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Discover 23,476 clinical trials near Baltimore, Maryland. Find research studies in your area.
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NCT00363779
Background: * Large granular lymphocyte (LGL) leukemia is a low-grade non-Hodgkin's lymphoma. * LGL is associated with low numbers of white blood cells (leading to recurring infections), red blood cells (causing anemia) and platelets (causing abnormal bleeding). * Cyclosporine (CSA) is an immunosuppressive drug that improves low blood cell counts in about 50 percent of patients with LGL leukemia. Objectives: * To identify what factors determine why cyclosporine works in some patients and not in others. * To identify what causes low blood counts in LGL leukemia. Eligibility: Patients 18 years of age and older with LGL leukemia. Design: * Patients have a medical history, physical examination blood tests, bone marrow biopsy and x-ray studies, including chest x-rays and computed tomography (CT) scans of the chest, abdomen and pelvis. Patients with an easily accessible enlarged lymph node have a node biopsy (removal of a small piece of tissue for microscopic examination). * Patients take cyclosporine twice a day by mouth. Blood samples are taken at least weekly to adjust the cyclosporine dosing to maintain therapeutic serum levels. * Patients undergo apheresis (collection of white blood cells) at a number of different time points in the study (maximum 6 times) to look at the differences in the leukemia cells before and during treatment with cyclosporine. For apheresis, blood is withdrawn through a needle in an arm vein and directed through a catheter (plastic tube) into a machine that separates it into its components. The white cells are extracted and the rest of the blood is returned through the same needle or through a second needle in the other arm.
NCT01443923
Background: \- Standard treatment for the hepatitis C virus (HCV) is a combination of the drugs peg-IFN and ribavirin. However, this treatment is not very effective in people with a serious type of HCV (HCV genotype 1) and also in people who have human immunodeficiency virus (HIV) coinfection. Researchers want to add a new drug, boceprevir to see if it can improve treatment results in people with both HCV genotype 1 and HIV. Boceprevir used in combination with peg-IFN and ribavirin has been recently approved for the treatment of people with HCV genotype 1 infection only, and is currently being studied in those with HIV and HCV. Objectives: \- To test boceprevir, peg-IFN, and ribavirin as a treatment for HCV genotype 1 in people with HCV monoinfection compared to those with both HIV and HCV infections. Eligibility: * Individuals at least 18 years of age who have HCV genotype 1 infection, and have not received interferon treatment for HCV * Half of the study participants will also have HIV infection. Design: * Participants will be screened with a medical history and physical exam. They will also have blood and urine tests. * Participants will also have heart and liver function tests, and answer questions about mood and depression. * Those in the study will receive ribavirin tablets to take twice a day, and peg-IFN to inject under the skin weekly. * Two weeks after starting treatment, participants will have blood tests to study the treatment. * Four weeks after starting treatment, participants will start taking boceprevir three times a day. * Participants will have regular study visits with blood samples and other tests. The length of therapy will depend on the level of virus detected in the blood at several clinic visits. Those who do not respond well to the medicines at 12 weeks will stop treatment. The full length of treatment is 48 weeks.
NCT00206908
This project is designed to evaluate the clinical utility of a novel blood test, the Triage Stroke Panel, as an aid in the diagnosis and assessment of stroke. The Triage Stroke Panel test device, used with the Triage MeterPlus, is a rapid, point-of-care immunoassay. The test measures the concentration of various analytes present in EDTA-anticoagulated whole blood or plasma, specifically B-type natriuretic peptide (BNP), fibrin degradation products containing D-Dimer, matrix metalloproteiase-9 (MMP-9), and S-100B. The test utilizes a proprietary algorithm for the automatic calculation of a single Multimarker Index (MMX) result from the individual biomarker values. The MMX result is being evaluated for use as an aid in the assessment and diagnosis of stroke.
NCT00505934
Keppra injection is approved in the US as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. The objective of the current study is to assess the safety, tolerability, and pharmacokinetics, of this formulation in children aged 1 month to 4 years.
NCT02193945
The purpose of this study is to retrospectively review and further characterize anatomic and symptomatic changes over six months immediately following treatment of symptomatic vitreomacular adhesion (VMA) with JETREA® (ocriplasmin), including incidence, time to onset and resolution of anatomy and symptoms.
NCT01649297
The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.
NCT00336102
RATIONALE: Learning about thyroid dysfunction in patients with breast cancer may help plan treatment and may help patients live more comfortably. PURPOSE: This clinical trial is studying how often thyroid dysfunction happens in women with newly diagnosed stage I, stage II, or stage III breast cancer who are planning to undergo chemotherapy compared to how often it happens in healthy volunteers.
NCT00844844
The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adolescent patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome (aHUS).
NCT00844545
The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adult patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome (aHUS).
NCT01478061
The Study plan is a post-market prospective, multi-center, open-label registry. The vein graft failure rates for the currently commercialized C-Port devices will be compared to an a priori rate taken from the peer-reviewed literature.
NCT00507507
The main objective of the study was to evaluate the antiviral activity of tenofovir disoproxil fumarate (tenofovir DF) monotherapy versus emtricitabine (FTC) plus tenofovir DF combination therapy for the treatment of chronic hepatitis B (HBV) in participants in the immune tolerant phase of HBV infection. The efficacy of tenofovir DF monotherapy versus FTC plus tenofovir DF combination therapy was evaluated for suppression of the virus (decrease in HBV DNA), serological response (generation of antibodies to the virus), biochemical response (changes in liver enzymes), and the development of drug-resistant mutations. The safety and tolerability of both tenofovir DF monotherapy and FTC plus tenofovir DF were evaluated by routine monitoring for adverse events and changes in laboratory parameters. Participants were randomized in a 1:1 ratio to receive tenofovir DF monotherapy or FTC plus tenofovir DF. All subjects were to continue on blinded study medication until the last subject reached Week 192. Participants who permanently discontinued study drug (on or before Week 192) were followed for a 24-week treatment-free follow-up period, or until initiation of alternative HBV therapy, whichever occurred first. Subjects who discontinued study drug on or after Week 48 because of hepatitis B surface antigen (HBsAg) loss or seroconversion to antibody to hepatitis B surface antigen (anti-HBs), however, were to have returned for their regularly scheduled through Week 192 and every 16 weeks thereafter until the last subject reached Week 192.
NCT00890305
This clinical trial will be performed in previously untreated patients with metastatic colorectal cancer. The study will evaluate the safety, tolerability and efficacy of the study drug, CT-011, in combination with FOLFOX chemotherapy (FOLFOX4 or mFOLFOX6) compared with treatment by FOLFOX alone.
NCT00907231
This is a multi-center study to assess the diagnostic accuracy of the Troponin I assay in the Biosite Triage Cardio3 Panel at the point-of-care (POC) in adults presenting to the emergency department with possible acute myocardial infarction (AMI).
NCT00951795
This is a multi-center study designed to assess the accuracy of Pima™ CD4 Test to enumerate CD4+ T-cells in whole blood over the measurement range expected for the intended population. The Pima CD4 Test consists of the Pima™ CD4 cartridge and Pima™ Analyzer to identify and determine the absolute counts of mature helper (CD3+/CD4+) T-lymphocytes in whole blood.
NCT02092233
The ARIES HSV 1\&2 Assay is a PCR based test for the direct detection and typing of herpes simplex virus (HSV 1 \& 2) DNA. The objective is to establish the diagnostic accuracy of ARIES HSV-1\&2 Assay.
NCT02322138
The study objective is to evaluate the gastrointestinal tolerance of infant formula supplemented with prebiotics.
NCT01049022
The purpose of this study is to describe the pharmacokinetics of moxifloxacin in children to see what the best dose should be for children in the future. Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the study drug. The pharmacokinetics of certain drugs may be altered in children due to developmental differences in various organ functions responsible for drug elimination, as well as in general distribution characteristics. The safety of moxifloxacin in children with infections will also be looked at. Results from this study will be used to guide dosing strategies of the larger clinical trial planned for children
NCT01347580
The aim of this study is to determine whether initiation of ticagrelor as early as in the ambulance setting leads to a rapid reperfusion of the infarct-related artery therefore facilitating the Percutaneous Coronary Intervention (PCI) and optimizing the outcome for the patient. The study will assess the efficacy and safety of pre-hospital compared to in-hospital administration of ticagrelor in co-administration with aspirin, on restoring the blood flow in the occluded heart artery and improving the myocardial perfusion in patients suffering from myocardial infarction and planned to have a PCI. Patients can be randomised in either one of the 2 arms: re-hospital ticagrelor arm: Patients will receive a loading dose of 180 mg ticagrelor for the pre-hospital administration and placebo for in-hospital administration. or In-hospital ticagrelor arm: Patients will receive a placebo for pre-hospital administration and 180 mg ticagrelor loading dose for in-hospital administration. Patients are initially managed by ambulance physician/personnel in pre hospital settings. They are then transferred into a Catheterization room to undergo a PCI. After the administration of the loading dose of ticagrelor (double blind), patients will continue on ticagrelor 90 mg bid and be followed in study for 30 days post randomisation.
NCT00310661
TD is a troublesome and potentially irreversible side effect associated with the use of neuroleptics. While the newer neuroleptics are improved in this regard, they all still carry the risk of TD. The present study proposes that sarizotan is a potential agent for treating neuroleptic-induced TD based on preliminary data indicating efficacy in the management of dyskinesias associated with Parkinson's disease. Its efficacy is further substantiated by pre-clinical data obtained from the vacuous chewing movement (VCM) model in rats, a model we employ ourselves in investigating the relationship between D2 occupancy and TD. The present study also examines the effects of sarizotan on cognitive function, given the association between TD and cognitive deficits.
NCT00235027
Patient safety is at the forefront of critical issues in health care. Medications are the single most frequent cause of adverse events, and in the inpatient setting adverse drug events (ADEs) are common, expensive, injurious to patients, and often preventable. Relatively little, however, is known about the frequency of ADEs in the ambulatory setting, how to monitor for outpatient ADEs, or on the impact of prevention strategies such as computerization of prescribing supplemented by decision-support.
