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October 1, 2009

Center Studies Currently Recruiting Participants

  • Assessment of Bleeding Symptoms in Normal Individuals Using a Comprehensive History Phenotyping Tool

    A wide variety of individuals are at risk for bleeding, but even though bleeding symptoms are common it is difficult to compare different people's symptoms. Recent research has found that carefully designed surveys can be used to calculate a bleeding score that is useful for diagnosing bleeding disorders, but normal individuals have not been specifically studied in large numbers with a comprehensive survey. Whether factors like race, ethnicity, age, sex, aspirin use, and previous trauma and surgery influence bleeding scores is also unknown. The primary goal of this study is to use a comprehensive computerized questionnaire to record the bleeding symptoms of normal individuals and then assess the range and severity of bleeding symptoms in this normal population. Secondary goals include determining whether race, ethnicity, age, sex, aspirin use, and previous trauma and surgery correlate with bleeding symptoms.

  • Killer T cell Activity in the Paraneoplastic Neurologic Syndromes

    Paraneoplastic neurologic disorders (PNDs) are diseases which occur in some cancer patients, and are thought to arise when cancer cells produce proteins that are normally produced only in nerve cells. The patient's immune system fights the cancer cells, but because the proteins that the cancer cells produce are the same as the proteins in certain nerve cells, the immune system mistakenly attacks the nerve cells. This misdirected immune attack is thought to cause the neurologic problems in patients with PNDs, such as difficulty walking and speaking, abnormal and decreased sensations, and poor memory. The reason for doing this research is to better understand how PNDs develop and to better understand the immune response, so that we can develop treatments for PNDs, for the underlying cancers, and for other diseases where the immune system attacks the body's own cells.

    We are studying patients with PNDs in several IRB-approved protocols at the Rockefeller University in the General Clinical Research Center. We would like to understand what is going right in patients with PNDs, in the hopes that we can learn how their often-successful immune attack against cancer may be used to help others with cancer. Of course, we need to be able to understand and separate this immune response from the neurologic degeneration. Studies on the neurologic degeneration are of two types. One set of studies is aimed at furthering our understanding of the cause of these neurologic diseases, an important first step into developing treatments. Based on what we have learned to date, we have a second study in which medicine is given on an experimental basis in an effort to lead us toward successful treatments for the neurologic degeneration.


  • Characterization of Clonal B Cell Populations in HCV Infection

    The reason for doing this study is to understand why a specific kind of antibodies (cryoglobulins) form in people infected with hepatitis C virus (HCV). About 10-40% of people with HCV eventually develop symptoms related to these antibodies, called cryoglobulinemia. We plan to study how a type of immune cell that makes antibodies, B cells, produce these cryoglobulins. After obtaining your blood, we will separate your B cells and analyze the proteins they produce. By doing this, we hope to gain understanding that may lead to improved therapies for HCV-related cryoglobulinemia.

  • A study to document the natural course and history of psoriasis before, during and after treatment with conventional therapies

    Psoriasis is thought to be due to an overly active immune system and has the tendency to be inherited from your parents. We are trying to gain a better understanding of psoriasis and how it responds to various conventional treatments.

  • Skin biopsy for analysis of cell growth, cell differentiation and inflammation in the skin

    Psoriasis is due to an overly active immune system and has the tendency to be inherited. We are conducting studies to answer basic biological questions concerning how cells differ from each other. There are many types of cells in the skin and blood, and we are studying how these cells grow in the laboratory. We are interested in how these cells are affected by factors such as age, sunlight or drugs.  We will compare these cells from people with skin diseases to those with healthy skin.

  • The Natural History of Pigmented Skin Lesions

  • Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single Rising, Open-label Doses of AbGn-168 Administered by Intravenous Infusion to Patients with Chronic Plaque Psoriasis
    The main purpose of this research study is to test the safety and tolerability of single increasing doses of AbGn-168 given intravenously (injection of a substance into a vein) in patients with chronic plaque psoriasis. A secondary objective is to assess how the body uses and gets rid of the study drug (Pharmacokinetic or PK testing) and to determine the chemical and physical effects of the drug within the body (Pharmacodynamic or PD testing). The effects of AbGn-168 on psoriasis disease activity in skin cells will be assessed by obtaining three small pieces of skin (biopsies) at different times (baseline (pre-treatment), 2 weeks and 4 weeks after treatment) during the study.

  • Vitamin D Repletion in Chronic Kidney Disease

    The reason for doing this research is that people with kidney disease often suffer from heart disease. Why this happens is not fully known. A possible cause may be high blood levels of a substance made by bacteria called “endotoxin”. The blood levels of this substance are high in people with medium-level kidney disease. We want to know if replacing normal amounts of Vitamin D can help lower the levels of this substance. We also want to know if replacing normal amounts of Vitamin D is associated with other changes that may help heart disease. We hope that our research will help figure out if levels of this substance can be lowered by replacing normal amounts of Vitamin D.

  • Methodological Pilot Study: Influence of Fasting Status and Processing Time on Serological Biomarkers of Energy Balance 

    We are doing this research because there is interest in finding substances in the blood that will improve the ability of doctors and researchers to identify who will be at higher risk of obesity-related diseases (like breast and endometrial cancers, some times called uterine cancer).

    Researchers do this type of research in large studies that include women who had blood drawn right after a meal (non-fasting) or hours after they last ate (fasting). Since some of the biological markers of research interest may be higher or lower in the blood right after a meal, the time between last meal and blood draw may be important. In research studies, it is sometimes difficult to separate the drawn blood quickly after it has been drawn. Once blood is outside of the body, it quickly begins to break down, which may affect the biological markers of research interest. So, we are looking at how the time between last meal and blood draw, as well as the time between blood draw and the processing of blood affects the measurement of substances in the blood. We believe that levels of obesity-related metabolic parameters are influenced by processing delays and by fasting status, and further that this latter effect varies by body size.

  • An Observational Study of Treated and Untreated Acute and Early HIV-1

    This is an observational study for people who are newly infected with HIV infection. In this study you can choose to receive treatment or not.

    We are asking you to take part in this research study because either (1) you have just been diagnosed as having acute or primary HIV-1 infection based on the pattern of your HIV-1 antibody test and your viral load (Group A), or (2) you have been diagnosed with acute or primary HIV-1 infection in the past and have participated in a study of treatment of acute HIV infection at The Rockefeller University Hospital and are now considering changing medications (Group B).

  • Viral and host factors in the transmission and pathogenesis of HIV

    If you join the research study, you will take part for about 5 to 15 minutes. The research study as a whole will last about 10 years.

    The physicians at the Rockefeller University Hospital are engaged in research on the nature, diagnosis and treatment of disease. You have been informed that this study involves research and that the purpose is to study viral and host factors involved in the transmission and pathogenesis of HIV infection.

    The reason for doing this research is to study viral and host factors involved in the transmission and pathogenesis of HIV infection.

    We are asking you to take part in this research study because you are or may have been infected with the virus that causes HIV infection. Blood will be drawn to determine this possibility, and to assist in defining diagnosis, or prognosis, or clinical management.


  • The Role of the Gastrointestinal Lymphoid System in the Pathogenesis of HIV-1 Infection and Health

    It has been found that human immunodeficiency virus (HIV) infected cells are significantly higher in lymphoid tissue (lymph nodes and tonsils) than in the blood of HIV-infected people.

    The gastrointestinal tissue is the body’s largest area of lymphoid tissue. However a comparison between the numbers of HIV infected cells detectable in the gastrointestinal tract (the stomach and intestines) with the number of HIV infected cells from the blood has not been performed.

    The reason for doing this research is to determine which cells in the gastrointestinal tract are infected with HIV, if the number of HIV-infected cells in the gastrointestinal tract are greater than in the blood and to assess the response of immune cells in the intestines towards the HIV virus.

  • HIV Elite Controller Study

    The focus of the studies to be conducted under this protocol and consent form is on the detailed analysis of host cellular and humoral immune responses, comprehensive human genome analysis and genomic analysis of the infecting viruses isolated from persons that control HIV infection.

  • A Pilot Study of the New York HIV Transmission Study: Project HITS-NYC. Illicit Drug Use and Social Network Effects Among At Risk and Recently HIV-Infected Men

    This research study is about sexual and drug taking behaviors and other factors such as race, religion, level of education, employment and income that may affect risk of HIV infection.

    After over 25 years, HIV/AIDS still poses a serious public helath threat. Men who have sex with men still hear the highest burden of new infections in NYC, particularly in Manhattan. We are doing this research to better understand the factors that are associated with people getting infect with HIV.

  • A Phase II, Randomized Trial of Open-Label Truvada with Atazanavir/ritonavir versus Multi-class Therapy with Truvada, Atazanavir/ritonavir, Maraviroc and Raltegravir in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects

    The reason for conducting this research is to see if antiretroviral (ARV) medications that target HIV at 4 different steps in the viral life cycle better prevents HIV from making copies of itself when compared to a standard three-drug treatment commonly used to treat HIV infection that targets 2 different steps in the viral life cycle.

  • A study of the safety, tolerability and pharmacokinetics of experimental drug KD-247

    The reason for doing this research is to determine the safety and tolerability of 3 infusions (the introduction of fluid into a vein) over 2 weeks of the experimental study drug KD-247 in HIV-1 seropositive (infected) individuals.

    We also want to know how much of the drug gets into your bloodstream and what effect KD-247 has on plasma HIV-1 RNA load (amount of virus in your blood, also called ‘viral load’) and on CD4+ T cell counts (CD4+ count measures the number of a type of white blood cell in the body that fights infection).

  • Quality of Life and Metabolic Alterations in Patients with Statin-Associated Myopathy

    The Rockefeller University Hospital is conducting a study looking at the relationship between statin medications and muscle pain. Volunteers who participate in the study will be randomly placed in a group that will receive statin treatment or a group that will receive a placebo – a pill that looks like the statin, but is a sugar or a starch pill. Researchers will compare the volunteers’ progress while taking these pills, over a period of about 8 weeks.

  • Effects of a Western-Type Diet on Colorectal Inflammation

    This study will look at the inflammatory (changes usually associated with infection/injury to the body) and bowel permeability (bowel's ability to allow contents to enter the body) effects of a Western-style diet (high fat and low in calcium) and a prudent-style diet (low fat and high in calcium) on the colon (large bowel). This study may provide information to prevent colorectal cancer in a high-risk population.

  • Entrance into the International Fanconi Anemia Registry (IFAR)

    We want to obtain clinical and genetic information on patients with this heterogeneous disorder, in order to learn how to optimize clinical care of affected children, and to increase our understanding of this rare syndrome.

  • Polycystic Kidney Disease Data Repository

    Autosomal dominant polycystic kidney disease (PKD) is the most common inherited kidney disease, affecting more than 400,000 people in the U.S. and 5 million people worldwide. PKD is the 4th most common cause of kidney failure requiring dialysis and/or transplantation. Over half of all PKD patients develop kidney failure by age 60 years, although age of onset of kidney disease varies widely, even among members of the same family.

    Despite the fact this is a relatively common problem, relatively few patients have been studied for a sufficient period of time to fully understand how patients are affected over the course of their lifetime. The reason for creating this repository is to collect information about PKD so that we may fully understand its complications, including high blood pressure, heart attack, and stroke. This information may also aid in the development of improved treatment strategies.


  • Inherited Blood Platelet Disorders

    Our goals for this study are to look at: • the interactions among normal and abnormal blood cells • the interactions among normal and abnormal blood cells & the blood vessel wall • the genetic and functional basis of inherited blood cell and coagulation disorders. We are asking you to take part in this research study because you are a normal volunteer and we need to study normal blood. Your participation will consist of: • Being asked about your general health and the medications you are taking • Donating blood • 15 minute visit(s) to the Rockefeller University Hospital Outpatient Clinic per blood donation

  • Hepatitis C Virus and the Humoral Immune System 

    The purpose of this study is to learn how hepatitis C virus infection affects the function of B cells. B cells are a type of white blood cell that makes antibodies. Antibodies are proteins that your body uses to fight infection.