University of Tennessee

Assessment of Thoughts and Feelings Occurring During and After a Meal
Kelsey Wallour and Dr. Hollie Raynor are doing a study to investigate the effect of focusing on certain thoughts and feelings during a meal on liking of items in the meal. A total of 36 women are anticipated to participate in this study.
Status: Recruiting Start Date: July 2013 Completion Date: 
Eat Well for Life: A Weight Loss Maintenance Study
A study to investigate the effect of a low-ED prescription (consume ≥10 foods ≤ 1.0 kcal/g and ≤ 2 foods ≥ 3.0 kcal/g per day) versus an energy balance prescription (consume a daily energy intake at estimated energy needs for maintenance) on weight loss [more...]  maintenance.
Status: Recruiting Start Date: April 2013 Completion Date: January 2014
Eating Frequency Study
The purpose of this study is to examine the influence of two Eating Frequency prescriptions, meal (energy intake occurring during three meals per day) and grazing (energy intake occurring every two to three hours per day), on consumption during an ad libitum meal [more...]  consumed at the end of the day, overall daily energy intake, and ratio of energy intake to energy expenditure. It is hypothesized that the grazing condition will produce lower consumption during an evening ad libitum meal, lower daily energy intake, and a lower ratio of energy intake to energy expenditure than the meal condition.
Status: Recruiting Start Date: December 2012 Completion Date: December 2013
The Effect of Portion Sizes on Mood
The purpose of this study is to investigate the whether different portion sizes will effect overall mood.
Status: Recruiting Start Date: October 2012 Completion Date: December 2013
The Effect of Watching a Television Show on the Liking of Snack Foods
The purpose of the study is to investigate the effect of watching a television show with healthy food commercials, unhealthy food commercials, or neutral commercials on the consumption of healthy snack foods or unhealthy snack foods. There are three hypotheses: 1) [more...]  Women exposed to a television show with commercials imbedded advertising food will consume more food than women exposed to a television show with non-food related commercials. 2) Women will consume more food when exposed to a television show with commercials advertising "unhealthy" food as compared to a television show with commercials advertising "healthy" food. 3) Women will consume the most food when exposed to a television show with "unhealthy" food commercials and have "unhealthy" snack foods available to consume.
Status: Recruiting Start Date: August 2012 Completion Date: August 2013
Healthy Eating Patterns During a Lifestyle Intervention
The purpose of this study is to address the gap in knowledge regarding the relationship between eating frequency and weight loss.
Status: Recruiting Start Date: August 2012 Completion Date: December 2013
Effect of Diet Composition on Weight Change and Metabolic Parameters
This study will assess the effect of high protein (HP) and high carbohydrate (HC) diets on weight loss and other metabolic parameters. Rationale: The prevalence of obesity is on the rise in the US. The health hazards of [more...]  obesity have been well established. The detrimental effects of obesity on cardiovascular, metabolic and psychological parameters as well as the excess cost to the national health budget are astounding. One way of treatment and prevention of obesity has been the use of diet and exercise. In the absence of well-established superiority of one diet over another, different scientifically unproven diets are in common use. A palatable diet providing satiety as well as all essential nutrients may go a long way in treating over-weight individuals. Another factor has been the long-term adherence to such weight loss regimens, which in general have been poor. Protein diets have been known to provide greater satiety and reduced energy intake than carbohydrate diets, but definite long-term studies are sparse. For this study the investigators will recruit and study 24 normal, pre-menopausal obese women (12 on HP diet and 12 on HC diet), and compare their weight loss and changes in metabolic parameters between the two diets.
Status: Recruiting Start Date: January 2009 Completion Date: June 2013
The Effect of Three Different Dietary Messages on Dietary Intake and Health in Families
Examine the effect of three different dietary messages on dietary intake and the health of parents and their children.
Status: Recruiting Start Date: January 2012 Completion Date: July 2013
Influence of Changes in Food Group Variety on Food Cravings, Energy Intake, and Weight Loss After Bariatric Surgery
The purpose of this study is to find out if there is any change in diet on food cravings and weight loss in the 12 months following bariatric surgery.
Status: Recruiting Start Date: June 2011 Completion Date: December 2014
Prevention of Alcohol Related Incidents in Air Force Technical Training
The prevalence of alcohol related incidents in technical training is too high. A brief group alcohol intervention was designed to reduce the number of alcohol related incidents in Technical Training. Hypotheses or Research Questions: [more...]  Can a brief group alcohol intervention, focused on responsible use of alcohol during technical training reduce the prevalence of alcohol related incidents?
Status: Recruiting Start Date: October 2010 Completion Date: April 2012
Preventing Relapse Following Involuntary Smoking Abstinence
The prevalence of tobacco use in the military is too high. This study is designed to take advantage of the 8.5 weeks of forced tobacco cessation during Basic Military Training and develop effective interventions to prevent tobacco relapse. [more...]  Hypotheses or Research Questions: - Are there differences in the rate of relapse between three groups participating in a tobacco abstinence maintenance intervention? - Do the tobacco abstinence maintenance interventions delay relapse?
Status: Recruiting Start Date: May 2011 Completion Date: January 2015
Trial of Steroids in Pediatric Acute Lung Injury/ARDS
Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are devastating disorders associated with lung inflammation, low oxygen levels and respiratory failure in children. Prevalence of ALI ranges from 2.2 to 12 per 100,000 children per year. Using [more...]  these estimates, up to 9,000 children each year will develop ALI/ARDS, which may cause upto 2,000 deaths per year. Currently, there are no specific therapies directed against ARDS/ALI in children. In adult patients, use of steroids early in the course of ARDS appears promising. There are no published clinical trials examining the use of steroids for the treatment of ALI/ARDS in children. Hypothesis: Subjects with ALI/ARDS receiving steroids early in the course of disease (within 72 hours) and longer than 7 days will have improved clinical outcomes as compared to placebo control group as defined by (a) a decreased duration of mechanical ventilation and (b) significantly increased PaO2/FiO2 ratios.
Status: Recruiting Start Date: October 2010 Completion Date: December 2012
Topical Lidocaine on the Cervix and Intra-Cervical Prior to Insertion of Intrauterine Devices
The hypothesis of this study is that topical cervical and intra-cervical lidocaine will decrease pain associated with the insertion of a Mirena® (levonorgestrel intrauterine device). 1. Primary Aim- Determine if topical lidocaine intra-cervically and on the cervix decreases [more...]  the pain associated with insertion of a Mirena® (levonorgestrel intrauterine device).
Status: Recruiting Start Date: August 2010 Completion Date: December 2012
A Trial of Gabapentin in Vulvodynia: Biological Correlates of Response
The Specific aims of this project are to (1) test the prediction that pain from tampon insertion (primary outcome measure) is lower in PVD patients when treated with gabapentin compared to when treated with placebo. Secondary outcome measures include intercourse pain [more...]  and 24-hour pain and (2)perform a mechanism-based analysis of gabapentin effectiveness, and to gain insight into the underlying pathophysiology of subtypes of PVD that may lead to more specific treatment options.
Status: Recruiting Start Date: August 2012 Completion Date: March 2015
Parenteral Nutrition Associated Liver Disease: Early Markers and Therapy Wih Enteral Omega-3 Supplementation
Cholestatic liver disease is a common complication associated with long term parenteral nutrition (PN). PN associated liver disease (PNALD) is much more common in premature infants and the incidence increases with duration of PN. The use of intravenous omega-3 long chain [more...]  polyunsaturated fatty acids (ω3PUFA) or fish oil has recently shown promise in the treatment of PNALD. We hypothesize that there are early markers for PNALD that precede the increase in total and direct bilirubin. We further hypothesize that patients with PNALD who receive enteral ω3PUFA supplementation will have an improvement in PNALD or reversal of PNALD. These hypotheses will be tested by a two part study that includes an initial observation period when markers for PNALD are evaluated, followed by a randomized, controlled trial of enteral ω3PUFA supplementation for treatment of PNALD. Infants expected to be on PN for 4 weeks or longer will be eligible for enrollment in this study. The observational part of the study will entail periodic assessment of potential markers for PNALD. Markers will be evaluated for inflammatory cytokines (IL-1, IL-6, TNF-alpha), oxidative stress (8-isoprostane, 8-hydroxydeoxyguanosine, glutathione peroxidase), liver fibrosis (TIMP-1), endogenous steroid production (glucagon and ACTH), total serum bile acids, essential fatty acid profiles, and calprotectin, a novel marker of gut inflammation. Patients will be observed for 6 months duration. Patients enrolled in the study who develop PNALD will be randomized to either the current standard of care (control group) or enteral ω3PUFA supplementation (treatment group). Once able to take oral medications, treatment group patients will receive enteral ω3PUFA 1 g/kg/day for 12 weeks. At the end of the 12 weeks, the protocol will be open label in which any patients who continue to have PNALD in either group will receive enteral ω3PUFA. All patients enrolled in the study (whether or not they develop PNALD or receive ω3PUFA supplementation) will be followed for a total of 6 months. The results of this study will increase our knowledge of the pathogenesis of PNALD, as well as potentially confirm the effectiveness of a novel therapy for this costly and debilitating disease.
Status: Recruiting Start Date: October 2008 Completion Date: December 2014
Safety and Efficacy Study of Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis
Primary sclerosing cholangitis (PSC), although uncommon, is a devastating and insidiously progressive liver disease, resulting from advancing inflammation, fibrosis and obliteration of the bile ducts in the liver, leading to cirrhosis and end-stage liver disease. Although prognosis in children [more...]  may be somewhat better than that of adults, approximately one third of pediatric patients require transplantation by adulthood. Other than transplantation, there is to date no therapy conclusively proven to improve the long-term outcome. Ursodeoxycholic acid (UDCA) improves biochemical markers of liver disease, although in high doses does not clearly improve the long-term outcome in adults, and in a recent study may have actually worsened outcome. Childhood PSC is different from that of adult PSC in many ways, and children may derive more short-term, as well as long-term, benefit than adults. This unique multicenter study will carefully monitor the effects of withdrawal and restarting UDCA on liver injury and inflammation in children with PSC. The preliminary data will help in the design of a more definitive larger study to determine if UDCA has a beneficial role in the treatment of PSC in children. Funding Source - FDA OOPD
Status: Recruiting Start Date: October 2010 Completion Date: April 2015
Low-Molecular-Weight Heparin (LMWH) for Deep Venous Thrombosis (DVT) Prophylaxis
1. The use of LMWH following open reduction and internal fixation of ankle fractures will reduce the number of thrombi formed. 2. The rates of clinically significant DVT will be equivalent between two groups.
Status: Recruiting Start Date: February 2010 Completion Date: December 2013
Prevention of Infection in Surgical Treatment of Closed Fractures: Comparative of Cefazolin vs Vancomycin
With the growing incidence of MRSA in the hospital and community setting it would be hypothesized that Vancomycin would decrease the risk of infection in patients requiring surgical treatment of closed fracture as compared to Cefazolin.
Status: Recruiting Start Date: February 2010 Completion Date: February 2013
Evaluating a Telephone-Based Smoking Cessation Program Among People in the Military (The AFIII Study)
Rates of cigarette smoking in the military are high. Tobacco telephone quit lines are telephone-based services that provide information and guidance to people who want to quit smoking. This study will evaluate the effectiveness of a tobacco quit line program, in [more...]  addition to nicotine replacement patches, at helping people in the military quit smoking cigarettes.
Status: Recruiting Start Date: April 2008 Completion Date: April 2013
MRSA in a Trauma Population: Does Decolonization Prevent Infection?
All trauma patients admitted to certain Intensive Care Units (ICU) will have Methicillin-resistant Staphylococcus aureus (MRSA) nasal swabs performed to determine MRSA colonization status. Only those patients who are determined to be colonized with MRSA at admission will [more...]  be included in the study. All patients must be age 18 and older, admitted directly to the ICU from either the Emergency Department or the operating room with trauma-related injuries, and must not have active or recent known history of MRSA infections. Once patients have been determined to be colonized with MRSA, they will be randomized to receive "decolonization" treatment or placebo. "Decolonization" treatment will include Chlorhexidine baths and Mupirocin ointment to both nares for 5 days and placebo will entail "routine" soap baths and Lubricating Jelly. Both groups will be kept on standard contact precautions throughout the course of the study. Repeat nasal swabs will be performed at the completion of the treatment regimen to determine the efficacy. Patients will be screened for invasive MRSA infections as dictated by their clinical course. The primary outcome measure will be invasive MRSA infection rate (pneumonia, urinary tract infection, bacteremia and soft tissue infection). Secondary endpoints include hospital lengths of stay, ICU lengths of stay, mechanical ventilatory support requirements, colonization status at the end of treatment, and death rates. As determined by our power analysis, we aim to enroll 75 patients in each arm over the course of 12-24 months.
Status: Enrolling by invitation Start Date: January 2012 Completion Date: January 2014
Vaginal Cuff Closure Time Using Unidirectional Barbed Suture in Robotic Hysterectomy
This study is designed to determine if using the V-Loc Wound Closure System expedites operative time in robotic hysterectomy.
Status: Enrolling by invitation Start Date: July 2012 Completion Date: August 2013
Behavioral Contract Adherence Intervention
There is a critical gap in the knowledge on how to implement effective interventions for renal transplant recipients (RTRs) to improve immunosuppressant therapy (IST) adherence and clinical outcomes. The objectives of this project were to address this gap through: (1) [more...]  designing, implementing, and evaluating a patient-specific behavioral contract intervention to improve RTRs' IST adherence rates (contracts are written, signed agreements between the RTR and healthcare provider in which the RTR agrees to be adherent to IST according to mutually agreed upon criteria); and (2) measuring the effects of IST adherence on RTRs' health-related quality of life (HQoL) and healthcare utilizations and costs. The primary hypothesis was that at one year post trial enrollment, RTRs who establish behavioral contracts with healthcare professionals will be more adherent than those who do not establish behavioral contracts and subsequently will have greater HQoL and lower healthcare utilizations and costs. Once it is better understood how to implement effective IST adherence intervention programs, clinicians will have a valuable tool to promote therapeutic success, improve HQoL, and reduce healthcare utilizations and costs. Therefore, we pursued the following Specific Aims: (1) determine the effectiveness of an IST adherence contract-based intervention on IST adherence; (2) determine the relationship between IST adherence, the intervention, and RTRs' HQoL; and (3) determine the influence of IST adherence and the intervention on RTRs' healthcare utilizations/costs. To achieve the Specific Aims, a randomized controlled trial of the patient-specific behavioral contract-based intervention was conducted, and data regarding adherence, HQoL, and healthcare utilizations/costs were collected over a 12-month period for each RTR study participant and analyzed. This project will promote healthy lives, increase well-being, and reduce burden of illness and disparity among adult RTRs by providing data regarding an adherence intervention and the impact of IST adherence and the behavioral contract intervention on RTRs' health and economic outcomes and HQoL. Collectively, this new knowledge will provide critical steps toward optimizing RTRs' graft maintenance, productivity, and HQoL, while decreasing graft rejection, return to dialysis, morbidity, mortality, and healthcare costs.
Status: Active, not recruiting Start Date: January 2010 Completion Date: June 2013
Electronic Application of a Severe Sepsis Screening Tool and Management Bundle
Thousands of children die from Sepsis following routine infections. Many of these deaths can be prevented with earlier recognition and focused management. No tools are currently available to recognize the signs of early sepsis in children. The investigators have [more...]  developed a electronic health record-based tool that will recognize children with sepsis early and trigger an alert to their hospital caregivers. The caregivers will be prompted to launch a focused management bundle that can stabilize these children, prevent further deterioration and reduce their chances of sepsis related complications and death. The proposed study will test the validity and effectiveness of this electronic tool in reducing sepsis mortality rates.
Status: Active, not recruiting Start Date: October 2012 Completion Date: October 2016
Repeated Food Exposure Via the Olfactory and Gustatory Systems
Increasing exposure to a single orosensory cue without ingestion of additional energy may promote an increased rate of habituation, more rapid satiation, and reduced intake. This exposure can occur via smell (olfactory) and taste (gustatory) systems.It is not clear if [more...]  repeated exposure via the combined olfactory and gustatory systems increases the rate of habituation more so than repeated exposure through one of these systems. Thus, the purpose of this investigation is to examine the amount of salivation occurring in 12 trials of exposure to a food via the olfactory, gustatory, and combined olfactory and gustatory systems. The primary dependent variable will be the amount of salivation in the 12 trials. It is hypothesized that a more rapid decrease in salivation will occur across trials in the combined olfactory and gustatory exposure as compared to the other two conditions, indicating a more rapid rate of habituation.
Status: Active, not recruiting Start Date: July 2012 Completion Date: December 2013
The Effect of Variety on Physical Activity
Increasing physical activity continues to be a challenge among many individuals, particularly those who are overweight. Recent data from the National Health and Nutrition Examination Survey (NHANES) showed that individuals who reported engaging in a variety of activities were [more...]  more likely to meet national physical activity recommendations compared to those who reported no variety. Incorporating a variety of activities into a physical activity program may be a way to increase physical increase physical activity levels. One method to increase variety in physical activities is to use active videogames. Videogames that use motion sensors allow a gamer to physically perform a variety of activities. Thus, the purpose ot this laboratory-based investigation is to conduct a study to examine the effect of engaging in a greater variety of active videogames on energy expenditure in 30 non-obese, regularly active adults.
Status: Active, not recruiting Start Date: September 2011 Completion Date: 
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Clinical trials allow volunteers access to medical treatment options before they are available to the general public. Participants often receive the best healthcare available for their condition.

Risks are a reality, however, and may include more frequent doctor visits, health risks (possibly life-threatening), and/or the treatment being ineffective. Trials are federally regulated with strict guidelines to protect participants.

University of Tennessee Clinical Trials Information presented on is not intended to be a substitute for qualified medical advice visit or treatment with a real physician. We are not physicians. Always consult with a medical doctor (MD). is a website dedicated to listing clinical research studies in human subjects, including those specifically related to University of Tennessee. Clinical research trials and medical trials take place in hundreds of cities across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectiveness of new treatments and drugs. The purpose of the studies is to answer specific human health questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions. Clinical trials allow volunteers access to medical treatment options before they are available to the general public. Many times the participants receive treatment for free, and sometimes they are paid for their time. Participants often receive the best healthcare available possible for their condition. Risks are a reality, however, and may include more frequent doctor visits, health risks (possibly life-threatening), and/or the treatment being ineffective. U.S. - based University of Tennessee studies are federally regulated with strict guidelines to protect patients.

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