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NCT02230670
This is a multicenter study to see if treatment with IDN-6556 can help improve the liver function of patients with liver cirrhosis with Model for End-Stage Liver Disease scores between 11-18.
NCT00097682
This study will explore what research patients understand about financial collaborations in the research setting and their concerns about these collaborations. Financial partnerships are crucial to advancing medical research; however, they are giving rise to increasing concerns about financial conflicts of interest and possible impacts on the integrity of research and patient safety. This study will examine patients' views about financial ties between drug companies and the doctors running research studies, as well as ties between the drug companies and the cancer centers where the studies are conducted. Patients 18 years of age and older who are enrolled in cancer studies at the National Cancer Institute in Bethesda, MD; the Fred Hutchinson Cancer Research Center in Seattle, WA; the Dana-Farber Cancer Institute in Boston, MA; the Columbia Comprehensive University Herbert Irving Cancer Center in New York, NY; and the University of Colorado Cancer Center in Denver, CO, may be eligible for this study. Participants are interviewed about the following: * Patients' awareness and understanding about individual and institutional financial conflicts of interest, and how such conflicts, if they exist, are being managed * The impact of a researcher's financial ties on the patient's decision to participate in that researcher's study * The impact of the institution's financial ties on the patient's decision to participate in research at that institution * Attitudes about policies and practices regarding conflicts of interest in the research setting * Attitudes about disclosure of conflicts of interest in the research setting * Patient symptoms and performance * Patient's cancer trial * Patient's cancer history * Patient's trust * Patient demographics (gender, age, race, religion, education, income, health insurance, employment).
NCT01522235
The purpose of the study is to see if administering intravenous immune globulin (IVIG) (putting immune globulin directly into your blood) helps to improve the symptoms of orthostatic hypotension (sudden fall in blood pressure when a person stands up) and quality of life in men and women who have autoimmune autonomic ganglionopathy (AAG).
NCT00072813
This study will examine the possible structural and functional abnormalities in patients with an inherited form of epilepsy. It will use magnetic resonance imaging (MRI). Uncontrolled epilepsy is a serious neurological problem with major harmful medical, social, and psychological effects, as well as greater mortality compared with the general population. The cost per year in the United States is at least $12.5 billion. There have been advances in diagnosing the disease, but the cause cannot be determined in many cases. Recently, several seizure syndromes found in families have been described. One syndrome of particular interest involves the lateral temporal lobe of the brain and often includes auditory features. Patients with that kind of syndrome may hear monotonous unformed sounds, but sometimes they may hear complex sounds, such as a song. Patients are eligible for this study if they have a specific form of familial epilepsy that is being studied at Columbia University in New York. Family members without seizures are eligible as well. All the patients in the study will be evaluated at Columbia before participating. Healthy volunteers aged 18 to 55 also may be eligible for this study. Participants will undergo a medical history and physical examination. During the study, they may have three or four sessions of MRI. During the MRI, patients will lie still on a table that can slide in and out of a metal cylinder surrounded by a strong magnetic field. Scanning time varies from 20 minutes to 3 hours, with most scans lasting between 45 and 90 minutes. Patients may be asked to lie still for up to 60 minutes at a time. As the scanner takes pictures, there will be loud knocking noises, and the patients will wear earplugs to muffle the sound. Patients will be able to communicate with the MRI staff at all times during the scan and may ask to be moved out of the machine at any time. Some scans may be done in a 3 Tesla scanner. It is the latest advance in MRI, with a stronger magnetic field than in the more common 1.5 Tesla scanner. Functional MRI (fMRI) is done while patients are performing tasks, such as moving a limb or speaking. Patients will have an opportunity to practice such tasks before entering the scanner. The fMRI will take about 1 hour. ...
NCT00428948
This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD.
NCT02197065
Up to 35% of hip fracture patients have been shown to experience heart injury after surgery, and as many as 10% have a heart attack or die in the three months after surgery. Hip and knee arthroplasty patients are also at risk of cardiovascular complications. Patients who have these complications have higher levels of inflammation postoperatively. Statins (such as atorvastatin/Lipitor) lower cholesterol and also lessen inflammation. Both of these effects are important in preventing heart attacks. Statins have been shown to reduce the risk of heart attacks in non-surgical patients, and to protect from heart attacks in patients having heart surgery. Whether statins can prevent heart attacks in orthopedic patients is not known. In this pilot study the investigators will treat 30 orthopedic surgery patients (hip fracture, hip or knee arthroplasty) with either atorvastatin or placebo (a capsule with no study drug). Patients will start the study drug prior to surgery and take it for 45 days after surgery. Neither the doctors nor the patients will know whether they are taking atorvastatin or placebo. The investigators will look for evidence of inflammation and heart injury after surgery. The investigators hypothesize that atorvastatin will lessen the degree of postoperative inflammation found in these patients. In this study, the investigators will use a very sensitive test of heart injury that can detect problems even when patients have no symptoms. The investigators hypothesize that this test will demonstrate silent heart injury in over 50% of the hip fracture patients and over 30% of arthroplasty patients in our study. The results of this trial will help us to develop a larger study in 1000 hip fracture and joint replacement patients to determine whether atorvastatin protects orthopedic surgery patients from heart injury and other complications of surgery.
NCT00316498
This study is done in conjunction with a trial, conducted at Columbia University College of Physicians and Surgeons in New York and the Royal Manchester Children's Hospital in England, to examine the effectiveness of a new drug called OGT 918 for treating Niemann-Pick Type C (NPC) disease. Patients with this genetic disorder do not transport lipids (fatty substances) in their cells, resulting in problems of the liver, spleen and brain. An early sign of NPC is a reduced ability to move the eyes rapidly up and down or from side to side. These voluntary eye movements are called saccades. Patients in the OGT 918 trial who participate in this sub-study will have their saccadic eye movements measured to see if improvement occurs with OGT 918 treatment. Patients with Niemann-Pick Type C disease 12 years of age and older who are enrolled in the OGT 918 trial described above may be eligible for this study. Participants will have both vertical (up and down) and horizontal (side to side) saccadic eye movements measured at two time points before starting treatment with OGT 918 and after 12 months of treatment. For the test, patients sit in a chair with their head positioned as for a regular eye examination (steadied by a chin cup and headrest) and follow with their eyes a series of lights or laser spots moving on a screen at a distance of 1 meter (3 feet). During the test, patients wear either special recording glasses, infrared goggles, or special contact lenses for measuring eye movements. A full eye evaluation lasts about 1 hour, and each eye is evaluated twice. The evaluations are separated in time by at least an hour, and possibly a day.
NCT00710593
The purpose of this study is to evaluate the immunogenicity, safety, tolerability, and behavioral impact of an HPV-6, -11, -16, -18 vaccine in HIV-infected young women.
NCT00001192
This study will allow researchers to use various types of tests to evaluate cognitive and sensory functions. These tests, referred to as "batteries" will evaluate attention, executive functions, general intellectual functioning, language, memory, motor functions, orientation, personality, selected sensory and perceptual functions, vigilance (alertness), and visual-spatial functions. Children and adult patient will receive different test batteries. The goals of this research study are to; 1. Create descriptions based on the performance of each patient on the test batteries. Then use this information to relate patient behavior to their neurophysiological, neuroradiological, and biochemical descriptions. 2. Define subgroups of patients based on their neurobehavior in order to decrease the variability of psychiatric diagnoses, treatments, and prognoses.
NCT01693029
The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US licensed reference product Epogen®/Procrit® when applied subcutaneously. This study is intended to generate data supporting that the efficacy and safety under treatment with HX575 and Epogen®/Procrit® are comparable.
NCT02305212
This study will examine a cognitive rehabilitation protocol targeted at working memory deficits for adults and children with Traumatic Brain Injury (TBI). In this randomized clinical trial, the efficacy of Cogmed, a cognitive rehabilitation protocol designed to improve working memory, will be examined in children with TBI. Neuropsychological and daily life functioning will be measured. Participants will be children (N=20) and adults (N=20) with a documented history of TBI. Participants will be randomized to a treatment group or a wait list control group. The Experimental Group will receive the Cogmed working memory training program 30-40 minutes per day, 5 days a week for 5 weeks for a total training time of approximately 15 hours. The Control Group will be a wait list control group that will cross over into treatment after the follow-up assessment. All subjects will undergo repeat assessments following completion of the working memory training protocol after the 7th week and again at 13 weeks to document changes in working memory performance.
NCT02433834
A Randomized, Double-Blind, Chronic Dosing (14 days), 5-Period, 7-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-center, Dose-ranging Study to Assess the Efficacy and Safety of Glycopyrronium MDI (PT001) Relative to Placebo MDI and Open-Label Serevent Diskus in Adult Subjects With Intermittent Asthma or Mild to Moderate Persistent Asthma
NCT00918047
Study to evaluate the pharmacokinetics, safety, and tolerability of OXC XR as adjunctive therapy in pediatric subjects with refractory partial epilepsy.
NCT01026493
RATIONALE: Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide. work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving veliparib together with temozolomide may kill more tumor cells. PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of giving veliparib together with temozolomide and to see how well it works in treating patients with recurrent glioblastoma.
NCT02643914
Nicotine is the most common drug of abuse in the United States, and has addiction strength comparable to cocaine, heroin, and alcohol. It is the primary addictive component of tobacco, and its use markedly increases risk for cancer, heart disease, asthma, miscarriage, and infant mortality. Addiction is thought to be caused primarily by the intersection of two components: 1) the impact of drug pharmacokinetics on the dynamics of dopamine response, and 2) dysregulation of the brain's reward circuit. While the term 'dysregulated' tends to be used qualitatively within the neuroscience literature, regulation has a precise and testable meaning in control systems engineering, which has yet to be addressed in a quantitative manner by current neuroimaging methods or models of addiction. Current approaches to neuroimaging have primarily focused on identifying nodes and causal connections within the meso-circuit of interest, but have yet to take the next step in treating these nodes and connection as a self-interacting dynamical system evolving over time. Such an approach is critical for improving our understanding, and therefore prediction, of trajectories for addiction as well as recovery.
NCT02459158
This study is a randomized, open-label phase I study. The primary objective of this study is to assess the pharmacokinetic (PK) profile of ME1100 in subjects with mechanically ventilated bacterial pneumonia (MVBP). The secondary objective of this study is to assess the safety and tolerability of ME1100 for the treatment of subjects with MVBP to assess the safety and tolerability of ME1100.
NCT00048880
Background: * Some cancers, such as Hodgkin's disease, anaplastic large cell lymphoma and others, have a protein on the surface of the cancer cell called CD30. * HeFi-1 is an antibody that binds to the CD30 protein and sends signals to the cancer cells that can cause them to die. Objectives: * To determine the highest dose of HeFi-1 that can safely be given to patients with tumors that have the CD30 protein. * To determine the response of the tumor to treatment with HeFi-1. Eligibility: * Patients 18 years of age and older with Hodgkin's disease, anaplastic large cell lymphoma, cutaneous T cell lymphoma and adult T cell leukemia or lymphoma who have signs of tumor growth or recurrence following standard treatment * Patients' tumor cells must have the CD30 protein. Design: * Groups of three patients are treated with increasingly higher doses of HeFi-1 (ranging from 0.5 to 5 mg/kg) to determine the highest safe dose. * HeFi-1 is infused through a vein on 4 days, followed by 2 days of rest over a 10-day period. Patients may receive up to 2 treatment courses if they show some response and do not have severe side effects. * Blood samples are collected several times during the study to determine safety. A lymph node biopsy is done at the beginning of the study to test the effect of HeFi-1 on cancer cells in the test tube, and a bone marrow biopsy may be done at the end of treatment if the bone marrow was positive for tumor cells at the beginning of treatment.
NCT00069693
This study will conduct tests with patients with primary chronic orthostatic intolerance (COI) to learn more about this disorder of the autonomic nervous system. Healthy normal volunteers and patients 18 years of age and older with COI may be eligible for this study. Participants undergo one or more of the following tests and procedures: * Blood studies, including arterial catheter insertion to measure blood pressure and collect arterial blood samples, blood flow studies using sensors applied to the skin and a pressure cuff around a limb, blood volume studies using injection of radioactively labeled human serum albumin and gene studies to look for genetic abnormalities associated with certain proteins. * Imaging studies, including CT scan of the adrenal glands, heart ultrasound, and PET scanning. * Electrocardiogram * Microdialysis to measures levels of chemicals in the body fluid of certain tissues. A thin tube is inserted into the skin and a solution is passed through it. Chemicals in the body tissues enter the solution in the tube. The solution is collected and the chemical levels are measured. * Neck suction. Neck suction is applied to test a reflex the brain uses to regulate blood pressure. * Perometry. Limb volume is measured using an infrared light that moves up the limb. * Quantitative sudomotor axon reflex test to evaluate an aspect of autonomic nervous system function. A small amount of a brain chemical (acetylcholine) is applied to the skin with a tiny amount of electricity, and the sweat in a nearby patch of skin is measured. * Skin electrical conduction test using sensors on the skin to measure sweat production. * Skin and core temperature measurements using sensors on the skin and in the ear canal. * Tilt table test. The subject lies on a table, secured with straps around the chest and legs. Sensors are placed on the arms and chest to monitor blood pressure, pulse rate, and heart rhythm. A catheter is placed in a vein in each arm to collect blood samples and give drugs. Another catheter is placed in an artery to draw blood and monitor blood pressure. The subject is given an infusion of norepinephrine and epinephrine, and baseline measures and blood samples are taken. The table is tilted upright and more measurements and blood samples are taken at intervals for up to 30 minutes. The table is returned to a horizontal position and additional measurements and samples may be taken. Drugs may be administered during the tests, including acetylcholine, epinephrine, and norepinephrine, radioactive chemicals used in imaging studies, and drugs that affect blood vessels, heart rate, and force of heart contractions.
NCT02104076
The Evolution® Biliary Stent System-Fully Covered study is a clinical trial approved by the US FDA to evaluate the effectiveness of the Evolution® Biliary Stent System-Fully Covered when used in palliation of malignant neoplasms in the biliary tree.
NCT00978952
This study is designed as a prospective, multicenter, non-randomized, single arm study to assess the safety and effectiveness of the Large Diameter Advanta™ V12 Covered Stent for stent implantation in coarctations of the aorta.