based on plasma levels of CEVal, a surrogate marker for acrylonitrile exposure. The rationale underlying the selection of BoEs and Health Effect indicators, coupled with the statistical analysis plan will be central to understanding the potential Health Effects of replacing smoking with THP use for one year.
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Evaluating the Effects of switching from cigarette smoking to using a heated tobacco product on Health Effect indicators in Healthy subjects: study protocol for a randomized controlled trial
Internal and Emergency Medicine, 2019Co-Authors: Nik Newland, Oscar M. Camacho, Nathan Gale, Mike Mcewan, James Ebajemito, George Hardie, James Murphy, Frazer John Lowe, Christopher ProctorAbstract:Tobacco heating products (THPs) are a potentially safer alternative to combustible cigarette smoking. Through continued use, THPs may reduce smoking-related disease risk, whilst maintaining the sensorial experience and nicotine delivery sought by smokers. While literature evidence of the biological Effects of THP aerosol exposure is increasing, there remains a knowledge gap with respect to substantiation of THP reduced risk potential in longer term real-life use. This randomized, multi-centre, controlled clinical study will test the hypotheses that following a switch from combustible cigarettes to a THP for 1 year, participants will experience a sustained reduction in exposure to tobacco-related toxicants that will lead to favourable changes in Health Effect indicators associated with smoking-related disease development. Changes in such indicators will be contextualized against smoking cessation and never-smoker cohorts. Up to 280 participants who do not intend to quit smoking will be randomized to continued combustible smoking (arm A, up to n = 80) or a commercially available THP (arm B n = 200). Furthermore, up to 190 participants with a high intent to quit smoking will undergo smoking cessation (arm D), and 40 never smokers will serve as a control group (arm E). Recruitment numbers were determined to be sufficient to achieve n = 50 in arms A, B and D, at study end. Enrolment started in March 2018 and the trial is scheduled to be completed in March 2020. Data from this study will be a valuable addition to the growing body of evidence in the field of understanding the individual and public Health impact of THPs. Clinical Trial Registration: https://www.isrctn.com/ISRCTN81075760
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Evaluating the Effects of switching from cigarette smoking to using a heated tobacco product on Health Effect indicators in Healthy subjects: study protocol for a randomized controlled trial.
Internal and Emergency Medicine, 2019Co-Authors: Nik Newland, Oscar M. Camacho, Frazer Lowe, Nathan Gale, Mike Mcewan, James Ebajemito, George Hardie, James Murphy, Christopher ProctorAbstract:Tobacco heating products (THPs) are a potentially safer alternative to combustible cigarette smoking. Through continued use, THPs may reduce smoking-related disease risk, whilst maintaining the sensorial experience and nicotine delivery sought by smokers. While literature evidence of the biological Effects of THP aerosol exposure is increasing, there remains a knowledge gap with respect to substantiation of THP reduced risk potential in longer term real-life use. This randomized, multi-centre, controlled clinical study will test the hypotheses that following a switch from combustible cigarettes to a THP for 1 year, participants will experience a sustained reduction in exposure to tobacco-related toxicants that will lead to favourable changes in Health Effect indicators associated with smoking-related disease development. Changes in such indicators will be contextualized against smoking cessation and never-smoker cohorts. Up to 280 participants who do not intend to quit smoking will be randomized to continued combustible smoking (arm A, up to n = 80) or a commercially available THP (arm B n = 200). Furthermore, up to 190 participants with a high intent to quit smoking will undergo smoking cessation (arm D), and 40 never smokers will serve as a control group (arm E). Recruitment numbers were determined to be sufficient to achieve n = 50 in arms A, B and D, at study end. Enrolment started in March 2018 and the trial is scheduled to be completed in March 2020. Data from this study will be a valuable addition to the growing body of evidence in the field of understanding the individual and public Health impact of THPs.
Michael Mckee - One of the best experts on this subject based on the ideXlab platform.
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the public Health Effect of economic crises and alternative policy responses in europe an empirical analysis
The Lancet, 2009Co-Authors: David Stuckler, Sanjay Basu, Marc Suhrcke, Adam Coutts, Michael MckeeAbstract:Summary Background There is widespread concern that the present economic crisis, particularly its Effect on unemployment, will adversely affect population Health. We investigated how economic changes have affected mortality rates over the past three decades and identified how governments might reduce adverse Effects. Methods We used multivariate regression, correcting for population ageing, past mortality and employment trends, and country-specific differences in Health-care infrastructure, to examine associations between changes in employment and mortality, and how associations were modified by different types of government expenditure for 26 European Union (EU) countries between 1970 and 2007. Findings We noted that every 1% increase in unemployment was associated with a 0·79% rise in suicides at ages younger than 65 years (95% CI 0·16–1·42; 60–550 potential excess deaths [mean 310] EU-wide), although the Effect size was non-significant at all ages (0·49%, −0·04 to 1·02), and with a 0·79% rise in homicides (95% CI 0·06–1·52; 3–80 potential excess deaths [mean 40] EU-wide). By contrast, road-traffic deaths decreased by 1·39% (0·64–2·14; 290–980 potential fewer deaths [mean 630] EU-wide). A more than 3% increase in unemployment had a greater Effect on suicides at ages younger than 65 years (4·45%, 95% CI 0·65–8·24; 250–3220 potential excess deaths [mean 1740] EU-wide) and deaths from alcohol abuse (28·0%, 12·30–43·70; 1550–5490 potential excess deaths [mean 3500] EU-wide). We noted no consistent evidence across the EU that all-cause mortality rates increased when unemployment rose, although populations varied substantially in how sensitive mortality was to economic crises, depending partly on differences in social protection. Every US$10 per person increased investment in active labour market programmes reduced the Effect of unemployment on suicides by 0·038% (95% CI −0·004 to −0·071). Interpretation Rises in unemployment are associated with significant short-term increases in premature deaths from intentional violence, while reducing traffic fatalities. Active labour market programmes that keep and reintegrate workers in jobs could mitigate some adverse Health Effects of economic downturns. Funding Centre for Crime and Justice Studies, King's College, London, UK; and Wates Foundation (UK).
Oscar M. Camacho - One of the best experts on this subject based on the ideXlab platform.
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Statistical analysis plan for "A randomised, controlled study to evaluate the Effects of switching from cigarette smoking to using a tobacco heating product on Health Effect indicators in Healthy subjects".
Contemporary clinical trials communications, 2020Co-Authors: Oscar M. Camacho, Andrew Hedge, Frazer Lowe, Nik Newland, Nathan Gale, Mike Mcewan, Christopher ProctorAbstract:Abstract Tobacco harm reduction strategies aim to substitute smoking with potentially reduced risk products (PRRPs) such as e-cigarettes and tobacco-heating products (THPs). The Health benefits of switching from smoking to PRRPs is unknown. A randomised controlled trial is being conducted to increase understanding of the Health Effects of switching from smoking to a THP in a 12-month long ambulatory study (ISRCTN81075760). Here we describe the study endpoints and the statistical analysis plan. Endpoints are divided into biomarkers of exposure (BoE) to tobacco smoke constituents and Health Effect indicators related to risk of lung cancer, cardiovascular and obstructive lung disease. These have been selected on the basis of extensive literature evidence. Three primary endpoints, augmentation index (risk factor for cardiovascular disease), total NNAL (linked to lung cancer) and 8-Epi-PGF2α type III (indicator of oxidative stress linked to various diseases), and multiple secondary endpoints will be analysed at 90, 180, and 360 days. Changes from baseline will be compared between study arms by specific contrasts in mixed models. Study wise multiple comparisons adjustments will be performed to account for multiplicity of timepoints and comparisons within timepoints. Generalisability of outcomes will be tested by a sensitivity analysis adjusting for age and gender. Importantly, an ancillary analysis will be performed to assess product compliance during the study based on plasma levels of CEVal, a surrogate marker for acrylonitrile exposure. The rationale underlying the selection of BoEs and Health Effect indicators, coupled with the statistical analysis plan will be central to understanding the potential Health Effects of replacing smoking with THP use for one year.
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Evaluating the Effects of switching from cigarette smoking to using a heated tobacco product on Health Effect indicators in Healthy subjects: study protocol for a randomized controlled trial
Internal and Emergency Medicine, 2019Co-Authors: Nik Newland, Oscar M. Camacho, Nathan Gale, Mike Mcewan, James Ebajemito, George Hardie, James Murphy, Frazer John Lowe, Christopher ProctorAbstract:Tobacco heating products (THPs) are a potentially safer alternative to combustible cigarette smoking. Through continued use, THPs may reduce smoking-related disease risk, whilst maintaining the sensorial experience and nicotine delivery sought by smokers. While literature evidence of the biological Effects of THP aerosol exposure is increasing, there remains a knowledge gap with respect to substantiation of THP reduced risk potential in longer term real-life use. This randomized, multi-centre, controlled clinical study will test the hypotheses that following a switch from combustible cigarettes to a THP for 1 year, participants will experience a sustained reduction in exposure to tobacco-related toxicants that will lead to favourable changes in Health Effect indicators associated with smoking-related disease development. Changes in such indicators will be contextualized against smoking cessation and never-smoker cohorts. Up to 280 participants who do not intend to quit smoking will be randomized to continued combustible smoking (arm A, up to n = 80) or a commercially available THP (arm B n = 200). Furthermore, up to 190 participants with a high intent to quit smoking will undergo smoking cessation (arm D), and 40 never smokers will serve as a control group (arm E). Recruitment numbers were determined to be sufficient to achieve n = 50 in arms A, B and D, at study end. Enrolment started in March 2018 and the trial is scheduled to be completed in March 2020. Data from this study will be a valuable addition to the growing body of evidence in the field of understanding the individual and public Health impact of THPs. Clinical Trial Registration: https://www.isrctn.com/ISRCTN81075760
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Evaluating the Effects of switching from cigarette smoking to using a heated tobacco product on Health Effect indicators in Healthy subjects: study protocol for a randomized controlled trial.
Internal and Emergency Medicine, 2019Co-Authors: Nik Newland, Oscar M. Camacho, Frazer Lowe, Nathan Gale, Mike Mcewan, James Ebajemito, George Hardie, James Murphy, Christopher ProctorAbstract:Tobacco heating products (THPs) are a potentially safer alternative to combustible cigarette smoking. Through continued use, THPs may reduce smoking-related disease risk, whilst maintaining the sensorial experience and nicotine delivery sought by smokers. While literature evidence of the biological Effects of THP aerosol exposure is increasing, there remains a knowledge gap with respect to substantiation of THP reduced risk potential in longer term real-life use. This randomized, multi-centre, controlled clinical study will test the hypotheses that following a switch from combustible cigarettes to a THP for 1 year, participants will experience a sustained reduction in exposure to tobacco-related toxicants that will lead to favourable changes in Health Effect indicators associated with smoking-related disease development. Changes in such indicators will be contextualized against smoking cessation and never-smoker cohorts. Up to 280 participants who do not intend to quit smoking will be randomized to continued combustible smoking (arm A, up to n = 80) or a commercially available THP (arm B n = 200). Furthermore, up to 190 participants with a high intent to quit smoking will undergo smoking cessation (arm D), and 40 never smokers will serve as a control group (arm E). Recruitment numbers were determined to be sufficient to achieve n = 50 in arms A, B and D, at study end. Enrolment started in March 2018 and the trial is scheduled to be completed in March 2020. Data from this study will be a valuable addition to the growing body of evidence in the field of understanding the individual and public Health impact of THPs.
