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overflow: hidden; text-overflow: ellipsis; -webkit-line-clamp: 3; -webkit-box-orient: vertical; }</style><div class="col-xs-12 clearfix"><div class="u-floatLeft"><h1 class="PageHeader-title u-m0x u-fs30">Clinical Trials</h1><div class="u-tcGrayDark">16,142 Followers</div><div class="u-tcGrayDark u-mt2x">Recent papers in <b>Clinical Trials</b></div></div></div></div></div></div><div class="TabbedNavigation"><div class="container"><div class="row"><div class="col-xs-12 clearfix"><ul class="nav u-m0x u-p0x list-inline u-displayFlex"><li class="active"><a href="https://www.academia.edu/Documents/in/Clinical_Trials">Top Papers</a></li><li><a href="https://www.academia.edu/Documents/in/Clinical_Trials/MostCited">Most Cited Papers</a></li><li><a href="https://www.academia.edu/Documents/in/Clinical_Trials/MostDownloaded">Most Downloaded Papers</a></li><li><a href="https://www.academia.edu/Documents/in/Clinical_Trials/MostRecent">Newest Papers</a></li><li><a class="" href="https://www.academia.edu/People/Clinical_Trials">People</a></li></ul></div><style type="text/css">ul.nav{flex-direction:row}@media(max-width: 567px){ul.nav{flex-direction:column}.TabbedNavigation li{max-width:100%}.TabbedNavigation li.active{background-color:var(--background-grey, #dddde2)}.TabbedNavigation li.active:before,.TabbedNavigation li.active:after{display:none}}</style></div></div></div><div class="container"><div class="row"><div class="col-xs-12"><div class="u-displayFlex"><div class="u-flexGrow1"><div class="works"><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_40588958" data-work_id="40588958" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/40588958/Caffeic_acid_phenethyl_ester_CAPE_pharmacodynamics_and_potential_for_therapeutic_application">Caffeic acid phenethyl ester (CAPE): pharmacodynamics and potential for therapeutic application</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Caffeic acid phenethyl ester (CAPE) is the major pharmacologically-active component of some propolis types, rich in polyphenols, such as poplar propolis types. CAPE has the potential to be applied as a pharmaceutical as it possesses most... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_40588958" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Caffeic acid phenethyl ester (CAPE) is the major pharmacologically-active component of some propolis types, rich in polyphenols, such as poplar propolis types. CAPE has the potential to be applied as a pharmaceutical as it possesses most of the pharmacological activities of propolis, such as anti-proliferative, antioxidant, immunomodulatory, antidiabetic, anti-inflammatory and antimicrobial. Its advantage is that it lacks some of the downsides of total propolis extracts, such as inability for unified standardization, which is cornerstone for implementing its therapeutic potential as a drug. The current paper provides an overview on the pharmacodynamic principles of CAPE. We present literature search outcomes form ClinicalTrials.gov database and from scientific publications, available on Scopus and Crossref databases. We take a round view of CAPE’s potential therapeutic implications in light of approved drugs with related modes of action.</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/40588958" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="db1af41bb2a0a8125216eedb8d06bedf" rel="nofollow" data-download="{"attachment_id":60868889,"asset_id":40588958,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/60868889/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="18371458" href="https://mu-sofia.academia.edu/YordanYordanov">Yordan Yordanov</a><script data-card-contents-for-user="18371458" type="text/json">{"id":18371458,"first_name":"Yordan","last_name":"Yordanov","domain_name":"mu-sofia","page_name":"YordanYordanov","display_name":"Yordan Yordanov","profile_url":"https://mu-sofia.academia.edu/YordanYordanov?f_ri=4387","photo":"https://0.academia-photos.com/18371458/5132614/5881022/s65_yordan.yordanov.jpg_oh_b3f07063057f8b9c09c35c26d324dbb5_oe_54c34262___gda___1420717300_b575bbb8df748b62f3cc570854fb0bd3"}</script></span></span></li><li class="js-paper-rank-work_40588958 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="40588958"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 40588958, container: ".js-paper-rank-work_40588958", }); 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CAPE has the potential to be applied as a pharmaceutical as it possesses most of the pharmacological activities of propolis, such as anti-proliferative, antioxidant, immunomodulatory, antidiabetic, anti-inflammatory and antimicrobial. Its advantage is that it lacks some of the downsides of total propolis extracts, such as inability for unified standardization, which is cornerstone for implementing its therapeutic potential as a drug. The current paper provides an overview on the pharmacodynamic principles of CAPE. We present literature search outcomes form ClinicalTrials.gov database and from scientific publications, available on Scopus and Crossref databases. We take a round view of CAPE’s potential therapeutic implications in light of approved drugs with related modes of action.","downloadable_attachments":[{"id":60868889,"asset_id":40588958,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":18371458,"first_name":"Yordan","last_name":"Yordanov","domain_name":"mu-sofia","page_name":"YordanYordanov","display_name":"Yordan Yordanov","profile_url":"https://mu-sofia.academia.edu/YordanYordanov?f_ri=4387","photo":"https://0.academia-photos.com/18371458/5132614/5881022/s65_yordan.yordanov.jpg_oh_b3f07063057f8b9c09c35c26d324dbb5_oe_54c34262___gda___1420717300_b575bbb8df748b62f3cc570854fb0bd3"}],"research_interests":[{"id":140,"name":"Pharmacology","url":"https://www.academia.edu/Documents/in/Pharmacology?f_ri=4387","nofollow":true},{"id":1290,"name":"Immunology","url":"https://www.academia.edu/Documents/in/Immunology?f_ri=4387","nofollow":true},{"id":2168,"name":"Natural 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u-mb0x js-work-card work_30880079" data-work_id="30880079" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/30880079/Bridging_the_Cultural_Gap_between_Eastern_and_Western_Thinking_From_an_Occupational_Therapy_Perspective">Bridging the Cultural Gap between Eastern and Western Thinking: From an Occupational Therapy Perspective</a></div></div><div class="u-pb4x u-mt3x"></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/30880079" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li 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js-work-card work_65149212" data-work_id="65149212" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/65149212/A_quasi_experimental_study_on_exploring_the_use_of_mobile_phone_technology_for_optimizing_tracking_and_responding_to_childrens_developmental_progress_in_Korogocho_Nairobi_Kenya_study_protocol">A quasi-experimental study on exploring the use of mobile phone technology for optimizing, tracking and responding to children's developmental progress in Korogocho, Nairobi, Kenya: study protocol</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Background: The massive use of technology can be leveraged to facilitate access to growth and development programs for children. Existing programs supporting such initiatives for children younger than three years are inadequate and not... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_65149212" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Background: The massive use of technology can be leveraged to facilitate access to growth and development programs for children. Existing programs supporting such initiatives for children younger than three years are inadequate and not accessible to most families. In most cases, primary caregivers are unable to identify delayed milestones in their children’s growth and development due to inadequate information. They therefore often report the cases when they have become very severe and difficult to reverse. In order to promote early identification of possible developmental delays, African Population and Health Research Center together with Val Partners will develop, implement and evaluate the use of mobile phone technology to help caregivers track their children&#39;s developmental outcomes.Methods: The study will employ a quasi-experimental design and will use a mixed-methods approach combining quantitative and qualitative methodologies. In one arm, 110 caregivers will be trained o...</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/65149212" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="2755596345aa70d25f2851fb25b5addf" rel="nofollow" data-download="{"attachment_id":76869226,"asset_id":65149212,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/76869226/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="462989" href="https://independent.academia.edu/PatriciaKitsaoWekulo">Patricia Kitsao-Wekulo</a><script data-card-contents-for-user="462989" type="text/json">{"id":462989,"first_name":"Patricia","last_name":"Kitsao-Wekulo","domain_name":"independent","page_name":"PatriciaKitsaoWekulo","display_name":"Patricia Kitsao-Wekulo","profile_url":"https://independent.academia.edu/PatriciaKitsaoWekulo?f_ri=4387","photo":"/images/s65_no_pic.png"}</script></span></span></li><li class="js-paper-rank-work_65149212 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="65149212"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 65149212, container: ".js-paper-rank-work_65149212", }); 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$(".js-view-count[data-work-id=65149212]").text(description); $(".js-view-count-work_65149212").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_65149212").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="65149212"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i></div><span class="InlineList-item-text u-textTruncate u-pl6x"><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a><script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (false) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=65149212]'), work: {"id":65149212,"title":"A quasi-experimental study on exploring the use of mobile phone technology for optimizing, tracking and responding to children's developmental progress in Korogocho, Nairobi, Kenya: study protocol","created_at":"2021-12-19T20:45:17.195-08:00","url":"https://www.academia.edu/65149212/A_quasi_experimental_study_on_exploring_the_use_of_mobile_phone_technology_for_optimizing_tracking_and_responding_to_childrens_developmental_progress_in_Korogocho_Nairobi_Kenya_study_protocol?f_ri=4387","dom_id":"work_65149212","summary":"Background: The massive use of technology can be leveraged to facilitate access to growth and development programs for children. Existing programs supporting such initiatives for children younger than three years are inadequate and not accessible to most families. In most cases, primary caregivers are unable to identify delayed milestones in their children’s growth and development due to inadequate information. They therefore often report the cases when they have become very severe and difficult to reverse. In order to promote early identification of possible developmental delays, African Population and Health Research Center together with Val Partners will develop, implement and evaluate the use of mobile phone technology to help caregivers track their children\u0026#39;s developmental outcomes.Methods: The study will employ a quasi-experimental design and will use a mixed-methods approach combining quantitative and qualitative methodologies. In one arm, 110 caregivers will be trained o...","downloadable_attachments":[{"id":76869226,"asset_id":65149212,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":462989,"first_name":"Patricia","last_name":"Kitsao-Wekulo","domain_name":"independent","page_name":"PatriciaKitsaoWekulo","display_name":"Patricia Kitsao-Wekulo","profile_url":"https://independent.academia.edu/PatriciaKitsaoWekulo?f_ri=4387","photo":"/images/s65_no_pic.png"}],"research_interests":[{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_68291666" data-work_id="68291666" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/68291666/Spotlight_on_Clinical_Trial_Sponsorship">Spotlight on Clinical Trial Sponsorship</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">The Company as SponsorThe FDA regulations define &quot;sponsor&quot; asa person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency academic... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_68291666" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">The Company as SponsorThe FDA regulations define &quot;sponsor&quot; asa person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency academic institution, private organization, or other organization. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. A person other than an individual that uses one or more of its own employees to conduct an investigation that it has initiated is a sponsor, not a sponsor-investigator, and the employees are investigators. 21 CFR § 312.3(b) (2014)As this definition makes clear, there is a difference between sponsoring a trial and conducting a trial, and this distinction can impact the sponsor&#39;s responsibilities and liability. Further, an investigator can also operate as a sponsor, with all the attendant responsibilities, if they both initiate and conduct an investigation.2 Id. Sponsors are primarily respo...</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/68291666" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="168e0510145b986f5d375fc30d03b19a" rel="nofollow" data-download="{"attachment_id":78819196,"asset_id":68291666,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/78819196/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="3245308" href="https://washington.academia.edu/dougmounce">Doug Mounce</a><script data-card-contents-for-user="3245308" type="text/json">{"id":3245308,"first_name":"Doug","last_name":"Mounce","domain_name":"washington","page_name":"dougmounce","display_name":"Doug Mounce","profile_url":"https://washington.academia.edu/dougmounce?f_ri=4387","photo":"https://0.academia-photos.com/3245308/1071115/1336817/s65_doug.mounce.jpg"}</script></span></span></li><li class="js-paper-rank-work_68291666 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="68291666"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 68291666, container: ".js-paper-rank-work_68291666", }); });</script></li><li class="js-percentile-work_68291666 InlineList-item InlineList-item--bordered hidden u-tcGrayDark"><span class="percentile-widget hidden"><span class="u-mr2x percentile-widget" style="display: none">•</span><span class="u-mr2x work-percentile"></span></span><script>$(function () { var workId = 68291666; window.Academia.workPercentilesFetcher.queue(workId, function (percentileText) { var container = $(".js-percentile-work_68291666"); container.find('.work-percentile').text(percentileText.charAt(0).toUpperCase() + percentileText.slice(1)); container.find('.percentile-widget').show(); container.find('.percentile-widget').removeClass('hidden'); }); });</script></li><li class="js-view-count-work_68291666 InlineList-item InlineList-item--bordered hidden"><div><span><span class="js-view-count view-count u-mr2x" data-work-id="68291666"><i class="fa fa-spinner fa-spin"></i></span><script>$(function () { var workId = 68291666; window.Academia.workViewCountsFetcher.queue(workId, function (count) { var description = window.$h.commaizeInt(count) + " " + window.$h.pluralize(count, 'View'); $(".js-view-count[data-work-id=68291666]").text(description); $(".js-view-count-work_68291666").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_68291666").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="68291666"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">3</a>  </div><span class="InlineList-item-text u-textTruncate u-pl9x"><a class="InlineList-item-text" data-has-card-for-ri="26" rel="nofollow" href="https://www.academia.edu/Documents/in/Business">Business</a>, <script data-card-contents-for-ri="26" type="text/json">{"id":26,"name":"Business","url":"https://www.academia.edu/Documents/in/Business?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="23326" rel="nofollow" href="https://www.academia.edu/Documents/in/Administration">Administration</a><script data-card-contents-for-ri="23326" type="text/json">{"id":23326,"name":"Administration","url":"https://www.academia.edu/Documents/in/Administration?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=68291666]'), work: {"id":68291666,"title":"Spotlight on Clinical Trial Sponsorship","created_at":"2022-01-15T07:58:15.126-08:00","url":"https://www.academia.edu/68291666/Spotlight_on_Clinical_Trial_Sponsorship?f_ri=4387","dom_id":"work_68291666","summary":"The Company as SponsorThe FDA regulations define \u0026quot;sponsor\u0026quot; asa person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency academic institution, private organization, or other organization. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. A person other than an individual that uses one or more of its own employees to conduct an investigation that it has initiated is a sponsor, not a sponsor-investigator, and the employees are investigators. 21 CFR § 312.3(b) (2014)As this definition makes clear, there is a difference between sponsoring a trial and conducting a trial, and this distinction can impact the sponsor\u0026#39;s responsibilities and liability. Further, an investigator can also operate as a sponsor, with all the attendant responsibilities, if they both initiate and conduct an investigation.2 Id. Sponsors are primarily respo...","downloadable_attachments":[{"id":78819196,"asset_id":68291666,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":3245308,"first_name":"Doug","last_name":"Mounce","domain_name":"washington","page_name":"dougmounce","display_name":"Doug Mounce","profile_url":"https://washington.academia.edu/dougmounce?f_ri=4387","photo":"https://0.academia-photos.com/3245308/1071115/1336817/s65_doug.mounce.jpg"}],"research_interests":[{"id":26,"name":"Business","url":"https://www.academia.edu/Documents/in/Business?f_ri=4387","nofollow":true},{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":23326,"name":"Administration","url":"https://www.academia.edu/Documents/in/Administration?f_ri=4387","nofollow":true}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_63709767 coauthored" data-work_id="63709767" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/63709767/Effect_of_a_suite_of_aggression_management_modules_on_health_professions_student_knowledge_skills_and_confidence_an_investigator_blinded_parallel_group_randomised_controlled_trial_protocol">Effect of a suite of aggression management modules on health professions student knowledge, skills and confidence: an investigator-blinded, parallel-group randomised controlled trial protocol</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Background: Incidents of aggression are increasing in healthcare. Students are at higher risk of being on the receiving end of client aggression due to their lack of experience. Students also do not feel prepared to manage these... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_63709767" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Background: Incidents of aggression are increasing in healthcare. Students are at higher risk of being on the receiving end of client aggression due to their lack of experience. Students also do not feel prepared to manage these situations.Methods: Students of health professions in the School of Primary and Allied Health Care will be eligible and contacted within lectures/via the learning management system Moodle. A randomised controlled trial (RCT) will be conducted to evaluate a suite of online aggression management modules for health professions students prior to entering their clinical years of study. If students are able to undertake face to face simulations they will be assessed by academic staff members using the English modified de-escalating aggressive behaviour scale (EMDABS). Mock clients will assess the students using the consultation and relational empathy (CARE) measure. Students will complete a self-assessment using the confidence with coping with patient aggression i...</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/63709767" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="a3651203f9e71bc6206dfc5901b9f8bd" rel="nofollow" data-download="{"attachment_id":76048785,"asset_id":63709767,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/76048785/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="36315534" href="https://independent.academia.edu/KristinLo">Kristin Lo</a><script data-card-contents-for-user="36315534" type="text/json">{"id":36315534,"first_name":"Kristin","last_name":"Lo","domain_name":"independent","page_name":"KristinLo","display_name":"Kristin Lo","profile_url":"https://independent.academia.edu/KristinLo?f_ri=4387","photo":"/images/s65_no_pic.png"}</script></span></span><span class="u-displayInlineBlock InlineList-item-text"> and <span class="u-textDecorationUnderline u-clickable InlineList-item-text js-work-more-authors-63709767">+1</span><div class="hidden js-additional-users-63709767"><div><span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a href="https://monash.academia.edu/KatrinaRecoche">Katrina Recoche</a></span></div></div></span><script>(function(){ var popoverSettings = { el: $('.js-work-more-authors-63709767'), placement: 'bottom', hide_delay: 200, html: true, content: function(){ return $('.js-additional-users-63709767').html(); } } new HoverPopover(popoverSettings); })();</script></li><li class="js-paper-rank-work_63709767 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="63709767"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 63709767, container: ".js-paper-rank-work_63709767", }); });</script></li><li class="js-percentile-work_63709767 InlineList-item InlineList-item--bordered hidden u-tcGrayDark"><span class="percentile-widget hidden"><span class="u-mr2x percentile-widget" style="display: none">•</span><span class="u-mr2x work-percentile"></span></span><script>$(function () { var workId = 63709767; window.Academia.workPercentilesFetcher.queue(workId, function (percentileText) { var container = $(".js-percentile-work_63709767"); container.find('.work-percentile').text(percentileText.charAt(0).toUpperCase() + percentileText.slice(1)); container.find('.percentile-widget').show(); container.find('.percentile-widget').removeClass('hidden'); }); });</script></li><li class="js-view-count-work_63709767 InlineList-item InlineList-item--bordered hidden"><div><span><span class="js-view-count view-count u-mr2x" data-work-id="63709767"><i class="fa fa-spinner fa-spin"></i></span><script>$(function () { var workId = 63709767; window.Academia.workViewCountsFetcher.queue(workId, function (count) { var description = window.$h.commaizeInt(count) + " " + window.$h.pluralize(count, 'View'); $(".js-view-count[data-work-id=63709767]").text(description); $(".js-view-count-work_63709767").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_63709767").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="63709767"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i></div><span class="InlineList-item-text u-textTruncate u-pl6x"><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a><script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (false) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=63709767]'), work: {"id":63709767,"title":"Effect of a suite of aggression management modules on health professions student knowledge, skills and confidence: an investigator-blinded, parallel-group randomised controlled trial protocol","created_at":"2021-12-09T23:47:09.742-08:00","url":"https://www.academia.edu/63709767/Effect_of_a_suite_of_aggression_management_modules_on_health_professions_student_knowledge_skills_and_confidence_an_investigator_blinded_parallel_group_randomised_controlled_trial_protocol?f_ri=4387","dom_id":"work_63709767","summary":"Background: Incidents of aggression are increasing in healthcare. Students are at higher risk of being on the receiving end of client aggression due to their lack of experience. Students also do not feel prepared to manage these situations.Methods: Students of health professions in the School of Primary and Allied Health Care will be eligible and contacted within lectures/via the learning management system Moodle. A randomised controlled trial (RCT) will be conducted to evaluate a suite of online aggression management modules for health professions students prior to entering their clinical years of study. If students are able to undertake face to face simulations they will be assessed by academic staff members using the English modified de-escalating aggressive behaviour scale (EMDABS). Mock clients will assess the students using the consultation and relational empathy (CARE) measure. Students will complete a self-assessment using the confidence with coping with patient aggression i...","downloadable_attachments":[{"id":76048785,"asset_id":63709767,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":36315534,"first_name":"Kristin","last_name":"Lo","domain_name":"independent","page_name":"KristinLo","display_name":"Kristin Lo","profile_url":"https://independent.academia.edu/KristinLo?f_ri=4387","photo":"/images/s65_no_pic.png"},{"id":33990672,"first_name":"Katrina","last_name":"Recoche","domain_name":"monash","page_name":"KatrinaRecoche","display_name":"Katrina Recoche","profile_url":"https://monash.academia.edu/KatrinaRecoche?f_ri=4387","photo":"/images/s65_no_pic.png"}],"research_interests":[{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_11065454" data-work_id="11065454" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/11065454/The_PRIME_North_America_randomized_double_blind_clinical_trial_of_olanzapine_versus_placebo_in_patients_at_risk_of_being_prodromally_symptomatic_for_psychosis">The PRIME North America randomized double-blind clinical trial of olanzapine versus placebo in patients at risk of being prodromally symptomatic for psychosis</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">The first double-blind placebo-controlled clinical trial of an atypical neuroleptic medication is being conducted in symptomatic treatment-seeking patients meeting new diagnostic criteria for a putative prodromal syndrome. This identifies... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_11065454" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">The first double-blind placebo-controlled clinical trial of an atypical neuroleptic medication is being conducted in symptomatic treatment-seeking patients meeting new diagnostic criteria for a putative prodromal syndrome. This identifies them as being at high risk for developing psychosis in the near future. The study aims include prevention of psychosis onset and disability, as well as palliation of ongoing symptomatology.</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/11065454" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="00ec7fb3fb4913be6f8d026ba7f7acaf" rel="nofollow" data-download="{"attachment_id":46927748,"asset_id":11065454,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/46927748/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="26755260" href="https://uci.academia.edu/APreda">Adrian Preda</a><script data-card-contents-for-user="26755260" type="text/json">{"id":26755260,"first_name":"Adrian","last_name":"Preda","domain_name":"uci","page_name":"APreda","display_name":"Adrian Preda","profile_url":"https://uci.academia.edu/APreda?f_ri=4387","photo":"https://0.academia-photos.com/26755260/10816319/12072140/s65_adrian.preda.jpg"}</script></span></span></li><li class="js-paper-rank-work_11065454 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="11065454"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 11065454, container: ".js-paper-rank-work_11065454", }); 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$(".js-view-count[data-work-id=11065454]").text(description); $(".js-view-count-work_11065454").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_11065454").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="11065454"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">28</a>  </div><span class="InlineList-item-text u-textTruncate u-pl10x"><a class="InlineList-item-text" data-has-card-for-ri="1059" rel="nofollow" href="https://www.academia.edu/Documents/in/Early_Intervention">Early Intervention</a>, <script data-card-contents-for-ri="1059" type="text/json">{"id":1059,"name":"Early Intervention","url":"https://www.academia.edu/Documents/in/Early_Intervention?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="3227" rel="nofollow" href="https://www.academia.edu/Documents/in/Schizophrenia">Schizophrenia</a>, <script data-card-contents-for-ri="3227" type="text/json">{"id":3227,"name":"Schizophrenia","url":"https://www.academia.edu/Documents/in/Schizophrenia?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="3230" rel="nofollow" href="https://www.academia.edu/Documents/in/Bipolar_Disorder">Bipolar Disorder</a>, <script data-card-contents-for-ri="3230" type="text/json">{"id":3230,"name":"Bipolar Disorder","url":"https://www.academia.edu/Documents/in/Bipolar_Disorder?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a><script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=11065454]'), work: {"id":11065454,"title":"The PRIME North America randomized double-blind clinical trial of olanzapine versus placebo in patients at risk of being prodromally symptomatic for psychosis","created_at":"2015-02-24T20:10:29.933-08:00","url":"https://www.academia.edu/11065454/The_PRIME_North_America_randomized_double_blind_clinical_trial_of_olanzapine_versus_placebo_in_patients_at_risk_of_being_prodromally_symptomatic_for_psychosis?f_ri=4387","dom_id":"work_11065454","summary":"The first double-blind placebo-controlled clinical trial of an atypical neuroleptic medication is being conducted in symptomatic treatment-seeking patients meeting new diagnostic criteria for a putative prodromal syndrome. This identifies them as being at high risk for developing psychosis in the near future. The study aims include prevention of psychosis onset and disability, as well as palliation of ongoing symptomatology.","downloadable_attachments":[{"id":46927748,"asset_id":11065454,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":26755260,"first_name":"Adrian","last_name":"Preda","domain_name":"uci","page_name":"APreda","display_name":"Adrian Preda","profile_url":"https://uci.academia.edu/APreda?f_ri=4387","photo":"https://0.academia-photos.com/26755260/10816319/12072140/s65_adrian.preda.jpg"}],"research_interests":[{"id":1059,"name":"Early Intervention","url":"https://www.academia.edu/Documents/in/Early_Intervention?f_ri=4387","nofollow":true},{"id":3227,"name":"Schizophrenia","url":"https://www.academia.edu/Documents/in/Schizophrenia?f_ri=4387","nofollow":true},{"id":3230,"name":"Bipolar Disorder","url":"https://www.academia.edu/Documents/in/Bipolar_Disorder?f_ri=4387","nofollow":true},{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":4531,"name":"Clinical Trial","url":"https://www.academia.edu/Documents/in/Clinical_Trial?f_ri=4387"},{"id":18342,"name":"Speech Disorders","url":"https://www.academia.edu/Documents/in/Speech_Disorders?f_ri=4387"},{"id":22506,"name":"Adolescent","url":"https://www.academia.edu/Documents/in/Adolescent?f_ri=4387"},{"id":28973,"name":"Comorbidity","url":"https://www.academia.edu/Documents/in/Comorbidity?f_ri=4387"},{"id":62112,"name":"Prospective studies","url":"https://www.academia.edu/Documents/in/Prospective_studies?f_ri=4387"},{"id":64933,"name":"Child","url":"https://www.academia.edu/Documents/in/Child?f_ri=4387"},{"id":66110,"name":"Clinical research","url":"https://www.academia.edu/Documents/in/Clinical_research?f_ri=4387"},{"id":72353,"name":"Substance Use","url":"https://www.academia.edu/Documents/in/Substance_Use?f_ri=4387"},{"id":77794,"name":"Major Depressive Disorder","url":"https://www.academia.edu/Documents/in/Major_Depressive_Disorder?f_ri=4387"},{"id":100540,"name":"Feasibility Studies","url":"https://www.academia.edu/Documents/in/Feasibility_Studies?f_ri=4387"},{"id":106431,"name":"Sleep disorders","url":"https://www.academia.edu/Documents/in/Sleep_disorders?f_ri=4387"},{"id":116018,"name":"Prodromal Schizophrenia","url":"https://www.academia.edu/Documents/in/Prodromal_Schizophrenia?f_ri=4387"},{"id":133351,"name":"Benzodiazepines","url":"https://www.academia.edu/Documents/in/Benzodiazepines?f_ri=4387"},{"id":192721,"name":"Risk factors","url":"https://www.academia.edu/Documents/in/Risk_factors?f_ri=4387"},{"id":253469,"name":"North America","url":"https://www.academia.edu/Documents/in/North_America?f_ri=4387"},{"id":266030,"name":"Serious Mental Illness","url":"https://www.academia.edu/Documents/in/Serious_Mental_Illness?f_ri=4387"},{"id":284201,"name":"Mood Disorders","url":"https://www.academia.edu/Documents/in/Mood_Disorders?f_ri=4387"},{"id":538554,"name":"Study design","url":"https://www.academia.edu/Documents/in/Study_design?f_ri=4387"},{"id":584597,"name":"Controlled Clinical Trial","url":"https://www.academia.edu/Documents/in/Controlled_Clinical_Trial?f_ri=4387"},{"id":612870,"name":"Psychotic Disorders","url":"https://www.academia.edu/Documents/in/Psychotic_Disorders?f_ri=4387"},{"id":620049,"name":"Risk Factors","url":"https://www.academia.edu/Documents/in/Risk_Factors-1?f_ri=4387"},{"id":1112315,"name":"Psychomotor Disorders","url":"https://www.academia.edu/Documents/in/Psychomotor_Disorders?f_ri=4387"},{"id":1297868,"name":"Preventive Health Services","url":"https://www.academia.edu/Documents/in/Preventive_Health_Services?f_ri=4387"},{"id":2330264,"name":"Diagnostic Criteria","url":"https://www.academia.edu/Documents/in/Diagnostic_Criteria?f_ri=4387"}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_986781" data-work_id="986781" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/986781/Sensible_approaches_for_reducing_clinical_trial_costs">Sensible approaches for reducing clinical trial costs</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Background Over the past decade, annual funding for biomedical research has more than doubled while new molecular entity approvals have declined by one third. Objective To assess the value of practices commonly employed in the conduct of... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_986781" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Background Over the past decade, annual funding for biomedical research has more than doubled while new molecular entity approvals have declined by one third. Objective To assess the value of practices commonly employed in the conduct of large-scale clinical trials, and to identify areas where costs could be reduced without compromising scientific validity. Methods In the qualitative phase of the study, an expert panel recommended potential modifications of mega-trial designs and operations in order to maximize their value (cost versus scientific benefit tradeoff). In the quantitative phase, a mega-trial economic model was used to assess the financial implications of these recommendations. Our initial chronic disease trial design included 20,000 patients randomized at 1000 sites. Each site was assigned 24 monitoring visits and a $10,000 per patient site payment. The case report form (CRF) was 60 pages long, and trial duration was assumed to be 48 months. Results The total costs of the initial trial design were $421 million ($US 2007). Following the expert panel's recommendations, we varied study duration, CRF length, number of sites, electronic data capture (EDC), and site management components to determine their individual and combined effects upon total trial costs. The use of EDC and modified site management practices were associated with significant reductions in total trial costs. When reductions in all five trial components were combined in a streamlined pharmaceutical industry design, a 59% reduction in total trial costs resulted. When we assumed an even more streamlined trial design than has typically been considered for regulatory submissions in the past, there was a 90% reduction in total trial costs. Conclusion Our results suggest that it is possible to reduce substantially the cost of large-scale clinical trials without compromising the scientific validity of their results. If implemented, our recommendations could free billions of dollars annually for additional clinical studies. Research in the setting of clinical trials should be conducted to refine these findings. Clinical Trials 2008; 5: 75-84. http://</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/986781" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="d2733bb71935ab96b0327cc0b889b8e0" rel="nofollow" data-download="{"attachment_id":6251331,"asset_id":986781,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/6251331/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="821247" href="https://uba.academia.edu/OscarPodesta">Oscar Podesta</a><script data-card-contents-for-user="821247" type="text/json">{"id":821247,"first_name":"Oscar","last_name":"Podesta","domain_name":"uba","page_name":"OscarPodesta","display_name":"Oscar Podesta","profile_url":"https://uba.academia.edu/OscarPodesta?f_ri=4387","photo":"/images/s65_no_pic.png"}</script></span></span></li><li class="js-paper-rank-work_986781 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="986781"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 986781, container: ".js-paper-rank-work_986781", }); 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$(".js-view-count[data-work-id=986781]").text(description); $(".js-view-count-work_986781").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_986781").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="986781"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">18</a>  </div><span class="InlineList-item-text u-textTruncate u-pl10x"><a class="InlineList-item-text" data-has-card-for-ri="37" rel="nofollow" href="https://www.academia.edu/Documents/in/Information_Systems">Information Systems</a>, <script data-card-contents-for-ri="37" type="text/json">{"id":37,"name":"Information Systems","url":"https://www.academia.edu/Documents/in/Information_Systems?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="892" rel="nofollow" href="https://www.academia.edu/Documents/in/Statistics">Statistics</a>, <script data-card-contents-for-ri="892" type="text/json">{"id":892,"name":"Statistics","url":"https://www.academia.edu/Documents/in/Statistics?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="2066" rel="nofollow" href="https://www.academia.edu/Documents/in/Research_Design">Research Design</a>, <script data-card-contents-for-ri="2066" type="text/json">{"id":2066,"name":"Research Design","url":"https://www.academia.edu/Documents/in/Research_Design?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a><script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=986781]'), work: {"id":986781,"title":"Sensible approaches for reducing clinical trial costs","created_at":"2011-10-07T06:31:03.295-07:00","url":"https://www.academia.edu/986781/Sensible_approaches_for_reducing_clinical_trial_costs?f_ri=4387","dom_id":"work_986781","summary":"Background Over the past decade, annual funding for biomedical research has more than doubled while new molecular entity approvals have declined by one third. Objective To assess the value of practices commonly employed in the conduct of large-scale clinical trials, and to identify areas where costs could be reduced without compromising scientific validity. Methods In the qualitative phase of the study, an expert panel recommended potential modifications of mega-trial designs and operations in order to maximize their value (cost versus scientific benefit tradeoff). In the quantitative phase, a mega-trial economic model was used to assess the financial implications of these recommendations. Our initial chronic disease trial design included 20,000 patients randomized at 1000 sites. Each site was assigned 24 monitoring visits and a $10,000 per patient site payment. The case report form (CRF) was 60 pages long, and trial duration was assumed to be 48 months. Results The total costs of the initial trial design were $421 million ($US 2007). Following the expert panel's recommendations, we varied study duration, CRF length, number of sites, electronic data capture (EDC), and site management components to determine their individual and combined effects upon total trial costs. The use of EDC and modified site management practices were associated with significant reductions in total trial costs. When reductions in all five trial components were combined in a streamlined pharmaceutical industry design, a 59% reduction in total trial costs resulted. When we assumed an even more streamlined trial design than has typically been considered for regulatory submissions in the past, there was a 90% reduction in total trial costs. Conclusion Our results suggest that it is possible to reduce substantially the cost of large-scale clinical trials without compromising the scientific validity of their results. If implemented, our recommendations could free billions of dollars annually for additional clinical studies. Research in the setting of clinical trials should be conducted to refine these findings. Clinical Trials 2008; 5: 75-84. http://","downloadable_attachments":[{"id":6251331,"asset_id":986781,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":821247,"first_name":"Oscar","last_name":"Podesta","domain_name":"uba","page_name":"OscarPodesta","display_name":"Oscar Podesta","profile_url":"https://uba.academia.edu/OscarPodesta?f_ri=4387","photo":"/images/s65_no_pic.png"}],"research_interests":[{"id":37,"name":"Information Systems","url":"https://www.academia.edu/Documents/in/Information_Systems?f_ri=4387","nofollow":true},{"id":892,"name":"Statistics","url":"https://www.academia.edu/Documents/in/Statistics?f_ri=4387","nofollow":true},{"id":2066,"name":"Research Design","url":"https://www.academia.edu/Documents/in/Research_Design?f_ri=4387","nofollow":true},{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":4531,"name":"Clinical Trial","url":"https://www.academia.edu/Documents/in/Clinical_Trial?f_ri=4387"},{"id":46182,"name":"Pharmaceutical industry","url":"https://www.academia.edu/Documents/in/Pharmaceutical_industry?f_ri=4387"},{"id":63886,"name":"Case Report","url":"https://www.academia.edu/Documents/in/Case_Report?f_ri=4387"},{"id":69542,"name":"Computer Simulation","url":"https://www.academia.edu/Documents/in/Computer_Simulation?f_ri=4387"},{"id":97269,"name":"Chronic Disease","url":"https://www.academia.edu/Documents/in/Chronic_Disease?f_ri=4387"},{"id":99708,"name":"Clinical","url":"https://www.academia.edu/Documents/in/Clinical?f_ri=4387"},{"id":244814,"name":"Clinical Sciences","url":"https://www.academia.edu/Documents/in/Clinical_Sciences?f_ri=4387"},{"id":422088,"name":"Management Practice","url":"https://www.academia.edu/Documents/in/Management_Practice?f_ri=4387"},{"id":536693,"name":"Economic Model","url":"https://www.academia.edu/Documents/in/Economic_Model?f_ri=4387"},{"id":546356,"name":"Clinical Study","url":"https://www.academia.edu/Documents/in/Clinical_Study?f_ri=4387"},{"id":758278,"name":"Large Scale","url":"https://www.academia.edu/Documents/in/Large_Scale?f_ri=4387"},{"id":1877673,"name":"Electronic Data Capture","url":"https://www.academia.edu/Documents/in/Electronic_Data_Capture?f_ri=4387"},{"id":2463778,"name":"Clinical Trials as Topic","url":"https://www.academia.edu/Documents/in/Clinical_Trials_as_Topic?f_ri=4387"},{"id":2471457,"name":"Multicenter Studies as Topic","url":"https://www.academia.edu/Documents/in/Multicenter_Studies_as_Topic?f_ri=4387"}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_977977" data-work_id="977977" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/977977/Writing_for_the_Participants_of_International_Clinical_Trials_Law_Ethics_and_Culture_Technical_Communication_57_3_2010_266_281_Society_for_Technical_Communication_Frank_R_Smith_Outstanding_Journal_Article_Award">Writing for the Participants of International Clinical Trials: Law, Ethics, and Culture, Technical Communication 57.3 (2010): 266-281. Society for Technical Communication: Frank R. Smith Outstanding Journal Article Award</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Purpose: Regulatory authorities and health care practitioners participating in international clinical trials are often discussed in the technical writing literature. However, the most vulnerable audience-the participants-is left out of... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_977977" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Purpose: Regulatory authorities and health care practitioners participating in international clinical trials are often discussed in the technical writing literature. However, the most vulnerable audience-the participants-is left out of the conversation. The purpose of this article is to examine the influence of legal and cultural contexts on participant-directed informed consent documentation. Such examination will help technical communicators make informed consent documentation more user-centered. Method: Using excerpts from informed consents that I translated into Russian, examples from my six years as a localization specialist, and an overview of contradictory U.S., Russian, and international laws, I analyze the legal, ethical, and cultural considerations for informed consent documentation in international clinical trials.</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/977977" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="77b181bf228421c19220ee4293c47eb9" rel="nofollow" data-download="{"attachment_id":38661546,"asset_id":977977,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/38661546/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="244655" href="https://asu.academia.edu/TatianaBatova">Tatiana Batova</a><script data-card-contents-for-user="244655" type="text/json">{"id":244655,"first_name":"Tatiana","last_name":"Batova","domain_name":"asu","page_name":"TatianaBatova","display_name":"Tatiana Batova","profile_url":"https://asu.academia.edu/TatianaBatova?f_ri=4387","photo":"https://0.academia-photos.com/244655/484769/20050768/s65_tatiana.batova.jpg"}</script></span></span></li><li class="js-paper-rank-work_977977 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="977977"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 977977, container: ".js-paper-rank-work_977977", }); });</script></li><li class="js-percentile-work_977977 InlineList-item InlineList-item--bordered hidden u-tcGrayDark"><span class="percentile-widget hidden"><span class="u-mr2x percentile-widget" style="display: none">•</span><span class="u-mr2x work-percentile"></span></span><script>$(function () { var workId = 977977; window.Academia.workPercentilesFetcher.queue(workId, function (percentileText) { var container = $(".js-percentile-work_977977"); container.find('.work-percentile').text(percentileText.charAt(0).toUpperCase() + percentileText.slice(1)); container.find('.percentile-widget').show(); container.find('.percentile-widget').removeClass('hidden'); }); });</script></li><li class="js-view-count-work_977977 InlineList-item InlineList-item--bordered hidden"><div><span><span class="js-view-count view-count u-mr2x" data-work-id="977977"><i class="fa fa-spinner fa-spin"></i></span><script>$(function () { var workId = 977977; window.Academia.workViewCountsFetcher.queue(workId, function (count) { var description = window.$h.commaizeInt(count) + " " + window.$h.pluralize(count, 'View'); $(".js-view-count[data-work-id=977977]").text(description); $(".js-view-count-work_977977").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_977977").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="977977"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">8</a>  </div><span class="InlineList-item-text u-textTruncate u-pl9x"><a class="InlineList-item-text" data-has-card-for-ri="1615" rel="nofollow" href="https://www.academia.edu/Documents/in/Usability">Usability</a>, <script data-card-contents-for-ri="1615" type="text/json">{"id":1615,"name":"Usability","url":"https://www.academia.edu/Documents/in/Usability?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="8733" rel="nofollow" href="https://www.academia.edu/Documents/in/Technical_Communication">Technical Communication</a>, <script data-card-contents-for-ri="8733" type="text/json">{"id":8733,"name":"Technical Communication","url":"https://www.academia.edu/Documents/in/Technical_Communication?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="10194" rel="nofollow" href="https://www.academia.edu/Documents/in/Localization">Localization</a><script data-card-contents-for-ri="10194" type="text/json">{"id":10194,"name":"Localization","url":"https://www.academia.edu/Documents/in/Localization?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=977977]'), work: {"id":977977,"title":"Writing for the Participants of International Clinical Trials: Law, Ethics, and Culture, Technical Communication 57.3 (2010): 266-281. Society for Technical Communication: Frank R. Smith Outstanding Journal Article Award","created_at":"2011-10-04T13:13:02.563-07:00","url":"https://www.academia.edu/977977/Writing_for_the_Participants_of_International_Clinical_Trials_Law_Ethics_and_Culture_Technical_Communication_57_3_2010_266_281_Society_for_Technical_Communication_Frank_R_Smith_Outstanding_Journal_Article_Award?f_ri=4387","dom_id":"work_977977","summary":"Purpose: Regulatory authorities and health care practitioners participating in international clinical trials are often discussed in the technical writing literature. However, the most vulnerable audience-the participants-is left out of the conversation. The purpose of this article is to examine the influence of legal and cultural contexts on participant-directed informed consent documentation. Such examination will help technical communicators make informed consent documentation more user-centered. Method: Using excerpts from informed consents that I translated into Russian, examples from my six years as a localization specialist, and an overview of contradictory U.S., Russian, and international laws, I analyze the legal, ethical, and cultural considerations for informed consent documentation in international clinical trials.","downloadable_attachments":[{"id":38661546,"asset_id":977977,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":244655,"first_name":"Tatiana","last_name":"Batova","domain_name":"asu","page_name":"TatianaBatova","display_name":"Tatiana Batova","profile_url":"https://asu.academia.edu/TatianaBatova?f_ri=4387","photo":"https://0.academia-photos.com/244655/484769/20050768/s65_tatiana.batova.jpg"}],"research_interests":[{"id":1615,"name":"Usability","url":"https://www.academia.edu/Documents/in/Usability?f_ri=4387","nofollow":true},{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":8733,"name":"Technical Communication","url":"https://www.academia.edu/Documents/in/Technical_Communication?f_ri=4387","nofollow":true},{"id":10194,"name":"Localization","url":"https://www.academia.edu/Documents/in/Localization?f_ri=4387","nofollow":true},{"id":30347,"name":"Translation","url":"https://www.academia.edu/Documents/in/Translation?f_ri=4387"},{"id":36495,"name":"Cross-Cultural Communication","url":"https://www.academia.edu/Documents/in/Cross-Cultural_Communication?f_ri=4387"},{"id":616291,"name":"Health care communication","url":"https://www.academia.edu/Documents/in/Health_care_communication?f_ri=4387"},{"id":616294,"name":"Cultural usability","url":"https://www.academia.edu/Documents/in/Cultural_usability?f_ri=4387"}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_78904094" data-work_id="78904094" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/78904094/A_randomised_control_trial_to_compare_comfort_rate_of_injury_and_speed_whilst_running_using_prefabricated_orthotics_inserted_into_running_shoes_versus_running_with_no_additional_orthotics_inside_the_running_shoe">A randomised control trial to compare comfort, rate of injury and speed whilst running using prefabricated orthotics inserted into running shoes versus running with no additional orthotics inside the running shoe</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Background: Running is one of the most accessible and most popular sports globally. However, an increase in popularity has been followed by an increase in running-related injuries. An orthotic is a device fitted into the shoe for the... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_78904094" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Background: Running is one of the most accessible and most popular sports globally. However, an increase in popularity has been followed by an increase in running-related injuries. An orthotic is a device fitted into the shoe for the proposed function of improving cushioning, sensory feedback, and comfort whilst also reducing the incidence of running-related injuries. The current study was a randomised control trial to assess the injury incidence, performance and comfort of runners using a prefabricated orthotic, compared to runners not using a prefabricated orthotic.Methods: One hundred and six runners will be randomised either into the intervention group or the control group. The intervention group will be supplied with prefabricated orthotics and the control group won’t be supplied with orthotics. Data will be collected regarding running-related injuries, distance run, time spent running and comfort during running. The study will span eight weeks. The first two and last two weeks...</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/78904094" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="3b8e2e73135f1d8725269c9279df1327" rel="nofollow" data-download="{"attachment_id":85793069,"asset_id":78904094,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/85793069/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="36324713" href="https://liverpool.academia.edu/GeorgeAmpat">George Ampat</a><script data-card-contents-for-user="36324713" type="text/json">{"id":36324713,"first_name":"George","last_name":"Ampat","domain_name":"liverpool","page_name":"GeorgeAmpat","display_name":"George Ampat","profile_url":"https://liverpool.academia.edu/GeorgeAmpat?f_ri=4387","photo":"/images/s65_no_pic.png"}</script></span></span></li><li class="js-paper-rank-work_78904094 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="78904094"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 78904094, container: ".js-paper-rank-work_78904094", }); });</script></li><li class="js-percentile-work_78904094 InlineList-item InlineList-item--bordered hidden u-tcGrayDark"><span class="percentile-widget hidden"><span class="u-mr2x percentile-widget" style="display: none">•</span><span class="u-mr2x work-percentile"></span></span><script>$(function () { var workId = 78904094; window.Academia.workPercentilesFetcher.queue(workId, function (percentileText) { var container = $(".js-percentile-work_78904094"); container.find('.work-percentile').text(percentileText.charAt(0).toUpperCase() + percentileText.slice(1)); container.find('.percentile-widget').show(); container.find('.percentile-widget').removeClass('hidden'); }); });</script></li><li class="js-view-count-work_78904094 InlineList-item InlineList-item--bordered hidden"><div><span><span class="js-view-count view-count u-mr2x" data-work-id="78904094"><i class="fa fa-spinner fa-spin"></i></span><script>$(function () { var workId = 78904094; window.Academia.workViewCountsFetcher.queue(workId, function (count) { var description = window.$h.commaizeInt(count) + " " + window.$h.pluralize(count, 'View'); $(".js-view-count[data-work-id=78904094]").text(description); $(".js-view-count-work_78904094").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_78904094").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="78904094"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">4</a>  </div><span class="InlineList-item-text u-textTruncate u-pl9x"><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="18020" rel="nofollow" href="https://www.academia.edu/Documents/in/Orthotics">Orthotics</a>, <script data-card-contents-for-ri="18020" type="text/json">{"id":18020,"name":"Orthotics","url":"https://www.academia.edu/Documents/in/Orthotics?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="26327" rel="nofollow" href="https://www.academia.edu/Documents/in/Medicine">Medicine</a>, <script data-card-contents-for-ri="26327" type="text/json">{"id":26327,"name":"Medicine","url":"https://www.academia.edu/Documents/in/Medicine?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="32473" rel="nofollow" href="https://www.academia.edu/Documents/in/Physical_Therapy">Physical Therapy</a><script data-card-contents-for-ri="32473" type="text/json">{"id":32473,"name":"Physical Therapy","url":"https://www.academia.edu/Documents/in/Physical_Therapy?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=78904094]'), work: {"id":78904094,"title":"A randomised control trial to compare comfort, rate of injury and speed whilst running using prefabricated orthotics inserted into running shoes versus running with no additional orthotics inside the running shoe","created_at":"2022-05-10T00:50:19.324-07:00","url":"https://www.academia.edu/78904094/A_randomised_control_trial_to_compare_comfort_rate_of_injury_and_speed_whilst_running_using_prefabricated_orthotics_inserted_into_running_shoes_versus_running_with_no_additional_orthotics_inside_the_running_shoe?f_ri=4387","dom_id":"work_78904094","summary":"Background: Running is one of the most accessible and most popular sports globally. However, an increase in popularity has been followed by an increase in running-related injuries. An orthotic is a device fitted into the shoe for the proposed function of improving cushioning, sensory feedback, and comfort whilst also reducing the incidence of running-related injuries. The current study was a randomised control trial to assess the injury incidence, performance and comfort of runners using a prefabricated orthotic, compared to runners not using a prefabricated orthotic.Methods: One hundred and six runners will be randomised either into the intervention group or the control group. The intervention group will be supplied with prefabricated orthotics and the control group won’t be supplied with orthotics. Data will be collected regarding running-related injuries, distance run, time spent running and comfort during running. The study will span eight weeks. The first two and last two weeks...","downloadable_attachments":[{"id":85793069,"asset_id":78904094,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":36324713,"first_name":"George","last_name":"Ampat","domain_name":"liverpool","page_name":"GeorgeAmpat","display_name":"George Ampat","profile_url":"https://liverpool.academia.edu/GeorgeAmpat?f_ri=4387","photo":"/images/s65_no_pic.png"}],"research_interests":[{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":18020,"name":"Orthotics","url":"https://www.academia.edu/Documents/in/Orthotics?f_ri=4387","nofollow":true},{"id":26327,"name":"Medicine","url":"https://www.academia.edu/Documents/in/Medicine?f_ri=4387","nofollow":true},{"id":32473,"name":"Physical Therapy","url":"https://www.academia.edu/Documents/in/Physical_Therapy?f_ri=4387","nofollow":true}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_72630952" data-work_id="72630952" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/72630952/Pre_delivery_administration_of_azithromycin_to_prevent_neonatal_sepsis_and_death_a_phase_iii_double_blind_randomized_clinical_trial_PregnAnZI_2_trial_">Pre-delivery administration of azithromycin to prevent neonatal sepsis and death: a phase iii double-blind randomized clinical trial (PregnAnZI-2 trial)</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Background: Despite reduction in the risk of under-5 mortality in the last decade and a half, neonatal deaths have remained stable globally. Gram-positive bacterial infections are leading causes of neonatal sepsis and death. Because the... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_72630952" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Background: Despite reduction in the risk of under-5 mortality in the last decade and a half, neonatal deaths have remained stable globally. Gram-positive bacterial infections are leading causes of neonatal sepsis and death. Because the mother is an important source for bacterial transmission to babies during the perinatal period, interventions that lower risk of transmission can potentially reduce invasive bacterial infections. The primary objective of the trial will assess the effect of intrapartum azithromycin on neonatal sepsis and mortality. Secondary objectives include the impact of the intervention on prevalence of carriage and resistance, puerperal infections, and infant growth.Methods: This is a phase III, double-blinded, placebo-controlled randomized trial in which 12,000 women in labour are randomized to either a single dose of 2 g of oral azithromycin (AZI) or placebo in The Gambia and Burkina Faso. Mother/newborn pairs are followed-up at 28-days post-delivery to assess ...</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/72630952" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="aa6ee241d915b96d0c1615891fee099c" rel="nofollow" data-download="{"attachment_id":81483286,"asset_id":72630952,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/81483286/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="210571480" href="https://independent.academia.edu/GarbaZakaria">Garba Zakaria</a><script data-card-contents-for-user="210571480" type="text/json">{"id":210571480,"first_name":"Garba","last_name":"Zakaria","domain_name":"independent","page_name":"GarbaZakaria","display_name":"Garba Zakaria","profile_url":"https://independent.academia.edu/GarbaZakaria?f_ri=4387","photo":"https://0.academia-photos.com/210571480/70149760/58562087/s65_garba.zakaria.png"}</script></span></span></li><li class="js-paper-rank-work_72630952 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="72630952"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 72630952, container: ".js-paper-rank-work_72630952", }); 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$(".js-view-count[data-work-id=72630952]").text(description); $(".js-view-count-work_72630952").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_72630952").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="72630952"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i></div><span class="InlineList-item-text u-textTruncate u-pl6x"><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a><script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (false) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=72630952]'), work: {"id":72630952,"title":"Pre-delivery administration of azithromycin to prevent neonatal sepsis and death: a phase iii double-blind randomized clinical trial (PregnAnZI-2 trial)","created_at":"2022-02-28T17:23:11.434-08:00","url":"https://www.academia.edu/72630952/Pre_delivery_administration_of_azithromycin_to_prevent_neonatal_sepsis_and_death_a_phase_iii_double_blind_randomized_clinical_trial_PregnAnZI_2_trial_?f_ri=4387","dom_id":"work_72630952","summary":"Background: Despite reduction in the risk of under-5 mortality in the last decade and a half, neonatal deaths have remained stable globally. Gram-positive bacterial infections are leading causes of neonatal sepsis and death. Because the mother is an important source for bacterial transmission to babies during the perinatal period, interventions that lower risk of transmission can potentially reduce invasive bacterial infections. The primary objective of the trial will assess the effect of intrapartum azithromycin on neonatal sepsis and mortality. Secondary objectives include the impact of the intervention on prevalence of carriage and resistance, puerperal infections, and infant growth.Methods: This is a phase III, double-blinded, placebo-controlled randomized trial in which 12,000 women in labour are randomized to either a single dose of 2 g of oral azithromycin (AZI) or placebo in The Gambia and Burkina Faso. Mother/newborn pairs are followed-up at 28-days post-delivery to assess ...","downloadable_attachments":[{"id":81483286,"asset_id":72630952,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":210571480,"first_name":"Garba","last_name":"Zakaria","domain_name":"independent","page_name":"GarbaZakaria","display_name":"Garba Zakaria","profile_url":"https://independent.academia.edu/GarbaZakaria?f_ri=4387","photo":"https://0.academia-photos.com/210571480/70149760/58562087/s65_garba.zakaria.png"}],"research_interests":[{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_29841588" data-work_id="29841588" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/29841588/When_a_study_is_not_a_clinical_trial_trials_and_intersections_with_the_Guardianship_Act">When a study is not a clinical trial — trials and intersections with the Guardianship Act</a></div></div><div class="u-pb4x u-mt3x"></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/29841588" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="1e0718a517f3d0e7170e15dfe1e44ca5" rel="nofollow" data-download="{"attachment_id":50315462,"asset_id":29841588,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/50315462/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="416187" href="https://uwa.academia.edu/AndrewLu">Andrew Lu</a><script data-card-contents-for-user="416187" type="text/json">{"id":416187,"first_name":"Andrew","last_name":"Lu","domain_name":"uwa","page_name":"AndrewLu","display_name":"Andrew Lu","profile_url":"https://uwa.academia.edu/AndrewLu?f_ri=4387","photo":"https://0.academia-photos.com/416187/100719/36128938/s65_andrew.lu.jpeg"}</script></span></span></li><li class="js-paper-rank-work_29841588 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="29841588"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 29841588, container: ".js-paper-rank-work_29841588", }); 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$(".js-view-count[data-work-id=29841588]").text(description); $(".js-view-count-work_29841588").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_29841588").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="29841588"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i></div><span class="InlineList-item-text u-textTruncate u-pl6x"><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a><script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (false) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=29841588]'), work: {"id":29841588,"title":"When a study is not a clinical trial — trials and intersections with the Guardianship Act","created_at":"2016-11-14T21:50:09.326-08:00","url":"https://www.academia.edu/29841588/When_a_study_is_not_a_clinical_trial_trials_and_intersections_with_the_Guardianship_Act?f_ri=4387","dom_id":"work_29841588","summary":null,"downloadable_attachments":[{"id":50315462,"asset_id":29841588,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":416187,"first_name":"Andrew","last_name":"Lu","domain_name":"uwa","page_name":"AndrewLu","display_name":"Andrew Lu","profile_url":"https://uwa.academia.edu/AndrewLu?f_ri=4387","photo":"https://0.academia-photos.com/416187/100719/36128938/s65_andrew.lu.jpeg"}],"research_interests":[{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_70359800 coauthored" data-work_id="70359800" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/70359800/A_Review_of_the_Antiviral_Activity_of_Ivermectin_and_Its_Use_in_the_Treatment_of_Coronavirus_Disease_2019">A Review of the Antiviral Activity of Ivermectin and Its Use in the Treatment of Coronavirus Disease-2019</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Background The coronavirus disease-2019 (COVID-19) originated in China and was declared a pandemic by the World Health Organization (WHO) on 11th March 2020. Since its emergence in December 2019, there have been challenges in developing... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_70359800" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Background<br />The coronavirus disease-2019 (COVID-19) originated in China and was declared a pandemic by the World Health Organization<br />(WHO) on 11th March 2020. Since its emergence in December 2019, there have been challenges in developing drugs that are effective against the virus. Currently, COVID-19 is managed using symptomatic and supportive therapies, antiviral agents, cellular<br />and immunotherapy. Besides, most of the treatment modalities are still under investigation and treatment guidelines vary from<br />one country to another. Ivermectin is among the drugs that are being used as part of treatment guidelines in certain countries like<br />the Republic of Peru. However, the WHO recommends that ivermectin only be used in clinical trials.<br />Aim<br />The authors conducted this review to explore published studies on the possible therapeutic effects of ivermectin against active<br />infection with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), a causative agent of COVID-19.<br />Methods<br />A literature search was conducted using Google Scholar, PubMed and EMBASE for articles published from 2016 to 2021. Search<br />words used included ivermectin, antiviral, COVID-19, efficacy, safety, dosing, lower mortality rate, hospitalised patients and the<br />Boolean operator ‘AND’.<br />Results<br />A few clinical trials have shown that ivermectin is safe for use in humans at specific doses and reduces the severity of the infection. Ivermectin was seen to reduce the signs and symptoms associated with COVID-19 in some studies while others showed no<br />significant reduction. However, more studies must be conducted to ascertain its use in treating COVID-19.<br />Conclusion<br />Since many clinical trials are being conducted on the use of ivermectin to treat COVID-19, full evidence will be used to support<br />its use in humans. Currently, some countries that are using ivermectin for treating COVID-19 have reported it to be effective and<br />reduces morbidity and mortality associated with the disease. Therefore, countries should collaborate and provide full evidence for<br />the use of ivermectin in humans to manage COVID-19.</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/70359800" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="ab8fa8f410869c7093d2a418376cde88" rel="nofollow" data-download="{"attachment_id":80147090,"asset_id":70359800,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/80147090/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="102727080" rel="nofollow" href="https://independent.academia.edu/EpidemilogyOpenJournal">Epidemiology – Open Journal (EPOJ)</a><script data-card-contents-for-user="102727080" type="text/json">{"id":102727080,"first_name":"Epidemiology","last_name":"– Open Journal (EPOJ)","domain_name":"independent","page_name":"EpidemilogyOpenJournal","display_name":"Epidemiology – Open Journal (EPOJ)","profile_url":"https://independent.academia.edu/EpidemilogyOpenJournal?f_ri=4387","photo":"https://0.academia-photos.com/102727080/22740793/92840991/s65_epidemiology.open_journal.png"}</script></span></span><span class="u-displayInlineBlock InlineList-item-text"> and <span class="u-textDecorationUnderline u-clickable InlineList-item-text js-work-more-authors-70359800">+6</span><div class="hidden js-additional-users-70359800"><div><span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a href="https://independent.academia.edu/CHRISTABELHIKAAMBO">CHRISTABEL N A N G ' A N D U HIKAAMBO</a></span></div><div><span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a href="https://unza-zm.academia.edu/StewardMudenda">Steward Mudenda, PhD</a></span></div><div><span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a href="https://anadolu.academia.edu/fernandobwalya">fernando bwalya</a></span></div><div><span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a href="https://independent.academia.edu/TadiousChimombe">Tadious Chimombe</a></span></div><div><span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a rel="nofollow" href="https://independent.academia.edu/MicheloBanda">Michelo Banda</a></span></div><div><span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a href="https://independent.academia.edu/CHikaambo">Christabel Hikaambo</a></span></div></div></span><script>(function(){ var popoverSettings = { el: $('.js-work-more-authors-70359800'), placement: 'bottom', hide_delay: 200, html: true, content: function(){ return $('.js-additional-users-70359800').html(); 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container.find('.percentile-widget').removeClass('hidden'); }); });</script></li><li class="js-view-count-work_70359800 InlineList-item InlineList-item--bordered hidden"><div><span><span class="js-view-count view-count u-mr2x" data-work-id="70359800"><i class="fa fa-spinner fa-spin"></i></span><script>$(function () { var workId = 70359800; window.Academia.workViewCountsFetcher.queue(workId, function (count) { var description = window.$h.commaizeInt(count) + " " + window.$h.pluralize(count, 'View'); $(".js-view-count[data-work-id=70359800]").text(description); $(".js-view-count-work_70359800").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_70359800").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="70359800"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">6</a>  </div><span class="InlineList-item-text u-textTruncate u-pl9x"><a class="InlineList-item-text" data-has-card-for-ri="1085" rel="nofollow" href="https://www.academia.edu/Documents/in/Epidemiology">Epidemiology</a>, <script data-card-contents-for-ri="1085" type="text/json">{"id":1085,"name":"Epidemiology","url":"https://www.academia.edu/Documents/in/Epidemiology?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="29420" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_trials_Health_Sciences_">Clinical trials (Health Sciences)</a>, <script data-card-contents-for-ri="29420" type="text/json">{"id":29420,"name":"Clinical trials (Health Sciences)","url":"https://www.academia.edu/Documents/in/Clinical_trials_Health_Sciences_?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="1381504" rel="nofollow" href="https://www.academia.edu/Documents/in/Ivermectin">Ivermectin</a><script data-card-contents-for-ri="1381504" type="text/json">{"id":1381504,"name":"Ivermectin","url":"https://www.academia.edu/Documents/in/Ivermectin?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=70359800]'), work: {"id":70359800,"title":"A Review of the Antiviral Activity of Ivermectin and Its Use in the Treatment of Coronavirus Disease-2019","created_at":"2022-02-03T21:23:13.563-08:00","url":"https://www.academia.edu/70359800/A_Review_of_the_Antiviral_Activity_of_Ivermectin_and_Its_Use_in_the_Treatment_of_Coronavirus_Disease_2019?f_ri=4387","dom_id":"work_70359800","summary":"Background\nThe coronavirus disease-2019 (COVID-19) originated in China and was declared a pandemic by the World Health Organization\n(WHO) on 11th March 2020. Since its emergence in December 2019, there have been challenges in developing drugs that are effective against the virus. Currently, COVID-19 is managed using symptomatic and supportive therapies, antiviral agents, cellular\nand immunotherapy. Besides, most of the treatment modalities are still under investigation and treatment guidelines vary from\none country to another. Ivermectin is among the drugs that are being used as part of treatment guidelines in certain countries like\nthe Republic of Peru. However, the WHO recommends that ivermectin only be used in clinical trials.\nAim\nThe authors conducted this review to explore published studies on the possible therapeutic effects of ivermectin against active\ninfection with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), a causative agent of COVID-19.\nMethods\nA literature search was conducted using Google Scholar, PubMed and EMBASE for articles published from 2016 to 2021. Search\nwords used included ivermectin, antiviral, COVID-19, efficacy, safety, dosing, lower mortality rate, hospitalised patients and the\nBoolean operator ‘AND’.\nResults\nA few clinical trials have shown that ivermectin is safe for use in humans at specific doses and reduces the severity of the infection. Ivermectin was seen to reduce the signs and symptoms associated with COVID-19 in some studies while others showed no\nsignificant reduction. However, more studies must be conducted to ascertain its use in treating COVID-19.\nConclusion\nSince many clinical trials are being conducted on the use of ivermectin to treat COVID-19, full evidence will be used to support\nits use in humans. Currently, some countries that are using ivermectin for treating COVID-19 have reported it to be effective and\nreduces morbidity and mortality associated with the disease. Therefore, countries should collaborate and provide full evidence for\nthe use of ivermectin in humans to manage COVID-19.","downloadable_attachments":[{"id":80147090,"asset_id":70359800,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":102727080,"first_name":"Epidemiology","last_name":"– Open Journal (EPOJ)","domain_name":"independent","page_name":"EpidemilogyOpenJournal","display_name":"Epidemiology – Open Journal (EPOJ)","profile_url":"https://independent.academia.edu/EpidemilogyOpenJournal?f_ri=4387","photo":"https://0.academia-photos.com/102727080/22740793/92840991/s65_epidemiology.open_journal.png"},{"id":114011717,"first_name":"CHRISTABEL","last_name":"HIKAAMBO","domain_name":"independent","page_name":"CHRISTABELHIKAAMBO","display_name":"CHRISTABEL N A N G ' A N D U HIKAAMBO","profile_url":"https://independent.academia.edu/CHRISTABELHIKAAMBO?f_ri=4387","photo":"https://0.academia-photos.com/114011717/72638622/61106936/s65_christabel.hikaambo.jpeg"},{"id":23385509,"first_name":"Steward","last_name":"Mudenda, PhD","domain_name":"unza-zm","page_name":"StewardMudenda","display_name":"Steward Mudenda, PhD","profile_url":"https://unza-zm.academia.edu/StewardMudenda?f_ri=4387","photo":"https://0.academia-photos.com/23385509/6346858/39760806/s65_steward.mudenda.jpg"},{"id":21662836,"first_name":"fernando","last_name":"bwalya","domain_name":"anadolu","page_name":"fernandobwalya","display_name":"fernando bwalya","profile_url":"https://anadolu.academia.edu/fernandobwalya?f_ri=4387","photo":"https://0.academia-photos.com/21662836/15819677/16337029/s65_fernando.bwalya.jpg"},{"id":214556241,"first_name":"Tadious","last_name":"Chimombe","domain_name":"independent","page_name":"TadiousChimombe","display_name":"Tadious Chimombe","profile_url":"https://independent.academia.edu/TadiousChimombe?f_ri=4387","photo":"/images/s65_no_pic.png"},{"id":214571393,"first_name":"Michelo","last_name":"Banda","domain_name":"independent","page_name":"MicheloBanda","display_name":"Michelo Banda","profile_url":"https://independent.academia.edu/MicheloBanda?f_ri=4387","photo":"/images/s65_no_pic.png"},{"id":255258980,"first_name":"Christabel","last_name":"Hikaambo","domain_name":"independent","page_name":"CHikaambo","display_name":"Christabel Hikaambo","profile_url":"https://independent.academia.edu/CHikaambo?f_ri=4387","photo":"/images/s65_no_pic.png"}],"research_interests":[{"id":1085,"name":"Epidemiology","url":"https://www.academia.edu/Documents/in/Epidemiology?f_ri=4387","nofollow":true},{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":29420,"name":"Clinical trials (Health 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href="https://www.academia.edu/Documents/in/Biostatistics">Biostatistics</a>, <script data-card-contents-for-ri="3058" type="text/json">{"id":3058,"name":"Biostatistics","url":"https://www.academia.edu/Documents/in/Biostatistics?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="13841" rel="nofollow" href="https://www.academia.edu/Documents/in/Drug_development">Drug development</a>, <script data-card-contents-for-ri="13841" type="text/json">{"id":13841,"name":"Drug development","url":"https://www.academia.edu/Documents/in/Drug_development?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" 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Peace","profile_url":"https://georgiasouthern.academia.edu/KarlPeace?f_ri=4387","photo":"/images/s65_no_pic.png"}],"research_interests":[{"id":3058,"name":"Biostatistics","url":"https://www.academia.edu/Documents/in/Biostatistics?f_ri=4387","nofollow":true},{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":13841,"name":"Drug development","url":"https://www.academia.edu/Documents/in/Drug_development?f_ri=4387","nofollow":true},{"id":15043,"name":"SAS","url":"https://www.academia.edu/Documents/in/SAS?f_ri=4387","nofollow":false},{"id":16288,"name":"Public 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Training(Stata)","url":"https://www.academia.edu/Documents/in/Statistical_Analysis_Software_Training_Stata_?f_ri=4387"}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_9870450" data-work_id="9870450" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/9870450/Clinical_efficacy_and_tolerability_of_valacyclovir_versus_acyclovir_in_treatment_of_herpes_zoster">Clinical efficacy and tolerability of valacyclovir versus acyclovir in treatment of herpes zoster</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Background: Acyclovir, a specific and selective inhibitor of replication of herpesviridae family, has well documented efficacy for speedy rash healing and decreasing pain of herpes zoster. Limited oral bioavailability of acyclovir... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_9870450" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Background: Acyclovir, a specific and selective inhibitor of<br />replication of herpesviridae family, has well documented efficacy<br />for speedy rash healing and decreasing pain of herpes zoster.<br />Limited oral bioavailability of acyclovir requires frequent dosing.<br />Valacyclovir is rapidly and almost completely converted to<br />acyclovir in vivo and gives three to fivefold increase in acyclovir<br />bioavailability. The aim of this study was to assess the clinical<br />efficacy, safety and tolerability of oral valacyclovir versus standard<br />oral acyclovir in the treatment of herpes zoster.<br />Methods: A blind randomized prospective study was performed<br />during May 2007 to August 2007 in Midnapore Medical College.<br />Immunocompetent patients, aged ≥40yrs presenting with herpes<br />zoster within 72 hours after onset of rash were enrolled and<br />randomized to receive one of the following treatments: 1000<br />mg of valacyclovir thrice daily for 7 days or acyclovir 800 mg 5<br />times daily for 7 days. A total of 60 patients were included and<br />randomized to receive either valacyclovir (n=30) or acyclovir<br />(n=30) and they were evaluated at 8 days, 15 days and 29 days,<br />respectively.<br />Results: A statistically significant reduction of skin lesion and<br />zoster associated pain were noticed in valacyclovir compared to<br />acyclovir group. However, presence of post herpetic neuralgia<br />on the 29th day was less in acyclovir compared to valacyclovir<br />group (70.0% vs. 83.3%, P>0.05). Only one patient on valacyclovir<br />and two patients on acyclovir complained of nausea and mild<br />abdominal pain.<br />Conclusion: We conclude that for the management of herpes<br />zoster, valacyclovir might be superior to acyclovir in respect to<br />reduction of skin lesions and pain.<br />Keywords: acyclovir, herpes zoster, treatment,</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/9870450" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="1e643cd33e73d0aa479cb7ccf9c0ce98" rel="nofollow" data-download="{"attachment_id":36032103,"asset_id":9870450,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/36032103/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="9546501" href="https://skbu.academia.edu/SamiranBisai">Samiran Bisai</a><script data-card-contents-for-user="9546501" type="text/json">{"id":9546501,"first_name":"Samiran","last_name":"Bisai","domain_name":"skbu","page_name":"SamiranBisai","display_name":"Samiran Bisai","profile_url":"https://skbu.academia.edu/SamiranBisai?f_ri=4387","photo":"https://0.academia-photos.com/9546501/3188614/162704518/s65_samiran.bisai.jpg"}</script></span></span></li><li class="js-paper-rank-work_9870450 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="9870450"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 9870450, container: ".js-paper-rank-work_9870450", }); 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$(".js-view-count[data-work-id=9870450]").text(description); $(".js-view-count-work_9870450").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_9870450").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="9870450"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">3</a>  </div><span class="InlineList-item-text u-textTruncate u-pl9x"><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="12729" rel="nofollow" href="https://www.academia.edu/Documents/in/Dermatology">Dermatology</a>, <script data-card-contents-for-ri="12729" type="text/json">{"id":12729,"name":"Dermatology","url":"https://www.academia.edu/Documents/in/Dermatology?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="1720508" rel="nofollow" href="https://www.academia.edu/Documents/in/Acyclovir">Acyclovir</a><script data-card-contents-for-ri="1720508" type="text/json">{"id":1720508,"name":"Acyclovir","url":"https://www.academia.edu/Documents/in/Acyclovir?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=9870450]'), work: {"id":9870450,"title":"Clinical efficacy and tolerability of valacyclovir versus acyclovir in treatment of herpes zoster","created_at":"2014-12-22T20:16:57.021-08:00","url":"https://www.academia.edu/9870450/Clinical_efficacy_and_tolerability_of_valacyclovir_versus_acyclovir_in_treatment_of_herpes_zoster?f_ri=4387","dom_id":"work_9870450","summary":"Background: Acyclovir, a specific and selective inhibitor of\nreplication of herpesviridae family, has well documented efficacy\nfor speedy rash healing and decreasing pain of herpes zoster.\nLimited oral bioavailability of acyclovir requires frequent dosing.\nValacyclovir is rapidly and almost completely converted to\nacyclovir in vivo and gives three to fivefold increase in acyclovir\nbioavailability. The aim of this study was to assess the clinical\nefficacy, safety and tolerability of oral valacyclovir versus standard\noral acyclovir in the treatment of herpes zoster.\nMethods: A blind randomized prospective study was performed\nduring May 2007 to August 2007 in Midnapore Medical College.\nImmunocompetent patients, aged ≥40yrs presenting with herpes\nzoster within 72 hours after onset of rash were enrolled and\nrandomized to receive one of the following treatments: 1000\nmg of valacyclovir thrice daily for 7 days or acyclovir 800 mg 5\ntimes daily for 7 days. A total of 60 patients were included and\nrandomized to receive either valacyclovir (n=30) or acyclovir\n(n=30) and they were evaluated at 8 days, 15 days and 29 days,\nrespectively.\nResults: A statistically significant reduction of skin lesion and\nzoster associated pain were noticed in valacyclovir compared to\nacyclovir group. However, presence of post herpetic neuralgia\non the 29th day was less in acyclovir compared to valacyclovir\ngroup (70.0% vs. 83.3%, P\u003e0.05). Only one patient on valacyclovir\nand two patients on acyclovir complained of nausea and mild\nabdominal pain.\nConclusion: We conclude that for the management of herpes\nzoster, valacyclovir might be superior to acyclovir in respect to\nreduction of skin lesions and pain.\nKeywords: acyclovir, herpes zoster, treatment,\n","downloadable_attachments":[{"id":36032103,"asset_id":9870450,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":9546501,"first_name":"Samiran","last_name":"Bisai","domain_name":"skbu","page_name":"SamiranBisai","display_name":"Samiran Bisai","profile_url":"https://skbu.academia.edu/SamiranBisai?f_ri=4387","photo":"https://0.academia-photos.com/9546501/3188614/162704518/s65_samiran.bisai.jpg"}],"research_interests":[{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":12729,"name":"Dermatology","url":"https://www.academia.edu/Documents/in/Dermatology?f_ri=4387","nofollow":true},{"id":1720508,"name":"Acyclovir","url":"https://www.academia.edu/Documents/in/Acyclovir?f_ri=4387","nofollow":true}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_16209596" data-work_id="16209596" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/16209596/R%C3%A9diger_une_%C3%A9tude_par_la_m%C3%A9thode_quantitative_Recherche_infirmi%C3%A8re_et_param%C3%A9dicale_Guide_de_r%C3%A9daction_d_un_protocole_de_recherche">Rédiger une étude par la méthode quantitative. Recherche infirmière et paramédicale. Guide de rédaction d’un protocole de recherche.</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Cet ouvrage est destiné aux infirmières et à tous les paramédicaux qui souhaitent entamer une recherche. On assiste aujourd'hui à l'émergence et à l'affirmation d'une culture scientifique au sein du groupe professionnel des paramédicaux.... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_16209596" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Cet ouvrage est destiné aux infirmières et à tous les paramédicaux qui souhaitent entamer une recherche. On assiste aujourd'hui à l'émergence et à l'affirmation d'une culture scientifique au sein du groupe professionnel des paramédicaux. Le monde de la santé a compris ce changement et soutient la recherche infirmière et paramédicale, en particulier au travers des programmes de PHRI.<br />Mais conduire une recherche ne s’invente pas. Il faut en respecter les règles, il faut être rigoureux, intègre, mais aussi passionné, curieux et organisé. Une recherche se prépare avec soin.<br />Une bonne préparation du travail de recherche est le garant de sa réussite. De même, une étude bien préparée permet aussi d’obtenir des financements.<br />L’objectif de cet ouvrage n’a qu’une ambition : se familiariser avec la méthodologie de recherche. Il se veut simple, il comporte de précieux conseils pour aider les infirmières et autres professionnels de la santé à préparer un travail de recherche. Ces conseils sont basés à la fois sur des éléments théoriques, sur la littérature et sur l’expérience des auteurs. Des exemples complètent ces conseils. Les différents chapitres abordent les points suivants :<br />• Définir et conceptualiser le thème de recherche<br />• Préparer le travail de recherche<br />• Rédiger le contexte et présenter la question de recherche <br />• Elaborer et rédiger la méthode de recherche<br />• Préparer et rédiger les aspects organisationnels de la recherche mesurés dans un échantillon ?<br /><br />Un outil indispensable !<br /><br />Sous la direction de Monique Rothan-Tondeur<br />ISBN: 978-2-224-03429-6<br />136pp.</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/16209596" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="8ed8c338b44fe9fd7b2869554b090709" rel="nofollow" data-download="{"attachment_id":38901160,"asset_id":16209596,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/38901160/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="21656968" href="https://univ-lyon1.academia.edu/HuguesLefort">Hugues Lefort</a><script data-card-contents-for-user="21656968" type="text/json">{"id":21656968,"first_name":"Hugues","last_name":"Lefort","domain_name":"univ-lyon1","page_name":"HuguesLefort","display_name":"Hugues Lefort","profile_url":"https://univ-lyon1.academia.edu/HuguesLefort?f_ri=4387","photo":"https://0.academia-photos.com/21656968/5957733/47467151/s65_hugues.lefort.jpg"}</script></span></span></li><li class="js-paper-rank-work_16209596 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="16209596"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 16209596, container: ".js-paper-rank-work_16209596", }); });</script></li><li class="js-percentile-work_16209596 InlineList-item InlineList-item--bordered hidden u-tcGrayDark"><span class="percentile-widget hidden"><span class="u-mr2x percentile-widget" style="display: none">•</span><span class="u-mr2x work-percentile"></span></span><script>$(function () { var workId = 16209596; window.Academia.workPercentilesFetcher.queue(workId, function (percentileText) { var container = $(".js-percentile-work_16209596"); container.find('.work-percentile').text(percentileText.charAt(0).toUpperCase() + percentileText.slice(1)); container.find('.percentile-widget').show(); container.find('.percentile-widget').removeClass('hidden'); }); });</script></li><li class="js-view-count-work_16209596 InlineList-item InlineList-item--bordered hidden"><div><span><span class="js-view-count view-count u-mr2x" data-work-id="16209596"><i class="fa fa-spinner fa-spin"></i></span><script>$(function () { var workId = 16209596; window.Academia.workViewCountsFetcher.queue(workId, function (count) { var description = window.$h.commaizeInt(count) + " " + window.$h.pluralize(count, 'View'); $(".js-view-count[data-work-id=16209596]").text(description); $(".js-view-count-work_16209596").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_16209596").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="16209596"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">14</a>  </div><span class="InlineList-item-text u-textTruncate u-pl10x"><a class="InlineList-item-text" data-has-card-for-ri="2065" rel="nofollow" href="https://www.academia.edu/Documents/in/Research_Methodology">Research Methodology</a>, <script data-card-contents-for-ri="2065" type="text/json">{"id":2065,"name":"Research Methodology","url":"https://www.academia.edu/Documents/in/Research_Methodology?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="3136" rel="nofollow" href="https://www.academia.edu/Documents/in/Qualitative_methodology">Qualitative methodology</a>, <script data-card-contents-for-ri="3136" type="text/json">{"id":3136,"name":"Qualitative methodology","url":"https://www.academia.edu/Documents/in/Qualitative_methodology?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="6601" rel="nofollow" href="https://www.academia.edu/Documents/in/Nurse_Education">Nurse Education</a><script data-card-contents-for-ri="6601" type="text/json">{"id":6601,"name":"Nurse Education","url":"https://www.academia.edu/Documents/in/Nurse_Education?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=16209596]'), work: {"id":16209596,"title":"Rédiger une étude par la méthode quantitative. Recherche infirmière et paramédicale. Guide de rédaction d’un protocole de recherche.","created_at":"2015-09-26T14:24:44.578-07:00","url":"https://www.academia.edu/16209596/R%C3%A9diger_une_%C3%A9tude_par_la_m%C3%A9thode_quantitative_Recherche_infirmi%C3%A8re_et_param%C3%A9dicale_Guide_de_r%C3%A9daction_d_un_protocole_de_recherche?f_ri=4387","dom_id":"work_16209596","summary":"Cet ouvrage est destiné aux infirmières et à tous les paramédicaux qui souhaitent entamer une recherche. On assiste aujourd'hui à l'émergence et à l'affirmation d'une culture scientifique au sein du groupe professionnel des paramédicaux. Le monde de la santé a compris ce changement et soutient la recherche infirmière et paramédicale, en particulier au travers des programmes de PHRI.\nMais conduire une recherche ne s’invente pas. Il faut en respecter les règles, il faut être rigoureux, intègre, mais aussi passionné, curieux et organisé. Une recherche se prépare avec soin.\nUne bonne préparation du travail de recherche est le garant de sa réussite. De même, une étude bien préparée permet aussi d’obtenir des financements.\nL’objectif de cet ouvrage n’a qu’une ambition : se familiariser avec la méthodologie de recherche. Il se veut simple, il comporte de précieux conseils pour aider les infirmières et autres professionnels de la santé à préparer un travail de recherche. Ces conseils sont basés à la fois sur des éléments théoriques, sur la littérature et sur l’expérience des auteurs. Des exemples complètent ces conseils. Les différents chapitres abordent les points suivants :\n•\tDéfinir et conceptualiser le thème de recherche\n•\tPréparer le travail de recherche\n•\tRédiger le contexte et présenter la question de recherche \n•\tElaborer et rédiger la méthode de recherche\n•\tPréparer et rédiger les aspects organisationnels de la recherche mesurés dans un échantillon ?\n\nUn outil indispensable !\n\nSous la direction de Monique Rothan-Tondeur\nISBN: 978-2-224-03429-6\n136pp.","downloadable_attachments":[{"id":38901160,"asset_id":16209596,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":21656968,"first_name":"Hugues","last_name":"Lefort","domain_name":"univ-lyon1","page_name":"HuguesLefort","display_name":"Hugues Lefort","profile_url":"https://univ-lyon1.academia.edu/HuguesLefort?f_ri=4387","photo":"https://0.academia-photos.com/21656968/5957733/47467151/s65_hugues.lefort.jpg"}],"research_interests":[{"id":2065,"name":"Research Methodology","url":"https://www.academia.edu/Documents/in/Research_Methodology?f_ri=4387","nofollow":true},{"id":3136,"name":"Qualitative methodology","url":"https://www.academia.edu/Documents/in/Qualitative_methodology?f_ri=4387","nofollow":true},{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":6601,"name":"Nurse Education","url":"https://www.academia.edu/Documents/in/Nurse_Education?f_ri=4387","nofollow":true},{"id":6602,"name":"Nurse education research","url":"https://www.academia.edu/Documents/in/Nurse_education_research?f_ri=4387"},{"id":11847,"name":"Quantitative Research","url":"https://www.academia.edu/Documents/in/Quantitative_Research?f_ri=4387"},{"id":12135,"name":"Qualitative Research","url":"https://www.academia.edu/Documents/in/Qualitative_Research?f_ri=4387"},{"id":12620,"name":"Quantitative Methods","url":"https://www.academia.edu/Documents/in/Quantitative_Methods?f_ri=4387"},{"id":12621,"name":"Quantitative methodology","url":"https://www.academia.edu/Documents/in/Quantitative_methodology?f_ri=4387"},{"id":26327,"name":"Medicine","url":"https://www.academia.edu/Documents/in/Medicine?f_ri=4387"},{"id":40250,"name":"Clinical Nurse","url":"https://www.academia.edu/Documents/in/Clinical_Nurse?f_ri=4387"},{"id":66110,"name":"Clinical research","url":"https://www.academia.edu/Documents/in/Clinical_research?f_ri=4387"},{"id":153039,"name":"Nurses","url":"https://www.academia.edu/Documents/in/Nurses?f_ri=4387"},{"id":243803,"name":"Nurse","url":"https://www.academia.edu/Documents/in/Nurse?f_ri=4387"}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_72144994" data-work_id="72144994" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/72144994/Improvement_of_Quality_of_Life_in_Patients_with_Peripheral_Neuropathy_Treated_with_a_Fixed_Dose_Combination_of_High_Dose_Vitamin_B1_B6_and_B12_Results_from_a_12_week_Prospective_Non_interventional_Study_in_Indonesia">Improvement of Quality of Life in Patients with Peripheral Neuropathy Treated with a Fixed Dose Combination of High-Dose Vitamin B1, B6 and B12: Results from a 12-week Prospective Non-interventional Study in Indonesia</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Objective: The 12-week prospective, non-interventional study conducted in Indonesia aimed to evaluate the effectiveness and safety of a fixed combination of high-dose vitamin B1, B6 and B12 in subjects with peripheral neuropathy (PN) of... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_72144994" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Objective: The 12-week prospective, non-interventional study conducted in Indonesia aimed to evaluate the effectiveness and safety of a fixed combination of high-dose vitamin B1, B6 and B12 in subjects with peripheral neuropathy (PN) of various etiology. As PN is known to significantly impair patients’ quality of life (QoL), special attention has been paid to this aspect and QoL data were collected as secondary outcome parameters over time. Methods: The study enrolled subjects aged 18–65 years with mild or moderate PN of various etiologies. PN symptoms were measured by Total Symptom Score (TSS) and Visual Analogue Scale (VAS) at visit 1 (baseline), visit 2 (day 14), visit 3 (day 30), visit 4 (day 60), and visit 5 (day 90). At visits 1, 3, 4, and 5, the subjects also reported QoL data as assessed by the Short Form 8 (SF-8) Health Survey Questionnaire. Changes from baseline to other follow-up visits were calculated by exploratory analysis for TSS, VAS, and QoL scores. Results: Data of...</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/72144994" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="34c15d02b58127881324df7f6330abdb" rel="nofollow" data-download="{"attachment_id":81191885,"asset_id":72144994,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/81191885/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="17137076" href="https://independent.academia.edu/HasnawiHaddani">Hasnawi Haddani</a><script data-card-contents-for-user="17137076" type="text/json">{"id":17137076,"first_name":"Hasnawi","last_name":"Haddani","domain_name":"independent","page_name":"HasnawiHaddani","display_name":"Hasnawi Haddani","profile_url":"https://independent.academia.edu/HasnawiHaddani?f_ri=4387","photo":"/images/s65_no_pic.png"}</script></span></span></li><li class="js-paper-rank-work_72144994 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="72144994"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 72144994, container: ".js-paper-rank-work_72144994", }); 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$(".js-view-count[data-work-id=72144994]").text(description); $(".js-view-count-work_72144994").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_72144994").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="72144994"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">2</a>  </div><span class="InlineList-item-text u-textTruncate u-pl9x"><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="26327" rel="nofollow" href="https://www.academia.edu/Documents/in/Medicine">Medicine</a><script data-card-contents-for-ri="26327" type="text/json">{"id":26327,"name":"Medicine","url":"https://www.academia.edu/Documents/in/Medicine?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=72144994]'), work: {"id":72144994,"title":"Improvement of Quality of Life in Patients with Peripheral Neuropathy Treated with a Fixed Dose Combination of High-Dose Vitamin B1, B6 and B12: Results from a 12-week Prospective Non-interventional Study in Indonesia","created_at":"2022-02-21T15:48:36.953-08:00","url":"https://www.academia.edu/72144994/Improvement_of_Quality_of_Life_in_Patients_with_Peripheral_Neuropathy_Treated_with_a_Fixed_Dose_Combination_of_High_Dose_Vitamin_B1_B6_and_B12_Results_from_a_12_week_Prospective_Non_interventional_Study_in_Indonesia?f_ri=4387","dom_id":"work_72144994","summary":"Objective: The 12-week prospective, non-interventional study conducted in Indonesia aimed to evaluate the effectiveness and safety of a fixed combination of high-dose vitamin B1, B6 and B12 in subjects with peripheral neuropathy (PN) of various etiology. As PN is known to significantly impair patients’ quality of life (QoL), special attention has been paid to this aspect and QoL data were collected as secondary outcome parameters over time. Methods: The study enrolled subjects aged 18–65 years with mild or moderate PN of various etiologies. PN symptoms were measured by Total Symptom Score (TSS) and Visual Analogue Scale (VAS) at visit 1 (baseline), visit 2 (day 14), visit 3 (day 30), visit 4 (day 60), and visit 5 (day 90). At visits 1, 3, 4, and 5, the subjects also reported QoL data as assessed by the Short Form 8 (SF-8) Health Survey Questionnaire. Changes from baseline to other follow-up visits were calculated by exploratory analysis for TSS, VAS, and QoL scores. Results: Data of...","downloadable_attachments":[{"id":81191885,"asset_id":72144994,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":17137076,"first_name":"Hasnawi","last_name":"Haddani","domain_name":"independent","page_name":"HasnawiHaddani","display_name":"Hasnawi Haddani","profile_url":"https://independent.academia.edu/HasnawiHaddani?f_ri=4387","photo":"/images/s65_no_pic.png"}],"research_interests":[{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":26327,"name":"Medicine","url":"https://www.academia.edu/Documents/in/Medicine?f_ri=4387","nofollow":true}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_1896030" data-work_id="1896030" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/1896030/Early_stopping_of_clinical_trials_charting_the_ethical_terrain">Early stopping of clinical trials: charting the ethical terrain</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">The decision to terminate a clinical trial earlier than planned is often described as ethically problematic, but it is rarely systematically analyzed as an ethical issue in its own right. This paper provides an overview of the main... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_1896030" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">The decision to terminate a clinical trial earlier than planned is often described as ethically problematic, but it is rarely systematically analyzed as an ethical issue in its own right. This paper provides an overview of the main ethical considerations at stake in such decisions and of the main tensions between these considerations. Arguments about informed consent and the impact of early stopping on research and society are explored. We devote particular attention to a familiar conflict that arises with special urgency when early data suggest that the experimental treatment is superior. Should the trial be stopped so that participants in the control group will not be allocated a seemingly inferior treatment, or should it continue in pursuit of evidence conclusive enough to improve the care of future patients? We scrutinize three ways to address this problem. Rather than dissolving the tension, they represent different trade-offs between the respective welfare interests of subjects and future patients.</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/1896030" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="d873295e2de0350992e6ee55cad7933e" rel="nofollow" data-download="{"attachment_id":27179445,"asset_id":1896030,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/27179445/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="1272309" href="https://gu-se.academia.edu/ErikMalmqvist">Erik Malmqvist</a><script data-card-contents-for-user="1272309" type="text/json">{"id":1272309,"first_name":"Erik","last_name":"Malmqvist","domain_name":"gu-se","page_name":"ErikMalmqvist","display_name":"Erik Malmqvist","profile_url":"https://gu-se.academia.edu/ErikMalmqvist?f_ri=4387","photo":"https://0.academia-photos.com/1272309/467433/12855637/s65_erik.malmqvist.jpg"}</script></span></span></li><li class="js-paper-rank-work_1896030 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="1896030"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 1896030, container: ".js-paper-rank-work_1896030", }); });</script></li><li class="js-percentile-work_1896030 InlineList-item InlineList-item--bordered hidden u-tcGrayDark"><span class="percentile-widget hidden"><span class="u-mr2x percentile-widget" style="display: none">•</span><span class="u-mr2x work-percentile"></span></span><script>$(function () { var workId = 1896030; window.Academia.workPercentilesFetcher.queue(workId, function (percentileText) { var container = $(".js-percentile-work_1896030"); container.find('.work-percentile').text(percentileText.charAt(0).toUpperCase() + percentileText.slice(1)); container.find('.percentile-widget').show(); container.find('.percentile-widget').removeClass('hidden'); }); });</script></li><li class="js-view-count-work_1896030 InlineList-item InlineList-item--bordered hidden"><div><span><span class="js-view-count view-count u-mr2x" data-work-id="1896030"><i class="fa fa-spinner fa-spin"></i></span><script>$(function () { var workId = 1896030; window.Academia.workViewCountsFetcher.queue(workId, function (count) { var description = window.$h.commaizeInt(count) + " " + window.$h.pluralize(count, 'View'); $(".js-view-count[data-work-id=1896030]").text(description); $(".js-view-count-work_1896030").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_1896030").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="1896030"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">2</a>  </div><span class="InlineList-item-text u-textTruncate u-pl9x"><a class="InlineList-item-text" data-has-card-for-ri="2504" rel="nofollow" href="https://www.academia.edu/Documents/in/Research_Ethics">Research Ethics</a>, <script data-card-contents-for-ri="2504" type="text/json">{"id":2504,"name":"Research Ethics","url":"https://www.academia.edu/Documents/in/Research_Ethics?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a><script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=1896030]'), work: {"id":1896030,"title":"Early stopping of clinical trials: charting the ethical terrain","created_at":"2012-08-29T19:07:16.084-07:00","url":"https://www.academia.edu/1896030/Early_stopping_of_clinical_trials_charting_the_ethical_terrain?f_ri=4387","dom_id":"work_1896030","summary":"The decision to terminate a clinical trial earlier than planned is often described as ethically problematic, but it is rarely systematically analyzed as an ethical issue in its own right. This paper provides an overview of the main ethical considerations at stake in such decisions and of the main tensions between these considerations. Arguments about informed consent and the impact of early stopping on research and society are explored. We devote particular attention to a familiar conflict that arises with special urgency when early data suggest that the experimental treatment is superior. Should the trial be stopped so that participants in the control group will not be allocated a seemingly inferior treatment, or should it continue in pursuit of evidence conclusive enough to improve the care of future patients? We scrutinize three ways to address this problem. Rather than dissolving the tension, they represent different trade-offs between the respective welfare interests of subjects and future patients.","downloadable_attachments":[{"id":27179445,"asset_id":1896030,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":1272309,"first_name":"Erik","last_name":"Malmqvist","domain_name":"gu-se","page_name":"ErikMalmqvist","display_name":"Erik Malmqvist","profile_url":"https://gu-se.academia.edu/ErikMalmqvist?f_ri=4387","photo":"https://0.academia-photos.com/1272309/467433/12855637/s65_erik.malmqvist.jpg"}],"research_interests":[{"id":2504,"name":"Research Ethics","url":"https://www.academia.edu/Documents/in/Research_Ethics?f_ri=4387","nofollow":true},{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_69820383" data-work_id="69820383" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/69820383/Study_protocol_of_a_single_arm_pre_post_study_to_assess_the_preliminary_effectiveness_and_feasibility_of_a_home_based_bimodal_prehabilitation_program_on_preoperative_aerobic_fitness_in_high_risk_patients_scheduled_for_liver_or_pancreatic_resection">Study protocol of a single-arm pre-post study to assess the preliminary effectiveness and feasibility of a home-based bimodal prehabilitation program on preoperative aerobic fitness in high-risk patients scheduled for liver or pancreatic resection</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Background: Controversial evidence currently exists regarding the feasibility and effectiveness to improve preoperative aerobic fitness during home-based prehabilitation in patients scheduled for liver or pancreatic resection, whereas... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_69820383" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Background: Controversial evidence currently exists regarding the feasibility and effectiveness to improve preoperative aerobic fitness during home-based prehabilitation in patients scheduled for liver or pancreatic resection, whereas morbidity rates are high following these resections. The primary aim of this study is to evaluate the preoperative oxygen uptake (VO2) at the ventilatory anaerobic threshold before and after a four-week home-based preoperative training program with nutritional supplementation in high-risk patients scheduled for elective liver or pancreatic resection. Secondary aims are to evaluate program feasibility, immune system function, cardiopulmonary exercise test responses, individual progression profiles on training responses, quality of life, and postoperative course.Methods: In this multicenter study with a pretest-posttest design, patients with a liver or pancreatic tumor scheduled for elective resection will be recruited. To select the high-risk fraction o...</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/69820383" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="b2d8cba02a3402eadc92c8bad4d68f80" rel="nofollow" data-download="{"attachment_id":79769474,"asset_id":69820383,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/79769474/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="46444223" href="https://unimaas.academia.edu/BartBongers">Bart Bongers</a><script data-card-contents-for-user="46444223" type="text/json">{"id":46444223,"first_name":"Bart","last_name":"Bongers","domain_name":"unimaas","page_name":"BartBongers","display_name":"Bart Bongers","profile_url":"https://unimaas.academia.edu/BartBongers?f_ri=4387","photo":"/images/s65_no_pic.png"}</script></span></span></li><li class="js-paper-rank-work_69820383 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="69820383"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 69820383, container: ".js-paper-rank-work_69820383", }); });</script></li><li class="js-percentile-work_69820383 InlineList-item InlineList-item--bordered hidden u-tcGrayDark"><span class="percentile-widget hidden"><span class="u-mr2x percentile-widget" style="display: none">•</span><span class="u-mr2x work-percentile"></span></span><script>$(function () { var workId = 69820383; window.Academia.workPercentilesFetcher.queue(workId, function (percentileText) { var container = $(".js-percentile-work_69820383"); container.find('.work-percentile').text(percentileText.charAt(0).toUpperCase() + percentileText.slice(1)); container.find('.percentile-widget').show(); container.find('.percentile-widget').removeClass('hidden'); }); });</script></li><li class="js-view-count-work_69820383 InlineList-item InlineList-item--bordered hidden"><div><span><span class="js-view-count view-count u-mr2x" data-work-id="69820383"><i class="fa fa-spinner fa-spin"></i></span><script>$(function () { var workId = 69820383; window.Academia.workViewCountsFetcher.queue(workId, function (count) { var description = window.$h.commaizeInt(count) + " " + window.$h.pluralize(count, 'View'); $(".js-view-count[data-work-id=69820383]").text(description); $(".js-view-count-work_69820383").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_69820383").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="69820383"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i></div><span class="InlineList-item-text u-textTruncate u-pl6x"><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a><script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (false) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=69820383]'), work: {"id":69820383,"title":"Study protocol of a single-arm pre-post study to assess the preliminary effectiveness and feasibility of a home-based bimodal prehabilitation program on preoperative aerobic fitness in high-risk patients scheduled for liver or pancreatic resection","created_at":"2022-01-28T12:32:25.825-08:00","url":"https://www.academia.edu/69820383/Study_protocol_of_a_single_arm_pre_post_study_to_assess_the_preliminary_effectiveness_and_feasibility_of_a_home_based_bimodal_prehabilitation_program_on_preoperative_aerobic_fitness_in_high_risk_patients_scheduled_for_liver_or_pancreatic_resection?f_ri=4387","dom_id":"work_69820383","summary":"Background: Controversial evidence currently exists regarding the feasibility and effectiveness to improve preoperative aerobic fitness during home-based prehabilitation in patients scheduled for liver or pancreatic resection, whereas morbidity rates are high following these resections. The primary aim of this study is to evaluate the preoperative oxygen uptake (VO2) at the ventilatory anaerobic threshold before and after a four-week home-based preoperative training program with nutritional supplementation in high-risk patients scheduled for elective liver or pancreatic resection. Secondary aims are to evaluate program feasibility, immune system function, cardiopulmonary exercise test responses, individual progression profiles on training responses, quality of life, and postoperative course.Methods: In this multicenter study with a pretest-posttest design, patients with a liver or pancreatic tumor scheduled for elective resection will be recruited. To select the high-risk fraction o...","downloadable_attachments":[{"id":79769474,"asset_id":69820383,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":46444223,"first_name":"Bart","last_name":"Bongers","domain_name":"unimaas","page_name":"BartBongers","display_name":"Bart Bongers","profile_url":"https://unimaas.academia.edu/BartBongers?f_ri=4387","photo":"/images/s65_no_pic.png"}],"research_interests":[{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_8532905" data-work_id="8532905" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/8532905/Generalized_multidimensional_dynamic_allocation_method">Generalized multidimensional dynamic allocation method</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Dynamic allocation has received considerable attention since it was first proposed in the 1970s as an alternative means of allocating treatments in clinical trials which helps to secure the balance of prognostic factors across treatment... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_8532905" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Dynamic allocation has received considerable attention since it was first proposed in the 1970s as an alternative means of allocating treatments in clinical trials which helps to secure the balance of prognostic factors across treatment groups. The purpose of this paper is to present a generalized multidimensional dynamic allocation method that simultaneously balances treatment assignments at three key levels: within the overall study, within each level of each prognostic factor, and within each stratum, that is, combination of levels of different factors Further it offers capabilities for unbalanced and adaptive designs for trials. The treatment balancing performance of the proposed method is investigated through simulations which compare multidimensional dynamic allocation with traditional stratified block randomization and the Pocock-Simon method. On the basis of these results, we conclude that this generalized multidimensional dynamic allocation method is an improvement over conventional dynamic allocation methods and is flexible enough to be applied for most trial settings including Phases I, II and III trials.</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/8532905" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="ec7837c0256b2db46f0cbbd467ec47d7" rel="nofollow" data-download="{"attachment_id":34909591,"asset_id":8532905,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/34909591/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="17523410" href="https://independent.academia.edu/JohnnDoee">Johnn Doee</a><script data-card-contents-for-user="17523410" type="text/json">{"id":17523410,"first_name":"Johnn","last_name":"Doee","domain_name":"independent","page_name":"JohnnDoee","display_name":"Johnn Doee","profile_url":"https://independent.academia.edu/JohnnDoee?f_ri=4387","photo":"/images/s65_no_pic.png"}</script></span></span></li><li class="js-paper-rank-work_8532905 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="8532905"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 8532905, container: ".js-paper-rank-work_8532905", }); });</script></li><li class="js-percentile-work_8532905 InlineList-item InlineList-item--bordered hidden u-tcGrayDark"><span class="percentile-widget hidden"><span class="u-mr2x percentile-widget" style="display: none">•</span><span class="u-mr2x work-percentile"></span></span><script>$(function () { var workId = 8532905; window.Academia.workPercentilesFetcher.queue(workId, function (percentileText) { var container = $(".js-percentile-work_8532905"); container.find('.work-percentile').text(percentileText.charAt(0).toUpperCase() + percentileText.slice(1)); container.find('.percentile-widget').show(); container.find('.percentile-widget').removeClass('hidden'); }); });</script></li><li class="js-view-count-work_8532905 InlineList-item InlineList-item--bordered hidden"><div><span><span class="js-view-count view-count u-mr2x" data-work-id="8532905"><i class="fa fa-spinner fa-spin"></i></span><script>$(function () { var workId = 8532905; window.Academia.workViewCountsFetcher.queue(workId, function (count) { var description = window.$h.commaizeInt(count) + " " + window.$h.pluralize(count, 'View'); $(".js-view-count[data-work-id=8532905]").text(description); $(".js-view-count-work_8532905").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_8532905").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="8532905"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">5</a>  </div><span class="InlineList-item-text u-textTruncate u-pl9x"><a class="InlineList-item-text" data-has-card-for-ri="892" rel="nofollow" href="https://www.academia.edu/Documents/in/Statistics">Statistics</a>, <script data-card-contents-for-ri="892" type="text/json">{"id":892,"name":"Statistics","url":"https://www.academia.edu/Documents/in/Statistics?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="7462" rel="nofollow" href="https://www.academia.edu/Documents/in/Randomization">Randomization</a>, <script data-card-contents-for-ri="7462" type="text/json">{"id":7462,"name":"Randomization","url":"https://www.academia.edu/Documents/in/Randomization?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="799329" rel="nofollow" href="https://www.academia.edu/Documents/in/Dynamic_Channel_Allocation">Dynamic Channel Allocation</a><script data-card-contents-for-ri="799329" type="text/json">{"id":799329,"name":"Dynamic Channel Allocation","url":"https://www.academia.edu/Documents/in/Dynamic_Channel_Allocation?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=8532905]'), work: {"id":8532905,"title":"Generalized multidimensional dynamic allocation method","created_at":"2014-09-28T06:35:23.392-07:00","url":"https://www.academia.edu/8532905/Generalized_multidimensional_dynamic_allocation_method?f_ri=4387","dom_id":"work_8532905","summary":"Dynamic allocation has received considerable attention since it was first proposed in the 1970s as an alternative means of allocating treatments in clinical trials which helps to secure the balance of prognostic factors across treatment groups. The purpose of this paper is to present a generalized multidimensional dynamic allocation method that simultaneously balances treatment assignments at three key levels: within the overall study, within each level of each prognostic factor, and within each stratum, that is, combination of levels of different factors Further it offers capabilities for unbalanced and adaptive designs for trials. The treatment balancing performance of the proposed method is investigated through simulations which compare multidimensional dynamic allocation with traditional stratified block randomization and the Pocock-Simon method. On the basis of these results, we conclude that this generalized multidimensional dynamic allocation method is an improvement over conventional dynamic allocation methods and is flexible enough to be applied for most trial settings including Phases I, II and III trials.","downloadable_attachments":[{"id":34909591,"asset_id":8532905,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":17523410,"first_name":"Johnn","last_name":"Doee","domain_name":"independent","page_name":"JohnnDoee","display_name":"Johnn Doee","profile_url":"https://independent.academia.edu/JohnnDoee?f_ri=4387","photo":"/images/s65_no_pic.png"}],"research_interests":[{"id":892,"name":"Statistics","url":"https://www.academia.edu/Documents/in/Statistics?f_ri=4387","nofollow":true},{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":7462,"name":"Randomization","url":"https://www.academia.edu/Documents/in/Randomization?f_ri=4387","nofollow":true},{"id":799329,"name":"Dynamic Channel Allocation","url":"https://www.academia.edu/Documents/in/Dynamic_Channel_Allocation?f_ri=4387","nofollow":true},{"id":1561665,"name":"Minimization","url":"https://www.academia.edu/Documents/in/Minimization?f_ri=4387"}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_73674404" data-work_id="73674404" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/73674404/Challenges_in_conducting_clinical_trials_in_nephrology_conclusions_from_a_Kidney_Disease_Improving_Global_Outcomes_KDIGO_Controversies_Conference">Challenges in conducting clinical trials in nephrology: conclusions from a Kidney Disease—Improving Global Outcomes (KDIGO) Controversies Conference</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Despite the high costs of treatment of people with kidney disease and associated comorbid conditions, the amount of reliable information available to guide the care of such patients is very limited. Some treatments have been assessed in... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_73674404" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Despite the high costs of treatment of people with kidney disease and associated comorbid conditions, the amount of reliable information available to guide the care of such patients is very limited. Some treatments have been assessed in randomized trials, but most such trials have been too small to detect treatment effects of a magnitude that would be realistic to achieve with a single intervention. Therefore, KDIGO convened an international, multidisciplinary controversies conference titled &quot; Challenges in the Conduct of Clinical Trials in Nephrology &quot; to identify the key barriers to conducting trials in patients with kidney disease. The conference began with plenary talks focusing on the key areas of discussion that included appropriate trial design (covering identification and evaluation of kidney and nonkidney disease outcomes) and sensible trial execution (with particular emphasis on streamlining both design and conduct). Break out group discussions followed in which ...</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/73674404" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="2cf18ed05f2a4a988a9c3b973f730733" rel="nofollow" data-download="{"attachment_id":82103406,"asset_id":73674404,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/82103406/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="33789107" href="https://independent.academia.edu/AdeeraLevin">Adeera Levin</a><script data-card-contents-for-user="33789107" type="text/json">{"id":33789107,"first_name":"Adeera","last_name":"Levin","domain_name":"independent","page_name":"AdeeraLevin","display_name":"Adeera Levin","profile_url":"https://independent.academia.edu/AdeeraLevin?f_ri=4387","photo":"/images/s65_no_pic.png"}</script></span></span></li><li class="js-paper-rank-work_73674404 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="73674404"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 73674404, container: ".js-paper-rank-work_73674404", }); });</script></li><li class="js-percentile-work_73674404 InlineList-item InlineList-item--bordered hidden u-tcGrayDark"><span class="percentile-widget hidden"><span class="u-mr2x percentile-widget" style="display: none">•</span><span class="u-mr2x work-percentile"></span></span><script>$(function () { var workId = 73674404; window.Academia.workPercentilesFetcher.queue(workId, function (percentileText) { var container = $(".js-percentile-work_73674404"); container.find('.work-percentile').text(percentileText.charAt(0).toUpperCase() + percentileText.slice(1)); container.find('.percentile-widget').show(); container.find('.percentile-widget').removeClass('hidden'); }); });</script></li><li class="js-view-count-work_73674404 InlineList-item InlineList-item--bordered hidden"><div><span><span class="js-view-count view-count u-mr2x" data-work-id="73674404"><i class="fa fa-spinner fa-spin"></i></span><script>$(function () { var workId = 73674404; window.Academia.workViewCountsFetcher.queue(workId, function (count) { var description = window.$h.commaizeInt(count) + " " + window.$h.pluralize(count, 'View'); $(".js-view-count[data-work-id=73674404]").text(description); $(".js-view-count-work_73674404").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_73674404").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="73674404"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">12</a>  </div><span class="InlineList-item-text u-textTruncate u-pl10x"><a class="InlineList-item-text" data-has-card-for-ri="622" rel="nofollow" href="https://www.academia.edu/Documents/in/Nephrology">Nephrology</a>, <script data-card-contents-for-ri="622" type="text/json">{"id":622,"name":"Nephrology","url":"https://www.academia.edu/Documents/in/Nephrology?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="4531" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trial">Clinical Trial</a>, <script data-card-contents-for-ri="4531" type="text/json">{"id":4531,"name":"Clinical Trial","url":"https://www.academia.edu/Documents/in/Clinical_Trial?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="8999" rel="nofollow" href="https://www.academia.edu/Documents/in/Kidney_diseases">Kidney diseases</a><script data-card-contents-for-ri="8999" type="text/json">{"id":8999,"name":"Kidney diseases","url":"https://www.academia.edu/Documents/in/Kidney_diseases?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=73674404]'), work: {"id":73674404,"title":"Challenges in conducting clinical trials in nephrology: conclusions from a Kidney Disease—Improving Global Outcomes (KDIGO) Controversies Conference","created_at":"2022-03-13T10:32:31.969-07:00","url":"https://www.academia.edu/73674404/Challenges_in_conducting_clinical_trials_in_nephrology_conclusions_from_a_Kidney_Disease_Improving_Global_Outcomes_KDIGO_Controversies_Conference?f_ri=4387","dom_id":"work_73674404","summary":"Despite the high costs of treatment of people with kidney disease and associated comorbid conditions, the amount of reliable information available to guide the care of such patients is very limited. Some treatments have been assessed in randomized trials, but most such trials have been too small to detect treatment effects of a magnitude that would be realistic to achieve with a single intervention. Therefore, KDIGO convened an international, multidisciplinary controversies conference titled \u0026quot; Challenges in the Conduct of Clinical Trials in Nephrology \u0026quot; to identify the key barriers to conducting trials in patients with kidney disease. The conference began with plenary talks focusing on the key areas of discussion that included appropriate trial design (covering identification and evaluation of kidney and nonkidney disease outcomes) and sensible trial execution (with particular emphasis on streamlining both design and conduct). Break out group discussions followed in which ...","downloadable_attachments":[{"id":82103406,"asset_id":73674404,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":33789107,"first_name":"Adeera","last_name":"Levin","domain_name":"independent","page_name":"AdeeraLevin","display_name":"Adeera Levin","profile_url":"https://independent.academia.edu/AdeeraLevin?f_ri=4387","photo":"/images/s65_no_pic.png"}],"research_interests":[{"id":622,"name":"Nephrology","url":"https://www.academia.edu/Documents/in/Nephrology?f_ri=4387","nofollow":true},{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":4531,"name":"Clinical Trial","url":"https://www.academia.edu/Documents/in/Clinical_Trial?f_ri=4387","nofollow":true},{"id":8999,"name":"Kidney diseases","url":"https://www.academia.edu/Documents/in/Kidney_diseases?f_ri=4387","nofollow":true},{"id":9000,"name":"Acute kidney injury","url":"https://www.academia.edu/Documents/in/Acute_kidney_injury?f_ri=4387"},{"id":9001,"name":"Chronic kidney disease","url":"https://www.academia.edu/Documents/in/Chronic_kidney_disease?f_ri=4387"},{"id":9003,"name":"Kidney transplantation","url":"https://www.academia.edu/Documents/in/Kidney_transplantation?f_ri=4387"},{"id":26327,"name":"Medicine","url":"https://www.academia.edu/Documents/in/Medicine?f_ri=4387"},{"id":71294,"name":"Kidney","url":"https://www.academia.edu/Documents/in/Kidney?f_ri=4387"},{"id":244814,"name":"Clinical Sciences","url":"https://www.academia.edu/Documents/in/Clinical_Sciences?f_ri=4387"},{"id":396050,"name":"Human Clinical Trials","url":"https://www.academia.edu/Documents/in/Human_Clinical_Trials?f_ri=4387"},{"id":2463778,"name":"Clinical Trials as Topic","url":"https://www.academia.edu/Documents/in/Clinical_Trials_as_Topic?f_ri=4387"}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_25270300" data-work_id="25270300" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/25270300/Physical_activity_during_pregnancy_and_maternal_child_health_PAMELA_study_protocol_for_a_randomized_controlled_trial_Physical_activity_during_pregnancy_and_maternal_child_health_PAMELA_study_protocol_for_a_randomized_controlled_trial">Physical activity during pregnancy and maternal- child health (PAMELA): study protocol for a randomized controlled trial Physical activity during pregnancy and maternal- child health (PAMELA): study protocol for a randomized controlled trial</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Background: Preterm birth is associated with most cases of neonatal deaths and negative health outcomes, and hypertensive disorders. Hypertension is influenced by maternal behavior, such as physical activity. Physical activity is... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_25270300" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Background: Preterm birth is associated with most cases of neonatal deaths and negative health outcomes, and hypertensive disorders. Hypertension is influenced by maternal behavior, such as physical activity. Physical activity is associated with better outcomes for mother and fetus, besides healthier weight gains during pregnancy. Few women are physically active during pregnancy and few clinical trials have been carried out with pregnant women. The aim of this paper is to describe the protocol of a controlled trial evaluating whether regular exercise during pregnancy may result in improved maternal-child health and neonatal outcomes. Methods/Design: The PAMELA (Physical Activity for Mothers Enrolled in Longitudinal Analysis) trial is a randomized controlled trial nested in a birth cohort study. Eligible women belonging to the birth cohort will be invited (between the 16th and 20th week of gestation) to enroll in the trial. Baseline data (blood and urine samples, anthropometry and pulmonary function) will be collected at enrollment. The same assessments will be repeated eight and 16 weeks after baseline. After randomization, women will be allocated into either one of these groups: control, 426 women who will be advised to keep their usual daily activities; and intervention, 213 women who will engage in an exercise program, three sessions a week. At least 70 % attendance over 16 weeks will be required to be considered compliant to the intervention. Exercise protocol will include aerobics, strength and flexibility training. Maternal and child outcomes will be measured at the 36th week of gestation, at birth and at three, 12, 24 and 48 months postpartum. An intention-to-treat analysis will be performed.</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/25270300" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="5906bd73783644e24afe42fd2961641e" rel="nofollow" data-download="{"attachment_id":45573225,"asset_id":25270300,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/45573225/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="39344674" href="https://ufpel.academia.edu/MDomingues">M. Domingues</a><script data-card-contents-for-user="39344674" type="text/json">{"id":39344674,"first_name":"M.","last_name":"Domingues","domain_name":"ufpel","page_name":"MDomingues","display_name":"M. Domingues","profile_url":"https://ufpel.academia.edu/MDomingues?f_ri=4387","photo":"https://0.academia-photos.com/39344674/10847642/12106579/s65_m..domingues.jpg"}</script></span></span></li><li class="js-paper-rank-work_25270300 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="25270300"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 25270300, container: ".js-paper-rank-work_25270300", }); });</script></li><li class="js-percentile-work_25270300 InlineList-item InlineList-item--bordered hidden u-tcGrayDark"><span class="percentile-widget hidden"><span class="u-mr2x percentile-widget" style="display: none">•</span><span class="u-mr2x work-percentile"></span></span><script>$(function () { var workId = 25270300; window.Academia.workPercentilesFetcher.queue(workId, function (percentileText) { var container = $(".js-percentile-work_25270300"); container.find('.work-percentile').text(percentileText.charAt(0).toUpperCase() + percentileText.slice(1)); container.find('.percentile-widget').show(); container.find('.percentile-widget').removeClass('hidden'); }); });</script></li><li class="js-view-count-work_25270300 InlineList-item InlineList-item--bordered hidden"><div><span><span class="js-view-count view-count u-mr2x" data-work-id="25270300"><i class="fa fa-spinner fa-spin"></i></span><script>$(function () { var workId = 25270300; window.Academia.workViewCountsFetcher.queue(workId, function (count) { var description = window.$h.commaizeInt(count) + " " + window.$h.pluralize(count, 'View'); $(".js-view-count[data-work-id=25270300]").text(description); $(".js-view-count-work_25270300").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_25270300").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="25270300"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">4</a>  </div><span class="InlineList-item-text u-textTruncate u-pl9x"><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="9112" rel="nofollow" href="https://www.academia.edu/Documents/in/Physical_Activity">Physical Activity</a>, <script data-card-contents-for-ri="9112" type="text/json">{"id":9112,"name":"Physical Activity","url":"https://www.academia.edu/Documents/in/Physical_Activity?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="62550" rel="nofollow" href="https://www.academia.edu/Documents/in/Pregnancy">Pregnancy</a>, <script data-card-contents-for-ri="62550" type="text/json">{"id":62550,"name":"Pregnancy","url":"https://www.academia.edu/Documents/in/Pregnancy?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="131185" rel="nofollow" href="https://www.academia.edu/Documents/in/Cohort_Study">Cohort Study</a><script data-card-contents-for-ri="131185" type="text/json">{"id":131185,"name":"Cohort Study","url":"https://www.academia.edu/Documents/in/Cohort_Study?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=25270300]'), work: {"id":25270300,"title":"Physical activity during pregnancy and maternal- child health (PAMELA): study protocol for a randomized controlled trial Physical activity during pregnancy and maternal- child health (PAMELA): study protocol for a randomized controlled trial","created_at":"2016-05-12T07:43:17.969-07:00","url":"https://www.academia.edu/25270300/Physical_activity_during_pregnancy_and_maternal_child_health_PAMELA_study_protocol_for_a_randomized_controlled_trial_Physical_activity_during_pregnancy_and_maternal_child_health_PAMELA_study_protocol_for_a_randomized_controlled_trial?f_ri=4387","dom_id":"work_25270300","summary":"Background: Preterm birth is associated with most cases of neonatal deaths and negative health outcomes, and hypertensive disorders. Hypertension is influenced by maternal behavior, such as physical activity. Physical activity is associated with better outcomes for mother and fetus, besides healthier weight gains during pregnancy. Few women are physically active during pregnancy and few clinical trials have been carried out with pregnant women. The aim of this paper is to describe the protocol of a controlled trial evaluating whether regular exercise during pregnancy may result in improved maternal-child health and neonatal outcomes. Methods/Design: The PAMELA (Physical Activity for Mothers Enrolled in Longitudinal Analysis) trial is a randomized controlled trial nested in a birth cohort study. Eligible women belonging to the birth cohort will be invited (between the 16th and 20th week of gestation) to enroll in the trial. Baseline data (blood and urine samples, anthropometry and pulmonary function) will be collected at enrollment. The same assessments will be repeated eight and 16 weeks after baseline. After randomization, women will be allocated into either one of these groups: control, 426 women who will be advised to keep their usual daily activities; and intervention, 213 women who will engage in an exercise program, three sessions a week. At least 70 % attendance over 16 weeks will be required to be considered compliant to the intervention. Exercise protocol will include aerobics, strength and flexibility training. Maternal and child outcomes will be measured at the 36th week of gestation, at birth and at three, 12, 24 and 48 months postpartum. An intention-to-treat analysis will be performed.","downloadable_attachments":[{"id":45573225,"asset_id":25270300,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":39344674,"first_name":"M.","last_name":"Domingues","domain_name":"ufpel","page_name":"MDomingues","display_name":"M. Domingues","profile_url":"https://ufpel.academia.edu/MDomingues?f_ri=4387","photo":"https://0.academia-photos.com/39344674/10847642/12106579/s65_m..domingues.jpg"}],"research_interests":[{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":9112,"name":"Physical Activity","url":"https://www.academia.edu/Documents/in/Physical_Activity?f_ri=4387","nofollow":true},{"id":62550,"name":"Pregnancy","url":"https://www.academia.edu/Documents/in/Pregnancy?f_ri=4387","nofollow":true},{"id":131185,"name":"Cohort Study","url":"https://www.academia.edu/Documents/in/Cohort_Study?f_ri=4387","nofollow":true}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_44910639" data-work_id="44910639" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/44910639/The_reality_of_informed_consent_empirical_studies_on_patient_comprehension_systematic_review">The reality of informed consent: empirical studies on patient comprehension-systematic review</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Background: Informed consent is a basic concept of contemporary, autonomy-based medical practice and facilitates a shared decision-making model for relations between physicians and patients. Thus, the extent to which patients can... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_44910639" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Background: Informed consent is a basic concept of contemporary, autonomy-based medical practice and facilitates a shared decision-making model for relations between physicians and patients. Thus, the extent to which patients can comprehend the consent they grant is essential to the ethical viability of medicine as it is pursued today. However, research on patients' comprehension of an informed consent's basic components shows that their level of understanding is limited. Methods: Systemic searches of the PubMed and Web of Science databases were performed to identify the literature on informed consent, specifically patients' comprehension of specific informed consent components. Results: In total, 14 relevant articles were retrieved. In most studies, few clinical trial participants correctly responded to items that examined their awareness of what they consented to. Participants demonstrated the highest level of understanding (over 50%) regarding voluntary participation, blinding (excluding knowledge about investigators' blinding), and freedom to withdraw at any time. Only a small minority of patients demonstrated comprehension of placebo concepts, randomisation, safety issues, risks, and side effects. Conclusions: We found that participants' comprehension of fundamental informed consent components was low, which is worrisome because this lack of understanding undermines an ethical pillar of contemporary clinical trial practice and questions the viability of patients' full and genuine involvement in a shared medical decision-making process.</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/44910639" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="052ee65c2bafede87479c2bded29e80f" rel="nofollow" data-download="{"attachment_id":65432203,"asset_id":44910639,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/65432203/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="262193" href="https://silesian.academia.edu/TomaszPietrzykowski">Tomasz Pietrzykowski</a><script data-card-contents-for-user="262193" type="text/json">{"id":262193,"first_name":"Tomasz","last_name":"Pietrzykowski","domain_name":"silesian","page_name":"TomaszPietrzykowski","display_name":"Tomasz Pietrzykowski","profile_url":"https://silesian.academia.edu/TomaszPietrzykowski?f_ri=4387","photo":"https://0.academia-photos.com/262193/64536/130626207/s65_tomasz.pietrzykowski.png"}</script></span></span></li><li class="js-paper-rank-work_44910639 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="44910639"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 44910639, container: ".js-paper-rank-work_44910639", }); });</script></li><li class="js-percentile-work_44910639 InlineList-item InlineList-item--bordered hidden u-tcGrayDark"><span class="percentile-widget hidden"><span class="u-mr2x percentile-widget" style="display: none">•</span><span class="u-mr2x work-percentile"></span></span><script>$(function () { var workId = 44910639; window.Academia.workPercentilesFetcher.queue(workId, function (percentileText) { var container = $(".js-percentile-work_44910639"); container.find('.work-percentile').text(percentileText.charAt(0).toUpperCase() + percentileText.slice(1)); container.find('.percentile-widget').show(); container.find('.percentile-widget').removeClass('hidden'); }); });</script></li><li class="js-view-count-work_44910639 InlineList-item InlineList-item--bordered hidden"><div><span><span class="js-view-count view-count u-mr2x" data-work-id="44910639"><i class="fa fa-spinner fa-spin"></i></span><script>$(function () { var workId = 44910639; window.Academia.workViewCountsFetcher.queue(workId, function (count) { var description = window.$h.commaizeInt(count) + " " + window.$h.pluralize(count, 'View'); $(".js-view-count[data-work-id=44910639]").text(description); $(".js-view-count-work_44910639").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_44910639").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="44910639"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">8</a>  </div><span class="InlineList-item-text u-textTruncate u-pl9x"><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="6728" rel="nofollow" href="https://www.academia.edu/Documents/in/Philosophy_Of_Law">Philosophy Of Law</a>, <script data-card-contents-for-ri="6728" type="text/json">{"id":6728,"name":"Philosophy Of Law","url":"https://www.academia.edu/Documents/in/Philosophy_Of_Law?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="9435" rel="nofollow" href="https://www.academia.edu/Documents/in/Medical_Ethics">Medical Ethics</a>, <script data-card-contents-for-ri="9435" type="text/json">{"id":9435,"name":"Medical Ethics","url":"https://www.academia.edu/Documents/in/Medical_Ethics?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="26327" rel="nofollow" href="https://www.academia.edu/Documents/in/Medicine">Medicine</a><script data-card-contents-for-ri="26327" type="text/json">{"id":26327,"name":"Medicine","url":"https://www.academia.edu/Documents/in/Medicine?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=44910639]'), work: {"id":44910639,"title":"The reality of informed consent: empirical studies on patient comprehension-systematic review","created_at":"2021-01-15T06:38:07.515-08:00","url":"https://www.academia.edu/44910639/The_reality_of_informed_consent_empirical_studies_on_patient_comprehension_systematic_review?f_ri=4387","dom_id":"work_44910639","summary":"Background: Informed consent is a basic concept of contemporary, autonomy-based medical practice and facilitates a shared decision-making model for relations between physicians and patients. Thus, the extent to which patients can comprehend the consent they grant is essential to the ethical viability of medicine as it is pursued today. However, research on patients' comprehension of an informed consent's basic components shows that their level of understanding is limited. Methods: Systemic searches of the PubMed and Web of Science databases were performed to identify the literature on informed consent, specifically patients' comprehension of specific informed consent components. Results: In total, 14 relevant articles were retrieved. In most studies, few clinical trial participants correctly responded to items that examined their awareness of what they consented to. Participants demonstrated the highest level of understanding (over 50%) regarding voluntary participation, blinding (excluding knowledge about investigators' blinding), and freedom to withdraw at any time. Only a small minority of patients demonstrated comprehension of placebo concepts, randomisation, safety issues, risks, and side effects. Conclusions: We found that participants' comprehension of fundamental informed consent components was low, which is worrisome because this lack of understanding undermines an ethical pillar of contemporary clinical trial practice and questions the viability of patients' full and genuine involvement in a shared medical decision-making process.","downloadable_attachments":[{"id":65432203,"asset_id":44910639,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":262193,"first_name":"Tomasz","last_name":"Pietrzykowski","domain_name":"silesian","page_name":"TomaszPietrzykowski","display_name":"Tomasz Pietrzykowski","profile_url":"https://silesian.academia.edu/TomaszPietrzykowski?f_ri=4387","photo":"https://0.academia-photos.com/262193/64536/130626207/s65_tomasz.pietrzykowski.png"}],"research_interests":[{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":6728,"name":"Philosophy Of Law","url":"https://www.academia.edu/Documents/in/Philosophy_Of_Law?f_ri=4387","nofollow":true},{"id":9435,"name":"Medical Ethics","url":"https://www.academia.edu/Documents/in/Medical_Ethics?f_ri=4387","nofollow":true},{"id":26327,"name":"Medicine","url":"https://www.academia.edu/Documents/in/Medicine?f_ri=4387","nofollow":true},{"id":29420,"name":"Clinical trials (Health Sciences)","url":"https://www.academia.edu/Documents/in/Clinical_trials_Health_Sciences_?f_ri=4387"},{"id":33093,"name":"Medical and Research ethics","url":"https://www.academia.edu/Documents/in/Medical_and_Research_ethics?f_ri=4387"},{"id":100552,"name":"Medical Law and Ethics","url":"https://www.academia.edu/Documents/in/Medical_Law_and_Ethics?f_ri=4387"},{"id":399736,"name":"Free Prior and Informed Consent","url":"https://www.academia.edu/Documents/in/Free_Prior_and_Informed_Consent?f_ri=4387"}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_41163340" data-work_id="41163340" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/41163340/Efficacy_of_pumpkin_oil_a_Persian_medicine_product_in_the_treatment_of_chronic_insomnia_A_randomized_double_blind_clinical_trial">Efficacy of pumpkin oil (a Persian medicine product) in the treatment of chronic insomnia: A randomized double-blind clinical trial</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Context: According to Persian medicine text, there are some topical herbal remedies for insomnia such as pumpkin oil as a nasal drop. Aims: To evaluate the effect of pumpkin oil (a Persian medicine product) in patients with chronic... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_41163340" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Context: According to Persian medicine text, there are some topical herbal remedies for insomnia such as pumpkin oil as a nasal drop.<br /><br />Aims: To evaluate the effect of pumpkin oil (a Persian medicine product) in patients with chronic insomnia.<br /><br />Methods: This study was conducted as a randomized double-blind clinical trial on pumpkin oil efficacy in 74 patients with chronic insomnia. The participants received two drops of intranasal pumpkin oil or placebo every night for two weeks. The effects of pumpkin oil and placebo on the pattern of sleep and sleep quality were assessed at baseline and at the end of two weeks of treatment by Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) questionnaires.<br /><br />Results: The scores of the ISI questioner were statistically different between groups after two weeks of intervention and patients in the pumpkin oil group had fewer scores for ISI questioner (p<0.001). The reduction of the total score of the Pittsburgh questioner was 10.08 ± 3.21 in the pumpkin oil group and 0.28 ± 0.98 (p<0.001) in the control group.<br /><br />Conclusions: Pumpkin oil could have a significant positive effect on the quantity and the quality of sleep in patients with chronic insomnia.</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/41163340" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="89b87e4b690d8827898a83f8e502d53f" rel="nofollow" data-download="{"attachment_id":61404823,"asset_id":41163340,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/61404823/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="13838875" href="https://independent.academia.edu/JournalPharmacyPharmacognosyResJPPRes">Journal Pharmacy Pharmacognosy Res JPPRes</a><script data-card-contents-for-user="13838875" type="text/json">{"id":13838875,"first_name":"Journal Pharmacy Pharmacognosy Res","last_name":"JPPRes","domain_name":"independent","page_name":"JournalPharmacyPharmacognosyResJPPRes","display_name":"Journal Pharmacy Pharmacognosy Res JPPRes","profile_url":"https://independent.academia.edu/JournalPharmacyPharmacognosyResJPPRes?f_ri=4387","photo":"https://gravatar.com/avatar/73db849da28752992bc1b6c420c97630?s=65"}</script></span></span></li><li class="js-paper-rank-work_41163340 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="41163340"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 41163340, container: ".js-paper-rank-work_41163340", }); 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$(".js-view-count[data-work-id=41163340]").text(description); $(".js-view-count-work_41163340").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_41163340").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="41163340"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">17</a>  </div><span class="InlineList-item-text u-textTruncate u-pl10x"><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="4531" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trial">Clinical Trial</a>, <script data-card-contents-for-ri="4531" type="text/json">{"id":4531,"name":"Clinical Trial","url":"https://www.academia.edu/Documents/in/Clinical_Trial?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="15019" rel="nofollow" href="https://www.academia.edu/Documents/in/Medicinal_Plants">Medicinal Plants</a>, <script data-card-contents-for-ri="15019" type="text/json">{"id":15019,"name":"Medicinal Plants","url":"https://www.academia.edu/Documents/in/Medicinal_Plants?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="29420" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_trials_Health_Sciences_">Clinical trials (Health Sciences)</a><script data-card-contents-for-ri="29420" type="text/json">{"id":29420,"name":"Clinical trials (Health Sciences)","url":"https://www.academia.edu/Documents/in/Clinical_trials_Health_Sciences_?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=41163340]'), work: {"id":41163340,"title":"Efficacy of pumpkin oil (a Persian medicine product) in the treatment of chronic insomnia: A randomized double-blind clinical trial","created_at":"2019-12-02T21:23:57.780-08:00","url":"https://www.academia.edu/41163340/Efficacy_of_pumpkin_oil_a_Persian_medicine_product_in_the_treatment_of_chronic_insomnia_A_randomized_double_blind_clinical_trial?f_ri=4387","dom_id":"work_41163340","summary":"Context: According to Persian medicine text, there are some topical herbal remedies for insomnia such as pumpkin oil as a nasal drop.\n\nAims: To evaluate the effect of pumpkin oil (a Persian medicine product) in patients with chronic insomnia.\n\nMethods: This study was conducted as a randomized double-blind clinical trial on pumpkin oil efficacy in 74 patients with chronic insomnia. The participants received two drops of intranasal pumpkin oil or placebo every night for two weeks. The effects of pumpkin oil and placebo on the pattern of sleep and sleep quality were assessed at baseline and at the end of two weeks of treatment by Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) questionnaires.\n\nResults: The scores of the ISI questioner were statistically different between groups after two weeks of intervention and patients in the pumpkin oil group had fewer scores for ISI questioner (p\u003c0.001). The reduction of the total score of the Pittsburgh questioner was 10.08 ± 3.21 in the pumpkin oil group and 0.28 ± 0.98 (p\u003c0.001) in the control group.\n\nConclusions: Pumpkin oil could have a significant positive effect on the quantity and the quality of sleep in patients with chronic insomnia.","downloadable_attachments":[{"id":61404823,"asset_id":41163340,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":13838875,"first_name":"Journal Pharmacy Pharmacognosy Res","last_name":"JPPRes","domain_name":"independent","page_name":"JournalPharmacyPharmacognosyResJPPRes","display_name":"Journal Pharmacy Pharmacognosy Res JPPRes","profile_url":"https://independent.academia.edu/JournalPharmacyPharmacognosyResJPPRes?f_ri=4387","photo":"https://gravatar.com/avatar/73db849da28752992bc1b6c420c97630?s=65"}],"research_interests":[{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":4531,"name":"Clinical Trial","url":"https://www.academia.edu/Documents/in/Clinical_Trial?f_ri=4387","nofollow":true},{"id":15019,"name":"Medicinal Plants","url":"https://www.academia.edu/Documents/in/Medicinal_Plants?f_ri=4387","nofollow":true},{"id":29420,"name":"Clinical trials (Health Sciences)","url":"https://www.academia.edu/Documents/in/Clinical_trials_Health_Sciences_?f_ri=4387","nofollow":true},{"id":37896,"name":"Insomnia","url":"https://www.academia.edu/Documents/in/Insomnia?f_ri=4387"},{"id":44297,"name":"Herbal Medicine","url":"https://www.academia.edu/Documents/in/Herbal_Medicine?f_ri=4387"},{"id":73418,"name":"Medicinal plants and natural products","url":"https://www.academia.edu/Documents/in/Medicinal_plants_and_natural_products?f_ri=4387"},{"id":141145,"name":"Plantas Medicinales","url":"https://www.academia.edu/Documents/in/Plantas_Medicinales?f_ri=4387"},{"id":373895,"name":"medicinal \u0026 Aromatic plants","url":"https://www.academia.edu/Documents/in/medicinal_and_Aromatic_plants?f_ri=4387"},{"id":396050,"name":"Human Clinical Trials","url":"https://www.academia.edu/Documents/in/Human_Clinical_Trials?f_ri=4387"},{"id":523212,"name":"Pumpkins","url":"https://www.academia.edu/Documents/in/Pumpkins?f_ri=4387"},{"id":923696,"name":"Pumpkin","url":"https://www.academia.edu/Documents/in/Pumpkin?f_ri=4387"},{"id":992299,"name":"Nasal Drops","url":"https://www.academia.edu/Documents/in/Nasal_Drops?f_ri=4387"},{"id":1134083,"name":"Medicinal Plant","url":"https://www.academia.edu/Documents/in/Medicinal_Plant?f_ri=4387"},{"id":1189254,"name":"Persian medicine","url":"https://www.academia.edu/Documents/in/Persian_medicine?f_ri=4387"},{"id":1931002,"name":"Traditional Persian Medicine","url":"https://www.academia.edu/Documents/in/Traditional_Persian_Medicine?f_ri=4387"},{"id":2960347,"name":"Oil extraction from Oil Seeds","url":"https://www.academia.edu/Documents/in/Oil_extraction_from_Oil_Seeds?f_ri=4387"}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_8615818" data-work_id="8615818" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/8615818/Development_and_reliability_of_the_HAM_D_MADRS_Interview_An_integrated_depression_symptom_rating_scale">Development and reliability of the HAM-D/MADRS Interview: An integrated depression symptom rating scale</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">The Hamilton Rating Scale for Depression (HAM-D) and the Montgomery-Å sberg Depression Rating Scale (MADRS), two widely used depression scales, each have unique advantages and limitations for research. The HAM-D's limited sensitivity and... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_8615818" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">The Hamilton Rating Scale for Depression (HAM-D) and the Montgomery-Å sberg Depression Rating Scale (MADRS), two widely used depression scales, each have unique advantages and limitations for research. The HAM-D's limited sensitivity and multidimensionality have been criticized, despite the scale's popularity. The MADRS, designed to be sensitive to treatment changes, is briefer and more uniform. A limitation of the MADRS is the lack of a structured interview, which may affect reliability. The HAM-D and the MADRS are often used conjointly as endpoints in depression trials. We designed a hybrid questionnaire that allows administration of MADRS and 31 HAM-D items simultaneously. Seventy mood disorder patients (60 bipolar I, 10 major depressive disorder) were administered the HAM-D/MADRS Interview (HMI) as part of a larger study. Interrater reliability for 50 patients was excellent for the HAM-D and the MADRS (ICC = 0.97-0.98). MADRS item reliabilities (ICC = 0.86-0.97) were higher than obtained in studies that did not use a structured interview. Reliability coefficients for seven HAM-D 31 datypicalT symptoms ranged from 0.77 to 0.95. HMI was highly correlated with the Global Clinical Impressions Scale. This is the first study we know of to investigate the reliability of a structured interview of either the MADRS or of the HAM-D 31 . The HMI provides an easily administered, reliable method of rating depression severity which may improve consistency and validity of study findings. D</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/8615818" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="57e6720a7410812128b8686e80530f27" rel="nofollow" data-download="{"attachment_id":34979980,"asset_id":8615818,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/34979980/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="17864459" href="https://ferkauf.academia.edu/JudithJaeger">Judith Jaeger</a><script data-card-contents-for-user="17864459" type="text/json">{"id":17864459,"first_name":"Judith","last_name":"Jaeger","domain_name":"ferkauf","page_name":"JudithJaeger","display_name":"Judith Jaeger","profile_url":"https://ferkauf.academia.edu/JudithJaeger?f_ri=4387","photo":"/images/s65_no_pic.png"}</script></span></span></li><li class="js-paper-rank-work_8615818 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="8615818"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 8615818, container: ".js-paper-rank-work_8615818", }); });</script></li><li class="js-percentile-work_8615818 InlineList-item InlineList-item--bordered hidden u-tcGrayDark"><span class="percentile-widget hidden"><span class="u-mr2x percentile-widget" style="display: none">•</span><span class="u-mr2x work-percentile"></span></span><script>$(function () { var workId = 8615818; window.Academia.workPercentilesFetcher.queue(workId, function (percentileText) { var container = $(".js-percentile-work_8615818"); container.find('.work-percentile').text(percentileText.charAt(0).toUpperCase() + percentileText.slice(1)); container.find('.percentile-widget').show(); container.find('.percentile-widget').removeClass('hidden'); }); });</script></li><li class="js-view-count-work_8615818 InlineList-item InlineList-item--bordered hidden"><div><span><span class="js-view-count view-count u-mr2x" data-work-id="8615818"><i class="fa fa-spinner fa-spin"></i></span><script>$(function () { var workId = 8615818; window.Academia.workViewCountsFetcher.queue(workId, function (count) { var description = window.$h.commaizeInt(count) + " " + window.$h.pluralize(count, 'View'); $(".js-view-count[data-work-id=8615818]").text(description); $(".js-view-count-work_8615818").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_8615818").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="8615818"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">4</a>  </div><span class="InlineList-item-text u-textTruncate u-pl9x"><a class="InlineList-item-text" data-has-card-for-ri="3217" rel="nofollow" href="https://www.academia.edu/Documents/in/Depression">Depression</a>, <script data-card-contents-for-ri="3217" type="text/json">{"id":3217,"name":"Depression","url":"https://www.academia.edu/Documents/in/Depression?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="77794" rel="nofollow" href="https://www.academia.edu/Documents/in/Major_Depressive_Disorder">Major Depressive Disorder</a>, <script data-card-contents-for-ri="77794" type="text/json">{"id":77794,"name":"Major Depressive Disorder","url":"https://www.academia.edu/Documents/in/Major_Depressive_Disorder?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="311947" rel="nofollow" href="https://www.academia.edu/Documents/in/Major_Depression">Major Depression</a><script data-card-contents-for-ri="311947" type="text/json">{"id":311947,"name":"Major Depression","url":"https://www.academia.edu/Documents/in/Major_Depression?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=8615818]'), work: {"id":8615818,"title":"Development and reliability of the HAM-D/MADRS Interview: An integrated depression symptom rating scale","created_at":"2014-10-03T01:02:12.142-07:00","url":"https://www.academia.edu/8615818/Development_and_reliability_of_the_HAM_D_MADRS_Interview_An_integrated_depression_symptom_rating_scale?f_ri=4387","dom_id":"work_8615818","summary":"The Hamilton Rating Scale for Depression (HAM-D) and the Montgomery-Å sberg Depression Rating Scale (MADRS), two widely used depression scales, each have unique advantages and limitations for research. The HAM-D's limited sensitivity and multidimensionality have been criticized, despite the scale's popularity. The MADRS, designed to be sensitive to treatment changes, is briefer and more uniform. A limitation of the MADRS is the lack of a structured interview, which may affect reliability. The HAM-D and the MADRS are often used conjointly as endpoints in depression trials. We designed a hybrid questionnaire that allows administration of MADRS and 31 HAM-D items simultaneously. Seventy mood disorder patients (60 bipolar I, 10 major depressive disorder) were administered the HAM-D/MADRS Interview (HMI) as part of a larger study. Interrater reliability for 50 patients was excellent for the HAM-D and the MADRS (ICC = 0.97-0.98). MADRS item reliabilities (ICC = 0.86-0.97) were higher than obtained in studies that did not use a structured interview. Reliability coefficients for seven HAM-D 31 datypicalT symptoms ranged from 0.77 to 0.95. HMI was highly correlated with the Global Clinical Impressions Scale. This is the first study we know of to investigate the reliability of a structured interview of either the MADRS or of the HAM-D 31 . The HMI provides an easily administered, reliable method of rating depression severity which may improve consistency and validity of study findings. D","downloadable_attachments":[{"id":34979980,"asset_id":8615818,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":17864459,"first_name":"Judith","last_name":"Jaeger","domain_name":"ferkauf","page_name":"JudithJaeger","display_name":"Judith Jaeger","profile_url":"https://ferkauf.academia.edu/JudithJaeger?f_ri=4387","photo":"/images/s65_no_pic.png"}],"research_interests":[{"id":3217,"name":"Depression","url":"https://www.academia.edu/Documents/in/Depression?f_ri=4387","nofollow":true},{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":77794,"name":"Major Depressive Disorder","url":"https://www.academia.edu/Documents/in/Major_Depressive_Disorder?f_ri=4387","nofollow":true},{"id":311947,"name":"Major Depression","url":"https://www.academia.edu/Documents/in/Major_Depression?f_ri=4387","nofollow":true}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_49413061" data-work_id="49413061" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/49413061/Efficacy_of_a_dilemma_focused_intervention_for_unipolar_depression_study_protocol_for_a_multicenter_randomized_controlled_trial">Efficacy of a dilemma-focused intervention for unipolar depression study protocol for a multicenter randomized controlled trial</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Background Depression is one of the more severe and serious health problems because of its morbidity, disabling effects and for its societal and economic burden. Despite the variety of existing pharmacological and psychological... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_49413061" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Background Depression is one of the more severe and serious health problems because of its morbidity, disabling effects and for its societal and economic burden. Despite the variety of existing pharmacological and psychological treatments, most of the cases evolve with only partial remission, relapse and recurrence. outcome measure, collected at baseline, at the end of therapy, and at 3-and 12-month follow-up; other secondary measures are also used. Discussion We expect that adding a dilemma-focused intervention to CBT will increase the efficacy of one of the more prestigious therapies for depression, thus resulting in a significant contribution to the psychological treatment of depression.</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/49413061" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="f6557429208151e3f5d9645ddee0ab5c" rel="nofollow" data-download="{"attachment_id":67771016,"asset_id":49413061,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/67771016/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="118078015" href="https://independent.academia.edu/Jos%C3%A9PedroGarc%C3%ADaSoriano">José Pedro García Soriano</a><script data-card-contents-for-user="118078015" type="text/json">{"id":118078015,"first_name":"José Pedro","last_name":"García Soriano","domain_name":"independent","page_name":"JoséPedroGarcíaSoriano","display_name":"José Pedro García Soriano","profile_url":"https://independent.academia.edu/Jos%C3%A9PedroGarc%C3%ADaSoriano?f_ri=4387","photo":"https://0.academia-photos.com/118078015/29699665/27605881/s65_jos_pedro.garc_a_soriano.jpg"}</script></span></span></li><li class="js-paper-rank-work_49413061 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="49413061"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 49413061, container: ".js-paper-rank-work_49413061", }); });</script></li><li class="js-percentile-work_49413061 InlineList-item InlineList-item--bordered hidden u-tcGrayDark"><span class="percentile-widget hidden"><span class="u-mr2x percentile-widget" style="display: none">•</span><span class="u-mr2x work-percentile"></span></span><script>$(function () { var workId = 49413061; window.Academia.workPercentilesFetcher.queue(workId, function (percentileText) { var container = $(".js-percentile-work_49413061"); container.find('.work-percentile').text(percentileText.charAt(0).toUpperCase() + percentileText.slice(1)); container.find('.percentile-widget').show(); container.find('.percentile-widget').removeClass('hidden'); }); });</script></li><li class="js-view-count-work_49413061 InlineList-item InlineList-item--bordered hidden"><div><span><span class="js-view-count view-count u-mr2x" data-work-id="49413061"><i class="fa fa-spinner fa-spin"></i></span><script>$(function () { var workId = 49413061; window.Academia.workViewCountsFetcher.queue(workId, function (count) { var description = window.$h.commaizeInt(count) + " " + window.$h.pluralize(count, 'View'); $(".js-view-count[data-work-id=49413061]").text(description); $(".js-view-count-work_49413061").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_49413061").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="49413061"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">19</a>  </div><span class="InlineList-item-text u-textTruncate u-pl10x"><a class="InlineList-item-text" data-has-card-for-ri="226" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Psychology">Clinical Psychology</a>, <script data-card-contents-for-ri="226" type="text/json">{"id":226,"name":"Clinical Psychology","url":"https://www.academia.edu/Documents/in/Clinical_Psychology?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="230" rel="nofollow" href="https://www.academia.edu/Documents/in/Cognitive_Behavioral_Therapy">Cognitive Behavioral Therapy</a>, <script data-card-contents-for-ri="230" type="text/json">{"id":230,"name":"Cognitive Behavioral Therapy","url":"https://www.academia.edu/Documents/in/Cognitive_Behavioral_Therapy?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="3217" rel="nofollow" href="https://www.academia.edu/Documents/in/Depression">Depression</a>, <script data-card-contents-for-ri="3217" type="text/json">{"id":3217,"name":"Depression","url":"https://www.academia.edu/Documents/in/Depression?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="3248" rel="nofollow" href="https://www.academia.edu/Documents/in/Constructivism">Constructivism</a><script data-card-contents-for-ri="3248" type="text/json">{"id":3248,"name":"Constructivism","url":"https://www.academia.edu/Documents/in/Constructivism?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=49413061]'), work: {"id":49413061,"title":"Efficacy of a dilemma-focused intervention for unipolar depression study protocol for a multicenter randomized controlled trial","created_at":"2021-06-26T21:10:45.715-07:00","url":"https://www.academia.edu/49413061/Efficacy_of_a_dilemma_focused_intervention_for_unipolar_depression_study_protocol_for_a_multicenter_randomized_controlled_trial?f_ri=4387","dom_id":"work_49413061","summary":"Background Depression is one of the more severe and serious health problems because of its morbidity, disabling effects and for its societal and economic burden. Despite the variety of existing pharmacological and psychological treatments, most of the cases evolve with only partial remission, relapse and recurrence. outcome measure, collected at baseline, at the end of therapy, and at 3-and 12-month follow-up; other secondary measures are also used. Discussion We expect that adding a dilemma-focused intervention to CBT will increase the efficacy of one of the more prestigious therapies for depression, thus resulting in a significant contribution to the psychological treatment of depression.","downloadable_attachments":[{"id":67771016,"asset_id":49413061,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":118078015,"first_name":"José Pedro","last_name":"García Soriano","domain_name":"independent","page_name":"JoséPedroGarcíaSoriano","display_name":"José Pedro García Soriano","profile_url":"https://independent.academia.edu/Jos%C3%A9PedroGarc%C3%ADaSoriano?f_ri=4387","photo":"https://0.academia-photos.com/118078015/29699665/27605881/s65_jos_pedro.garc_a_soriano.jpg"}],"research_interests":[{"id":226,"name":"Clinical Psychology","url":"https://www.academia.edu/Documents/in/Clinical_Psychology?f_ri=4387","nofollow":true},{"id":230,"name":"Cognitive Behavioral Therapy","url":"https://www.academia.edu/Documents/in/Cognitive_Behavioral_Therapy?f_ri=4387","nofollow":true},{"id":3217,"name":"Depression","url":"https://www.academia.edu/Documents/in/Depression?f_ri=4387","nofollow":true},{"id":3248,"name":"Constructivism","url":"https://www.academia.edu/Documents/in/Constructivism?f_ri=4387","nofollow":true},{"id":3279,"name":"Psychotherapy and Counseling","url":"https://www.academia.edu/Documents/in/Psychotherapy_and_Counseling?f_ri=4387"},{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387"},{"id":22517,"name":"CBT","url":"https://www.academia.edu/Documents/in/CBT?f_ri=4387"},{"id":25187,"name":"Group Psychotherapy","url":"https://www.academia.edu/Documents/in/Group_Psychotherapy?f_ri=4387"},{"id":101797,"name":"Cognitive Therapy","url":"https://www.academia.edu/Documents/in/Cognitive_Therapy?f_ri=4387"},{"id":105855,"name":"Cognitive Conflict","url":"https://www.academia.edu/Documents/in/Cognitive_Conflict?f_ri=4387"},{"id":131132,"name":"Personal Construct Theory","url":"https://www.academia.edu/Documents/in/Personal_Construct_Theory?f_ri=4387"},{"id":157943,"name":"Depressive Disorder","url":"https://www.academia.edu/Documents/in/Depressive_Disorder?f_ri=4387"},{"id":244814,"name":"Clinical Sciences","url":"https://www.academia.edu/Documents/in/Clinical_Sciences?f_ri=4387"},{"id":531565,"name":"Implicative dilemma","url":"https://www.academia.edu/Documents/in/Implicative_dilemma?f_ri=4387"},{"id":1011136,"name":"Clinical Protocols","url":"https://www.academia.edu/Documents/in/Clinical_Protocols?f_ri=4387"},{"id":1149340,"name":"Depression Psychology","url":"https://www.academia.edu/Documents/in/Depression_Psychology?f_ri=4387"},{"id":2467529,"name":"Psychiatric Status Rating Scales","url":"https://www.academia.edu/Documents/in/Psychiatric_Status_Rating_Scales?f_ri=4387"},{"id":2611891,"name":"Conflict Psychology","url":"https://www.academia.edu/Documents/in/Conflict_Psychology?f_ri=4387"},{"id":3789879,"name":"Cardiovascular medicine and haematology","url":"https://www.academia.edu/Documents/in/Cardiovascular_medicine_and_haematology?f_ri=4387"}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_12246037" data-work_id="12246037" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/12246037/Consenting_to_Heteronormativity_Sexual_Assumptions_in_Biomedical_Research">Consenting to Heteronormativity: Sexual Assumptions in Biomedical Research</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">The process of informed consent is fundamental to basic scientific research with human subjects. As one aspect of the scientific enterprise, clinical drug trials rely on informed consent documents to safeguard the ethical treatment of... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_12246037" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">The process of informed consent is fundamental to basic scientific research with human subjects. As one aspect of the scientific enterprise, clinical drug trials rely on informed consent documents to safeguard the ethical treatment of trial participants. This paper explores the role of heteronormative assumptions within this process, postulating the ways in which the biomedical texts that make up the informed consent process may render gay, lesbian, and non-binary gender-identifying participants discursively invisible. We argue that trial criteria and informed consent practices may reproduce a binary sex and gender system in which ‘male’ and ‘female’ subjects are presumed to identify as heterosexual and engage in procreative sex. This binary is not one of equivalence as female subjects who are able to have children may be wholly excluded or excessively controlled in studies while male subjects are merely admonished to use medically sanctioned birth control methods. Furthermore, we claim that the assumption of procreative heterosexual behaviors may pervade the informed consent process and the mundane practices of biomedical research more broadly. Given that these assumptions have important implications for risk and inclusivity in clinical trials, in the last part of this paper we outline directions for future research on the reproduction of heteronormativity in scientific discourse and practice. <br /> <br />Keywords: heteronormativity, biomedical research, clinical trials, gender binary, scientific discourse.</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/12246037" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="0146a32c1bf3777daec838e6a930aee2" rel="nofollow" data-download="{"attachment_id":37540497,"asset_id":12246037,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/37540497/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="337027" href="https://kenyon.academia.edu/MarciCottingham">Marci Cottingham</a><script data-card-contents-for-user="337027" type="text/json">{"id":337027,"first_name":"Marci","last_name":"Cottingham","domain_name":"kenyon","page_name":"MarciCottingham","display_name":"Marci Cottingham","profile_url":"https://kenyon.academia.edu/MarciCottingham?f_ri=4387","photo":"https://0.academia-photos.com/337027/1087152/24896112/s65_marci.cottingham.jpg"}</script></span></span></li><li class="js-paper-rank-work_12246037 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="12246037"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 12246037, container: ".js-paper-rank-work_12246037", }); });</script></li><li class="js-percentile-work_12246037 InlineList-item InlineList-item--bordered hidden u-tcGrayDark"><span class="percentile-widget hidden"><span class="u-mr2x percentile-widget" style="display: none">•</span><span class="u-mr2x work-percentile"></span></span><script>$(function () { var workId = 12246037; window.Academia.workPercentilesFetcher.queue(workId, function (percentileText) { var container = $(".js-percentile-work_12246037"); container.find('.work-percentile').text(percentileText.charAt(0).toUpperCase() + percentileText.slice(1)); container.find('.percentile-widget').show(); container.find('.percentile-widget').removeClass('hidden'); }); });</script></li><li class="js-view-count-work_12246037 InlineList-item InlineList-item--bordered hidden"><div><span><span class="js-view-count view-count u-mr2x" data-work-id="12246037"><i class="fa fa-spinner fa-spin"></i></span><script>$(function () { var workId = 12246037; window.Academia.workViewCountsFetcher.queue(workId, function (count) { var description = window.$h.commaizeInt(count) + " " + window.$h.pluralize(count, 'View'); $(".js-view-count[data-work-id=12246037]").text(description); $(".js-view-count-work_12246037").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_12246037").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="12246037"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">21</a>  </div><span class="InlineList-item-text u-textTruncate u-pl10x"><a class="InlineList-item-text" data-has-card-for-ri="94" rel="nofollow" href="https://www.academia.edu/Documents/in/Discourse_Analysis">Discourse Analysis</a>, <script data-card-contents-for-ri="94" type="text/json">{"id":94,"name":"Discourse Analysis","url":"https://www.academia.edu/Documents/in/Discourse_Analysis?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="200" rel="nofollow" href="https://www.academia.edu/Documents/in/Medical_Sociology">Medical Sociology</a>, <script data-card-contents-for-ri="200" type="text/json">{"id":200,"name":"Medical Sociology","url":"https://www.academia.edu/Documents/in/Medical_Sociology?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="696" rel="nofollow" href="https://www.academia.edu/Documents/in/Gender_Studies">Gender Studies</a>, <script data-card-contents-for-ri="696" type="text/json">{"id":696,"name":"Gender Studies","url":"https://www.academia.edu/Documents/in/Gender_Studies?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="2145" rel="nofollow" href="https://www.academia.edu/Documents/in/Sexual_and_Reproductive_Health">Sexual and Reproductive Health</a><script data-card-contents-for-ri="2145" type="text/json">{"id":2145,"name":"Sexual and Reproductive Health","url":"https://www.academia.edu/Documents/in/Sexual_and_Reproductive_Health?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=12246037]'), work: {"id":12246037,"title":"Consenting to Heteronormativity: Sexual Assumptions in Biomedical Research","created_at":"2015-05-05T08:18:19.276-07:00","url":"https://www.academia.edu/12246037/Consenting_to_Heteronormativity_Sexual_Assumptions_in_Biomedical_Research?f_ri=4387","dom_id":"work_12246037","summary":"The process of informed consent is fundamental to basic scientific research with human subjects. As one aspect of the scientific enterprise, clinical drug trials rely on informed consent documents to safeguard the ethical treatment of trial participants. This paper explores the role of heteronormative assumptions within this process, postulating the ways in which the biomedical texts that make up the informed consent process may render gay, lesbian, and non-binary gender-identifying participants discursively invisible. We argue that trial criteria and informed consent practices may reproduce a binary sex and gender system in which ‘male’ and ‘female’ subjects are presumed to identify as heterosexual and engage in procreative sex. This binary is not one of equivalence as female subjects who are able to have children may be wholly excluded or excessively controlled in studies while male subjects are merely admonished to use medically sanctioned birth control methods. Furthermore, we claim that the assumption of procreative heterosexual behaviors may pervade the informed consent process and the mundane practices of biomedical research more broadly. Given that these assumptions have important implications for risk and inclusivity in clinical trials, in the last part of this paper we outline directions for future research on the reproduction of heteronormativity in scientific discourse and practice.\r\n\r\nKeywords: heteronormativity, biomedical research, clinical trials, gender binary, scientific discourse.","downloadable_attachments":[{"id":37540497,"asset_id":12246037,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":337027,"first_name":"Marci","last_name":"Cottingham","domain_name":"kenyon","page_name":"MarciCottingham","display_name":"Marci Cottingham","profile_url":"https://kenyon.academia.edu/MarciCottingham?f_ri=4387","photo":"https://0.academia-photos.com/337027/1087152/24896112/s65_marci.cottingham.jpg"}],"research_interests":[{"id":94,"name":"Discourse Analysis","url":"https://www.academia.edu/Documents/in/Discourse_Analysis?f_ri=4387","nofollow":true},{"id":200,"name":"Medical Sociology","url":"https://www.academia.edu/Documents/in/Medical_Sociology?f_ri=4387","nofollow":true},{"id":696,"name":"Gender Studies","url":"https://www.academia.edu/Documents/in/Gender_Studies?f_ri=4387","nofollow":true},{"id":2145,"name":"Sexual and Reproductive Health","url":"https://www.academia.edu/Documents/in/Sexual_and_Reproductive_Health?f_ri=4387","nofollow":true},{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387"},{"id":4714,"name":"Sexuality","url":"https://www.academia.edu/Documents/in/Sexuality?f_ri=4387"},{"id":4917,"name":"Gender and Sexuality","url":"https://www.academia.edu/Documents/in/Gender_and_Sexuality?f_ri=4387"},{"id":7024,"name":"Gender","url":"https://www.academia.edu/Documents/in/Gender?f_ri=4387"},{"id":10011,"name":"Sociology of Health","url":"https://www.academia.edu/Documents/in/Sociology_of_Health?f_ri=4387"},{"id":14998,"name":"Gender and Sexuality Studies","url":"https://www.academia.edu/Documents/in/Gender_and_Sexuality_Studies?f_ri=4387"},{"id":16091,"name":"Sociology of Science","url":"https://www.academia.edu/Documents/in/Sociology_of_Science?f_ri=4387"},{"id":16323,"name":"Biopolitics","url":"https://www.academia.edu/Documents/in/Biopolitics?f_ri=4387"},{"id":21500,"name":"Social Studies Of Science","url":"https://www.academia.edu/Documents/in/Social_Studies_Of_Science?f_ri=4387"},{"id":30620,"name":"Sociology of Gender","url":"https://www.academia.edu/Documents/in/Sociology_of_Gender?f_ri=4387"},{"id":41745,"name":"Pharmaceutics","url":"https://www.academia.edu/Documents/in/Pharmaceutics?f_ri=4387"},{"id":42183,"name":"Heteronormativity","url":"https://www.academia.edu/Documents/in/Heteronormativity?f_ri=4387"},{"id":52738,"name":"Sociology of Medicine","url":"https://www.academia.edu/Documents/in/Sociology_of_Medicine?f_ri=4387"},{"id":53760,"name":"Sociology of Health and Illness","url":"https://www.academia.edu/Documents/in/Sociology_of_Health_and_Illness?f_ri=4387"},{"id":109741,"name":"Biomedical Sciences","url":"https://www.academia.edu/Documents/in/Biomedical_Sciences?f_ri=4387"},{"id":1030866,"name":"Sociology of Biomedicine and Health","url":"https://www.academia.edu/Documents/in/Sociology_of_Biomedicine_and_Health?f_ri=4387"},{"id":1744493,"name":"Science and Technology Studies","url":"https://www.academia.edu/Documents/in/Science_and_Technology_Studies?f_ri=4387"}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_50512745" data-work_id="50512745" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/50512745/Streamlining_and_Cycle_Time_Reduction_of_the_Start_up_Phase_of_Clinical_Trials">Streamlining and Cycle Time Reduction of the Start-up Phase of Clinical Trials</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Objective: The start up phase of a clinical trial (CT) plays a vital role in execution of novel drug development. Hence, this study aims to identify the factors responsible for delaying the CT start up phase. Further, it focuses on... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_50512745" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Objective: The start up phase of a clinical trial (CT) plays a vital role in execution of novel drug development. Hence, this study aims to identify the factors responsible for delaying the CT start up phase. Further, it focuses on streamlining and reducing the cycle time of the start up phase of newly sponsored CTs. Methodology: Thirteen sponsored CTs conducted (between 2016 and 2017) in clinical research department at King Fahad Medical City, Riyadh were analyzed to identify the data specific start up metrics using Find an improvement area Organize a team Clarify current practices Understand source of variation/problem Select a Strategy-Plan-Do-Check-Act (FOCUS-PDCA) cycle. Five measures incorporated in the metrics were: date of initial contact with site to the signing of confidentiality agreement; date of receiving questionnaire from sponsor to date of its completion; time taken to review protocol and approve investigational drug service (IDS) form; time taken to review protocol ...</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/50512745" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="e75111daf8c806b5d22a86ec3aac094d" rel="nofollow" data-download="{"attachment_id":68468680,"asset_id":50512745,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/68468680/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="51754301" href="https://independent.academia.edu/IAlfayyad">Isamme Alfayyad</a><script data-card-contents-for-user="51754301" type="text/json">{"id":51754301,"first_name":"Isamme","last_name":"Alfayyad","domain_name":"independent","page_name":"IAlfayyad","display_name":"Isamme Alfayyad","profile_url":"https://independent.academia.edu/IAlfayyad?f_ri=4387","photo":"/images/s65_no_pic.png"}</script></span></span></li><li class="js-paper-rank-work_50512745 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="50512745"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 50512745, container: ".js-paper-rank-work_50512745", }); });</script></li><li class="js-percentile-work_50512745 InlineList-item InlineList-item--bordered hidden u-tcGrayDark"><span class="percentile-widget hidden"><span class="u-mr2x percentile-widget" style="display: none">•</span><span class="u-mr2x work-percentile"></span></span><script>$(function () { var workId = 50512745; window.Academia.workPercentilesFetcher.queue(workId, function (percentileText) { var container = $(".js-percentile-work_50512745"); container.find('.work-percentile').text(percentileText.charAt(0).toUpperCase() + percentileText.slice(1)); container.find('.percentile-widget').show(); container.find('.percentile-widget').removeClass('hidden'); }); });</script></li><li class="js-view-count-work_50512745 InlineList-item InlineList-item--bordered hidden"><div><span><span class="js-view-count view-count u-mr2x" data-work-id="50512745"><i class="fa fa-spinner fa-spin"></i></span><script>$(function () { var workId = 50512745; window.Academia.workViewCountsFetcher.queue(workId, function (count) { var description = window.$h.commaizeInt(count) + " " + window.$h.pluralize(count, 'View'); $(".js-view-count[data-work-id=50512745]").text(description); $(".js-view-count-work_50512745").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_50512745").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="50512745"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">4</a>  </div><span class="InlineList-item-text u-textTruncate u-pl9x"><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="244814" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Sciences">Clinical Sciences</a>, <script data-card-contents-for-ri="244814" type="text/json">{"id":244814,"name":"Clinical Sciences","url":"https://www.academia.edu/Documents/in/Clinical_Sciences?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="435017" rel="nofollow" href="https://www.academia.edu/Documents/in/Trials">Trials</a>, <script data-card-contents-for-ri="435017" type="text/json">{"id":435017,"name":"Trials","url":"https://www.academia.edu/Documents/in/Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="3789879" rel="nofollow" href="https://www.academia.edu/Documents/in/Cardiovascular_medicine_and_haematology">Cardiovascular medicine and haematology</a><script data-card-contents-for-ri="3789879" type="text/json">{"id":3789879,"name":"Cardiovascular medicine and haematology","url":"https://www.academia.edu/Documents/in/Cardiovascular_medicine_and_haematology?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=50512745]'), work: {"id":50512745,"title":"Streamlining and Cycle Time Reduction of the Start-up Phase of Clinical Trials","created_at":"2021-08-01T07:39:29.941-07:00","url":"https://www.academia.edu/50512745/Streamlining_and_Cycle_Time_Reduction_of_the_Start_up_Phase_of_Clinical_Trials?f_ri=4387","dom_id":"work_50512745","summary":"Objective: The start up phase of a clinical trial (CT) plays a vital role in execution of novel drug development. Hence, this study aims to identify the factors responsible for delaying the CT start up phase. Further, it focuses on streamlining and reducing the cycle time of the start up phase of newly sponsored CTs. Methodology: Thirteen sponsored CTs conducted (between 2016 and 2017) in clinical research department at King Fahad Medical City, Riyadh were analyzed to identify the data specific start up metrics using Find an improvement area Organize a team Clarify current practices Understand source of variation/problem Select a Strategy-Plan-Do-Check-Act (FOCUS-PDCA) cycle. Five measures incorporated in the metrics were: date of initial contact with site to the signing of confidentiality agreement; date of receiving questionnaire from sponsor to date of its completion; time taken to review protocol and approve investigational drug service (IDS) form; time taken to review protocol ...","downloadable_attachments":[{"id":68468680,"asset_id":50512745,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":51754301,"first_name":"Isamme","last_name":"Alfayyad","domain_name":"independent","page_name":"IAlfayyad","display_name":"Isamme Alfayyad","profile_url":"https://independent.academia.edu/IAlfayyad?f_ri=4387","photo":"/images/s65_no_pic.png"}],"research_interests":[{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":244814,"name":"Clinical Sciences","url":"https://www.academia.edu/Documents/in/Clinical_Sciences?f_ri=4387","nofollow":true},{"id":435017,"name":"Trials","url":"https://www.academia.edu/Documents/in/Trials?f_ri=4387","nofollow":true},{"id":3789879,"name":"Cardiovascular medicine and haematology","url":"https://www.academia.edu/Documents/in/Cardiovascular_medicine_and_haematology?f_ri=4387","nofollow":true}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_6748941" data-work_id="6748941" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/6748941/Imagining_Atlanta_The_Politics_and_Poetics_of_Space_and_Marginality_in_Medical_Research_in_East_Africa">Imagining Atlanta: The Politics and Poetics of Space and Marginality in Medical Research in East Africa</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">to discuss the status of the trials and give updates on their participants. They discuss the number of new volunteers enrolled, and whether or not the weekly goals have been met; they report how many volunteers missed follow--up... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_6748941" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">to discuss the status of the trials and give updates on their participants. They discuss the number of new volunteers enrolled, and whether or not the weekly goals have been met; they report how many volunteers missed follow--up appointments and the number of new pregnancies, and how many volunteers seroconverted and how many withdrew from the study. These meetings usually begin with a prayer and conclude with 'AOBs'-or, 'any other business'. The chair queries each individual staff member-Apollo? Helena? Bryan?-and in response most silently shake their heads but every once in a while a team member will raise an issue that was not covered in the formal agenda. I was attending such a meeting in Kisumu, Kenya, in 2007 when one of the team members abruptly stopped the flow of the AOBs when she inquired about the possibility of buying a baby coffin for an infant enrolled in the study who had died. 1</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/6748941" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="058a0d9438d1fa3908f706997e6ba3c2" rel="nofollow" data-download="{"attachment_id":33462744,"asset_id":6748941,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/33462744/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="1073219" href="https://yorku.academia.edu/DenielleElliott">Denielle Elliott</a><script data-card-contents-for-user="1073219" type="text/json">{"id":1073219,"first_name":"Denielle","last_name":"Elliott","domain_name":"yorku","page_name":"DenielleElliott","display_name":"Denielle Elliott","profile_url":"https://yorku.academia.edu/DenielleElliott?f_ri=4387","photo":"https://0.academia-photos.com/1073219/371385/16631644/s65_denielle.elliott.jpg"}</script></span></span></li><li class="js-paper-rank-work_6748941 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="6748941"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 6748941, container: ".js-paper-rank-work_6748941", }); });</script></li><li class="js-percentile-work_6748941 InlineList-item InlineList-item--bordered hidden u-tcGrayDark"><span class="percentile-widget hidden"><span class="u-mr2x percentile-widget" style="display: none">•</span><span class="u-mr2x work-percentile"></span></span><script>$(function () { var workId = 6748941; window.Academia.workPercentilesFetcher.queue(workId, function (percentileText) { var container = $(".js-percentile-work_6748941"); container.find('.work-percentile').text(percentileText.charAt(0).toUpperCase() + percentileText.slice(1)); container.find('.percentile-widget').show(); container.find('.percentile-widget').removeClass('hidden'); }); });</script></li><li class="js-view-count-work_6748941 InlineList-item InlineList-item--bordered hidden"><div><span><span class="js-view-count view-count u-mr2x" data-work-id="6748941"><i class="fa fa-spinner fa-spin"></i></span><script>$(function () { var workId = 6748941; window.Academia.workViewCountsFetcher.queue(workId, function (count) { var description = window.$h.commaizeInt(count) + " " + window.$h.pluralize(count, 'View'); $(".js-view-count[data-work-id=6748941]").text(description); $(".js-view-count-work_6748941").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_6748941").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="6748941"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">4</a>  </div><span class="InlineList-item-text u-textTruncate u-pl9x"><a class="InlineList-item-text" data-has-card-for-ri="793" rel="nofollow" href="https://www.academia.edu/Documents/in/Medical_Anthropology">Medical Anthropology</a>, <script data-card-contents-for-ri="793" type="text/json">{"id":793,"name":"Medical Anthropology","url":"https://www.academia.edu/Documents/in/Medical_Anthropology?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="13514" rel="nofollow" href="https://www.academia.edu/Documents/in/STS_Anthropology_">STS (Anthropology)</a>, <script data-card-contents-for-ri="13514" type="text/json">{"id":13514,"name":"STS (Anthropology)","url":"https://www.academia.edu/Documents/in/STS_Anthropology_?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="18892" rel="nofollow" href="https://www.academia.edu/Documents/in/Kenya">Kenya</a><script data-card-contents-for-ri="18892" type="text/json">{"id":18892,"name":"Kenya","url":"https://www.academia.edu/Documents/in/Kenya?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=6748941]'), work: {"id":6748941,"title":"Imagining Atlanta: The Politics and Poetics of Space and Marginality in Medical Research in East Africa","created_at":"2014-04-13T21:23:40.479-07:00","url":"https://www.academia.edu/6748941/Imagining_Atlanta_The_Politics_and_Poetics_of_Space_and_Marginality_in_Medical_Research_in_East_Africa?f_ri=4387","dom_id":"work_6748941","summary":"to discuss the status of the trials and give updates on their participants. They discuss the number of new volunteers enrolled, and whether or not the weekly goals have been met; they report how many volunteers missed follow--up appointments and the number of new pregnancies, and how many volunteers seroconverted and how many withdrew from the study. These meetings usually begin with a prayer and conclude with 'AOBs'-or, 'any other business'. The chair queries each individual staff member-Apollo? Helena? Bryan?-and in response most silently shake their heads but every once in a while a team member will raise an issue that was not covered in the formal agenda. I was attending such a meeting in Kisumu, Kenya, in 2007 when one of the team members abruptly stopped the flow of the AOBs when she inquired about the possibility of buying a baby coffin for an infant enrolled in the study who had died. 1","downloadable_attachments":[{"id":33462744,"asset_id":6748941,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":1073219,"first_name":"Denielle","last_name":"Elliott","domain_name":"yorku","page_name":"DenielleElliott","display_name":"Denielle Elliott","profile_url":"https://yorku.academia.edu/DenielleElliott?f_ri=4387","photo":"https://0.academia-photos.com/1073219/371385/16631644/s65_denielle.elliott.jpg"}],"research_interests":[{"id":793,"name":"Medical Anthropology","url":"https://www.academia.edu/Documents/in/Medical_Anthropology?f_ri=4387","nofollow":true},{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":13514,"name":"STS (Anthropology)","url":"https://www.academia.edu/Documents/in/STS_Anthropology_?f_ri=4387","nofollow":true},{"id":18892,"name":"Kenya","url":"https://www.academia.edu/Documents/in/Kenya?f_ri=4387","nofollow":true}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_49886324" data-work_id="49886324" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/49886324/Information_and_Digital_Technology_Advances_in_Healthcare_and_Clinical_Research_Industry_during_the_COVID_19_Pandemic">Information and Digital Technology Advances in Healthcare & Clinical Research Industry during the COVID-19 Pandemic</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">COVID-19 has left a large impact on the way various Information Technology advances are applied in healthcare and day to day life. Digital surveillance has found its way into public health management across the world. Data Analytics is... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_49886324" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">COVID-19 has left a large impact on the way various Information Technology advances are applied in healthcare and day to day life. Digital surveillance has found its way into public health management across the world. Data Analytics is one of the most powerful tools being used in healthcare research, specifically COVID-19 research. Artificial Intelligence and Machine Learning are paving a new path into drug design and development along with revolutionizing Medical Care. Virtual Reality has found its due place as a tool for therapy and for better imaging. Starting from diagnostics to data analytics, Information Technology solutions have left a huge impact on the course of COVID-19. The world witnessed the fastest development of a vaccine with advances in technology. Virtual tools and remote solutions are realigning the Clinical Research industry and equipping researchers with novel study designs and solutions. The aim of this article is to provide a summary of the ways in which Information Technology has improved Healthcare during the pandemic and to list out the impact of COVID-19 on Clinical Trials. The industry has seen leaps and bounds of advances in the use of technology. The need of the hour, now, is to start building a framework to apply these tools routinely, so that preparedness is maintained for any future health crisis. A strong regulatory framework is much needed to back the industry to adapt to these advances.</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/49886324" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="f4587d30afc741165dfc6af2e61d57c9" rel="nofollow" data-download="{"attachment_id":68077025,"asset_id":49886324,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/68077025/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="198665230" href="https://independent.academia.edu/vidyasingan">Sai Vidhya Singan</a><script data-card-contents-for-user="198665230" type="text/json">{"id":198665230,"first_name":"Sai Vidhya","last_name":"Singan","domain_name":"independent","page_name":"vidyasingan","display_name":"Sai Vidhya Singan","profile_url":"https://independent.academia.edu/vidyasingan?f_ri=4387","photo":"https://0.academia-photos.com/198665230/60524546/48787144/s65_vidya.singan.jpeg"}</script></span></span></li><li class="js-paper-rank-work_49886324 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="49886324"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 49886324, container: ".js-paper-rank-work_49886324", }); });</script></li><li class="js-percentile-work_49886324 InlineList-item InlineList-item--bordered hidden u-tcGrayDark"><span class="percentile-widget hidden"><span class="u-mr2x percentile-widget" style="display: none">•</span><span class="u-mr2x work-percentile"></span></span><script>$(function () { var workId = 49886324; window.Academia.workPercentilesFetcher.queue(workId, function (percentileText) { var container = $(".js-percentile-work_49886324"); container.find('.work-percentile').text(percentileText.charAt(0).toUpperCase() + percentileText.slice(1)); container.find('.percentile-widget').show(); container.find('.percentile-widget').removeClass('hidden'); }); });</script></li><li class="js-view-count-work_49886324 InlineList-item InlineList-item--bordered hidden"><div><span><span class="js-view-count view-count u-mr2x" data-work-id="49886324"><i class="fa fa-spinner fa-spin"></i></span><script>$(function () { var workId = 49886324; window.Academia.workViewCountsFetcher.queue(workId, function (count) { var description = window.$h.commaizeInt(count) + " " + window.$h.pluralize(count, 'View'); $(".js-view-count[data-work-id=49886324]").text(description); $(".js-view-count-work_49886324").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_49886324").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="49886324"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">4</a>  </div><span class="InlineList-item-text u-textTruncate u-pl9x"><a class="InlineList-item-text" data-has-card-for-ri="3611" rel="nofollow" href="https://www.academia.edu/Documents/in/Digital_Technology">Digital Technology</a>, <script data-card-contents-for-ri="3611" type="text/json">{"id":3611,"name":"Digital Technology","url":"https://www.academia.edu/Documents/in/Digital_Technology?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="46182" rel="nofollow" href="https://www.academia.edu/Documents/in/Pharmaceutical_industry">Pharmaceutical industry</a>, <script data-card-contents-for-ri="46182" type="text/json">{"id":46182,"name":"Pharmaceutical industry","url":"https://www.academia.edu/Documents/in/Pharmaceutical_industry?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="129891" rel="nofollow" href="https://www.academia.edu/Documents/in/Research_and_Development-2">Research and Development</a><script data-card-contents-for-ri="129891" type="text/json">{"id":129891,"name":"Research and Development","url":"https://www.academia.edu/Documents/in/Research_and_Development-2?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=49886324]'), work: {"id":49886324,"title":"Information and Digital Technology Advances in Healthcare \u0026 Clinical Research Industry during the COVID-19 Pandemic","created_at":"2021-07-13T21:25:39.461-07:00","url":"https://www.academia.edu/49886324/Information_and_Digital_Technology_Advances_in_Healthcare_and_Clinical_Research_Industry_during_the_COVID_19_Pandemic?f_ri=4387","dom_id":"work_49886324","summary":"COVID-19 has left a large impact on the way various Information Technology advances are applied in healthcare and day to day life. Digital surveillance has found its way into public health management across the world. Data Analytics is one of the most powerful tools being used in healthcare research, specifically COVID-19 research. Artificial Intelligence and Machine Learning are paving a new path into drug design and development along with revolutionizing Medical Care. Virtual Reality has found its due place as a tool for therapy and for better imaging. Starting from diagnostics to data analytics, Information Technology solutions have left a huge impact on the course of COVID-19. The world witnessed the fastest development of a vaccine with advances in technology. Virtual tools and remote solutions are realigning the Clinical Research industry and equipping researchers with novel study designs and solutions. The aim of this article is to provide a summary of the ways in which Information Technology has improved Healthcare during the pandemic and to list out the impact of COVID-19 on Clinical Trials. The industry has seen leaps and bounds of advances in the use of technology. The need of the hour, now, is to start building a framework to apply these tools routinely, so that preparedness is maintained for any future health crisis. A strong regulatory framework is much needed to back the industry to adapt to these advances.","downloadable_attachments":[{"id":68077025,"asset_id":49886324,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":198665230,"first_name":"Sai Vidhya","last_name":"Singan","domain_name":"independent","page_name":"vidyasingan","display_name":"Sai Vidhya Singan","profile_url":"https://independent.academia.edu/vidyasingan?f_ri=4387","photo":"https://0.academia-photos.com/198665230/60524546/48787144/s65_vidya.singan.jpeg"}],"research_interests":[{"id":3611,"name":"Digital Technology","url":"https://www.academia.edu/Documents/in/Digital_Technology?f_ri=4387","nofollow":true},{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":46182,"name":"Pharmaceutical industry","url":"https://www.academia.edu/Documents/in/Pharmaceutical_industry?f_ri=4387","nofollow":true},{"id":129891,"name":"Research and Development","url":"https://www.academia.edu/Documents/in/Research_and_Development-2?f_ri=4387","nofollow":true}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_38961961" data-work_id="38961961" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/38961961/A_Questionnaire_Survey_on_awareness_of_Clinical_Trials_Among_Medical_Students">A Questionnaire Survey on awareness of Clinical Trials Among Medical Students</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">There is an immense need to inculcate research in the medical curriculum of undergraduate medical students, which will help them to interpret the evidence based literature like journal articles, analyze, interpret & to help their decision... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_38961961" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">There is an immense need to inculcate research in the medical curriculum of undergraduate medical students, which will help them to interpret the evidence based literature like journal articles, analyze, interpret & to help their decision making ability. Involvement in innovative research will help them develop a holistic attitude towards the patients especially in terms of informed consent and ethical decisions. This study a questionnaire survey was conducted on undergraduate medical students. It consists of statements spread over various aspects of clinical trials. The percentage of questions answered correctly in each group was graded as good, average and poor depending on scores. A total of 257 students participated in the study. Students had average knowledge about statements describing concept, need of clinical trial, participation, about Food and Drug Administration, informed consent had average knowledge. The response was poor for statements on Institutional Review Board (IRB) and Drug Controller General of India (DCGI). The medical undergraduates are future innovators, clinicians and scientific explorers. It would be better if they are trained at earlier days of learning about clinical trials/research and medical ethics these can be made a part of medical curriculum so that they can build their concrete future.</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/38961961" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="8ecacc8c865e854872039c5ef7b97e35" rel="nofollow" data-download="{"attachment_id":59065164,"asset_id":38961961,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/59065164/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="33720417" href="https://fmsc.academia.edu/RupamGill">Rupam Gill</a><script data-card-contents-for-user="33720417" type="text/json">{"id":33720417,"first_name":"Rupam","last_name":"Gill","domain_name":"fmsc","page_name":"RupamGill","display_name":"Rupam Gill","profile_url":"https://fmsc.academia.edu/RupamGill?f_ri=4387","photo":"https://0.academia-photos.com/33720417/11710808/13055956/s65_rupam_kaur.gill.jpg"}</script></span></span></li><li class="js-paper-rank-work_38961961 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="38961961"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 38961961, container: ".js-paper-rank-work_38961961", }); });</script></li><li class="js-percentile-work_38961961 InlineList-item InlineList-item--bordered hidden u-tcGrayDark"><span class="percentile-widget hidden"><span class="u-mr2x percentile-widget" style="display: none">•</span><span class="u-mr2x work-percentile"></span></span><script>$(function () { var workId = 38961961; window.Academia.workPercentilesFetcher.queue(workId, function (percentileText) { var container = $(".js-percentile-work_38961961"); container.find('.work-percentile').text(percentileText.charAt(0).toUpperCase() + percentileText.slice(1)); container.find('.percentile-widget').show(); container.find('.percentile-widget').removeClass('hidden'); }); });</script></li><li class="js-view-count-work_38961961 InlineList-item InlineList-item--bordered hidden"><div><span><span class="js-view-count view-count u-mr2x" data-work-id="38961961"><i class="fa fa-spinner fa-spin"></i></span><script>$(function () { var workId = 38961961; window.Academia.workViewCountsFetcher.queue(workId, function (count) { var description = window.$h.commaizeInt(count) + " " + window.$h.pluralize(count, 'View'); $(".js-view-count[data-work-id=38961961]").text(description); $(".js-view-count-work_38961961").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_38961961").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="38961961"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">3</a>  </div><span class="InlineList-item-text u-textTruncate u-pl9x"><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="14238" rel="nofollow" href="https://www.academia.edu/Documents/in/Survey_Research">Survey Research</a>, <script data-card-contents-for-ri="14238" type="text/json">{"id":14238,"name":"Survey Research","url":"https://www.academia.edu/Documents/in/Survey_Research?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="327850" rel="nofollow" href="https://www.academia.edu/Documents/in/Questionnaires">Questionnaires</a><script data-card-contents-for-ri="327850" type="text/json">{"id":327850,"name":"Questionnaires","url":"https://www.academia.edu/Documents/in/Questionnaires?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=38961961]'), work: {"id":38961961,"title":"A Questionnaire Survey on awareness of Clinical Trials Among Medical Students","created_at":"2019-04-28T11:29:35.858-07:00","url":"https://www.academia.edu/38961961/A_Questionnaire_Survey_on_awareness_of_Clinical_Trials_Among_Medical_Students?f_ri=4387","dom_id":"work_38961961","summary":"There is an immense need to inculcate research in the medical curriculum of undergraduate medical students, which will help them to interpret the evidence based literature like journal articles, analyze, interpret \u0026 to help their decision making ability. Involvement in innovative research will help them develop a holistic attitude towards the patients especially in terms of informed consent and ethical decisions. This study a questionnaire survey was conducted on undergraduate medical students. It consists of statements spread over various aspects of clinical trials. The percentage of questions answered correctly in each group was graded as good, average and poor depending on scores. A total of 257 students participated in the study. Students had average knowledge about statements describing concept, need of clinical trial, participation, about Food and Drug Administration, informed consent had average knowledge. The response was poor for statements on Institutional Review Board (IRB) and Drug Controller General of India (DCGI). The medical undergraduates are future innovators, clinicians and scientific explorers. It would be better if they are trained at earlier days of learning about clinical trials/research and medical ethics these can be made a part of medical curriculum so that they can build their concrete future.","downloadable_attachments":[{"id":59065164,"asset_id":38961961,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":33720417,"first_name":"Rupam","last_name":"Gill","domain_name":"fmsc","page_name":"RupamGill","display_name":"Rupam Gill","profile_url":"https://fmsc.academia.edu/RupamGill?f_ri=4387","photo":"https://0.academia-photos.com/33720417/11710808/13055956/s65_rupam_kaur.gill.jpg"}],"research_interests":[{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":14238,"name":"Survey Research","url":"https://www.academia.edu/Documents/in/Survey_Research?f_ri=4387","nofollow":true},{"id":327850,"name":"Questionnaires","url":"https://www.academia.edu/Documents/in/Questionnaires?f_ri=4387","nofollow":true}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_69119568" data-work_id="69119568" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/69119568/The_effects_of_bioactive_compounds_on_biomarkers_of_obesity">The effects of bioactive compounds on biomarkers of obesity</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Background: The world is presently facing a prolonged struggle without a predictable cure. Obesity causes hundreds of thousands of fatalities each year, along with holding a position as a primary contributor to several other virulent... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_69119568" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Background: The world is presently facing a prolonged struggle without a predictable cure. Obesity causes hundreds of thousands of fatalities each year, along with holding a position as a primary contributor to several other virulent chronic diseases. This review of scientific literature will examine the current state of obesity along with the mechanisms and biomarkers that lay the foundation for the development of the disease. Furthermore, this article will assess several functional foods and the bioactive compounds they contain that play an influential role in the prevention and treatment of obesity as a chronic disease. By presenting many relevant functional food research studies, this review aims to offer auxiliary support to traditional obesity treatments. The topic of functional foods and their relation to obesity is an extremely important topic to explore due to the severe expansion of obesity in the past few decades. Overall, the purpose of this review is to supply a compreh...</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/69119568" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="562d77199a0f4a122770e8e4c4ea0444" rel="nofollow" data-download="{"attachment_id":79339006,"asset_id":69119568,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/79339006/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="71697658" href="https://independent.academia.edu/MartirosyanDanik">Food Science Publisher</a><script data-card-contents-for-user="71697658" type="text/json">{"id":71697658,"first_name":"Food Science","last_name":"Publisher","domain_name":"independent","page_name":"MartirosyanDanik","display_name":"Food Science Publisher","profile_url":"https://independent.academia.edu/MartirosyanDanik?f_ri=4387","photo":"https://0.academia-photos.com/71697658/43007818/34320184/s65_food_science.publisher.jpg"}</script></span></span></li><li class="js-paper-rank-work_69119568 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="69119568"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 69119568, container: ".js-paper-rank-work_69119568", }); });</script></li><li class="js-percentile-work_69119568 InlineList-item InlineList-item--bordered hidden u-tcGrayDark"><span class="percentile-widget hidden"><span class="u-mr2x percentile-widget" style="display: none">•</span><span class="u-mr2x work-percentile"></span></span><script>$(function () { var workId = 69119568; window.Academia.workPercentilesFetcher.queue(workId, function (percentileText) { var container = $(".js-percentile-work_69119568"); container.find('.work-percentile').text(percentileText.charAt(0).toUpperCase() + percentileText.slice(1)); container.find('.percentile-widget').show(); container.find('.percentile-widget').removeClass('hidden'); }); });</script></li><li class="js-view-count-work_69119568 InlineList-item InlineList-item--bordered hidden"><div><span><span class="js-view-count view-count u-mr2x" data-work-id="69119568"><i class="fa fa-spinner fa-spin"></i></span><script>$(function () { var workId = 69119568; window.Academia.workViewCountsFetcher.queue(workId, function (count) { var description = window.$h.commaizeInt(count) + " " + window.$h.pluralize(count, 'View'); $(".js-view-count[data-work-id=69119568]").text(description); $(".js-view-count-work_69119568").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_69119568").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="69119568"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">6</a>  </div><span class="InlineList-item-text u-textTruncate u-pl9x"><a class="InlineList-item-text" data-has-card-for-ri="3851" rel="nofollow" href="https://www.academia.edu/Documents/in/Obesity">Obesity</a>, <script data-card-contents-for-ri="3851" type="text/json">{"id":3851,"name":"Obesity","url":"https://www.academia.edu/Documents/in/Obesity?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="26327" rel="nofollow" href="https://www.academia.edu/Documents/in/Medicine">Medicine</a>, <script data-card-contents-for-ri="26327" type="text/json">{"id":26327,"name":"Medicine","url":"https://www.academia.edu/Documents/in/Medicine?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="51369" rel="nofollow" href="https://www.academia.edu/Documents/in/Functional_Foods">Functional Foods</a><script data-card-contents-for-ri="51369" type="text/json">{"id":51369,"name":"Functional Foods","url":"https://www.academia.edu/Documents/in/Functional_Foods?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=69119568]'), work: {"id":69119568,"title":"The effects of bioactive compounds on biomarkers of obesity","created_at":"2022-01-22T01:56:24.063-08:00","url":"https://www.academia.edu/69119568/The_effects_of_bioactive_compounds_on_biomarkers_of_obesity?f_ri=4387","dom_id":"work_69119568","summary":"Background: The world is presently facing a prolonged struggle without a predictable cure. Obesity causes hundreds of thousands of fatalities each year, along with holding a position as a primary contributor to several other virulent chronic diseases. This review of scientific literature will examine the current state of obesity along with the mechanisms and biomarkers that lay the foundation for the development of the disease. Furthermore, this article will assess several functional foods and the bioactive compounds they contain that play an influential role in the prevention and treatment of obesity as a chronic disease. By presenting many relevant functional food research studies, this review aims to offer auxiliary support to traditional obesity treatments. The topic of functional foods and their relation to obesity is an extremely important topic to explore due to the severe expansion of obesity in the past few decades. Overall, the purpose of this review is to supply a compreh...","downloadable_attachments":[{"id":79339006,"asset_id":69119568,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":71697658,"first_name":"Food Science","last_name":"Publisher","domain_name":"independent","page_name":"MartirosyanDanik","display_name":"Food Science Publisher","profile_url":"https://independent.academia.edu/MartirosyanDanik?f_ri=4387","photo":"https://0.academia-photos.com/71697658/43007818/34320184/s65_food_science.publisher.jpg"}],"research_interests":[{"id":3851,"name":"Obesity","url":"https://www.academia.edu/Documents/in/Obesity?f_ri=4387","nofollow":true},{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":26327,"name":"Medicine","url":"https://www.academia.edu/Documents/in/Medicine?f_ri=4387","nofollow":true},{"id":51369,"name":"Functional Foods","url":"https://www.academia.edu/Documents/in/Functional_Foods?f_ri=4387","nofollow":true},{"id":99773,"name":"Disease","url":"https://www.academia.edu/Documents/in/Disease?f_ri=4387"},{"id":700808,"name":"Bioactive Compounds","url":"https://www.academia.edu/Documents/in/Bioactive_Compounds?f_ri=4387"}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_33971664" data-work_id="33971664" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/33971664/Neoliberal_pharmaceutical_science_and_the_Chicago_School_of_Economics">Neoliberal pharmaceutical science and the Chicago School of Economics</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">In recent years, science studies scholars have critically examined several methods used by the pharmaceutical industry to exert control over knowledge about drugs. Complementary literatures on "medical neoliberalism" and "neoliberal... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_33971664" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">In recent years, science studies scholars have critically examined several methods used by the pharmaceutical industry to exert control over knowledge about drugs. Complementary literatures on "medical neoliberalism" and "neoliberal science" draw attention to the economic ideas justifying such methods of organizing knowledge, and in so doing suggest that neoliberal thinkers may play an important role in developing them. As yet, the nature of this role remains unexplored. Relying on heretofore-unexamined archival evidence, this article establishes a direct link between the Chicago School of Economics and the mobilization of the pharmaceutical industry in the 1970s. It argues that economists affiliated with the Chicago School of Economics sought to influence pharmaceutical policy and science and constructed institutions to do so. These institutions--most notably the Center for the Study of Drug Development--remain highly influential. This article contributes to a historical understanding of how neoliberal ideas came to assume prominence in pharmaceutical policy, the management of science, and scientific practice.</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/33971664" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="6798c9fcc3ec26f0f67d52817cbad506" rel="nofollow" data-download="{"attachment_id":59425898,"asset_id":33971664,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/59425898/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="46258535" href="https://roanoke.academia.edu/EdwardNikKhah">Edward Nik-Khah</a><script data-card-contents-for-user="46258535" type="text/json">{"id":46258535,"first_name":"Edward","last_name":"Nik-Khah","domain_name":"roanoke","page_name":"EdwardNikKhah","display_name":"Edward Nik-Khah","profile_url":"https://roanoke.academia.edu/EdwardNikKhah?f_ri=4387","photo":"https://0.academia-photos.com/46258535/17338402/153018918/s65_edward.nik-khah.jpg"}</script></span></span></li><li class="js-paper-rank-work_33971664 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="33971664"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 33971664, container: ".js-paper-rank-work_33971664", }); 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$(".js-view-count[data-work-id=33971664]").text(description); $(".js-view-count-work_33971664").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_33971664").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="33971664"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">11</a>  </div><span class="InlineList-item-text u-textTruncate u-pl10x"><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="5709" rel="nofollow" href="https://www.academia.edu/Documents/in/Politics">Politics</a>, <script data-card-contents-for-ri="5709" type="text/json">{"id":5709,"name":"Politics","url":"https://www.academia.edu/Documents/in/Politics?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="7472" rel="nofollow" href="https://www.academia.edu/Documents/in/Chicago_School">Chicago School</a>, <script data-card-contents-for-ri="7472" type="text/json">{"id":7472,"name":"Chicago School","url":"https://www.academia.edu/Documents/in/Chicago_School?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="21500" rel="nofollow" href="https://www.academia.edu/Documents/in/Social_Studies_Of_Science">Social Studies Of Science</a><script data-card-contents-for-ri="21500" type="text/json">{"id":21500,"name":"Social Studies Of Science","url":"https://www.academia.edu/Documents/in/Social_Studies_Of_Science?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=33971664]'), work: {"id":33971664,"title":"Neoliberal pharmaceutical science and the Chicago School of Economics","created_at":"2017-07-20T09:24:42.216-07:00","url":"https://www.academia.edu/33971664/Neoliberal_pharmaceutical_science_and_the_Chicago_School_of_Economics?f_ri=4387","dom_id":"work_33971664","summary":"In recent years, science studies scholars have critically examined several methods used by the pharmaceutical industry to exert control over knowledge about drugs. Complementary literatures on \"medical neoliberalism\" and \"neoliberal science\" draw attention to the economic ideas justifying such methods of organizing knowledge, and in so doing suggest that neoliberal thinkers may play an important role in developing them. As yet, the nature of this role remains unexplored. Relying on heretofore-unexamined archival evidence, this article establishes a direct link between the Chicago School of Economics and the mobilization of the pharmaceutical industry in the 1970s. It argues that economists affiliated with the Chicago School of Economics sought to influence pharmaceutical policy and science and constructed institutions to do so. These institutions--most notably the Center for the Study of Drug Development--remain highly influential. This article contributes to a historical understanding of how neoliberal ideas came to assume prominence in pharmaceutical policy, the management of science, and scientific practice.","downloadable_attachments":[{"id":59425898,"asset_id":33971664,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":46258535,"first_name":"Edward","last_name":"Nik-Khah","domain_name":"roanoke","page_name":"EdwardNikKhah","display_name":"Edward Nik-Khah","profile_url":"https://roanoke.academia.edu/EdwardNikKhah?f_ri=4387","photo":"https://0.academia-photos.com/46258535/17338402/153018918/s65_edward.nik-khah.jpg"}],"research_interests":[{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":5709,"name":"Politics","url":"https://www.academia.edu/Documents/in/Politics?f_ri=4387","nofollow":true},{"id":7472,"name":"Chicago School","url":"https://www.academia.edu/Documents/in/Chicago_School?f_ri=4387","nofollow":true},{"id":21500,"name":"Social Studies Of Science","url":"https://www.academia.edu/Documents/in/Social_Studies_Of_Science?f_ri=4387","nofollow":true},{"id":46182,"name":"Pharmaceutical industry","url":"https://www.academia.edu/Documents/in/Pharmaceutical_industry?f_ri=4387"},{"id":46731,"name":"Think Tanks","url":"https://www.academia.edu/Documents/in/Think_Tanks?f_ri=4387"},{"id":62945,"name":"Drugs","url":"https://www.academia.edu/Documents/in/Drugs?f_ri=4387"},{"id":95387,"name":"Agnotology","url":"https://www.academia.edu/Documents/in/Agnotology?f_ri=4387"},{"id":114355,"name":"Academia and Neoliberalism","url":"https://www.academia.edu/Documents/in/Academia_and_Neoliberalism?f_ri=4387"},{"id":957553,"name":"Drug Industry","url":"https://www.academia.edu/Documents/in/Drug_Industry?f_ri=4387"},{"id":1744493,"name":"Science and Technology Studies","url":"https://www.academia.edu/Documents/in/Science_and_Technology_Studies?f_ri=4387"}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_19285585" data-work_id="19285585" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/19285585/Self_Hypnosis_for_Intrapartum_Pain_management_SHIP_trial">Self-Hypnosis for Intrapartum Pain management (SHIP) trial</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest">Objective (Primary) To establish the effect of antenatal group selfhypnosis for nulliparous women on intra-partum epidural use.</div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div 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href="https://www.academia.edu/Documents/in/Health_Sciences">Health Sciences</a>, <script data-card-contents-for-ri="586" type="text/json">{"id":586,"name":"Health Sciences","url":"https://www.academia.edu/Documents/in/Health_Sciences?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="1292" rel="nofollow" href="https://www.academia.edu/Documents/in/Health_Economics">Health Economics</a>, <script data-card-contents-for-ri="1292" type="text/json">{"id":1292,"name":"Health Economics","url":"https://www.academia.edu/Documents/in/Health_Economics?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a 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investigation of the biological and mechanical behaviour of resin-modified glass-ionomer cement containing chlorhexidine</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Glass ionomer cement Chlorhexidine digluconate Cell culture Antibacterial activity Mechanical properties Indirect pulp therapy a b s t r a c t Objectives: To evaluate: (1) the in vitro antibacterial, cytotoxic and mechanical properties of... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_10894827" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Glass ionomer cement Chlorhexidine digluconate Cell culture Antibacterial activity Mechanical properties Indirect pulp therapy a b s t r a c t Objectives: To evaluate: (1) the in vitro antibacterial, cytotoxic and mechanical properties of a resin-modified glass ionomer cement (RMGIC) containing different concentrations of chlorhexidine (CHX) and (2) the in vivo microbiologic action of the best concentration of CHX associated with the RMGIC applied on remaining dentine after indirect pulp treatment (IPT).</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/10894827" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="efed1f99c998d9f5b4fd2766ccbf15b2" rel="nofollow" data-download="{"attachment_id":36680866,"asset_id":10894827,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm 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(IPT).","downloadable_attachments":[{"id":36680866,"asset_id":10894827,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":20322313,"first_name":"Aline","last_name":"Castilho","domain_name":"unicamp","page_name":"alinecastilho","display_name":"Aline Castilho","profile_url":"https://unicamp.academia.edu/alinecastilho?f_ri=4387","photo":"https://0.academia-photos.com/20322313/29776429/27669382/s65_aline.castilho.jpg"}],"research_interests":[{"id":596,"name":"Dentistry","url":"https://www.academia.edu/Documents/in/Dentistry?f_ri=4387","nofollow":true},{"id":2978,"name":"Dental Research","url":"https://www.academia.edu/Documents/in/Dental_Research?f_ri=4387","nofollow":true},{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":25645,"name":"Antimicrobials","url":"https://www.academia.edu/Documents/in/Antimicrobials?f_ri=4387","nofollow":true},{"id":66110,"name":"Clinical 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Ionomers","url":"https://www.academia.edu/Documents/in/Glass_Ionomers?f_ri=4387"},{"id":627242,"name":"Resin Modified Glass Ionomer","url":"https://www.academia.edu/Documents/in/Resin_Modified_Glass_Ionomer?f_ri=4387"},{"id":637089,"name":"Biocompatibility of Glass Ionomer Cement","url":"https://www.academia.edu/Documents/in/Biocompatibility_of_Glass_Ionomer_Cement?f_ri=4387"},{"id":681259,"name":"Cariology, early childhood caries, pediatric dentistry","url":"https://www.academia.edu/Documents/in/Cariology_early_childhood_caries_pediatric_dentistry?f_ri=4387"}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_31924355 coauthored" data-work_id="31924355" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/31924355/The_interweaving_of_pharmaceutical_and_medical_expectations_as_dynamics_of_micro_pharmaceuticalisation_advanced_stage_cancer_patients_hope_in_medicines_alongside_trust_in_professionals">The interweaving of pharmaceutical and medical expectations as dynamics of micro- pharmaceuticalisation: advanced-stage cancer patients' hope in medicines alongside trust in professionals</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Existing pharmaceuticalisation research denotes the salience of expectations in novel medicines and in the medical contexts through which these may be accessed. Specific processes of expectation such as hope and trust, alongside their... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_31924355" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Existing pharmaceuticalisation research denotes the salience of expectations in novel medicines and in the medical contexts through which these may be accessed. Specific processes of expectation such as hope and trust, alongside their shaping of patients' lifeworlds around pharmaceutical use, remain neglected however. Considering data from in-depth interviews and observations involving thirteen patients with advanced-stage cancer diagnoses who were or had recently been involved in clinical trials, we develop a phenomenological analysis of the influence of hope and trust upon the accessing of novel medicines through trials, illuminating the depth and texture of pharmaceuticalisation at the micro-level. Trust in clinicians</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/31924355" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="a5c5fcfa37e899e84c128233e977100c" rel="nofollow" data-download="{"attachment_id":52203842,"asset_id":31924355,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/52203842/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="2884097" href="https://uva.academia.edu/PatrickBrown">Patrick Brown</a><script data-card-contents-for-user="2884097" type="text/json">{"id":2884097,"first_name":"Patrick","last_name":"Brown","domain_name":"uva","page_name":"PatrickBrown","display_name":"Patrick Brown","profile_url":"https://uva.academia.edu/PatrickBrown?f_ri=4387","photo":"https://0.academia-photos.com/2884097/951926/1192109/s65_patrick.brown.jpg"}</script></span></span><span class="u-displayInlineBlock InlineList-item-text"> and <span class="u-textDecorationUnderline u-clickable InlineList-item-text js-work-more-authors-31924355">+1</span><div class="hidden js-additional-users-31924355"><div><span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a href="https://ucl.academia.edu/SabinedeGraaf">Sabine de Graaf</a></span></div></div></span><script>(function(){ var popoverSettings = { el: $('.js-work-more-authors-31924355'), placement: 'bottom', hide_delay: 200, html: true, content: function(){ return $('.js-additional-users-31924355').html(); 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Specific processes of expectation such as hope and trust, alongside their shaping of patients' lifeworlds around pharmaceutical use, remain neglected however. Considering data from in-depth interviews and observations involving thirteen patients with advanced-stage cancer diagnoses who were or had recently been involved in clinical trials, we develop a phenomenological analysis of the influence of hope and trust upon the accessing of novel medicines through trials, illuminating the depth and texture of pharmaceuticalisation at the micro-level. Trust in clinicians","downloadable_attachments":[{"id":52203842,"asset_id":31924355,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":2884097,"first_name":"Patrick","last_name":"Brown","domain_name":"uva","page_name":"PatrickBrown","display_name":"Patrick Brown","profile_url":"https://uva.academia.edu/PatrickBrown?f_ri=4387","photo":"https://0.academia-photos.com/2884097/951926/1192109/s65_patrick.brown.jpg"},{"id":24566008,"first_name":"Sabine","last_name":"de Graaf","domain_name":"ucl","page_name":"SabinedeGraaf","display_name":"Sabine de Graaf","profile_url":"https://ucl.academia.edu/SabinedeGraaf?f_ri=4387","photo":"https://0.academia-photos.com/24566008/6638243/14665649/s65_sabine.de_graaf.jpg"}],"research_interests":[{"id":200,"name":"Medical Sociology","url":"https://www.academia.edu/Documents/in/Medical_Sociology?f_ri=4387","nofollow":true},{"id":626,"name":"Oncology","url":"https://www.academia.edu/Documents/in/Oncology?f_ri=4387","nofollow":true},{"id":793,"name":"Medical Anthropology","url":"https://www.academia.edu/Documents/in/Medical_Anthropology?f_ri=4387","nofollow":true},{"id":3043,"name":"Trust","url":"https://www.academia.edu/Documents/in/Trust?f_ri=4387","nofollow":true},{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387"},{"id":9186,"name":"Pharmaceutical Technology","url":"https://www.academia.edu/Documents/in/Pharmaceutical_Technology?f_ri=4387"},{"id":9230,"name":"Hope","url":"https://www.academia.edu/Documents/in/Hope?f_ri=4387"},{"id":9435,"name":"Medical Ethics","url":"https://www.academia.edu/Documents/in/Medical_Ethics?f_ri=4387"},{"id":12061,"name":"Risk Management","url":"https://www.academia.edu/Documents/in/Risk_Management?f_ri=4387"},{"id":14540,"name":"Politics And Sociology Of Risk","url":"https://www.academia.edu/Documents/in/Politics_And_Sociology_Of_Risk?f_ri=4387"},{"id":17615,"name":"Psychology of Hope","url":"https://www.academia.edu/Documents/in/Psychology_of_Hope?f_ri=4387"},{"id":58913,"name":"Medical Sociology / Anthropology","url":"https://www.academia.edu/Documents/in/Medical_Sociology_Anthropology?f_ri=4387"},{"id":61603,"name":"Uncertainty","url":"https://www.academia.edu/Documents/in/Uncertainty?f_ri=4387"},{"id":87421,"name":"Sociology of Risk and Uncertainty","url":"https://www.academia.edu/Documents/in/Sociology_of_Risk_and_Uncertainty?f_ri=4387"},{"id":147304,"name":"Medicalization","url":"https://www.academia.edu/Documents/in/Medicalization?f_ri=4387"},{"id":547934,"name":"Pharmaceuticalization","url":"https://www.academia.edu/Documents/in/Pharmaceuticalization?f_ri=4387"}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_16024023" data-work_id="16024023" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/16024023/Prescription_audit_in_outpatient_department_of_multispecialty_hospital_in_western_India_an_observational_study">Prescription audit in outpatient department of multispecialty hospital in western India: an observational study</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Background: Studying the prescribing audit is that part of the medical audit which seeks to monitor, evaluate and if necessary, suggest modifications in the prescribing practices of medical practitioners. Our objective was to study the... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_16024023" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Background: Studying the prescribing audit is that part of the medical audit which seeks to monitor, evaluate and if necessary, suggest modifications in the prescribing practices of medical practitioners. Our objective was to study the Prescription Audit in Out Patient Department of in Multispecialty Hospital in western India. Methods: An Observational study was carried out during the period of 2012-2013. Total 150 prescriptions of Outpatient department were collected, scrutinized and statistically analyzed with Reporting procedures to pharmacy and quality department. We have also considered Statistical Process control (SPC) to provide the guidance on how the process may be improved by reducing variation & to assess the performance of a process. Results: Total 150 patients were evaluated for Prescription Audit, out of which 60% were Male & 40% were Female cases. In the same mainly 13 parameter were assessed according to the checklist provided by the Hospital with total 1950 (150*13) counts; from this 1126 Counts were under compliance, 74 Counts were non-compliance & 750 Counts were not applicable. 50 cases were analyzed for 3 months, showed better compliance rate of prescription audit parameters in February 2013 compared to December 2012, while non-compliance rate in prescription audit was reduced as time progresses. Conclusions: A definite role of clinical pharmacist, in the process control by utilizing SPC during prescription audit. The members of the hospital and Quality committee need to focus on findings of it, which help them during accreditation by regulatory authority.</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/16024023" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="fb68458fd1baf0a58ef65bf326b01f2a" rel="nofollow" data-download="{"attachment_id":42782539,"asset_id":16024023,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/42782539/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="35165571" href="https://independent.academia.edu/ShahChaital">Chaital Shah</a><script data-card-contents-for-user="35165571" type="text/json">{"id":35165571,"first_name":"Chaital","last_name":"Shah","domain_name":"independent","page_name":"ShahChaital","display_name":"Chaital Shah","profile_url":"https://independent.academia.edu/ShahChaital?f_ri=4387","photo":"https://0.academia-photos.com/35165571/10233783/11420881/s65_chaital.shah.jpg"}</script></span></span></li><li class="js-paper-rank-work_16024023 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="16024023"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 16024023, container: ".js-paper-rank-work_16024023", }); });</script></li><li class="js-percentile-work_16024023 InlineList-item InlineList-item--bordered hidden u-tcGrayDark"><span class="percentile-widget hidden"><span class="u-mr2x percentile-widget" style="display: none">•</span><span class="u-mr2x work-percentile"></span></span><script>$(function () { var workId = 16024023; window.Academia.workPercentilesFetcher.queue(workId, function (percentileText) { var container = $(".js-percentile-work_16024023"); container.find('.work-percentile').text(percentileText.charAt(0).toUpperCase() + percentileText.slice(1)); container.find('.percentile-widget').show(); container.find('.percentile-widget').removeClass('hidden'); }); });</script></li><li class="js-view-count-work_16024023 InlineList-item InlineList-item--bordered hidden"><div><span><span class="js-view-count view-count u-mr2x" data-work-id="16024023"><i class="fa fa-spinner fa-spin"></i></span><script>$(function () { var workId = 16024023; window.Academia.workViewCountsFetcher.queue(workId, function (count) { var description = window.$h.commaizeInt(count) + " " + window.$h.pluralize(count, 'View'); $(".js-view-count[data-work-id=16024023]").text(description); $(".js-view-count-work_16024023").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_16024023").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="16024023"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i></div><span class="InlineList-item-text u-textTruncate u-pl6x"><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a><script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (false) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=16024023]'), work: {"id":16024023,"title":"Prescription audit in outpatient department of multispecialty hospital in western India: an observational study","created_at":"2015-09-22T06:14:33.026-07:00","url":"https://www.academia.edu/16024023/Prescription_audit_in_outpatient_department_of_multispecialty_hospital_in_western_India_an_observational_study?f_ri=4387","dom_id":"work_16024023","summary":"Background: Studying the prescribing audit is that part of the medical audit which seeks to monitor, evaluate and if necessary, suggest modifications in the prescribing practices of medical practitioners. Our objective was to study the Prescription Audit in Out Patient Department of in Multispecialty Hospital in western India. Methods: An Observational study was carried out during the period of 2012-2013. Total 150 prescriptions of Outpatient department were collected, scrutinized and statistically analyzed with Reporting procedures to pharmacy and quality department. We have also considered Statistical Process control (SPC) to provide the guidance on how the process may be improved by reducing variation \u0026 to assess the performance of a process. Results: Total 150 patients were evaluated for Prescription Audit, out of which 60% were Male \u0026 40% were Female cases. In the same mainly 13 parameter were assessed according to the checklist provided by the Hospital with total 1950 (150*13) counts; from this 1126 Counts were under compliance, 74 Counts were non-compliance \u0026 750 Counts were not applicable. 50 cases were analyzed for 3 months, showed better compliance rate of prescription audit parameters in February 2013 compared to December 2012, while non-compliance rate in prescription audit was reduced as time progresses. Conclusions: A definite role of clinical pharmacist, in the process control by utilizing SPC during prescription audit. The members of the hospital and Quality committee need to focus on findings of it, which help them during accreditation by regulatory authority.","downloadable_attachments":[{"id":42782539,"asset_id":16024023,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":35165571,"first_name":"Chaital","last_name":"Shah","domain_name":"independent","page_name":"ShahChaital","display_name":"Chaital Shah","profile_url":"https://independent.academia.edu/ShahChaital?f_ri=4387","photo":"https://0.academia-photos.com/35165571/10233783/11420881/s65_chaital.shah.jpg"}],"research_interests":[{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_57548560" data-work_id="57548560" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/57548560/A_Pilot_Study_of_Group_Mindfulness_Based_Cognitive_Therapy_MBCT_for_Combat_Veterans_with_Posttraumatic_Stress_Disorder_PTSD_">A Pilot Study of Group Mindfulness-Based Cognitive Therapy (MBCT) for Combat Veterans with Posttraumatic Stress Disorder (PTSD)</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Background: "Mindfulness-based" interventions show promise for stress reduction in general medical conditions, and initial evidence suggests that they are accepted in trauma-exposed individuals. Mindfulness-based cognitive therapy (MBCT)... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_57548560" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Background: "Mindfulness-based" interventions show promise for stress reduction in general medical conditions, and initial evidence suggests that they are accepted in trauma-exposed individuals. Mindfulness-based cognitive therapy (MBCT) shows substantial efficacy for prevention of depression relapse, but it has been less studied in anxiety disorders. This study investigated the feasibility, acceptability, and clinical outcomes of an MBCT group intervention adapted for combat posttraumatic stress disorder (PTSD). Methods: Consecutive patients seeking treatment for chronic PTSD at a VA outpatient clinic were enrolled in 8-week MBCT groups, modified for PTSD (four groups, n = 20) or brief treatment-as-usual (TAU) comparison group interventions (three groups, n = 17). Pre and posttherapy psychological assessments with clinician administered PTSD scale (CAPS) were performed with all patients, and self-report measures (PTSD diagnostic scale, PDS, and posttraumatic cognitions inventory, PTCI) were administered in the MBCT group. Results: Intent to treat analyses showed significant improvement in PTSD (CAPS (t(19) = 4.8, P < .001)) in the MBCT condition but not the TAU conditions, and a significant Condition × Time interaction (F[1,35] = 16.4, P < .005). MBCT completers (n = 15, 75%) showed good compliance with assigned homework exercises, and significant and clinically meaningful improvement in PTSD symptom severity on posttreatment assessment in CAPS and PDS (particularly in avoidance/numbing symptoms), and reduced PTSD-relevant cognitions in PTCI (self blame). Conclusions: These data suggest group MBCT as an acceptable brief intervention/adjunctive therapy for combat PTSD, with potential for reducing avoidance symptom cluster and PTSD cognitions. Further studies are needed to examine efficacy in a randomized controlled design and to identify factors influencing acceptability and efficacy. Depression and Anxiety 30:638-645, 2013.</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/57548560" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="6b92c6df46c839c55b070df799796dd5" rel="nofollow" data-download="{"attachment_id":72398614,"asset_id":57548560,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/72398614/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="32907409" href="https://independent.academia.edu/KulkarniMadhur">Madhur Kulkarni</a><script data-card-contents-for-user="32907409" type="text/json">{"id":32907409,"first_name":"Madhur","last_name":"Kulkarni","domain_name":"independent","page_name":"KulkarniMadhur","display_name":"Madhur Kulkarni","profile_url":"https://independent.academia.edu/KulkarniMadhur?f_ri=4387","photo":"/images/s65_no_pic.png"}</script></span></span></li><li class="js-paper-rank-work_57548560 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="57548560"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 57548560, container: ".js-paper-rank-work_57548560", }); });</script></li><li class="js-percentile-work_57548560 InlineList-item InlineList-item--bordered hidden u-tcGrayDark"><span class="percentile-widget hidden"><span class="u-mr2x percentile-widget" style="display: none">•</span><span class="u-mr2x work-percentile"></span></span><script>$(function () { var workId = 57548560; window.Academia.workPercentilesFetcher.queue(workId, function (percentileText) { var container = $(".js-percentile-work_57548560"); container.find('.work-percentile').text(percentileText.charAt(0).toUpperCase() + percentileText.slice(1)); container.find('.percentile-widget').show(); container.find('.percentile-widget').removeClass('hidden'); }); });</script></li><li class="js-view-count-work_57548560 InlineList-item InlineList-item--bordered hidden"><div><span><span class="js-view-count view-count u-mr2x" data-work-id="57548560"><i class="fa fa-spinner fa-spin"></i></span><script>$(function () { var workId = 57548560; window.Academia.workViewCountsFetcher.queue(workId, function (count) { var description = window.$h.commaizeInt(count) + " " + window.$h.pluralize(count, 'View'); $(".js-view-count[data-work-id=57548560]").text(description); $(".js-view-count-work_57548560").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_57548560").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="57548560"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">18</a>  </div><span class="InlineList-item-text u-textTruncate u-pl10x"><a class="InlineList-item-text" data-has-card-for-ri="221" rel="nofollow" href="https://www.academia.edu/Documents/in/Psychology">Psychology</a>, <script data-card-contents-for-ri="221" type="text/json">{"id":221,"name":"Psychology","url":"https://www.academia.edu/Documents/in/Psychology?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="226" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Psychology">Clinical Psychology</a>, <script data-card-contents-for-ri="226" type="text/json">{"id":226,"name":"Clinical Psychology","url":"https://www.academia.edu/Documents/in/Clinical_Psychology?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="229" rel="nofollow" href="https://www.academia.edu/Documents/in/Brief_Psychotherapy">Brief Psychotherapy</a>, <script data-card-contents-for-ri="229" type="text/json">{"id":229,"name":"Brief Psychotherapy","url":"https://www.academia.edu/Documents/in/Brief_Psychotherapy?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="635" rel="nofollow" href="https://www.academia.edu/Documents/in/Psychiatry">Psychiatry</a><script data-card-contents-for-ri="635" type="text/json">{"id":635,"name":"Psychiatry","url":"https://www.academia.edu/Documents/in/Psychiatry?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=57548560]'), work: {"id":57548560,"title":"A Pilot Study of Group Mindfulness-Based Cognitive Therapy (MBCT) for Combat Veterans with Posttraumatic Stress Disorder (PTSD)","created_at":"2021-10-13T08:11:28.905-07:00","url":"https://www.academia.edu/57548560/A_Pilot_Study_of_Group_Mindfulness_Based_Cognitive_Therapy_MBCT_for_Combat_Veterans_with_Posttraumatic_Stress_Disorder_PTSD_?f_ri=4387","dom_id":"work_57548560","summary":"Background: \"Mindfulness-based\" interventions show promise for stress reduction in general medical conditions, and initial evidence suggests that they are accepted in trauma-exposed individuals. Mindfulness-based cognitive therapy (MBCT) shows substantial efficacy for prevention of depression relapse, but it has been less studied in anxiety disorders. This study investigated the feasibility, acceptability, and clinical outcomes of an MBCT group intervention adapted for combat posttraumatic stress disorder (PTSD). Methods: Consecutive patients seeking treatment for chronic PTSD at a VA outpatient clinic were enrolled in 8-week MBCT groups, modified for PTSD (four groups, n = 20) or brief treatment-as-usual (TAU) comparison group interventions (three groups, n = 17). Pre and posttherapy psychological assessments with clinician administered PTSD scale (CAPS) were performed with all patients, and self-report measures (PTSD diagnostic scale, PDS, and posttraumatic cognitions inventory, PTCI) were administered in the MBCT group. Results: Intent to treat analyses showed significant improvement in PTSD (CAPS (t(19) = 4.8, P \u003c .001)) in the MBCT condition but not the TAU conditions, and a significant Condition × Time interaction (F[1,35] = 16.4, P \u003c .005). MBCT completers (n = 15, 75%) showed good compliance with assigned homework exercises, and significant and clinically meaningful improvement in PTSD symptom severity on posttreatment assessment in CAPS and PDS (particularly in avoidance/numbing symptoms), and reduced PTSD-relevant cognitions in PTCI (self blame). Conclusions: These data suggest group MBCT as an acceptable brief intervention/adjunctive therapy for combat PTSD, with potential for reducing avoidance symptom cluster and PTSD cognitions. Further studies are needed to examine efficacy in a randomized controlled design and to identify factors influencing acceptability and efficacy. 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400 registered cultivars. Lavandula are worldwide plants that occur over the Mediterranean, Europe, North Africa, southwest Asia to southeast India.... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_64775727" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">The Lavandula genus, belonging to the Lamiaceae, includes 39 species, with nearly 400 registered cultivars. Lavandula are worldwide plants that occur over the Mediterranean, Europe, North Africa, southwest Asia to southeast India. Lavandula plants have been used since ancient time to flavor and preserved food, to treat diseases including wound healing, sedative, antispasmodic, microbial and viral infections. Numerous researches have described the chemical composition and the primary components of lavender oils are the monoterpenoids (linalool, linalyl acetate, 1,8-cineole, β-ocimene, terpinen-4-ol, and camphor), sesquiterpenoids (β-caryophyllene and nerolidol) and other terpenoid compounds (e.g., perillyl alcohol). The high concentrations of linalyl acetate make them attractive in perfumery, flavoring, cosmetics and soap industries. Currently, data on the antimicrobial activity of lavender plants have been scientifically confirmed. 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Lavandula are worldwide plants that occur over the Mediterranean, Europe, North Africa, southwest Asia to southeast India. Lavandula plants have been used since ancient time to flavor and preserved food, to treat diseases including wound healing, sedative, antispasmodic, microbial and viral infections. Numerous researches have described the chemical composition and the primary components of lavender oils are the monoterpenoids (linalool, linalyl acetate, 1,8-cineole, β-ocimene, terpinen-4-ol, and camphor), sesquiterpenoids (β-caryophyllene and nerolidol) and other terpenoid compounds (e.g., perillyl alcohol). The high concentrations of linalyl acetate make them attractive in perfumery, flavoring, cosmetics and soap industries. Currently, data on the antimicrobial activity of lavender plants have been scientifically confirmed. Indeed, lavender essential oils possess wide spectr...","downloadable_attachments":[{"id":76654048,"asset_id":64775727,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":49597981,"first_name":"Surjit","last_name":"Sen","domain_name":"independent","page_name":"SurjitSen","display_name":"Surjit Sen","profile_url":"https://independent.academia.edu/SurjitSen?f_ri=4387","photo":"https://0.academia-photos.com/49597981/119272912/108590252/s65_surjit.sen.jpeg"}],"research_interests":[{"id":140,"name":"Pharmacology","url":"https://www.academia.edu/Documents/in/Pharmacology?f_ri=4387","nofollow":true},{"id":145,"name":"Biochemistry","url":"https://www.academia.edu/Documents/in/Biochemistry?f_ri=4387","nofollow":true},{"id":159,"name":"Microbiology","url":"https://www.academia.edu/Documents/in/Microbiology?f_ri=4387","nofollow":true},{"id":531,"name":"Organic Chemistry","url":"https://www.academia.edu/Documents/in/Organic_Chemistry?f_ri=4387","nofollow":true},{"id":656,"name":"Pharmacy","url":"https://www.academia.edu/Documents/in/Pharmacy?f_ri=4387"},{"id":1040,"name":"Food Science","url":"https://www.academia.edu/Documents/in/Food_Science?f_ri=4387"},{"id":1290,"name":"Immunology","url":"https://www.academia.edu/Documents/in/Immunology?f_ri=4387"},{"id":1907,"name":"Nutrition","url":"https://www.academia.edu/Documents/in/Nutrition?f_ri=4387"},{"id":2513,"name":"Molecular Biology","url":"https://www.academia.edu/Documents/in/Molecular_Biology?f_ri=4387"},{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387"},{"id":4553,"name":"Toxicology","url":"https://www.academia.edu/Documents/in/Toxicology?f_ri=4387"},{"id":5541,"name":"Plant Biology","url":"https://www.academia.edu/Documents/in/Plant_Biology?f_ri=4387"},{"id":6021,"name":"Cancer","url":"https://www.academia.edu/Documents/in/Cancer?f_ri=4387"},{"id":7710,"name":"Biology","url":"https://www.academia.edu/Documents/in/Biology?f_ri=4387"},{"id":10221,"name":"Food and Nutrition","url":"https://www.academia.edu/Documents/in/Food_and_Nutrition?f_ri=4387"},{"id":14195,"name":"Cancer Biology","url":"https://www.academia.edu/Documents/in/Cancer_Biology?f_ri=4387"},{"id":544330,"name":"Lavandula","url":"https://www.academia.edu/Documents/in/Lavandula?f_ri=4387"},{"id":1778620,"name":"Lavender","url":"https://www.academia.edu/Documents/in/Lavender?f_ri=4387"}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_38085332" data-work_id="38085332" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/38085332/Plants_of_the_Genus_Lavandula_From_Farm_to_Pharmacy">Plants of the Genus Lavandula From Farm to Pharmacy</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">The Lavandula genus, belonging to the Lamiaceae, includes 39 species, with nearly 400 registered cultivars. Lavandula are worldwide plants that occur over the Mediterranean, Europe, North Africa, southwest Asia to southeast India.... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_38085332" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">The Lavandula genus, belonging to the Lamiaceae, includes 39 species, with nearly 400 registered cultivars. Lavandula are worldwide plants that occur over the Mediterranean, Europe, North Africa, southwest Asia to southeast India. Lavandula plants have been used since ancient time to flavor and preserved food, to treat diseases including wound healing, sedative, antispasmodic, microbial and viral infections. Numerous researches have described the chemical composition and the primary components of lavender oils are the monoterpenoids (linalool, linalyl acetate, 1,8-cineole, β-ocimene, terpinen-4-ol, and camphor), sesquiterpenoids (β-caryophyllene and nerolidol) and other terpenoid compounds (e.g., perillyl alcohol). The high concentrations of linalyl acetate make them attractive in perfumery, flavoring, cosmetics and soap industries. Currently, data on the antimicrobial activity of lavender plants have been scientifically confirmed. Indeed, lavender essential oils possess wide spectra of biological activities such as antispasmodic, carminative, analgesic, sedative, hypotensive, antiseptic, antimicrobial, antifungal, antidiuretic and general tonic action. In addition, clinical studies support their uses as treatment of healthconditions. However, further clinical studies are necessary to define the magnitude of the efficacy, mechanisms of action, optimal doses, long-term safety, and,<br />potential side effects of lavender plants.</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/38085332" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="dd8637c6b96571bf3cb598ff2449e266" rel="nofollow" data-download="{"attachment_id":58112165,"asset_id":38085332,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/58112165/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="99847848" href="https://sbmu-ir.academia.edu/BahareSalehi">Dr. Bahare Salehi</a><script data-card-contents-for-user="99847848" type="text/json">{"id":99847848,"first_name":"Dr. Bahare","last_name":"Salehi","domain_name":"sbmu-ir","page_name":"BahareSalehi","display_name":"Dr. Bahare Salehi","profile_url":"https://sbmu-ir.academia.edu/BahareSalehi?f_ri=4387","photo":"https://0.academia-photos.com/99847848/21768134/64055019/s65_dr._bahare.salehi.jpg"}</script></span></span></li><li class="js-paper-rank-work_38085332 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="38085332"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 38085332, container: ".js-paper-rank-work_38085332", }); 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$(".js-view-count[data-work-id=38085332]").text(description); $(".js-view-count-work_38085332").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_38085332").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="38085332"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">15</a>  </div><span class="InlineList-item-text u-textTruncate u-pl10x"><a class="InlineList-item-text" data-has-card-for-ri="140" rel="nofollow" href="https://www.academia.edu/Documents/in/Pharmacology">Pharmacology</a>, <script data-card-contents-for-ri="140" type="text/json">{"id":140,"name":"Pharmacology","url":"https://www.academia.edu/Documents/in/Pharmacology?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="145" rel="nofollow" href="https://www.academia.edu/Documents/in/Biochemistry">Biochemistry</a>, <script data-card-contents-for-ri="145" type="text/json">{"id":145,"name":"Biochemistry","url":"https://www.academia.edu/Documents/in/Biochemistry?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="159" rel="nofollow" href="https://www.academia.edu/Documents/in/Microbiology">Microbiology</a>, <script data-card-contents-for-ri="159" type="text/json">{"id":159,"name":"Microbiology","url":"https://www.academia.edu/Documents/in/Microbiology?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="656" rel="nofollow" href="https://www.academia.edu/Documents/in/Pharmacy">Pharmacy</a><script data-card-contents-for-ri="656" type="text/json">{"id":656,"name":"Pharmacy","url":"https://www.academia.edu/Documents/in/Pharmacy?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=38085332]'), work: {"id":38085332,"title":"Plants of the Genus Lavandula From Farm to Pharmacy","created_at":"2019-01-04T00:39:39.387-08:00","url":"https://www.academia.edu/38085332/Plants_of_the_Genus_Lavandula_From_Farm_to_Pharmacy?f_ri=4387","dom_id":"work_38085332","summary":"The Lavandula genus, belonging to the Lamiaceae, includes 39 species, with nearly 400 registered cultivars. Lavandula are worldwide plants that occur over the Mediterranean, Europe, North Africa, southwest Asia to southeast India. Lavandula plants have been used since ancient time to flavor and preserved food, to treat diseases including wound healing, sedative, antispasmodic, microbial and viral infections. Numerous researches have described the chemical composition and the primary components of lavender oils are the monoterpenoids (linalool, linalyl acetate, 1,8-cineole, β-ocimene, terpinen-4-ol, and camphor), sesquiterpenoids (β-caryophyllene and nerolidol) and other terpenoid compounds (e.g., perillyl alcohol). The high concentrations of linalyl acetate make them attractive in perfumery, flavoring, cosmetics and soap industries. Currently, data on the antimicrobial activity of lavender plants have been scientifically confirmed. Indeed, lavender essential oils possess wide spectra of biological activities such as antispasmodic, carminative, analgesic, sedative, hypotensive, antiseptic, antimicrobial, antifungal, antidiuretic and general tonic action. In addition, clinical studies support their uses as treatment of healthconditions. However, further clinical studies are necessary to define the magnitude of the efficacy, mechanisms of action, optimal doses, long-term safety, and,\npotential side effects of lavender plants.","downloadable_attachments":[{"id":58112165,"asset_id":38085332,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":99847848,"first_name":"Dr. Bahare","last_name":"Salehi","domain_name":"sbmu-ir","page_name":"BahareSalehi","display_name":"Dr. Bahare Salehi","profile_url":"https://sbmu-ir.academia.edu/BahareSalehi?f_ri=4387","photo":"https://0.academia-photos.com/99847848/21768134/64055019/s65_dr._bahare.salehi.jpg"}],"research_interests":[{"id":140,"name":"Pharmacology","url":"https://www.academia.edu/Documents/in/Pharmacology?f_ri=4387","nofollow":true},{"id":145,"name":"Biochemistry","url":"https://www.academia.edu/Documents/in/Biochemistry?f_ri=4387","nofollow":true},{"id":159,"name":"Microbiology","url":"https://www.academia.edu/Documents/in/Microbiology?f_ri=4387","nofollow":true},{"id":656,"name":"Pharmacy","url":"https://www.academia.edu/Documents/in/Pharmacy?f_ri=4387","nofollow":true},{"id":1040,"name":"Food Science","url":"https://www.academia.edu/Documents/in/Food_Science?f_ri=4387"},{"id":1290,"name":"Immunology","url":"https://www.academia.edu/Documents/in/Immunology?f_ri=4387"},{"id":1907,"name":"Nutrition","url":"https://www.academia.edu/Documents/in/Nutrition?f_ri=4387"},{"id":2513,"name":"Molecular Biology","url":"https://www.academia.edu/Documents/in/Molecular_Biology?f_ri=4387"},{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387"},{"id":4553,"name":"Toxicology","url":"https://www.academia.edu/Documents/in/Toxicology?f_ri=4387"},{"id":6021,"name":"Cancer","url":"https://www.academia.edu/Documents/in/Cancer?f_ri=4387"},{"id":7710,"name":"Biology","url":"https://www.academia.edu/Documents/in/Biology?f_ri=4387"},{"id":10221,"name":"Food and Nutrition","url":"https://www.academia.edu/Documents/in/Food_and_Nutrition?f_ri=4387"},{"id":14195,"name":"Cancer Biology","url":"https://www.academia.edu/Documents/in/Cancer_Biology?f_ri=4387"},{"id":1778620,"name":"Lavender","url":"https://www.academia.edu/Documents/in/Lavender?f_ri=4387"}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_12536243" data-work_id="12536243" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/12536243/The_effects_of_International_Poi_on_physical_cognitive_and_emotional_health_in_healthy_older_adults_PhD_thesis_">The effects of International Poi on physical, cognitive, and emotional health in healthy older adults (PhD thesis)</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">We are currently experiencing unprecedented population ageing worldwide, and effective, affordable strategies for maintaining quality of life are urgently needed. International Poi involves swinging a weight on the end of a cord in... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_12536243" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">We are currently experiencing unprecedented population ageing worldwide, and effective, affordable strategies for maintaining quality of life are urgently needed. International Poi involves swinging a weight on the end of a cord in circular patterns around the body. The aim of this thesis was to investigate the effects of International Poi, as compared to Tai Chi, on physical, cognitive, and emotional health in healthy older adults. Seventy-nine participants (60 - 86 years old) were randomly allocated to the International Poi or Tai Chi group. Physical and cognitive function were measured one month before, immediately before, immediately after, and one month after the intervention (2 lessons a week for 4 weeks). Follow-up questionnaires were administered after each lesson, immediately after the intervention, and one month after the intervention. <br /> <br />Immediately post intervention both groups improved postural stability, upper limb strength, and simple attention. The Tai Chi group also improved systolic blood pressure. One month post intervention, compared to immediately post intervention, both groups improved upper limb strength, upper limb range of motion, and memory. The poi group also improved systolic blood pressure. Questionnaire results showed both groups felt primarily relaxed during the intervention, with the International Poi group feeling more challenged and happy, and the Tai Chi group feeling more calm and peaceful. The majority of participants reported wanting to continue their practice, suggesting both activities are enjoyable. <br /> <br />This was the first study to scientifically investigate the effects of International Poi on health in older adults. Based on this thesis, it can be concluded that International Poi seems to be as effective as Tai Chi for improving health in healthy older adults, and that International Poi and health is a legitimate area of scientific research. The possibilities for future poi and health research are vast, and the need for such research is paramount in order to replicate results, better understand potential long-term benefits, and begin to make recommendations for policy makers and practitioners regarding poi-health initiatives.</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/12536243" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="d3f4c5f88de208b870815d86e5a568e6" rel="nofollow" data-download="{"attachment_id":56856148,"asset_id":12536243,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/56856148/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="31068468" href="https://auckland.academia.edu/KatevanWest">Kate Riegle van West</a><script data-card-contents-for-user="31068468" type="text/json">{"id":31068468,"first_name":"Kate","last_name":"Riegle van West","domain_name":"auckland","page_name":"KatevanWest","display_name":"Kate Riegle van West","profile_url":"https://auckland.academia.edu/KatevanWest?f_ri=4387","photo":"https://0.academia-photos.com/31068468/9111972/35338083/s65_kate.riegle_van_west.jpg"}</script></span></span></li><li class="js-paper-rank-work_12536243 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="12536243"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 12536243, container: ".js-paper-rank-work_12536243", }); 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$(".js-view-count[data-work-id=12536243]").text(description); $(".js-view-count-work_12536243").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_12536243").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="12536243"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">5</a>  </div><span class="InlineList-item-text u-textTruncate u-pl9x"><a class="InlineList-item-text" data-has-card-for-ri="236" rel="nofollow" href="https://www.academia.edu/Documents/in/Cognitive_Psychology">Cognitive Psychology</a>, <script data-card-contents-for-ri="236" type="text/json">{"id":236,"name":"Cognitive Psychology","url":"https://www.academia.edu/Documents/in/Cognitive_Psychology?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="95689" rel="nofollow" href="https://www.academia.edu/Documents/in/Healthy_Aging">Healthy Aging</a>, <script data-card-contents-for-ri="95689" type="text/json">{"id":95689,"name":"Healthy Aging","url":"https://www.academia.edu/Documents/in/Healthy_Aging?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="438403" rel="nofollow" href="https://www.academia.edu/Documents/in/Tai_Chi_Exercise">Tai Chi Exercise</a><script data-card-contents-for-ri="438403" type="text/json">{"id":438403,"name":"Tai Chi Exercise","url":"https://www.academia.edu/Documents/in/Tai_Chi_Exercise?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=12536243]'), work: {"id":12536243,"title":"The effects of International Poi on physical, cognitive, and emotional health in healthy older adults (PhD thesis)","created_at":"2015-05-22T15:11:53.476-07:00","url":"https://www.academia.edu/12536243/The_effects_of_International_Poi_on_physical_cognitive_and_emotional_health_in_healthy_older_adults_PhD_thesis_?f_ri=4387","dom_id":"work_12536243","summary":"We are currently experiencing unprecedented population ageing worldwide, and effective, affordable strategies for maintaining quality of life are urgently needed. International Poi involves swinging a weight on the end of a cord in circular patterns around the body. The aim of this thesis was to investigate the effects of International Poi, as compared to Tai Chi, on physical, cognitive, and emotional health in healthy older adults. Seventy-nine participants (60 - 86 years old) were randomly allocated to the International Poi or Tai Chi group. Physical and cognitive function were measured one month before, immediately before, immediately after, and one month after the intervention (2 lessons a week for 4 weeks). Follow-up questionnaires were administered after each lesson, immediately after the intervention, and one month after the intervention.\r\n \r\nImmediately post intervention both groups improved postural stability, upper limb strength, and simple attention. The Tai Chi group also improved systolic blood pressure. One month post intervention, compared to immediately post intervention, both groups improved upper limb strength, upper limb range of motion, and memory. The poi group also improved systolic blood pressure. Questionnaire results showed both groups felt primarily relaxed during the intervention, with the International Poi group feeling more challenged and happy, and the Tai Chi group feeling more calm and peaceful. The majority of participants reported wanting to continue their practice, suggesting both activities are enjoyable.\r\n \r\nThis was the first study to scientifically investigate the effects of International Poi on health in older adults. Based on this thesis, it can be concluded that International Poi seems to be as effective as Tai Chi for improving health in healthy older adults, and that International Poi and health is a legitimate area of scientific research. The possibilities for future poi and health research are vast, and the need for such research is paramount in order to replicate results, better understand potential long-term benefits, and begin to make recommendations for policy makers and practitioners regarding poi-health initiatives. ","downloadable_attachments":[{"id":56856148,"asset_id":12536243,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":31068468,"first_name":"Kate","last_name":"Riegle van West","domain_name":"auckland","page_name":"KatevanWest","display_name":"Kate Riegle van West","profile_url":"https://auckland.academia.edu/KatevanWest?f_ri=4387","photo":"https://0.academia-photos.com/31068468/9111972/35338083/s65_kate.riegle_van_west.jpg"}],"research_interests":[{"id":236,"name":"Cognitive Psychology","url":"https://www.academia.edu/Documents/in/Cognitive_Psychology?f_ri=4387","nofollow":true},{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":95689,"name":"Healthy Aging","url":"https://www.academia.edu/Documents/in/Healthy_Aging?f_ri=4387","nofollow":true},{"id":438403,"name":"Tai Chi Exercise","url":"https://www.academia.edu/Documents/in/Tai_Chi_Exercise?f_ri=4387","nofollow":true},{"id":1171216,"name":"Positive Ageing","url":"https://www.academia.edu/Documents/in/Positive_Ageing?f_ri=4387"}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_2406997" data-work_id="2406997" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/2406997/Gydymo_ir_mokslinio_tyrimo_painiavos_problema_klinikiniuose_tyrimuose_Therapeutic_misconception_in_clinical_research_is_it_possible_to_overcome_the_misunderstanding_of_the_difference_between_research_and_clinical_practice_p_11_21_">Gydymo ir mokslinio tyrimo painiavos problema klinikiniuose tyrimuose (Therapeutic misconception in clinical research: is it possible to overcome the misunderstanding of the difference between research and clinical practice? (p. 11-21)</a></div></div><div class="u-pb4x u-mt3x"></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/2406997" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="c26965f5f1f354c5609353116d373e99" rel="nofollow" data-download="{"attachment_id":30880990,"asset_id":2406997,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/30880990/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="966029" href="https://vu-lt.academia.edu/AstaCekanauskaite">Asta Cekanauskaite</a><script data-card-contents-for-user="966029" type="text/json">{"id":966029,"first_name":"Asta","last_name":"Cekanauskaite","domain_name":"vu-lt","page_name":"AstaCekanauskaite","display_name":"Asta Cekanauskaite","profile_url":"https://vu-lt.academia.edu/AstaCekanauskaite?f_ri=4387","photo":"https://0.academia-photos.com/966029/2724249/8962164/s65_asta.cekanauskaite.jpg"}</script></span></span></li><li class="js-paper-rank-work_2406997 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="2406997"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 2406997, container: ".js-paper-rank-work_2406997", }); 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$(".js-view-count[data-work-id=2406997]").text(description); $(".js-view-count-work_2406997").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_2406997").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="2406997"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">4</a>  </div><span class="InlineList-item-text u-textTruncate u-pl9x"><a class="InlineList-item-text" data-has-card-for-ri="2504" rel="nofollow" href="https://www.academia.edu/Documents/in/Research_Ethics">Research Ethics</a>, <script data-card-contents-for-ri="2504" type="text/json">{"id":2504,"name":"Research Ethics","url":"https://www.academia.edu/Documents/in/Research_Ethics?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="9302" rel="nofollow" href="https://www.academia.edu/Documents/in/Understanding">Understanding</a>, <script data-card-contents-for-ri="9302" type="text/json">{"id":9302,"name":"Understanding","url":"https://www.academia.edu/Documents/in/Understanding?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="951983" rel="nofollow" href="https://www.academia.edu/Documents/in/Therapeutic_Misconcption">Therapeutic Misconcption</a><script data-card-contents-for-ri="951983" type="text/json">{"id":951983,"name":"Therapeutic Misconcption","url":"https://www.academia.edu/Documents/in/Therapeutic_Misconcption?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=2406997]'), work: {"id":2406997,"title":"Gydymo ir mokslinio tyrimo painiavos problema klinikiniuose tyrimuose (Therapeutic misconception in clinical research: is it possible to overcome the misunderstanding of the difference between research and clinical practice? (p. 11-21)","created_at":"2013-01-15T19:39:07.941-08:00","url":"https://www.academia.edu/2406997/Gydymo_ir_mokslinio_tyrimo_painiavos_problema_klinikiniuose_tyrimuose_Therapeutic_misconception_in_clinical_research_is_it_possible_to_overcome_the_misunderstanding_of_the_difference_between_research_and_clinical_practice_p_11_21_?f_ri=4387","dom_id":"work_2406997","summary":null,"downloadable_attachments":[{"id":30880990,"asset_id":2406997,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":966029,"first_name":"Asta","last_name":"Cekanauskaite","domain_name":"vu-lt","page_name":"AstaCekanauskaite","display_name":"Asta Cekanauskaite","profile_url":"https://vu-lt.academia.edu/AstaCekanauskaite?f_ri=4387","photo":"https://0.academia-photos.com/966029/2724249/8962164/s65_asta.cekanauskaite.jpg"}],"research_interests":[{"id":2504,"name":"Research Ethics","url":"https://www.academia.edu/Documents/in/Research_Ethics?f_ri=4387","nofollow":true},{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":9302,"name":"Understanding","url":"https://www.academia.edu/Documents/in/Understanding?f_ri=4387","nofollow":true},{"id":951983,"name":"Therapeutic Misconcption","url":"https://www.academia.edu/Documents/in/Therapeutic_Misconcption?f_ri=4387","nofollow":true}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_45969644" data-work_id="45969644" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/45969644/DESIGNING_PARAMETER_AGNOSTIC_FRAMEWORK_FOR_PREDICTING_DISEASE_ONSET_USING_DEEP_LEARNING_METHODS">DESIGNING PARAMETER AGNOSTIC FRAMEWORK FOR PREDICTING DISEASE ONSET USING DEEP LEARNING METHODS</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Health Care and Life Sciences have been one of the most researched domains. The advent of newer computing paradigms has opened many new and unexplored avenues. These were first initiated by the newer instruments which further gave rise to... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_45969644" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Health Care and Life Sciences have been one of the most researched domains. The advent of newer computing paradigms has opened many new and unexplored avenues. These were first initiated by the newer instruments which further gave rise to newer paradigms that leverage the data generated using these instruments. With the HighPerformance Computing paradigms, becoming more accessible, we can now leverage various machine learning / deep learning approaches to utilize the data by digitizing it in various forms like Electronic Health Record (EHR) and Electronic Medical Record (EMR), etc. Mostly the medical notes comprise a lot of unstructured data and leveraging only structured information will lead to the loss of a significant amount of information. Although EHR contains a ton of data that can give valuable insights, it is still challenging to extract the information due to its inherent quality of being unstructured and missing data, variable length, and more importantly the lack of domain knowledge, which helps in the analysis. The Long Short-Term Memory (LSTMs) based implementation of Recurrent Neural Networks (RNNs) can be employed to solve the problem of variable-length records but the other issues like linking domain knowledge and extracting information from unstructured data remains a challenge. Also, many researchers have been employing several Deep Learning models to predict the onset of certain diseases by leveraging the data set pertaining to only the particular disease in question leaving the disease agnostic avenue for the trail. We endeavour to develop a generic framework that can be used to predict the onset of any disease by extracting valuable information out of unstructured medical data. In this work, we propose a generic framework that is not specific for any disease/disorder for prediction of the possibility of occurrence of a particular disease/disorder. We have employed RNNs with LSTMs to solve the variable-length issue and then leveraged the NLP based techniques to build a corpus to help map the domain-related information and also to extract the relevant information form the unstructured data. Our results show that the current model has a very small loss of 0.005 and average accuracy of 98.72 % with an AUC of 75.89%</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/45969644" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="83f628f0928ccfd45fa22f08718b3104" rel="nofollow" data-download="{"attachment_id":66209846,"asset_id":45969644,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/66209846/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="39122404" href="https://iaeme.academia.edu/publication">IAEME Publication</a><script data-card-contents-for-user="39122404" type="text/json">{"id":39122404,"first_name":"IAEME","last_name":"Publication","domain_name":"iaeme","page_name":"publication","display_name":"IAEME Publication","profile_url":"https://iaeme.academia.edu/publication?f_ri=4387","photo":"https://0.academia-photos.com/39122404/12178523/13563629/s65_iaeme.publication.jpg"}</script></span></span></li><li class="js-paper-rank-work_45969644 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="45969644"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 45969644, container: ".js-paper-rank-work_45969644", }); 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$(".js-view-count[data-work-id=45969644]").text(description); $(".js-view-count-work_45969644").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_45969644").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="45969644"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">6</a>  </div><span class="InlineList-item-text u-textTruncate u-pl9x"><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="9350" rel="nofollow" href="https://www.academia.edu/Documents/in/Electronic_Health_Records">Electronic Health Records</a>, <script data-card-contents-for-ri="9350" type="text/json">{"id":9350,"name":"Electronic Health Records","url":"https://www.academia.edu/Documents/in/Electronic_Health_Records?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="19725" rel="nofollow" href="https://www.academia.edu/Documents/in/Unstructured_Data_Management">Unstructured Data Management</a>, <script data-card-contents-for-ri="19725" type="text/json">{"id":19725,"name":"Unstructured Data Management","url":"https://www.academia.edu/Documents/in/Unstructured_Data_Management?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="81182" rel="nofollow" href="https://www.academia.edu/Documents/in/Deep_Learning">Deep Learning</a><script data-card-contents-for-ri="81182" type="text/json">{"id":81182,"name":"Deep Learning","url":"https://www.academia.edu/Documents/in/Deep_Learning?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=45969644]'), work: {"id":45969644,"title":"DESIGNING PARAMETER AGNOSTIC FRAMEWORK FOR PREDICTING DISEASE ONSET USING DEEP LEARNING METHODS","created_at":"2021-04-08T02:49:41.114-07:00","url":"https://www.academia.edu/45969644/DESIGNING_PARAMETER_AGNOSTIC_FRAMEWORK_FOR_PREDICTING_DISEASE_ONSET_USING_DEEP_LEARNING_METHODS?f_ri=4387","dom_id":"work_45969644","summary":"Health Care and Life Sciences have been one of the most researched domains. The advent of newer computing paradigms has opened many new and unexplored avenues. These were first initiated by the newer instruments which further gave rise to newer paradigms that leverage the data generated using these instruments. With the HighPerformance Computing paradigms, becoming more accessible, we can now leverage various machine learning / deep learning approaches to utilize the data by digitizing it in various forms like Electronic Health Record (EHR) and Electronic Medical Record (EMR), etc. Mostly the medical notes comprise a lot of unstructured data and leveraging only structured information will lead to the loss of a significant amount of information. Although EHR contains a ton of data that can give valuable insights, it is still challenging to extract the information due to its inherent quality of being unstructured and missing data, variable length, and more importantly the lack of domain knowledge, which helps in the analysis. The Long Short-Term Memory (LSTMs) based implementation of Recurrent Neural Networks (RNNs) can be employed to solve the problem of variable-length records but the other issues like linking domain knowledge and extracting information from unstructured data remains a challenge. Also, many researchers have been employing several Deep Learning models to predict the onset of certain diseases by leveraging the data set pertaining to only the particular disease in question leaving the disease agnostic avenue for the trail. We endeavour to develop a generic framework that can be used to predict the onset of any disease by extracting valuable information out of unstructured medical data. In this work, we propose a generic framework that is not specific for any disease/disorder for prediction of the possibility of occurrence of a particular disease/disorder. We have employed RNNs with LSTMs to solve the variable-length issue and then leveraged the NLP based techniques to build a corpus to help map the domain-related information and also to extract the relevant information form the unstructured data. Our results show that the current model has a very small loss of 0.005 and average accuracy of 98.72 % with an AUC of 75.89%","downloadable_attachments":[{"id":66209846,"asset_id":45969644,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":39122404,"first_name":"IAEME","last_name":"Publication","domain_name":"iaeme","page_name":"publication","display_name":"IAEME Publication","profile_url":"https://iaeme.academia.edu/publication?f_ri=4387","photo":"https://0.academia-photos.com/39122404/12178523/13563629/s65_iaeme.publication.jpg"}],"research_interests":[{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":9350,"name":"Electronic Health Records","url":"https://www.academia.edu/Documents/in/Electronic_Health_Records?f_ri=4387","nofollow":true},{"id":19725,"name":"Unstructured Data Management","url":"https://www.academia.edu/Documents/in/Unstructured_Data_Management?f_ri=4387","nofollow":true},{"id":81182,"name":"Deep Learning","url":"https://www.academia.edu/Documents/in/Deep_Learning?f_ri=4387","nofollow":true},{"id":84486,"name":"Disease Prediction","url":"https://www.academia.edu/Documents/in/Disease_Prediction?f_ri=4387"},{"id":874382,"name":"Medical Records","url":"https://www.academia.edu/Documents/in/Medical_Records?f_ri=4387"}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_29231825 coauthored" data-work_id="29231825" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/29231825/Interventions_for_orthodontically_induced_white_spot_lesions_a_systematic_review_and_meta_analysis">Interventions for orthodontically induced white spot lesions: a systematic review and meta-analysis</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Background: Although orthodontic white spot lesions (WSLs) are one of the most often and most evident adverse effects of comprehensive fixed appliance treatment, the efficacy of interventions for WSLs has not yet been adequately assessed... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_29231825" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Background: Although orthodontic white spot lesions (WSLs) are one of the most often and most evident adverse effects of comprehensive fixed appliance treatment, the efficacy of interventions for WSLs has not yet been adequately assessed in an evidence-based manner. Objective: Aim of this systematic review was to assess the therapeutic and adverse effects of interventions to treat post-orthodontic WSLs from randomized trials in human patients. Search methods: An unrestricted electronic search of eight databases from inception to May 2016. Selection criteria: Randomized controlled trials assessing any interventions for post-orthodontic WSLs on human patients. Data collection and analysis: After duplicate study selection, data extraction, and risk of bias assessment according to the Cochrane guidelines, random-effects meta-analyses of mean differences (MDs), standardized mean differences (SMDs), and odds ratios (ORs), including their 95% confidence intervals (CIs) were performed, followed by subgroup and sensitivity analyses. Results: A total of 20 unique studies and a total of 942 (42 per cent male and 58% per cent female) patients were included, with an average age of 16.2 years and a mean number of 8.2 WSLs (range 2.2 to 45.4) per patient. These were allocated to adjunct treatment with casein phosphopeptide-stabilized amorphous calcium phosphate creams, external tooth bleaching, low-or high-concentration fluoride films, gels, mouthrinses or varnishes, resin infiltration, miswak chewing sticks, bioactive glass toothpastse, or to no adjunct treatment (i.e. conventional oral hygiene). The monthly use of fluoride varnish was the best supplement to improve WSLs in terms of lesion area (1 trial; MD = −0.80 mm 2 ; 95% CI = −1.10, −0.50 mm 2 ; P < 0.05; high quality) and enamel fluorescence (3 trials; SMD = −0.92; 95% CI = −1.32, −0.52; P < 0.05; high quality), followed by the use of fluoride film. WSL treatment did not provide a considerable improvement in their clinical evaluation (3 trials; OR = 0.97; 95% CI = 0.60, 1.56; P > 0.05; moderate quality), with imprecision due to small sample size being the main limitation of existing evidence. Conclusions: Based on the existing trials, interventions for post-orthodontic WSLs, mainly fluoride varnish, seem to be effective, but further research is needed to elucidate their clinical relevance. Registration: PROSPERO (CRD42016037538)</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/29231825" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="a6219f3f1e63f3d680119511036157c9" rel="nofollow" data-download="{"attachment_id":49684138,"asset_id":29231825,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/49684138/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="968588" href="https://uzh.academia.edu/SpyridonPapageorgiou">Spyridon Papageorgiou</a><script data-card-contents-for-user="968588" type="text/json">{"id":968588,"first_name":"Spyridon","last_name":"Papageorgiou","domain_name":"uzh","page_name":"SpyridonPapageorgiou","display_name":"Spyridon Papageorgiou","profile_url":"https://uzh.academia.edu/SpyridonPapageorgiou?f_ri=4387","photo":"https://0.academia-photos.com/968588/631896/15999667/s65_spyridon.papageorgiou.jpg"}</script></span></span><span class="u-displayInlineBlock InlineList-item-text"> and <span class="u-textDecorationUnderline u-clickable InlineList-item-text js-work-more-authors-29231825">+1</span><div class="hidden js-additional-users-29231825"><div><span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a href="https://independent.academia.edu/TheodoreEliades">Theodore Eliades</a></span></div></div></span><script>(function(){ var popoverSettings = { el: $('.js-work-more-authors-29231825'), placement: 'bottom', hide_delay: 200, html: true, content: function(){ return $('.js-additional-users-29231825').html(); } } new HoverPopover(popoverSettings); })();</script></li><li class="js-paper-rank-work_29231825 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="29231825"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 29231825, container: ".js-paper-rank-work_29231825", }); });</script></li><li class="js-percentile-work_29231825 InlineList-item InlineList-item--bordered hidden u-tcGrayDark"><span class="percentile-widget hidden"><span class="u-mr2x percentile-widget" style="display: none">•</span><span class="u-mr2x work-percentile"></span></span><script>$(function () { var workId = 29231825; window.Academia.workPercentilesFetcher.queue(workId, function (percentileText) { var container = $(".js-percentile-work_29231825"); container.find('.work-percentile').text(percentileText.charAt(0).toUpperCase() + percentileText.slice(1)); container.find('.percentile-widget').show(); container.find('.percentile-widget').removeClass('hidden'); }); });</script></li><li class="js-view-count-work_29231825 InlineList-item InlineList-item--bordered hidden"><div><span><span class="js-view-count view-count u-mr2x" data-work-id="29231825"><i class="fa fa-spinner fa-spin"></i></span><script>$(function () { var workId = 29231825; window.Academia.workViewCountsFetcher.queue(workId, function (count) { var description = window.$h.commaizeInt(count) + " " + window.$h.pluralize(count, 'View'); $(".js-view-count[data-work-id=29231825]").text(description); $(".js-view-count-work_29231825").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_29231825").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="29231825"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">56</a>  </div><span class="InlineList-item-text u-textTruncate u-pl10x"><a class="InlineList-item-text" data-has-card-for-ri="600" rel="nofollow" href="https://www.academia.edu/Documents/in/Orthodontics">Orthodontics</a>, <script data-card-contents-for-ri="600" type="text/json">{"id":600,"name":"Orthodontics","url":"https://www.academia.edu/Documents/in/Orthodontics?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="3645" rel="nofollow" href="https://www.academia.edu/Documents/in/Evidence_Based_Medicine">Evidence Based Medicine</a>, <script data-card-contents-for-ri="3645" type="text/json">{"id":3645,"name":"Evidence Based Medicine","url":"https://www.academia.edu/Documents/in/Evidence_Based_Medicine?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="4531" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trial">Clinical Trial</a><script data-card-contents-for-ri="4531" type="text/json">{"id":4531,"name":"Clinical Trial","url":"https://www.academia.edu/Documents/in/Clinical_Trial?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=29231825]'), work: {"id":29231825,"title":"Interventions for orthodontically induced white spot lesions: a systematic review and meta-analysis","created_at":"2016-10-18T02:31:04.105-07:00","url":"https://www.academia.edu/29231825/Interventions_for_orthodontically_induced_white_spot_lesions_a_systematic_review_and_meta_analysis?f_ri=4387","dom_id":"work_29231825","summary":"Background: Although orthodontic white spot lesions (WSLs) are one of the most often and most evident adverse effects of comprehensive fixed appliance treatment, the efficacy of interventions for WSLs has not yet been adequately assessed in an evidence-based manner. Objective: Aim of this systematic review was to assess the therapeutic and adverse effects of interventions to treat post-orthodontic WSLs from randomized trials in human patients. Search methods: An unrestricted electronic search of eight databases from inception to May 2016. Selection criteria: Randomized controlled trials assessing any interventions for post-orthodontic WSLs on human patients. Data collection and analysis: After duplicate study selection, data extraction, and risk of bias assessment according to the Cochrane guidelines, random-effects meta-analyses of mean differences (MDs), standardized mean differences (SMDs), and odds ratios (ORs), including their 95% confidence intervals (CIs) were performed, followed by subgroup and sensitivity analyses. Results: A total of 20 unique studies and a total of 942 (42 per cent male and 58% per cent female) patients were included, with an average age of 16.2 years and a mean number of 8.2 WSLs (range 2.2 to 45.4) per patient. These were allocated to adjunct treatment with casein phosphopeptide-stabilized amorphous calcium phosphate creams, external tooth bleaching, low-or high-concentration fluoride films, gels, mouthrinses or varnishes, resin infiltration, miswak chewing sticks, bioactive glass toothpastse, or to no adjunct treatment (i.e. conventional oral hygiene). The monthly use of fluoride varnish was the best supplement to improve WSLs in terms of lesion area (1 trial; MD = −0.80 mm 2 ; 95% CI = −1.10, −0.50 mm 2 ; P \u003c 0.05; high quality) and enamel fluorescence (3 trials; SMD = −0.92; 95% CI = −1.32, −0.52; P \u003c 0.05; high quality), followed by the use of fluoride film. WSL treatment did not provide a considerable improvement in their clinical evaluation (3 trials; OR = 0.97; 95% CI = 0.60, 1.56; P \u003e 0.05; moderate quality), with imprecision due to small sample size being the main limitation of existing evidence. Conclusions: Based on the existing trials, interventions for post-orthodontic WSLs, mainly fluoride varnish, seem to be effective, but further research is needed to elucidate their clinical relevance. Registration: PROSPERO (CRD42016037538)","downloadable_attachments":[{"id":49684138,"asset_id":29231825,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":968588,"first_name":"Spyridon","last_name":"Papageorgiou","domain_name":"uzh","page_name":"SpyridonPapageorgiou","display_name":"Spyridon Papageorgiou","profile_url":"https://uzh.academia.edu/SpyridonPapageorgiou?f_ri=4387","photo":"https://0.academia-photos.com/968588/631896/15999667/s65_spyridon.papageorgiou.jpg"},{"id":55269546,"first_name":"Theodore","last_name":"Eliades","domain_name":"independent","page_name":"TheodoreEliades","display_name":"Theodore Eliades","profile_url":"https://independent.academia.edu/TheodoreEliades?f_ri=4387","photo":"/images/s65_no_pic.png"}],"research_interests":[{"id":600,"name":"Orthodontics","url":"https://www.academia.edu/Documents/in/Orthodontics?f_ri=4387","nofollow":true},{"id":3645,"name":"Evidence Based Medicine","url":"https://www.academia.edu/Documents/in/Evidence_Based_Medicine?f_ri=4387","nofollow":true},{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":4531,"name":"Clinical Trial","url":"https://www.academia.edu/Documents/in/Clinical_Trial?f_ri=4387","nofollow":true},{"id":4886,"name":"Meta-Analysis (Statistics)","url":"https://www.academia.edu/Documents/in/Meta-Analysis_Statistics_?f_ri=4387"},{"id":6482,"name":"Meta-Analysis and Systematic Review","url":"https://www.academia.edu/Documents/in/Meta-Analysis_and_Systematic_Review?f_ri=4387"},{"id":7462,"name":"Randomization","url":"https://www.academia.edu/Documents/in/Randomization?f_ri=4387"},{"id":7463,"name":"Randomized Evaluation","url":"https://www.academia.edu/Documents/in/Randomized_Evaluation?f_ri=4387"},{"id":13014,"name":"Dissemination of Evidence Based 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u-mb0x js-work-card work_6890688" data-work_id="6890688" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/6890688/The_Clinical_Complications_of_Asthma_and_its_Pharmacotherapy">The Clinical Complications of Asthma and its Pharmacotherapy</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Asthma is a disease characterized by wide variations in pathogenesis that cause resistance to flow in intrapulmonary airways. The dramatic changes in the architecture of the airway walls are usually connected to allergic reaction or... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_6890688" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Asthma is a disease characterized by wide variations in <br />pathogenesis that cause resistance to flow in intrapulmonary <br />airways. The dramatic changes in the architecture of the airway <br />walls are usually connected to allergic reaction or other forms of <br />hyper sensitivity, causing marked spasms that lead to difficulty in <br />breathing. It is possible to relieve or remove the symptoms in the <br />majority of patients by adopting the clinical guidelines for <br />pharmacotherapy of asthma which include inhaled corticosteroids, <br />long and short acting beta agonists, muscarinic antagonists, <br />leukotriene modifiers, xanthine drugs and some allergy medicines. <br />The proper use of these agents can aid in reducing or reversing <br />many symptoms of asthma. Certain methods of using medicines, <br />for example the correct use of the inhaler for relief and <br />maintenance therapy, are also associated with a significant <br />reduction in symptoms. This can be achieved by a pharmacist’s <br />intervention that can provide a detailed understanding of the <br />current rational drug choices and proper medication use to the <br />patient. Nowadays massive resources are being ploughed into <br />research in a concerted effort to halt the progress of this illness <br />that can strike in all ages.</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/6890688" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="c08ef0b7d0b0a27f7ce9078d9562e71d" rel="nofollow" data-download="{"attachment_id":33573475,"asset_id":6890688,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/33573475/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="7856206" href="https://independent.academia.edu/EditorBBB">British Biomedical Bulletin</a><script data-card-contents-for-user="7856206" type="text/json">{"id":7856206,"first_name":"British Biomedical","last_name":"Bulletin","domain_name":"independent","page_name":"EditorBBB","display_name":"British Biomedical Bulletin","profile_url":"https://independent.academia.edu/EditorBBB?f_ri=4387","photo":"https://0.academia-photos.com/7856206/5915532/6716757/s65_british_biomedical.bulletin.jpg"}</script></span></span></li><li class="js-paper-rank-work_6890688 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="6890688"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 6890688, container: ".js-paper-rank-work_6890688", }); 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itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/75491980/Dalla_Cassazione_barlumi_di_chiarezza_nella_responsabilit%C3%A0_delle_sperimentazioni_cliniche_Commento_alla_sentenza_della_Corte_di_Cassazione_sez_III_civ_20_aprile_2021_n_10348">Dalla Cassazione barlumi di chiarezza nella responsabilità delle sperimentazioni cliniche - Commento alla sentenza della Corte di Cassazione, sez. III civ. 20 aprile 2021, n.10348</a></div></div><div class="u-pb4x u-mt3x"></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/75491980" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="8f22dbe5c78c2160cad09adb3b130d8c" rel="nofollow" data-download="{"attachment_id":83239630,"asset_id":75491980,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/83239630/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="5154130" href="https://roche.academia.edu/faustomassimino">fausto massimino</a><script data-card-contents-for-user="5154130" type="text/json">{"id":5154130,"first_name":"fausto","last_name":"massimino","domain_name":"roche","page_name":"faustomassimino","display_name":"fausto massimino","profile_url":"https://roche.academia.edu/faustomassimino?f_ri=4387","photo":"https://0.academia-photos.com/5154130/155357267/144979314/s65_fausto.massimino.jpeg"}</script></span></span></li><li class="js-paper-rank-work_75491980 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="75491980"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 75491980, container: ".js-paper-rank-work_75491980", }); 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u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_25323424" data-work_id="25323424" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/25323424/Effectiveness_of_early_orthopaedic_treatment_with_headgear_a_systematic_review_and_meta_analysis">Effectiveness of early orthopaedic treatment with headgear: a systematic review and meta-analysis</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">Background: Although the headgear appliance has been used extensively to correct anteroposterior discrepancies, its treatment effects have not yet been adequately assessed in an evidence-based manner. Objective: Aim of this systematic... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_25323424" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">Background: Although the headgear appliance has been used extensively to correct anteroposterior discrepancies, its treatment effects have not yet been adequately assessed in an evidence-based manner. Objective: Aim of this systematic review was to assess the therapeutic and adverse effects of early headgear treatment from controlled clinical trials on human patients in an evidence-based manner. Search methods: An unrestricted electronic search of six databases from inception to December 2015. Selection criteria: Randomized and prospective non-randomized controlled trials assessing the effects of headgear treatment on human patients. Data collection and analysis: After duplicate study selection, data extraction, and risk of bias assessment according to the Cochrane guidelines, random-effects meta-analyses of mean differences (MDs) and relative risks (RRs), including their 95% confidence intervals (CIs) were performed, followed by subgroup and sensitivity analyses. Results: A total of 18 unique studies with a total of 930 (56% male/44% female) patients were included. Headgear treatment was associated with a posterior translation of the anterior maxilla border in the short term, as seen by the mean annualized change in the SNA angle (MD = −1.63°/ year; 95% CI = −2.20 to −1.06°/year; high quality evidence) compared to untreated patients. This effect was independent of the rotation of the palatal plane and the inclination of the upper incisors, while a proportional relationship with the initial discrepancy in SNA was seen. The clinical significance of this improvement diminished in the long term, although only limited evidence existed. Additionally, early headgear treatment might decrease the risk of dental trauma during the following years (RR = 0.34; 95% CI = 0.14 to 0.80; moderate quality evidence). Low quality evidence on the effect of headgear on the rotation of the palatal plane, the nasolabial angle, the occlusal outcome, and signs of temporomandibular disorders precluded robust assessments, due to risk of bias, inconsistency, imprecision, and small-study effects. Conclusions: Based on existing trials, headgear is a viable treatment option to modify sagittal growth of the maxilla in the short term in Class II patients with maxillary prognathism. Registration: PROSPERO (CRD42015029837). Funding: None.</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/25323424" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="7a812eed08e6faf880f34ae2d8cea608" rel="nofollow" data-download="{"attachment_id":45622056,"asset_id":25323424,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/45622056/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="968588" href="https://uzh.academia.edu/SpyridonPapageorgiou">Spyridon Papageorgiou</a><script data-card-contents-for-user="968588" type="text/json">{"id":968588,"first_name":"Spyridon","last_name":"Papageorgiou","domain_name":"uzh","page_name":"SpyridonPapageorgiou","display_name":"Spyridon Papageorgiou","profile_url":"https://uzh.academia.edu/SpyridonPapageorgiou?f_ri=4387","photo":"https://0.academia-photos.com/968588/631896/15999667/s65_spyridon.papageorgiou.jpg"}</script></span></span></li><li class="js-paper-rank-work_25323424 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="25323424"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 25323424, container: ".js-paper-rank-work_25323424", }); });</script></li><li class="js-percentile-work_25323424 InlineList-item InlineList-item--bordered hidden u-tcGrayDark"><span class="percentile-widget hidden"><span class="u-mr2x percentile-widget" style="display: none">•</span><span class="u-mr2x work-percentile"></span></span><script>$(function () { var workId = 25323424; window.Academia.workPercentilesFetcher.queue(workId, function (percentileText) { var container = $(".js-percentile-work_25323424"); container.find('.work-percentile').text(percentileText.charAt(0).toUpperCase() + percentileText.slice(1)); container.find('.percentile-widget').show(); container.find('.percentile-widget').removeClass('hidden'); }); });</script></li><li class="js-view-count-work_25323424 InlineList-item InlineList-item--bordered hidden"><div><span><span class="js-view-count view-count u-mr2x" data-work-id="25323424"><i class="fa fa-spinner fa-spin"></i></span><script>$(function () { var workId = 25323424; window.Academia.workViewCountsFetcher.queue(workId, function (count) { var description = window.$h.commaizeInt(count) + " " + window.$h.pluralize(count, 'View'); $(".js-view-count[data-work-id=25323424]").text(description); $(".js-view-count-work_25323424").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_25323424").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="25323424"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">25</a>  </div><span class="InlineList-item-text u-textTruncate u-pl10x"><a class="InlineList-item-text" data-has-card-for-ri="600" rel="nofollow" href="https://www.academia.edu/Documents/in/Orthodontics">Orthodontics</a>, <script data-card-contents-for-ri="600" type="text/json">{"id":600,"name":"Orthodontics","url":"https://www.academia.edu/Documents/in/Orthodontics?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="4531" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trial">Clinical Trial</a>, <script data-card-contents-for-ri="4531" type="text/json">{"id":4531,"name":"Clinical Trial","url":"https://www.academia.edu/Documents/in/Clinical_Trial?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="4886" rel="nofollow" href="https://www.academia.edu/Documents/in/Meta-Analysis_Statistics_">Meta-Analysis (Statistics)</a><script data-card-contents-for-ri="4886" type="text/json">{"id":4886,"name":"Meta-Analysis (Statistics)","url":"https://www.academia.edu/Documents/in/Meta-Analysis_Statistics_?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=25323424]'), work: {"id":25323424,"title":"Effectiveness of early orthopaedic treatment with headgear: a systematic review and meta-analysis","created_at":"2016-05-14T07:50:44.626-07:00","url":"https://www.academia.edu/25323424/Effectiveness_of_early_orthopaedic_treatment_with_headgear_a_systematic_review_and_meta_analysis?f_ri=4387","dom_id":"work_25323424","summary":"Background: Although the headgear appliance has been used extensively to correct anteroposterior discrepancies, its treatment effects have not yet been adequately assessed in an evidence-based manner. Objective: Aim of this systematic review was to assess the therapeutic and adverse effects of early headgear treatment from controlled clinical trials on human patients in an evidence-based manner. Search methods: An unrestricted electronic search of six databases from inception to December 2015. Selection criteria: Randomized and prospective non-randomized controlled trials assessing the effects of headgear treatment on human patients. Data collection and analysis: After duplicate study selection, data extraction, and risk of bias assessment according to the Cochrane guidelines, random-effects meta-analyses of mean differences (MDs) and relative risks (RRs), including their 95% confidence intervals (CIs) were performed, followed by subgroup and sensitivity analyses. Results: A total of 18 unique studies with a total of 930 (56% male/44% female) patients were included. Headgear treatment was associated with a posterior translation of the anterior maxilla border in the short term, as seen by the mean annualized change in the SNA angle (MD = −1.63°/ year; 95% CI = −2.20 to −1.06°/year; high quality evidence) compared to untreated patients. This effect was independent of the rotation of the palatal plane and the inclination of the upper incisors, while a proportional relationship with the initial discrepancy in SNA was seen. The clinical significance of this improvement diminished in the long term, although only limited evidence existed. Additionally, early headgear treatment might decrease the risk of dental trauma during the following years (RR = 0.34; 95% CI = 0.14 to 0.80; moderate quality evidence). Low quality evidence on the effect of headgear on the rotation of the palatal plane, the nasolabial angle, the occlusal outcome, and signs of temporomandibular disorders precluded robust assessments, due to risk of bias, inconsistency, imprecision, and small-study effects. Conclusions: Based on existing trials, headgear is a viable treatment option to modify sagittal growth of the maxilla in the short term in Class II patients with maxillary prognathism. Registration: PROSPERO (CRD42015029837). Funding: None.","downloadable_attachments":[{"id":45622056,"asset_id":25323424,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":968588,"first_name":"Spyridon","last_name":"Papageorgiou","domain_name":"uzh","page_name":"SpyridonPapageorgiou","display_name":"Spyridon Papageorgiou","profile_url":"https://uzh.academia.edu/SpyridonPapageorgiou?f_ri=4387","photo":"https://0.academia-photos.com/968588/631896/15999667/s65_spyridon.papageorgiou.jpg"}],"research_interests":[{"id":600,"name":"Orthodontics","url":"https://www.academia.edu/Documents/in/Orthodontics?f_ri=4387","nofollow":true},{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true},{"id":4531,"name":"Clinical Trial","url":"https://www.academia.edu/Documents/in/Clinical_Trial?f_ri=4387","nofollow":true},{"id":4886,"name":"Meta-Analysis (Statistics)","url":"https://www.academia.edu/Documents/in/Meta-Analysis_Statistics_?f_ri=4387","nofollow":true},{"id":6482,"name":"Meta-Analysis and Systematic Review","url":"https://www.academia.edu/Documents/in/Meta-Analysis_and_Systematic_Review?f_ri=4387"},{"id":7462,"name":"Randomization","url":"https://www.academia.edu/Documents/in/Randomization?f_ri=4387"},{"id":22787,"name":"Meta-analysis and systematic review (Health Sciences)","url":"https://www.academia.edu/Documents/in/Meta-analysis_and_systematic_review_Health_Sciences_?f_ri=4387"},{"id":29420,"name":"Clinical trials (Health Sciences)","url":"https://www.academia.edu/Documents/in/Clinical_trials_Health_Sciences_?f_ri=4387"},{"id":42002,"name":"Meta-Analysis","url":"https://www.academia.edu/Documents/in/Meta-Analysis?f_ri=4387"},{"id":43934,"name":"Orthopaedics","url":"https://www.academia.edu/Documents/in/Orthopaedics?f_ri=4387"},{"id":44348,"name":"Systematic Reviews","url":"https://www.academia.edu/Documents/in/Systematic_Reviews?f_ri=4387"},{"id":52036,"name":"Biomechanics in Orthodontics","url":"https://www.academia.edu/Documents/in/Biomechanics_in_Orthodontics?f_ri=4387"},{"id":52041,"name":"Orthodontic Research","url":"https://www.academia.edu/Documents/in/Orthodontic_Research?f_ri=4387"},{"id":66683,"name":"Systematic Literature Review","url":"https://www.academia.edu/Documents/in/Systematic_Literature_Review?f_ri=4387"},{"id":74848,"name":"Randomized Controlled Trials","url":"https://www.academia.edu/Documents/in/Randomized_Controlled_Trials?f_ri=4387"},{"id":113960,"name":"Orthopedics","url":"https://www.academia.edu/Documents/in/Orthopedics?f_ri=4387"},{"id":191910,"name":"Dentistry and Orthodontics","url":"https://www.academia.edu/Documents/in/Dentistry_and_Orthodontics?f_ri=4387"},{"id":203752,"name":"Randomized Trial","url":"https://www.academia.edu/Documents/in/Randomized_Trial?f_ri=4387"},{"id":218206,"name":"Meta Analysis","url":"https://www.academia.edu/Documents/in/Meta_Analysis?f_ri=4387"},{"id":221411,"name":"Systematic review","url":"https://www.academia.edu/Documents/in/Systematic_review?f_ri=4387"},{"id":304751,"name":"Systematic review methodology","url":"https://www.academia.edu/Documents/in/Systematic_review_methodology?f_ri=4387"},{"id":396050,"name":"Human Clinical Trials","url":"https://www.academia.edu/Documents/in/Human_Clinical_Trials?f_ri=4387"},{"id":548506,"name":"ORTHODONTIC appliances","url":"https://www.academia.edu/Documents/in/ORTHODONTIC_appliances?f_ri=4387"},{"id":627505,"name":"Orthodontic","url":"https://www.academia.edu/Documents/in/Orthodontic?f_ri=4387"},{"id":1163409,"name":"Orthodontics and Dentofacial Orthopedics","url":"https://www.academia.edu/Documents/in/Orthodontics_and_Dentofacial_Orthopedics?f_ri=4387"}]}, }) } })();</script></ul></li></ul></div></div><div class="u-borderBottom1 u-borderColorGrayLighter"><div class="clearfix u-pv7x u-mb0x js-work-card work_17766120" data-work_id="17766120" itemscope="itemscope" itemtype="https://schema.org/ScholarlyArticle"><div class="header"><div class="title u-fontSerif u-fs22 u-lineHeight1_3"><a class="u-tcGrayDarkest js-work-link" href="https://www.academia.edu/17766120/The_mild_torture_economy_exploring_the_world_of_professional_research_subjects_and_its_ethical_implications">The “mild-torture economy”: exploring the world of professional research subjects and its ethical implications</a></div></div><div class="u-pb4x u-mt3x"><div class="summary u-fs14 u-fw300 u-lineHeight1_5 u-tcGrayDarkest"><div class="summarized">This paper documents the emergence of the subject of professional research in Phase I clinical trials that test the safety of drugs in development. Based on ethnographic research among subjects self-identified as “professional guinea... <a class="more_link u-tcGrayDark u-linkUnstyled" data-container=".work_17766120" data-show=".complete" data-hide=".summarized" data-more-link-behavior="true" href="#">more</a></div><div class="complete hidden">This paper documents the emergence<br />of the subject of professional research in Phase<br />I clinical trials that test the safety of drugs in<br />development. Based on ethnographic research<br />among subjects self-identified as “professional<br />guinea pigs" in Philadelphia, USA, it examines<br />their experiences and opinions on the conduct of<br />trials and risks they take. The author argues that<br />the risks posed by the continued participation,<br />such as exposure to potentially dangerous drug<br />interactions are minimized or ignored by research<br />subjects because of the prospect of financial gain.<br />Risks to the professional guinea pigs are also ignored<br />by the pharmaceutical industry, which has become<br />dependent on the usual participation of experienced<br />research subjects. Arguing that financial incentives<br />undermine the ethical imperative of informed consent<br />to be given freely by volunteers, this research confirms<br />the need to reform the policies governing the<br />participation of paid subjects in Phase I clinical trials.</div></div></div><ul class="InlineList u-ph0x u-fs13"><li class="InlineList-item logged_in_only"><div class="share_on_academia_work_button"><a class="academia_share Button Button--inverseBlue Button--sm js-bookmark-button" data-academia-share="Work/17766120" data-share-source="work_strip" data-spinner="small_white_hide_contents"><i class="fa fa-plus"></i><span class="work-strip-link-text u-ml1x" data-content="button_text">Bookmark</span></a></div></li><li class="InlineList-item"><div class="download"><a id="728f22993f42f10ef08f394ab28dbf7f" rel="nofollow" data-download="{"attachment_id":39697588,"asset_id":17766120,"asset_type":"Work","always_allow_download":false,"track":null,"button_location":"work_strip","source":null,"hide_modal":null}" class="Button Button--sm Button--inverseGreen js-download-button prompt_button doc_download" href="https://www.academia.edu/attachments/39697588/download_file?st=MTc0MDE2MDEwMiw4LjIyMi4yMDguMTQ2&s=work_strip"><i class="fa fa-arrow-circle-o-down fa-lg"></i><span class="u-textUppercase u-ml1x" data-content="button_text">Download</span></a></div></li><li class="InlineList-item"><ul class="InlineList InlineList--bordered u-ph0x"><li class="InlineList-item InlineList-item--bordered"><span class="InlineList-item-text">by <span itemscope="itemscope" itemprop="author" itemtype="https://schema.org/Person"><a class="u-tcGrayDark u-fw700" data-has-card-for-user="2802996" href="https://wisc.academia.edu/RobertoAbadie">Roberto Abadie</a><script data-card-contents-for-user="2802996" type="text/json">{"id":2802996,"first_name":"Roberto","last_name":"Abadie","domain_name":"wisc","page_name":"RobertoAbadie","display_name":"Roberto Abadie","profile_url":"https://wisc.academia.edu/RobertoAbadie?f_ri=4387","photo":"https://0.academia-photos.com/2802996/916771/17909345/s65_roberto.abadie.jpg"}</script></span></span></li><li class="js-paper-rank-work_17766120 InlineList-item InlineList-item--bordered hidden"><span class="js-paper-rank-view hidden u-tcGrayDark" data-paper-rank-work-id="17766120"><i class="u-m1x fa fa-bar-chart"></i><strong class="js-paper-rank"></strong></span><script>$(function() { new Works.PaperRankView({ workId: 17766120, container: ".js-paper-rank-work_17766120", }); 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$(".js-view-count[data-work-id=17766120]").text(description); $(".js-view-count-work_17766120").attr('title', description).tooltip(); }); });</script></span><script>$(function() { $(".js-view-count-work_17766120").removeClass('hidden') })</script></div></li><li class="InlineList-item u-positionRelative" style="max-width: 250px"><div class="u-positionAbsolute" data-has-card-for-ri-list="17766120"><i class="fa fa-tag InlineList-item-icon u-positionRelative"></i>  <a class="InlineList-item-text u-positionRelative">6</a>  </div><span class="InlineList-item-text u-textTruncate u-pl9x"><a class="InlineList-item-text" data-has-card-for-ri="814" rel="nofollow" href="https://www.academia.edu/Documents/in/Ethics">Ethics</a>, <script data-card-contents-for-ri="814" type="text/json">{"id":814,"name":"Ethics","url":"https://www.academia.edu/Documents/in/Ethics?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="4387" rel="nofollow" href="https://www.academia.edu/Documents/in/Clinical_Trials">Clinical Trials</a>, <script data-card-contents-for-ri="4387" type="text/json">{"id":4387,"name":"Clinical Trials","url":"https://www.academia.edu/Documents/in/Clinical_Trials?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="38872" rel="nofollow" href="https://www.academia.edu/Documents/in/Exploitation">Exploitation</a>, <script data-card-contents-for-ri="38872" type="text/json">{"id":38872,"name":"Exploitation","url":"https://www.academia.edu/Documents/in/Exploitation?f_ri=4387","nofollow":true}</script><a class="InlineList-item-text" data-has-card-for-ri="46182" rel="nofollow" href="https://www.academia.edu/Documents/in/Pharmaceutical_industry">Pharmaceutical industry</a><script data-card-contents-for-ri="46182" type="text/json">{"id":46182,"name":"Pharmaceutical industry","url":"https://www.academia.edu/Documents/in/Pharmaceutical_industry?f_ri=4387","nofollow":true}</script></span></li><script>(function(){ if (true) { new Aedu.ResearchInterestListCard({ el: $('*[data-has-card-for-ri-list=17766120]'), work: {"id":17766120,"title":"The “mild-torture economy”: exploring the world of professional research subjects and its ethical implications","created_at":"2015-11-04T15:23:25.436-08:00","url":"https://www.academia.edu/17766120/The_mild_torture_economy_exploring_the_world_of_professional_research_subjects_and_its_ethical_implications?f_ri=4387","dom_id":"work_17766120","summary":"This paper documents the emergence\nof the subject of professional research in Phase\nI clinical trials that test the safety of drugs in\ndevelopment. Based on ethnographic research\namong subjects self-identified as “professional\nguinea pigs\" in Philadelphia, USA, it examines\ntheir experiences and opinions on the conduct of\ntrials and risks they take. The author argues that\nthe risks posed by the continued participation,\nsuch as exposure to potentially dangerous drug\ninteractions are minimized or ignored by research\nsubjects because of the prospect of financial gain.\nRisks to the professional guinea pigs are also ignored\nby the pharmaceutical industry, which has become\ndependent on the usual participation of experienced\nresearch subjects. Arguing that financial incentives\nundermine the ethical imperative of informed consent\nto be given freely by volunteers, this research confirms\nthe need to reform the policies governing the\nparticipation of paid subjects in Phase I clinical trials.\n","downloadable_attachments":[{"id":39697588,"asset_id":17766120,"asset_type":"Work","always_allow_download":false}],"ordered_authors":[{"id":2802996,"first_name":"Roberto","last_name":"Abadie","domain_name":"wisc","page_name":"RobertoAbadie","display_name":"Roberto Abadie","profile_url":"https://wisc.academia.edu/RobertoAbadie?f_ri=4387","photo":"https://0.academia-photos.com/2802996/916771/17909345/s65_roberto.abadie.jpg"}],"research_interests":[{"id":814,"name":"Ethics","url":"https://www.academia.edu/Documents/in/Ethics?f_ri=4387","nofollow":true},{"id":4387,"name":"Clinical 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