Case Western Reserve University

Randomized Trial of an HIV Navigation Program for Early Palliative Care
With the advent of effective antiretroviral treatment for HIV has come a marked increase in the number of persons living with HIV/AIDS (PLWHA), with the highest prevalence since the epidemic began of more than 1.2 million. While PLWHA survive longer, they also experience [more...]  increased burdens of chronic conditions related to lifestyle factors, treatment side effects, and age. PLWHA are a population at great risk for high symptom burden, impaired coping and social functioning, decreased quality of life, and inadequate end-of-life care. The remarkable shift in attitudes towards HIV, from an inevitably fatal disease to a chronic condition, has been accompanied by a lessening emphasis on symptom management and end-of-life planning. However, while mortality from AIDS-defining conditions has decreased, PLWHA continue to have unaddressed needs for coordinated care, symptom management and proactive advance care planning. Palliative care, focused on comprehensive management of physical, psychological, social, and spiritual needs of persons with incurable, progressive illnesses, is a health service uniquely designed to meet these needs. This research project will test a model of early palliative care for PLWHA at high risk of mortality and morbidity. First, focus group methods will be used to explore views of PLWHA regarding their needs for symptom management and social support, and attitudes towards advance care planning and end-of-life concerns. We will then conduct a randomized trial of a novel HIV Navigation Program, which will be a modification of an existing navigation program that uses trained and experienced volunteers as a core component, offered by a large, comprehensive hospice and palliative care organization. The specific aims of this study are 1) to identify needs and preferences for palliative care and advance care planning of PLWHA, in order to tailor an existing Patient Navigation Program to the specific needs of PLWHA with chronic conditions; and 2) to test the effect of an HIV Patient Navigation Program intervention on outcomes of quality of life, symptom burden, coping ability, and advance care planning; and 3) to determine if effectiveness of the HIV Navigation Program intervention differs by age, gender, ethnicity, education, income level, and level of palliative care service need. Because of the increasing prevalence of HIV coexisting with chronic conditions, there is an urgent need to assess palliative care needs and preferences of PLWHA and design effective interventions. This interdisciplinary study will test, at the community level, a novel health service designed to meet the unique needs of chronically ill PLWHA, and improve and support advance care planning. Results from this study will increase understanding of who are PLWHA at highest risk for need of palliative services and provide a model for providing early palliative care support for PLWHA.
Status: Recruiting Start Date: June 2013 Completion Date: September 2016
Cancer Prevention and Care Among Aged
This research represents a pioneering effort to design a brief, cost effective and readily transportable program that will enable disadvantaged elders to become more effective participants in their health care. The intervention is expected to result in trained elders [more...]  becoming more knowledgeable health care partners. Trained patients will be prepared for appointments and will engage their primary care physicians in active dialogue regarding cancer prevention and screening. Based on self-advocacy, these patients are expected to receive better preventive care and report greater satisfaction with care. Program participation can subsequently contribute to general health improvements and minimize health disparities.
Status: Recruiting Start Date: January 2011 Completion Date: 
Heart Failure Management Program Versus Usual Care
Heart Failure patients discharged to Skilled Nursing Facilities have higher rehospitalization rates and mortality than patients discharged to home. Heart Failure disease management programs have been shown to reduce rehospitalizations in community settings, no national guidelines have been set [more...]  forth for Skilled Nursing Facilities (SNF). This study will investigate the the effect of a heart failure-disease management program on the outcome of all-cause hospital readmissions, emergency room admissions and mortality for 30 days post-SNF admission using 7 component heart failure disease management program.
Status: Recruiting Start Date: January 2013 Completion Date: December 2018
Targeted Management Intervention for African-American Men With TIA or Stroke
Stroke is the leading cause of disability, third leading cause of death, and one of the most resource-intensive diseases among Americans. African-Americans (AA) have a stroke rate nearly double that of Euro-Americans (EA), and AA who experience a first-ever stroke are [more...]  younger, have greater stroke disability, more post-stroke complications, and slower recovery compared to EA.
Status: Recruiting Start Date: May 2012 Completion Date: April 2014
Patient and Physician Intervention to Increase Organ Donation
The number of persons on the national solid organ waiting list continues to increase while the number of donated organs has failed to keep pace. In some portions of northeastern Ohio the donation rate is as low as 32%. There is a positive association [more...]  between discussing organ donation with a primary care physician and signing a donor card. However, such discussions are rare. The investigators propose a blinded randomized controlled trial to evaluate the effectiveness of two interventions: 1) showing a donation video to patients in primary care settings waiting to see their physician and 2) cueing of primary care providers to have donation discussions with their patients. The study will be conducted throughout Cuyahoga County in at least 10 ambulatory clinics associated with a single county medical system. Nine hundred patients over 15.5 years of age will be enrolled. The investigators hypothesize that patients exposed to the interventions will be 1) more likely to consent to donate organs, 2) more likely to have donation discussions with their primary care providers, and 3) equally satisfied with the time spent with their doctor compared to patients who are not exposed to the interventions.
Status: Recruiting Start Date: September 2012 Completion Date: October 2015
Interstitial Cystitis: Elucidation of the Psychophysiologic and Autonomic Characteristics (ICEPAC) Study
Interstitial cystitis/painful bladder syndrome (IC/PBS) causes severe bladder pain and extensive disability in a large group of women int he prime of their productive lives. Extensive study of the bladder itself has uncovered many abnormalities, but the investigators do [more...]  not know if these are the cause or result of the disorder. None of these has led to any real long-term progress in treatment, so far. The investigators have found that other autonomic disorders often occur in both the patients themselves and in the family members of patients with IC/PBS. The investigators therefore propose to determine whether the main abnormality in IC/PBS actually lies in the autonomic nervous system, rather than the bladder. The investigators will do this through careful measurements of autonomic function and sensation in patients who have IC/PBS, both at rest, and under controlled psychological stress. The investigators will compare their measurements to patients with myofascial pelvic pain, to know which abnormalities are truly linked to IC/PBS, and which simply reflect the presence of pelvic pain.
Status: Recruiting Start Date: September 2009 Completion Date: April 2015
Wheezing in Black Preterm Infants: Impact of Vitamin D Supplementation Strategy
The goal of this study is to identify a vitamin D supplementation strategy that best promotes the lung, immune, and overall health of black infants born preterm (30-36 weeks gestational age). This is a high risk population that seems to have unique vitamin D [more...]  needs, and inappropriate supplementation may promote wheezing or allergy. The results of this study will help form nutritional recommendations for the approximately 100,000 black infants born at 30-36 weeks gestational age in the U.S. every year.
Status: Recruiting Start Date: January 2013 Completion Date: 
Optimizing Posttraumatic Stress Disorder Treatment: Prolonged Exposure (PE) Versus PE Plus Sertraline
The specific aims of this study are: 1. To compare the effectiveness of a cognitive behavioral therapy (prolonged exposure, PE) to that of PE and medication (sertraline). 2. To compare [more...]  the durability of PE gains to that of PE and sertraline at 3, 6, and 9 months post-treatment. 3. To compare those who have chosen their treatment to those who have not in terms of completion of treatment, treatment satisfaction, and short- and long-term effectiveness of the treatment. 4. To examine cost effectiveness of treatment delivery to trauma survivors with PTSD.
Status: Recruiting Start Date: March 2011 Completion Date: January 2015
Treatment Adherence Enhancement in Bipolar Disorder
Bipolar disorder (BD) is a serious and chronic mental illness that is associated with substantial impairment in quality of life and functional outcomes, high rates of suicide, and high financial costs. In spite of a proliferation of treatments for BD, nearly half [more...]  of individuals with BD do not benefit from pharmacotherapy because of sub-optimal medication treatment adherence. Non-adherence with BD medication treatment dramatically worsens outcomes. Reasons for non-adherence among individuals with BD are multi-dimensional, and it has been suggested that adherence enhancement might work best if the intervention specifically addresses factors that are important and modifiable for a specific individual. In spite of the enormity of the problem, the literature on interventions to improve treatment adherence is surprisingly limited. There is an urgent need for interventions to enhance treatment adherence among BD patients that: 1) are at high risk for future treatment non-adherence; 2) may not have access to or interest in long-term, high-intensity, and specialized care; and 3) are flexible and patient-focused taking into account reasons for non-adherence for a specific individual. The proposed study is a first-ever RCT focused specifically on BD treatment adherence enhancement, and will test whether a customized adherence enhancement (CAE) psychosocial intervention improves adherence and mental health outcomes compared to broadly-directed, non-individualized education (EDU). The proposed project has the potential to greatly advance the care of BD patients who are at greatest risk for poor health outcomes, with findings expected to be generalizable across a variety of treatment settings. Hypothesis 1: CAE will be associated with greater improvement in treatment adherence compared to broadly-directed, non-individualized BD education (EDU). Hypothesis 2: CAE will be associated with improved BD symptoms compared to EDU.
Status: Recruiting Start Date: April 2012 Completion Date: March 2017
Cornea Preservation Time Study
The purpose of this study is to determine if the 3-year graft failure rate following endothelial keratoplasty performed with donor corneas with a preservation time of 8 to 14 days is non-inferior to the failure rate when donor corneas with a preservation time of [more...]  7 or fewer days are used.
Status: Recruiting Start Date: March 2012 Completion Date: 
A Neuroprosthesis for Seated Posture and Balance
The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate stability of the trunk and hips. FES involves applying small electric currents to the nerves, which cause the muscles to contract. This [more...]  study evaluates how stabilizing and stiffening the trunk with FES can change the way spinal cord injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.
Status: Recruiting Start Date: July 2011 Completion Date: January 2014
Improving Outcomes for Individuals With Serious Mental Illness and Diabetes
This project tests a model for improving illness self-management among persons who have both serious mental illness and diabetes and will be performed within a primary care setting at a safety net hospital system. The information gained from the randomized trial will be [more...]  supplemented with reports from participants about their experiences of trying to improve illness self-management. Improvements in self-management should result in a reduction of psychiatric symptoms and improvements in functioning and physical health.
Status: Recruiting Start Date: July 2011 Completion Date: May 2015
Improving Continence and Quality of Life in Prostate Cancer Patients
This is a randomized, controlled longitudinal study of 312 early-stage prostate cancer patients that experience urinary incontinence six months after the completion of cancer treatment. This "STAY DRY" research program uses biofeedback to teach pelvic floor muscle exercises [more...]  (PFME) and combines it with a telephone or support group intervention to treat persistent urinary incontinence. The study's primary aims are to improve continence, quality of life, and mood through enhancing adherence to PFME and self-management of bladder control. The secondary aims are to examine the physiological effects and cost effectiveness of the proposed interventions. The study hypothesizes that the proposed intervention will improve continence, quality of life and mood of prostate cancer patients and reduce the cost.
Status: Recruiting Start Date: January 2009 Completion Date: December 2012
Evaluation of an Advanced Lower Extremity Neuroprostheses
The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate exercise, standing, stepping and/or balance in people with various degrees of paralysis.
Status: Recruiting Start Date: May 2005 Completion Date: June 2015
Interferon-Gamma Release Assays in Tuberculosis (TB) - HIV Co-infected Children
Tuberculosis (TB) is a disease affecting the lungs that is caused by a germ spread by coughing. TB infection is currently diagnosed by a skin test that has limited accuracy. The purpose of this study is to look at the reliability of a new [more...]  blood test for diagnosing TB infection in children. Study participants will include 300 HIV-infected (HIV infection is a viral infection that causes disease which destroys the body's ability to protect itself from infection and disease.) children and 500 HIV-uninfected children, ages 3 months to 5 years, residing in the Khayelitsha and Ravensmead/Uitsig Communities of the Western Cape Province, South Africa. Study procedures will include questionnaires, HIV and TB testing, which will be performed by blood and skin tests. Participants may be involved in study related procedures for up to 24 months.
Status: Recruiting Start Date: August 2007 Completion Date: July 2013
Diagnosis of Tuberculosis Infection in HIV Co-infected Children
Background: The TB and HIV epidemics are closely linked in developing countries, where 450,000 children die from HIV annually. TB is a major cause of death in HIV-infected children and is reversing gains made in child survival. The [more...]  traditional tuberculin skin test (TST) has limited diagnostic accuracy for detecting TB infection. Adult studies suggest that new blood-based diagnostic TB testing offers a quicker, more accurate way to diagnose TB infection. Such diagnostic testing may directly guide clinical management and preventive strategies in immune-suppressed HIV-infected children, who are at high risk of becoming TB diseased following infection. Data regarding the usefulness of these tests in children is currently limited. Objective(s) and Hypothesis(es): The investigators hypothesize that blood-based TB diagnostic testing can accurately identify children with TB infection. In a community with high rates of TB and HIV infection, the following specific aims will be investigated in HIV-infected and uninfected children: 1. assess the agreement between the TST and blood-based diagnostic testing, 2. compare the performance of the TST and blood-based diagnostic testing to a standardized history of TB exposure, 3. measure the impact of age, nutritional and immune status on children's response to blood-based testing, 4. describe factors that might modify children's response to testing over time, and 5) examine the effect of environmental exposures and previous vaccination on the TST, blood-based testing and other measures of immune responses to TB. Potential Impact: The benefits of an accurate, rapid diagnostic test of TB infection in children include 1) timely institution of treatment for TB infection to prevent severe disease and mortality, and 2) preclusion of over diagnosis and treatment. Treatment of childhood TB infection also prevents future contagious adult disease, thus decreasing community transmission. Blood-based diagnostic testing may also be able to identify children that are more likely to become ill following TB infection. Therefore, blood-based diagnostic testing has great potential to improve TB control and the health of HIV-infected and uninfected children, their households and communities.
Status: Recruiting Start Date: October 2007 Completion Date: September 2010
Enhancing Teachable Moment Communication for Smoking Cessation and Weight Management
The goal of this study is to test an intervention that teaches clinicians to integrate the use of 'teachable moments' with the key skills of motivational interviewing tailored to address smoking and weight management in the primary care outpatient visit setting.
Status: Enrolling by invitation Start Date: July 2009 Completion Date: July 2012
Ideas Moving Parents and Adolescents to Change Together (IMPACT)
The National Heart, Lung, and Blood Institute (NHLBI) of the National Institute of Health (NIH) has sponsored a consortium of four sites across the United States, entitled Childhood Obesity Prevention and Treatment Research (COPTR). Each site has its own protocol. Case [more...]  Western Reserve/Cleveland's project is entitled "Targeting Obesity and Blood Pressure in Urban Youth". The site name is IMPACT (Ideas Moving Parents and Adolescents to Change Together). The project assesses the effects of three interventions on Body Mass Index(BMI) in overweight and obese urban 5th-8th grade youth: a cognitive-behavioral intervention (HealthyChange), a systems improvement intervention (SystemsChange), and an education-only intervention (Tools4Change). In addition the study assesses the potential additional impact of a school-community based intervention on outcomes. The project has two phases: a formative phase (including focus groups and a pilot) and the main trial. The main trial will take place over approximately four years.
Status: Enrolling by invitation Start Date: February 2011 Completion Date: December 2017
Home or Office Visit for the Insertion of Implantable Birth Control
This is a pilot study in which women who desire an etonogestrel implant will be randomized to either a home or office insertion visit. The purpose of this research is to study the interest in, feasibility of, and rates of insertion for implantable birth [more...]  control (Implanon┬«/Nexplanon┬«) when inserted at home visit appointments compared to standard office visit appointments. The ultimate goal of the study is to reduce barriers to insertion of the etonogestrel implant and increase consistent and correct contraception use by introducing a previously unexplored method of access, the home visit.
Status: Not yet recruiting Start Date: April 2013 Completion Date: December 2013
Electronic Self-management Resource Training for Mental Health
The purpose of this study is to determine whether mental health treatment disengagement may be mitigated by reducing barriers to self-management and enhancing self-management skills.
Status: Not yet recruiting Start Date: February 2011 Completion Date: December 2011
Human Immunity to MSP-1 in Western Kenya
This is a study of 125 healthy male and female Kenyan adults aged 18 years and above, and 300 healthy male and female Kenyan infants enrolled at 1 month of age and followed to 3 years of age. Twenty healthy adults (US residents) [more...]  who have no self-reported history of Malaria exposure, infection or travel to malaria endemic areas of the world will serve as Malaria Naive Negative Controls. The proposed study represents a continuation of molecular and immunologic studies done in human populations describing mechanisms of protection against malaria infection and disease. Human investigation of those experiencing natural exposure to malaria infections are justified since they will eventually be the target population for testing malaria vaccine safety and efficacy.
Status: Not yet recruiting Start Date:  Completion Date: 
Pharmacokinetics of Vancomycin for Inhalation in Cystic Fibrosis
The purpose of this study is to determine the pharmacokinetics and safety of inhaled vancomycin in patients with cystic fibrosis.
Status: Active, not recruiting Start Date: January 2012 Completion Date: May 2013
Dose of Early Therapeutic Mobility: Does Type or Frequency Matter?
This study will examine the effects of once and twice daily activity performed with patients who are breathing with the aid of a machine in an intensive care unit. Activity can occur in bed. Activity can include transfer to a chair and [more...]  even walking once the patient's condition allows safe, out-of-bed activity. The investigators hypothesize that early, progressive activity will reduce inflammatory molecules in the blood, promote muscle and physical health and help patients to recover more quickly from critical illness.
Status: Active, not recruiting Start Date: May 2009 Completion Date: May 2012
Evaluation of Wire Electrodes to Activate the Expiratory Muscles to Restore Cough
Respiratory infections, such as pneumonia and bronchitis, occur frequently in the spinal cord injured population, due to paralysis of the muscles responsible for coughing. Using spinal cord stimulation techniques, these muscles can be activated to restore an effective cough [more...]  mechanism.
Status: Active, not recruiting Start Date: October 2009 Completion Date: March 2013
Comparison of Two Treatments for Post-Traumatic Stress Disorder
This study will compare the short- and long-term effectiveness of two different treatments for people with post-traumatic stress disorder.
Status: Active, not recruiting Start Date: September 2004 Completion Date: June 2012
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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.

Case Western Reserve University Clinical Trials Information presented on ClinicalTrialsSearch.org 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). ClinicalTrialsSearch.org is a website dedicated to listing clinical research studies in human subjects, including those specifically related to Case Western Reserve University. 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 Case Western Reserve University studies are federally regulated with strict guidelines to protect patients.

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