International journal of clinical research & trials最新文献

{"title":"Incidence and Associated Risk Factors of Chemotherapy-Induced Cardiomyopathy in the African American and Afro-Caribbean Populations.","authors":"Mohammed Al-Sadawi,&nbsp;Kurnvir Singh,&nbsp;Violeta Capric,&nbsp;Amena Mohiuddin,&nbsp;Michael Haddadin,&nbsp;Arismendy Nunez,&nbsp;Shakil Shaikh,&nbsp;Inna Bukharovich,&nbsp;Samy I McFarlane","doi":"10.15344/2456-8007/2020/154","DOIUrl":"https://doi.org/10.15344/2456-8007/2020/154","url":null,"abstract":"<p><strong>Background: </strong>Chemotherapy-induced cardiomyopathy (CICM) and heart failure are major complications of cancer therapeutics and can result in significant morbidity and mortality. There is limited data on the incidence and risk factors of CICM in African American and Afro-Caribbean patients.</p><p><strong>Methods: </strong>We performed a retrospective chart review to evaluate the baseline characteristics that may predispose to CICM. Patients were African American and Afro-Caribbean ethnicity. Data was collected between 2014 to 2018. Patients had transthoracic echocardiogram (TTE) or multigated acquisition scan (MUGA) prior to cancer therapy and every 3 months thereafter, until the end of the regimen. CICM was defined as a ≥16% reduction in LVEF or ≥10% reduction in LVEF to a value <50%.</p><p><strong>Results: </strong>A total of 230 patients were studied, with a mean age of 54±12 years with 91% were females, BMI 30±4, 81% were taking anthracyclines, 87% were on Trastuzumab while 5% were receiving both medications. The prevalence of comorbidities was as follows: hypertension 8%, diabetes mellitus 8%, ESRD 8%, dyslipidemia 8%, CAD 7%. The incidence of CICM was 7% overall, while it was 6% and 8% for patients taking Anthracyclines and Trastuzumab, respectively. CICM was associated with dyslipidemia (r= .22, p= .001), hypertension (r= .12, p= .05), baseline ejection fraction (r= -.21, p= .001) and concomitant use of radiation therapy (r= .147, p= .02), but not with age, gender, beta blocker use, angiotensin converting enzyme inhibitor use, number of chemotherapy cycles or stage of the malignancy. On multivariate analysis CICM was independently associated with baseline ejection fraction (β= -.193, P= .003) and dyslipidemia (β= -.20, P= .003).</p><p><strong>Conclusion: </strong>The incidence of CICM in African Americans and Afro-Caribbean is higher than reported in the general population. Dyslipidemia and baseline ejection fraction were seen as the major risk factors associated with the higher incidence of CICM.</p>","PeriodicalId":73437,"journal":{"name":"International journal of clinical research & trials","volume":"5 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10537381","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hypothyroidism and Heart Failure: Epidemiology, Pathogenetic Mechanisms & Therapeutic Rationale.","authors":"Jonathan Francois,&nbsp;Mohammed Al-Sadawi,&nbsp;Joseph Casillas,&nbsp;Evan Botti,&nbsp;Lina Soni,&nbsp;Debora Ponse,&nbsp;Scarlett Maria Decamps,&nbsp;Samy I McFarlane","doi":"10.15344/2456-8007/2020/146","DOIUrl":"https://doi.org/10.15344/2456-8007/2020/146","url":null,"abstract":"<p><p>Heart Failure (HF) is a major public health problem and a major cause of morbidity and mortality worldwide. Thyroid hormones (TH) have multiple effects on the heart and cardiovascular system. In recent years, studies have shown that hypothyroidism, including subclinical hypothyroidism, is associated with an increased risk for developing and worsening of HF. This review addresses the relationship between HF and hypothyroidism by highlighting the epidemiology, pathophysiology and management.</p>","PeriodicalId":73437,"journal":{"name":"International journal of clinical research & trials","volume":"5 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10545754","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Obstructive Sleep Apnea Risk and Stroke among Blacks with Metabolic Syndrome: Results from Metabolic Syndrome Outcome (MetSO) Registry.","authors":"April J Rogers, Ian Kaplan, Alicia Chung, Samy I McFarlane, Girardin Jean-Louis","doi":"10.15344/2456-8007/2020/143","DOIUrl":"10.15344/2456-8007/2020/143","url":null,"abstract":"<p><strong>Introduction: </strong>The American Stroke Association estimates that stroke is the fifth leading cause of death in the United States. According to the Center for Disease Control and Prevention someone in the United States has a stoke every 40 seconds, affecting more than 795,000 people of which 140,000 result in death [1]. Emerging evidence suggests that obstructive sleep apnea (OSA) is a strong risk factor for stroke. This study using The Metabolic Syndrome Outcome (MetSO) registry explored whether blacks at risk for obstructive sleep apnea (OSA) are at greater risk for a stroke.</p><p><strong>Method: </strong>The present study utilized data from the MetSO study, an NIH-funded cohort study of blacks with metabolic syndrome (MetS). Patients were diagnosed with MetS using standard criteria articulated in the joint interim statement for harmonizing the MetS. The study assessed OSA risk using the Apnea Risk Evaluation System (ARES); defining high risk as a total ARES score ≥6. Data was coded and analyzed by an experienced statistician using SPSS 20.0.</p><p><strong>Results: </strong>A total of 1035 participants were screened for MetS in the MetSO registry. During the data collection period 875 participants were enrolled during the time of analysis. The average age of the sample was 62±14 years (range: 20-97); 71% were female, and all were of black race/ethnicity. Seventy-one percent reported finishing high school, and 43% reported annual income <10K. Descriptive analyses showed 93% of the participants were diagnosed with hypertension; 61%, diabetes; 72%, dyslipidemia; 90% were overweight/obese; 33% had a history of heart disease and 10% had a stroke history. Using the ARES screener, we estimated that 48% were at high risk for OSA. Logistic regression analysis, adjusting for age and gender, showed that patients at high risk for OSA had a nearly three-fold increase in the odds of having a stroke (OR = 2.79, 95% CI: 1.64-4.73).</p><p><strong>Conclusion: </strong>In the MetSO registry, a cohort of blacks with MetS, the prevalence of stroke is greater than in the general US population. Blacks at risk for OSA are particularly vulnerable to experiencing a stroke.</p>","PeriodicalId":73437,"journal":{"name":"International journal of clinical research & trials","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7316191/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38089171","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Insights into Potential Mechanisms of Injury and Treatment Targets in COVID-19, SARS-Cov-2 Infection.","authors":"Angelina Zhyvotovska,&nbsp;Denis Yusupov,&nbsp;Robert Foronjy,&nbsp;Mohammed Nakeshbandi,&nbsp;Samy I McFarlane,&nbsp;Moro Salifu","doi":"10.15344/2456-8007/2020/147","DOIUrl":"https://doi.org/10.15344/2456-8007/2020/147","url":null,"abstract":"<p><p>The severe acute respiratory syndrome coronavirus 2, SARS-CoV-2, is the most serious pandemic in modern times. The disease was first reported in January of 2020 in China's city of Wuhan, Hubei province, and since then it has spread worldwide. Given the rapid spread of the virus and the burden it has taken on the healthcare systems it has swept through, there is the need for a concise description of current understanding of the pathogenesis of organ failure in SARS-CoV-2 infection while acknowledging that more is yet to be uncovered. This review will not only inform decision making at the bedside but will also help illustrate potential therapeutic targets for research. We searched the available literature to-date, and present the pathophysiology underlying increased morbidity and mortality of SARS-CoV-2 infection in the lungs, heart and kidneys in a highly illustrated presentation that is easy-to-understand for the clinician, researcher, and student alike.</p>","PeriodicalId":73437,"journal":{"name":"International journal of clinical research & trials","volume":"5 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9095356","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"COVID-19 Guidelines Changing Faster than the Virus: Implications of a Clinical Decision Support App.","authors":"Yair Saperstein,&nbsp;Shawn Y Ong,&nbsp;Tarik Al-Bermani,&nbsp;Joongheum Park,&nbsp;Yiela Saperstein,&nbsp;Jadesola Olayinka,&nbsp;Anjali Jaiman,&nbsp;Andrew Winer,&nbsp;Moro O Salifu,&nbsp;Samy I McFarlane","doi":"10.15344/2456-8007/2020/148","DOIUrl":"https://doi.org/10.15344/2456-8007/2020/148","url":null,"abstract":"<p><p>Novel coronavirus disease (COVID-19) is a pandemic affecting over 10 million people in 160 countries. Its spread, and the medical communities' response, cast light on an important deficiency in the speed and effectiveness for evidence-based recommendations to reach the bedside in academic medical practice. We built a clinical decision support tool on the avoMD platform that systematizes and personalizes the treatment of COVID-19 by bringing point-of-care access to the guidelines specific to individual cases to the clinician's hands. This app has the potential to improve the mortality for COVID-19.</p>","PeriodicalId":73437,"journal":{"name":"International journal of clinical research & trials","volume":"5 2","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10549851","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Non-Obstructive Coronary Artery Disease in Women: Current Evidence and Future Directions.","authors":"Leanna R Smith,&nbsp;Moro O Salifu,&nbsp;Isabel M McFarlane","doi":"10.15344/2456-8007/2020/152","DOIUrl":"https://doi.org/10.15344/2456-8007/2020/152","url":null,"abstract":"<p><strong>Background: </strong>Over half of women who present with angina are found to have negative coronary angiographic assessments. Of these patients, up to 50% are diagnosed with coronary microvascular dysfunction (CMD), which refers to pathologic changes within the small vessels of the coronary circulation. The hallmark of the pathophysiology of CMD is that endothelial damage, which occurs due to a multitude of conditions and risk factors, is the inciting event for the development and progression of CMD. CMD leads to a mismatch in myocardial demand and perfusion, leading to signs and symptoms of cardiac ischemia in the absence of obstructive lesions in the major vessels. CMD can be diagnosed through a variety of both invasive methods that allow a more specific evaluation of the microvasculature and non-invasive imaging techniques, such as cardiac positron emission tomography (PET) and magnetic resonance imaging (MRI). Risk factors for CMD overlap significantly with those of obstructive coronary artery disease (CAD) - hypertension, hypercholesterolemia, and diabetes remain salient predictors. However, these conditions only account for 20% of CMD cases in females.</p><p><strong>Findings: </strong>Women have sex-specific risk factors such as menopause, pregnancy, polycystic ovarian syndrome (PCOS), and a higher proclivity toward chronic inflammatory disorders. Estrogen has a cardioprotective effect by increasing production of nitric oxide, a potent vasodilator released by endothelial cells. As a result, the hormonal changes of menopause may accelerate endothelial damage, and in turn, CMD. Current treatments focus on addressing the risk factors of cardiovascular disease, such as anti-hypertensive drugs, weight loss, and glucose control.</p><p><strong>Conclusion: </strong>Given the multifactorial nature of CMD in women, and the extensive atypical risk factors for cardiac disease, a more nuanced approach is needed that addresses the varied pathophysiology of CMD.</p>","PeriodicalId":73437,"journal":{"name":"International journal of clinical research & trials","volume":"5 2","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10545467","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"CRISPR and The Ethics of Gene Editing: A Modest Framework for Discussion","authors":"G. Santas","doi":"10.15344/2456-8007/2019/138","DOIUrl":"https://doi.org/10.15344/2456-8007/2019/138","url":null,"abstract":"CRISPR is a powerful new biochemical tool that can be used to edit the DNA of somatic cells or the germline. It can be used for good ends such as the treatment or prevention of illness or disability, or for bad ends. All its uses for good ends can be sorted out into six kinds of cases: editing somatic cells to treat or prevent disease-a therapeutic use; editing somatic cells to enhance a living thing; editing the germline to prevent future disease-a second therapeutic use; editing the germline to enhance future living things; editing somatic cells for research to understand nature and unlock its secrets; and editing the germline for the same research purposes. Recent discussions by various experts, in the science, ethics, and governance of gene editing, show confidence in the first kind of case-that it is a good use provided the editing is safe and effective; and hesitation, doubts, and calls to stop editing in the next three cases. The paper explores the basis of our confidence in the somatic therapeutic case, and compares it systematically to the enhancement cases, while using the research cases for what they teach us about good ends. The center of this approach is that our confidence in the therapeutic somatic case is based on our agreement that health is a fundamental good, and the paper suggests an analogy between the ethics of therapy and the ethics of enhancement, which throws some light on the difficult cases of human enhancement.","PeriodicalId":73437,"journal":{"name":"International journal of clinical research & trials","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.15344/2456-8007/2019/138","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42785495","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Method for Estimating Non-study Cigarette Use among Switchers to Low Nicotine Content Cigarettes in Ambulatory Clinical Studies","authors":"Mingda Zhang, J. Edmiston, G. Karles, Donna C. Smith","doi":"10.21203/rs.2.14909/v1","DOIUrl":"https://doi.org/10.21203/rs.2.14909/v1","url":null,"abstract":"\u0000 Background FDA is considering to establish a product standard to reduce nicotine in cigarettes to make them “minimally addictive or nonaddictive.” FDA has funded many clinical studies where smokers are switched to smoking low nicotine cigarettes to determine a nicotine ceiling that is appropriate for the protection of the public health. Unlike typical clinical trials involving pharmaceuticals or medical devices, ambulatory studies with low nicotine cigarettes face a unique challenge in that conventional nicotine non-study cigarettes are readily available to participants when protocols require them to exclusively use study cigarettes. As a consequence, protocol deviation in non-study product use is a major limitation common in such ambulatory studies, with up to 80 percent of participants using non-study cigarettes during the study. There is no published method for estimating the magnitude of such protocol deviation, i.e., the number of non-study cigarettes smoked by participants, in such studies.Methods We present a method for estimating the magnitude of noncompliance based on the proposition that the level of biomarker of exposure to a smoke constituent is proportional to the amount of the constituent per cigarette and the number of cigarettes smoked by participants. The method estimates the number of non-study cigarettes smoked by participants based on the discrepancies between the yield of smoke constituents (e.g., nicotine) and the level of the corresponding biomarkers measured in a study.Results Data from a confined study confirmed the validity of this method. Under-reporting on the magnitude of non-study cigarette use is widespread across studies using different low nicotine cigarettes. Participants in one of the largest published studies under-reported the number of non-study cigarette used by 79-90%.Conclusions Controlling and accurately estimating non-study cigarette use is critical for ambulatory low nicotine cigarette switching studies to ensure the resulting data can be appropriately evaluated to support science-based regulatory decision-making. In planning future studies, researchers should consider incorporating specific biomarkers that would enable objective assessment of both the prevalence and the magnitude of non-study cigarette use.","PeriodicalId":73437,"journal":{"name":"International journal of clinical research & trials","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44898408","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Role of Brown Adipose Tissue in Cardiovascular Disease Protection: Current Evidence and Future Directions","authors":"R. Pereira, Samy I McFarlane","doi":"10.15344/2456-8007/2019/136","DOIUrl":"https://doi.org/10.15344/2456-8007/2019/136","url":null,"abstract":"The Role of Brown Adipose Tissue in Cardiovascular Disease Protection: Current Evidence and Future Directions","PeriodicalId":73437,"journal":{"name":"International journal of clinical research & trials","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43452470","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Application effect of comprehensive evaluation nursing model in elderly patients in hospitalized patients","authors":"","doi":"10.26855/j.ijcr.20190006","DOIUrl":"https://doi.org/10.26855/j.ijcr.20190006","url":null,"abstract":"","PeriodicalId":73437,"journal":{"name":"International journal of clinical research & trials","volume":"64 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77948911","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}