The Center for Liver Diseases is recruiting participants for the following studies:

• Patients with hepatic encephalopathy
This study will compare Lactulose and Rifaximin to determine the benefit of either drug, or a combination of both. We will be enrolling patients with cirrhosis of the liver and a history of a previous hospitalization for hepatic encephalopathy. Patients will be followed for six months and a one-month post-treatment. Contact Macy Ho, CRC 305-243-4648 or email Mho@med.miami.edu

• Patients with chronic liver disease
This studies the correlation between liver histology and elasticity measured in patients with chronic liver disease using a device known as Fibroscan. This is a painless, non-invasive test. Qualifying patient must have received a laparoscopic liver biopsy within the past two months or scheduled a laparoscopic liver biopsy within the next two months by their PCP at Cedars Medical Center-Miami. This is a one time visit. Liver cancer patients are excluded. Contact: A. Brown at 305-243-2184 or abrown@med.miami.edu

• Vaccine test in patients with chronic hepatitis C.
The Center for Liver Diseases is conducting a Phase I, double-blind, placebo controlled, dose escalation, multi-center trial of a therapeutic vaccine in patients with chronic hepatitis C infection. Subject must be > 18, have no hypersensitivity to baker's yeast, non-cirrhotic, compensated liver disease, and must have received a liver biopsy within the past two years or be willing to have one performed. Subjects can be naïve to previous treatment, or a relapser or partial responder to an interferon-based treatment. Must meet other criteria as well. Contact A. Brown at 305-243-2184 or abrown@med.miami.edu

• Study of three treatments
The Center for Liver Diseases is conducting a phase 2, double-blind, multi-center, randomized research study in HBV decompensated subjects. Adult subjects with CPT score of 7-12 and no history of HCC will be assigned to one of the three treatment arms: Tenofovir Disoproxil Fumarate (TDF), Emtricitabine plus Tenofovir Disprocil Fumarate (FTC/TDF) or Entecavir (ETV). Patients can be on lamivudine or adefovir dipivoxil. Must meet other criteria. Contact Clinical Research Coordinator Karina Herrera at 305-243-2148 or at kherrera@med.miami.edu 

• Study of liver diseases
The Center for Liver Diseases is conducting a Phase II study for men and women, investigational oral medication for liver scarring caused by chronic Hepatitis C. Subjects must be between 40 and 70 years old, have been diagnosed with chronic Hepatitis C, have failed prior Hepatitis C therapy with interferon and ribavirin treatments, which must have been discontinued at least 12 months ago. Study staff will review additional criteria if you are interested in learning more. The study should last approximately 56 weeks with 14 clinic visits. Contact Macy Ho, CRC 305-243-4648 or Mho@med.miami.edu

Do you or does someone you know experience pain related to spinal cord injury? Eva Widerström-Noga, Ph.D., and her colleagues are conducting research into the nature and treatment of pain associated with spinal cord injury. Studies are enrolling now.  Eligible participants will be 18 to 70 years of age and at least two years post-injury.  If you are interested in enrolling, please call The Miami Project to Cure Paralysis at 305-243-8132 for information.

The Center for Liver Diseases is conducting a phase 2, double-blind, multi-center, randomized study in HBV decompensated subjects. Adult subjects with CPT score of 7-12 and no history of HCC will be assigned to one of the three treatment arms: Tenofovir Disoproxil Fumarate (TDF), Emtxticitabine plus Tenofovir Disoproxil Fumarate (FTC/TDF) or Bntecavir (ETV). Patients can be on lamivudine or adefovir dipivoxil. Must meet other criteria. For further information, please contact clinical research coordinator Karina Herrera at 305-243-2148, or at kherrera@med.miami.edu.

Heather Woolery-Lloyd, M.D., of the Division of Cosmetic Dermatology, is looking for people between the ages of 18 and 39 who have mild to severe acne to participate in a research study to determine whether use of an investigational topical treatment will improve acne.  If you are interested, please contact a member of the research staff at 305-531-5788.

The Department of Psychology is recruiting participants for the following studies:

• A schizophrenia family study 
Have you or one of your relatives been diagnosed with schizophrenia or schizoaffective disorder? Are you in regular contact with this person? If so, you and your family may be eligible to participate in a free family-focused treatment research study. During the treatment, clinicians will provide factual information about schizophrenia and schizoaffective disorder. In addition, techniques to assist the family in coping with mental illness will be presented. Treatment is available in English and Spanish. If interested, please contact the Schizophrenia Family Project at 305-284-5455.

• A family factors and autism study
The aim of this project is to better understand families’ emotional reactions to autism spectrum disorders. We seek the participation of adults with high-functioning autism or Asperger’s and one of his or her parents. Participation will involve one hour-long telephone call. If you would like to help with this study or if you have any questions, please contact Stephanie Wasserman at 305-284-2307.

Researchers at the MRI Center need healthy subjects for a magnetic resonance imaging study. For more information, please visit http://midas.med.miami.edu/Research/MRStudies.htm.

Patients with idiopathic pulmonary fibrosis (IPF) are being recruited for a study of effects of sildenafil on exercise and breathlessness. Participants must have a firm clinical diagnosis of IPF, be 40 to 85 years of age, and not be on medication for IPF. Interested patients or physicians wishing to refer patients should call 305-575-3548, fax 305-575-3126, or e-mail rjackson2@med.miami.edu.

The Department of Obstetrics and Gynecology is testing experimental medications and therapies for the treatment of cervical dysplasia, a pre-cancerous condition that can lead to cancer if left untreated. Current treatments are surgical or invasive. This study is testing an investigational gene therapy to see if it safely and effectively treats HPV medicated cervical lesions as a result of dysplasia. If you are between 18 and 25 and have had an abnormal PAP test, you may be able to take part in this research study. Qualified participants will receive all study-related care and study therapy. To find out more, call Iliana Rivas at (305) 243-5832 or i.rivas@miami.edu

The Department of Psychology and the Division of Cancer Prevention and Control is conducting a quality of life research intervention with advanced prostate cancer patients. Participants should have Stage III or IV prostate cancer and have recently or currently been treated with hormone therapy. Eligible participants will take part in a ten-week cognitive behavioral stress and affect management program or a health promotions program. Three psychosocial/medical assessments are also required. If you are interested in this study or would like more information, please contact Frank Penedo, Ph.D., at 305-243-3329, or fpenedo@miami.edu.

Daniel Santisteban, Ph.D., of the Center for Family Studies in the Department of Psychiatry and Behavioral Sciences, is currently conducting a research program that would provide adolescents and/or their family treatment for free. Participants must be 14 to 17 years old, have a parent or legal guardian willing to participate, meet DSM criteria for both substance abuse disorder and borderline personality disorder, and be willing to participate in four separate but paid evaluations. If interested, please contact Henry Calderon, clinical research specialist/assessor, at 305-243-2225, or hcalderon@med.miami.edu for details.

The Center for Research and Education on Aging and Technology Enhancement is conducting research with family caregivers of dementia patients who speak English and are 50 years of age or older. If you are not a caregiver but are interested in participating, you may be able to help as well. Participants will receive basic training on how to use the Internet and will be asked to look for information about care-giving and dementia. If you are interested in being a part of this research study, please call 305-355-9200. You will be paid for your time and effort.

Jennifer B. Marks, M.D., is currently recruiting patients ages 18 through 40 with type 1 diabetes mellitus with a recent diagnosis for participation in a research study to test the safety and effectiveness of an investigational medication. Patients must be taking multiple insulin injections daily and in good health. Those who are interested should contact Rogelio Suarez at 305-243-6573 or rsuarez2@med.miami.edu.

The AIDS Clinical Research Unit, directed by Margaret Fischl, M.D., is recruiting participants for the following studies:

• A phase I IL-7 study (IL-7 is a cytokine that aids T-cell development and improves T-cell survival). Participants must be 18 to 50 years of age, receiving antiretroviral therapy for at least 12 months, have an HIV-1 RNA level less than or equal to 50,000 copies/ml, and have a CD4 cell count of 100 cells/ccm or higher. Participants must be willing to do 12-hour IL-7 blood level monitoring. Up to $200 in food certificates provided.

• An investigational CC-chemokine receptor 5 (CCR5) entry inhibitor for patients with HIV. The study will look at single dose, dose escalations of a study drug (0.5 mg, 2.0 mg and 5.0 mg) and a placebo. The study will determine how well the study drug blocks CCR5 receptors and is tolerated. Participants must be 18 and older, not taking antiretroviral therapy for at least three months and have a viral load greater than 5,000 and a CD4 count greater than 250. Must be willing to do six-hour drug level monitoring. Up to $250 provided.

For more information on studies conducted by the AIDS Clinical Research Unit, contact Juan at 305-243-3838 or Leslie at L.Thompson@miami.edu.

The SPARE Study (Soy Phytoestrogens As Replacement Estrogen) is currently recruiting women 45 to 60 years of age to study the role of soy phytoestrogens given in tablet form to prevent bone loss. Participants will be given a physical exam at study entry, an annual mammogram and bone density test, and will be asked to come for 10 study visits over a period of two years for blood tests and to complete questionnaires about diet, exercise, and well-being. Interested women should contact the SPARE Study Office at 305-243-4330 or via e-mail at aherrin@med.miami.edu.

The University of Miami Skin Research Group, directed by Brian Berman, M.D., Ph.D., is looking for people with acne, atopic dermatitis (eczema), and keloids. Participants should be 18 or older for the acne and keloid studies and ages 2 to 17 for the atopic dermatitis studies. If interested, please contact the research staff at 305-243-5519 or visit our website at www.skininvestigation.com.

Bruce Rubin, M.D., is currently performing a study on trigeminal neuralgia (TN) treatment with subcutaneous injections of BOTOX® to evaluate the effectiveness of treating facial pain associated with TN. Patients must have a diagnosis of TN for more than three months and be at least 18 years of age.
 
Dr. Rubin is also seeking patients for a research study on the treatment of tightness/spasticity in the wrist, fingers, and elbow caused by a stroke while evaluating the effect of BOTOX® on pulmonary functioning. Patients must be 18 years of age, have had a stroke six months ago or longer, have a pulmonary/breathing problem and cannot have used BOTOX® or any other botulinum toxin previously for any condition. Please contact Amy L. Kaye, ARNP, at 305-243-6223 for additional information on either of these studies.