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A Quantitative And Qualitative Evaluation Of Reports Of Clinical Trials Published In Six Brazilian Dental Journals Indexed In The Scientific Electronic Library Online (Scielo)., Souza Rf De, Cdal Chaves, Mona Nasser, Zbys Fedorowicz

More Faculty of Health Research

INTRODUCTION: Open access publishing is becoming increasingly popular within the biomedical sciences. SciELO, the Scientific Electronic Library Online, is a digital library covering a selected collection of Brazilian scientific journals many of which provide open access to full-text articles.This library includes a number of dental journals some of which may include reports of clinical trials in English, Portuguese and/or Spanish. Thus, SciELO could play an important role as a source of evidence for dental healthcare interventions especially if it yields a sizeable number of high quality reports. OBJECTIVE: The aim of this study was to identify reports of clinical trials …

Fagerstrom Test For Nicotine Dependence Vs Heavy Smoking Index In A General Population Survey, M. Pérez-Ríos, M. I. Santiago-Pérez, B. Alonso, A. Malvar, X. Hervada, Jose De Leon

Psychiatry Faculty Publications

BACKGROUND: The Fagerström Test for Nicotine Dependence (FTND) is used for assessing nicotine dependence. A shorter test derived from the FTND used for the general population is the Heavy Smoking Index (HSI) (six questions vs. two). The objective of this study is to compare the validity of the HSI versus the FTND.

METHODS: A survey of tobacco use in the general population was carried out in the northern Spanish region of Galicia using both the FTND and the HSI to study a representative sample of 1655 daily smokers. The HSI was compared with the FTND, considered the gold standard. Measures …

Chylomicrons Promote Intestinal Absorption And Systemic Dissemination Of Dietary Antigen (Ovalbumin) In Mice, Yuehui Wang, Sarbani Ghoshal, Martin Ward, Willem De Villiers, Jerold Woodward, Erik Eckhardt

Internal Medicine Faculty Publications

BACKGROUND: A small fraction of dietary protein survives enzymatic degradation and is absorbed in potentially antigenic form. This can trigger inflammatory responses in patients with celiac disease or food allergies, but typically induces systemic immunological tolerance (oral tolerance). At present it is not clear how dietary antigens are absorbed. Most food staples, including those with common antigens such as peanuts, eggs, and milk, contain long-chain triglycerides (LCT), which stimulate mesenteric lymph flux and postprandial transport of chylomicrons through mesenteric lymph nodes (MLN) and blood. Most dietary antigens, like ovalbumin (OVA), are emulsifiers, predicting affinity for chylomicrons. We hypothesized that chylomicron …

Identifying Blood Biomarkers And Physiological Processes That Distinguish Humans With Superior Performance Under Psychological Stress., Amanda M. Cooksey, Nausheen Momen, Russell Stocker, Shane C. Burgess

CVM Publications

BACKGROUND: Attrition of students from aviation training is a serious financial and operational concern for the U.S. Navy. Each late stage navy aviator training failure costs the taxpayer over $1,000,000 and ultimately results in decreased operational readiness of the fleet. Currently, potential aviators are selected based on the Aviation Selection Test Battery (ASTB), which is a series of multiple-choice tests that evaluate basic and aviation-related knowledge and ability. However, the ASTB does not evaluate a person's response to stress. This is important because operating sophisticated aircraft demands exceptional performance and causes high psychological stress. Some people are more resistant to …

Documentation Of Body Mass Index And Control Of Associated Risk Factors In A Large Primary Care Network, Stephanie A. Rose, Alexander Turchin, Richard W. Grant, James B. Meigs

Internal Medicine Faculty Publications

BACKGROUND: Body mass index (BMI) will be a reportable health measure in the United States (US) through implementation of Healthcare Effectiveness Data and Information Set (HEDIS) guidelines. We evaluated current documentation of BMI, and documentation and control of associated risk factors by BMI category, based on electronic health records from a 12-clinic primary care network.

METHODS: We conducted a cross-sectional analysis of 79,947 active network patients greater than 18 years of age seen between 7/05 - 12/06. We defined BMI category as normal weight (NW, 18-24.9 kg/m²), overweight (OW, 25-29.9), and obese (OB, ≥ 30). We measured documentation …

Manganese Flux Across The Blood-Brain Barrier, Robert A. Yokel

Pharmaceutical Sciences Faculty Publications

Manganese (Mn) is essential for brain growth and metabolism, but in excess can be a neurotoxicant. The chemical form (species) of Mn influences its kinetics and toxicity. Significant Mn species entering the brain are the Mn²⁺ ion and Mn citrate which, along with Mn transferrin, enter the brain by carrier-mediated processes. Although the divalent metal transporter (DMT-1) was suggested to be a candidate for brain Mn uptake, brain Mn influx was not different in Belgrade rats, which do not express functional DMT-1, compared to controls. Brain Mn influx was not sodium dependent or dependent on ATP hydrolysis, but was …

Impact Of Empire Expansion On Household Diet: The Inka In Northern Chile's Atacama Desert, Sheila Dorsey Vinton, Linda Perry, Karl J. Reinhard, Calogero M. Santoro, Isabel Teixeira-Santos

Anthropology Faculty Publications

The impact of expanding civilization on the health of American indigenous societies has long been studied. Most studies have focused on infections and malnutrition that occurred when less complex societies were incorporated into more complex civilizations. The details of dietary change, however, have rarely been explored. Using the analysis of starch residues recovered from coprolites, here we evaluate the dietary adaptations of indigenous farmers in northern Chile's Atacama Desert during the time that the Inka Empire incorporated these communities into their economic system. This system has been described as "complementarity" because it involves interaction and trade in goods produced at …

Combination Of Vandetanib, Radiotherapy, And Irinotecan In The Lovo Human Colorectal Cancer Xenograft Model., Phyllis Wachsberger, Randy Burd, Anderson Ryan, Constantine Daskalakis, Adam P. Dicker

Department of Radiation Oncology Faculty Papers

PURPOSE: The tumor growth kinetics of the human LoVo colorectal xenograft model was assessed in response to vandetanib, an orally available receptor tyrosine kinase inhibitor, radiotherapy (RT), or irinotecan (CPT-11), as single therapies and in combination. METHODS AND MATERIALS: LoVo cells were injected subcutaneously into the right hind limb (5 x 10(6) cells in 100 microL phosphate-buffered saline) of athymic NCR NUM mice and tumors were grown to a volume of 200-300 mm(3) before treatment. Vandetanib was administered at 50 mg/kg daily orally for 14 days starting on Day 1. RT was given as three fractions (3 x 3 Gy) …

Ethnic Differences In Do-Not-Resuscitate Orders After Intracerebral Hemorrhage, Darin B Zahuranec, Devin L Brown, Lynda D Lisabeth, Nicole R Gonzales, Paxton J Longwell, Melinda A Smith, Nelda M Garcia, Lewis B Morgenstern

Faculty, Staff and Student Publications

OBJECTIVE: To explore ethnic differences in do-not-resuscitate orders after intracerebral hemorrhage.

DESIGN: Population-based surveillance.

SETTING: Corpus Christi, Texas.

PATIENTS: All cases of intracerebral hemorrhage in the community of Corpus Christi, TX were ascertained as part of the Brain Attack Surveillance in Corpus Christi (BASIC) project.

INTERVENTIONS: None.

MEASUREMENTS AND MAIN RESULTS: Medical records were reviewed for do-not-resuscitate orders. Unadjusted and multivariable logistic regression were used to test for associations between ethnicity and do-not-resuscitate orders, both overall ("any do-not-resuscitate") and within 24 hrs of presentation ("early do-not-resuscitate"), adjusted for age, gender, Glasgow Coma Scale, intracerebral hemorrhage volume, intraventricular hemorrhage, infratentorial hemorrhage, …

Genetic Population Structure Analysis In New Hampshire Reveals Eastern European Ancestry, Chantel D. Sloan, Angeline D. Andrew, Eric J. Duell, Scott M. Williams, Margaret R. Karagas, Jason H. Moore

Dartmouth Scholarship

Genetic structure due to ancestry has been well documented among many divergent human populations. However, the ability to associate ancestry with genetic substructure without using supervised clustering has not been explored in more presumably homogeneous and admixed US populations. The goal of this study was to determine if genetic structure could be detected in a United States population from a single state where the individuals have mixed European ancestry. Using Bayesian clustering with a set of 960 single nucleotide polymorphisms (SNPs) we found evidence of population stratification in 864 individuals from New Hampshire that can be used to differentiate the …

The Medicine Wheel Nutrition Intervention: A Diabetes Education Study With The Cheyenne River Sioux Tribe, Kendra K. Kattelmann, Kibbe Conti, Cuirong Ren

Health and Nutritional Sciences Faculty Publications

OBJECTIVE: The Northern Plains Indians of the Cheyenne River Sioux Tribe have experienced significant lifestyle and dietary changes over the past seven generations that have resulted in increased rates of diabetes and obesity. The objective of this study was to determine if Northern Plains Indians with type 2 diabetes mellitus who are randomized to receive culturally adapted educational lessons based on the Medicine Wheel Model for Nutrition in addition to their usual dietary education will have better control of their type 2 diabetes than a nonintervention, usual care group who received only the usual dietary education from their personal providers. …

Clinical Decision Support Capabilities Of Commercially-Available Clinical Information Systems, Adam Wright, Dean F Sittig, Joan S Ash, Sapna Sharma, Justine E Pang, Blackford Middleton

Faculty, Staff and Student Publications

BACKGROUND: The most effective decision support systems are integrated with clinical information systems, such as inpatient and outpatient electronic health records (EHRs) and computerized provider order entry (CPOE) systems. Purpose The goal of this project was to describe and quantify the results of a study of decision support capabilities in Certification Commission for Health Information Technology (CCHIT) certified electronic health record systems.

METHODS: The authors conducted a series of interviews with representatives of nine commercially available clinical information systems, evaluating their capabilities against 42 different clinical decision support features.

RESULTS: Six of the nine reviewed systems offered all the applicable …

Advances In Progenitor Cell Therapy Using Scaffolding Constructs For Central Nervous System Injury, Peter A Walker, Kevin R Aroom, Fernando Jimenez, Shinil K Shah, Matthew T Harting, Brijesh S Gill, Charles S Cox

Faculty, Staff and Student Publications

Traumatic brain injury (TBI) is a major cause of morbidity and mortality in the United States. Current clinical therapy is focused on optimization of the acute/subacute intracerebral milieu, minimizing continued cell death, and subsequent intense rehabilitation to ameliorate the prolonged physical, cognitive, and psychosocial deficits that result from TBI. Adult progenitor (stem) cell therapies have shown promise in pre-clinical studies and remain a focus of intense scientific investigation. One of the fundamental challenges to successful translation of the large body of pre-clinical work is the delivery of progenitor cells to the target location/organ. Classically used vehicles such as intravenous and …

Functional State Following The Fontan Procedure., Ismee A. Williams, Lynn A. Sleeper, Steven D. Colan, Minmin Lu, Elizabeth A. Stephenson, Jane W. Newburger, Welton M. Gersony, Meryl S. Cohen, James F. Cnota, Andrew M. Atz, Richard V. Williams, Renee Margossian, Andrew J. Powell, Mario P. Stylianou, Daphne T. Hsu, Pediatric Heart Network Investigators, Girish S. Shirali

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: Despite improvements in outcomes after completion of the Fontan circulation, long-term functional state varies. We sought to identify pre- and postoperative characteristics associated with overall function.

METHODS AND RESULTS: We analyzed data from 476 survivors with the Fontan circulation enrolled in the Pediatric Heart Network Fontan Cross-sectional Study. Mean age at creation of the Fontan circulation was 3.4 plus or minus 2.1 years, with a range from 0.7 to 17.5 years, and time since completion was 8.7 plus or minus 3.4 years, the range being from 1.1 to 17.3 years. We calculated a functional score for the survivors by …

Food Insecurity Among Homeless And Marginally Housed Individuals Living With Hiv/Aids In San Francisco, Sheri D. Weiser, David R. Bangsberg, Susan Kegeles, Kathleen Ragland, Margot B. Kushel, Edward A. Frongillo Jr.

Faculty Publications

Food insecurity is a risk factor for both HIV transmission and worse HIV clinical outcomes. We examined the prevalence of and factors associated with food insecurity among homeless and marginally housed HIV-infected individuals in San Francisco recruited from the Research on Access to Care in the Homeless Cohort. We used multiple logistic regression to determine socio-demographic and behavioral factors associated with food insecurity, which was measured using the Household Food Insecurity Access Scale. Among 250 participants, over half (53.6%) were food insecure. Higher odds of food insecurity was associated with being white, low CD4 counts, recent crack use, lack of …

Hiv-1 And Helminth Co-Infection In Adults In Kenya, Cameron Page

Yale Medicine Thesis Digital Library

BACKGROUND: As part of rapidly expanding HIV-1 Care Programs in sub-Saharan Africa, many HIV-1 infected individuals are being identified who do not yet qualify for ART. These individuals may benefit from treatment of co-infections, such as soil-transmitted helminths. Treatment of helminth infection in HIV-1 infected individuals may improve health and nutrition and may slow progression to AIDS. In this setting, access to both medical care and diagnostic testing is limited. Determining correlates of helminth infection in HIV-I infected individuals may allow clinicians to better target empiric anti-helminth therapy in HIV-1 infected individuals. METHODS: To describe the prevalence and correlates of …

The Utility Of Plain Radiography In The Evaluation Of Degenerative Spine Disease, Andrew Simpson

Yale Medicine Thesis Digital Library

Study Designs: Questionnaire, Retrospective chart review, Cadaver study, and cross-sectional study. Objectives: Assess current imaging practices; determine utility of accessory radiographic studies, including dynamic and oblique radiographs; calculate effective radiation doses of routine spine radiographs. Summary of Background Data: Plain radiography is generally considered the initial imaging modality for evaluation of degenerative spine complaints. In addition to anteroposterior (AP) and lateral views, dynamic and oblique views may also be obtained. There is currently no data on imaging practices of spine specialists, the utility of these accessory radiographic views, or the radiation exposure patients receive as a result of various spine …

Epidemiology And Outcomes Of Candidemia In 2019 Patients: Data From The Prospective Antifungal Therapy Alliance Registry., David L Horn, Dionissios Neofytos, Elias J Anaissie, Jay A Fishman, William J Steinbach, Ali J Olyaei, Kieren A Marr, Michael A Pfaller, Chi-Hsing Chang, Karen M Webster

Jefferson Hospital Staff Papers and Presentations

BACKGROUND: Candidemia remains a major cause of morbidity and mortality in the health care setting, and the epidemiology of Candida infection is changing.

METHODS: Clinical data from patients with candidemia were extracted from the Prospective Antifungal Therapy (PATH) Alliance database, a comprehensive registry that collects information regarding invasive fungal infections. A total of 2019 patients, enrolled from 1 July 2004 through 5 March 2008, were identified. Data regarding the candidemia episode were analyzed, including the specific fungal species and patient survival at 12 weeks after diagnosis.

RESULTS: The incidence of candidemia caused by non-Candida albicans Candida species (54.4%) was higher …

A Truncation Mutation In Tbc1d4 In A Family With Acanthosis Nigricans And Postprandial Hyperinsulinemia, Satya Dash, Hiroyuki Sano, Justin J. Rochford, Robert K. Semple

Dartmouth Scholarship

Tre-2, BUB2, CDC16, 1 domain family member 4 (TBC1D4) (AS160) is a Rab-GTPase activating protein implicated in insulin-stimulated glucose transporter 4 (GLUT4) translocation in adipocytes and myotubes. To determine whether loss-of-function mutations in TBC1D4 might impair GLUT4 translocation and cause insulin resistance in humans, we screened the coding regions of this gene in 156 severely insulin-resistant patients. A female presenting at age 11 years with acanthosis nigricans and extreme postprandial hyperinsulinemia was heterozygous for a premature stop mutation (R363X) in TBC1D4. After demonstrating reduced expression of wild-type TBC1D4 protein and expression of the truncated protein in lymphocytes from the proband, …

The Relationship Between Liver Fat Content And Unenhanced Computed Tomography, Karen Shoebotham

Yale Medicine Thesis Digital Library

The purpose of this study was to chart unenhanced CT liver and spleen attenuation data on patients with normal and fatty livers to demonstrate a relationship between liver fat content and attenuation on unenhanced CT using MR chemical shift imaging as a reference standard. Retrospective data was gathered on 116 patients from NYU Tisch Hospital who had undergone both an unenhanced CT and MR opposed-phase imaging of the liver within 2 months. MR fat fraction (MR FF) was calculated using signal decrease on in]phase and opposed]phase imaging, with a cutoff of 0.2 considered significant fatty infiltration. Three CT liver attenuation …

Laparoscopic Treatment Of Pancreatic Pseudocysts In Children., Suzanne M. Yoder, Steven Rothenberg, Kuojen Tsao, Mark L. Wulkan, Todd A. Ponsky, Shawn D. St Peter, Daniel J. Ostlie, Timothy D. Kane

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: Pancreatic pseudocysts are problematic sequelae of pancreatitis or pancreatic trauma causing persistent abdominal pain, nausea, and gastric outlet obstruction. Due to the low volume of disease in children, there is scant information in the literature on the operative management of pseudocysts with minimally invasive techniques. We conducted a multi-institutional review to illustrate several technical variations utilized in achieving laparoscopic cystgastrostomy in the pediatric population.

METHODS: A retrospective review was conducted of all patients who underwent laparoscopic cystgastrostomy in five institutions. Patient data, operative techniques, and postoperative course were analyzed.

RESULTS: There were 13 patients with a mean age of …

Laparoscopic Duodenojejunostomy For Superior Mesenteric Artery Syndrome., Jason D. Fraser, Shawn D. St Peter, Jenevieve H. Hughes, James M. Swain

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: Superior mesenteric artery (SMA) syndrome, also called Wilkie's syndrome, is a rare clinical phenomenon believed to be caused by compression of the third portion of the duodenum by the overlying superior mesenteric artery. We present the case of a 32-year-old female who presented with epigastric pain, weight loss, and vomiting.

METHODS: Her workup included a normal upper endoscopy as well as an abdominal CT scan and upper GI contrast study that confirmed the diagnosis of superior mesenteric artery syndrome. The patient was taken to the operating room and underwent successful treatment with laparoscopic duodenojejunostomy.

RESULTS: The patient achieved complete …

Comorbidities, Patient Knowledge, And Disease Management In A National Sample Of Patients With Copd, R Graham Barr, Bartolome R Celli, David M Mannino, Thomas Petty, Stephen I Rennard, Frank C Sciurba, James K Stoller, Byron M Thomashow, Gerard M Turino

Faculty, Staff and Student Publications

OBJECTIVE: Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death in the United States but is often undertreated. COPD often overlaps with other conditions such as hypertension and osteoporosis, which are less morbid but may be treated more aggressively. We evaluated the prevalence of these comorbid conditions and compared testing, patient knowledge, and management in a national sample of patients with COPD.

METHODS: A survey was administered by telephone in 2006 to 1003 patients with COPD to evaluate the prevalence of comorbid conditions, diagnostic testing, knowledge, and management using standardized instruments. The completion rate was 87%.

RESULTS: …

The Association Between Pediatric Overweight And Ankle Injuries: A Case-Control Analysis, Ellen Margaret House

Yale Medicine Thesis Digital Library

Pediatric obesity has become a worldwide pandemic and trauma is the leading cause of pediatric morbidity and mortality. Our hypothesis is that being overweight increases the likelihood of acute ankle injuries in children. Our study consisted of a case-control analysis in an urban pediatric emergency department with subjects between 5-19 years of age. Cases consisted of children presenting with acute ankle injury; controls had chief complaints of fever, headache, or sore throat. Demographic information, physical activity score, heights, and weights were obtained on all participants; injury severity was calculated for the cases. Age and gender specific body mass index percentiles …

Reproductive Desires And Intentions Among Hiv-Infected Individuals In Chennai, India, Elizabeth Houle

Yale Medicine Thesis Digital Library

Despite the personal and cultural importance of childbearing in India, limited information exists on the extent of childbearing desires and intentions among HIV-infected individuals in this setting. The purpose of this study was to measure the extent of childbearing desires among HIV-infected individuals in Chennai, India, thereby testing the hypothesis that HIV significantly influences the desire to have children. Three hundred HIV-infected individuals were interviewed about childbearing desires and intentions during routine visits for HIV care at an HIV specialty care clinic in Chennai, South India. Sixteen percent of participants expressed desire for childbearing, and 9% expressed intention to have …

Understanding Pitch Perception As A Hierarchical Process With Top-Down Modulation., E Balaguer-Ballester, Nr Clark, M Coath, K Krumbholz, Sl Denham

School of Psychology

Pitch is one of the most important features of natural sounds, underlying the perception of melody in music and prosody in speech. However, the temporal dynamics of pitch processing are still poorly understood. Previous studies suggest that the auditory system uses a wide range of time scales to integrate pitch-related information and that the effective integration time is both task- and stimulus-dependent. None of the existing models of pitch processing can account for such task- and stimulus-dependent variations in processing time scales. This study presents an idealized neurocomputational model, which provides a unified account of the multiple time scales observed …

Clinical Trial Of Tailored Activity And Eating Newsletters With Older Rural Women., Susan Noble Walker, Carol H. Pullen, Linda Boeckner, Patricia A. Hageman, Melody Hertzog, Maureen K. Oberdorfer, Matthew J. Rutledge

Journal Articles: College of Nursing

BACKGROUND: Unhealthy diet and lack of physical activity increase rural midlife and older women's risk of chronic diseases and premature death, and they are behind urban residents in meeting Healthy People 2010 objectives.

OBJECTIVES: The objective of this study was to compare a tailored intervention based on the Health Promotion Model with a generic intervention to increase physical activity and healthy eating among rural women.

METHODS: In a randomized-by-site, community-based, controlled, clinical trial, Wellness for Women, 225 women aged 50 to 69 years were recruited in two similar rural areas. Over 12 months, women received by mail either 18 generic …

Life Expectancy And Years Of Life Lost In Chronic Obstructive Pulmonary Disease: Findings From The Nhanes Iii Follow-Up Study, Robert M. Shavelle, David R. Paculdo, Scott J. Kush, David M. Mannino, David J. Strauss

Internal Medicine Faculty Publications

RATIONALE: Previous studies have demonstrated that chronic obstructive pulmonary disease (COPD) causes increased mortality in the general population. But life expectancy and the years of life lost have not been reported.

OBJECTIVES: To quantify mortality, examine how it varies with age, sex, and other risk factors, and determine how life expectancy is affected.

METHODS: We constructed mortality models using the Third National Health and Nutrition Examination Survey, adjusting for age, sex, race, and major medical conditions. We used these to compute life expectancy and the years of life lost.

MEASUREMENTS AND MAIN RESULTS: Pulmonary function testing classified patients as having …

Endothelial Progenitor Cell Number And Colony-Forming Capacity In Overweight And Obese Adults, O J Maceneaney, E J Kushner, Gary P. Van Guilder, J J Greiner, B L Stauffer, C A Desouza

Health and Nutritional Sciences Faculty Publications

OBJECTIVE: To investigate whether adiposity influences endothelial progenitor cell (EPC) number and colony-forming capacity.
DESIGN: Cross-sectional study of normal weight, overweight and obese adult humans.
PARTICIPANTS: Sixty-seven sedentary adults (aged 45-65 years): 25 normal weight (body mass index (BMI) or=30 kg/m(2); 18 males/6 females). All participants were non-smokers and free of overt cardiometabolic disease.
MEASUREMENTS: Peripheral blood samples were collected and circulating EPC number was assessed by flow cytometry. Putative EPCs were defined as CD45(-)/CD34(+)/VEGFR-2(+)/CD133(+) or CD45(-)/CD34(+) cells. EPC colony-forming capacity was measured in vitro using a colony-forming unit (CFU) assay.
RESULTS: Number of circulating putative EPCs (either CD45(-)/CD34(+)/VEGFR-2(+)/CD133(+) or …

The Future (Or Lack Of Future) Of Personalized Prescription In Psychiatry, Jose De Leon

Psychiatry Faculty Publications

Rapid technological advances in genetics have created conceptual chaos regarding the genetics of drug response. Terms for differing concepts are used interchangeably: pharmacogenetics with pharmacogenomics, personalized medicine with personalized prescription. Biomarker has many definitions. The author prefers the concept of personalized prescription and uses it with implications beyond pharmacogenetics by considering all scientific information valid for prescribing medication. Genetics may not be crucial for all drugs. In this comprehensive view, clinicians must consider genetic, environmental and personal variables when prescribing medication and incorporate some basic pharmacological principles: (1) safety and efficacy, (2) pharmacokinetics and pharmacodynamics, (3) therapeutic window and prescriber's …