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NCT00089778
This study will evaluate the safety and side effects of two experimental vaccines in patients with kidney cancer and determine whether the vaccines "turn on" an immune response to the cancer. Each vaccine contains one of two peptides (pieces of proteins) from the fibroblast growth factor 5 (FGF-5) antigen, a protein produced by some cancer cells, and an oil-based liquid called Incomplete Freud's Adjuvant (Montanide ISA-51) that enhances the immune response to the vaccine. Patients 16 years of age and older who have kidney cancer that has spread beyond the kidney or whose primary kidney tumor has been removed within 6 months before entering the study and are at high risk for disease recurrence may be eligible for this study. Patients must have tissue type human leukocyte antigen serotype within HLA-A A serotype group (HLA-A2) or human leukocyte antigen serotype within HLA-A A serotype group (HLA-A3) (determined by a blood test for human leukocyte antigen (HLA) typing) and their tumors must produce the FGF-5 peptide. Candidates are screened with a physical examination, blood and urine tests, electrocardiogram (EKG), tumor biopsy (removal of a small sample of tumor for examination) in patients whose tumor is easily accessible, and scans (computed tomography (CT), bone scans) and x-rays if current scans are not available. Participants are divided into two groups according to their HLA type (HLA-A2 or HLA-A3) to receive the vaccine appropriate for their HLA type. They are then further divided into three groups: 1) Group 1 includes patients who do not need or are ineligible for treatment with interleukin-2 (IL-2), a protein made by certain infection-fighting white cells that helps fight tumors) and patients who have previously had IL-2 therapy; 2) Group 2 includes patients who require immediate treatment with IL-2; and 3) Group 3 includes patients whose cancer has been surgically removed but who are at risk for recurrence. Patients in Groups 1 and 3 receive two peptide injections four times a week every 3 weeks for up to a year, or until their tumor grows (or returns in patients in Group 3) or the side effects are too severe to continue. Tumors are evaluated with a physical examination and scans or x-rays every 12 weeks and blood tests are done every 3 weeks. Patients in Group 2 receive two peptide injections every day for 4 days, along with doses of IL-2 starting the day after the first peptide injection. The vaccines are given as injections under the skin of the thigh. IL-2 is infused through a vein over 15 minutes every 8 hours for up to 12 doses, depending on tolerance. The vaccine and IL-2 are repeated every 10 to 14 days, with tumor evaluations every 2 months. Patients stay in the hospital about 1 week during each treatment cycle to receive the IL-2. All patients undergo leukapheresis, a procedure for collecting large numbers of white blood cells. Blood is collected through a needle in an arm vein and flows through a cell separator machine, where the white cells are extracted. The rest of the blood is returned to the patient through the same needle or a needle in the other arm. The white cells are examined to evaluate how the vaccines change the action of immune cells. Some patients may undergo an additional biopsy of normal skin and tumor or lymph node to look at the effects of the vaccine on the immune cells in the tumor. Patients in Group 1 whose cancer grows and patients in Group C whose cancer returns may be offered IL-2 treatments as given to Group 2 patients, along with the peptide vaccine. If the disease responds to IL-2, the treatment may be repeated after 2 months.
NCT00068328
RATIONALE: Studying how older women make treatment decisions and how these decisions affect the outcome of treatment may help doctors plan more effective treatments and improve patient quality of life. PURPOSE: This clinical trial is studying how a patient's treatment preferences and decisions about chemotherapy affect the outcome of treatment in older women with newly diagnosed breast cancer.
NCT02740348
The purpose of this trial is to determine whether setting up a follow-up appointment for patients who received treatment and were discharged from the emergency department increases their compliance with the follow-up appointment. We are enrolling patients who need a follow-up visit, have health insurance but report do not have a primary care doctor. Patients are randomized to one of three treatment groups: (1) assistance setting up a follow-up appointment by a research assistant using ZocDoc; (2) ZocDoc information given to the subject to set up follow-up appointment by him/herself; or (3) usual discharge instructions by ED staff. Subjects are phoned approximately 2 weeks after the ED visit and asked whether they completed a follow-up visit, satisfaction with their ED visit, satisfaction with their follow-up visit, and additional ED treatment and recovery.
NCT00973284
The purpose of this study was to evaluate the efficacy of the Norwalk virus-like particle (VLP) vaccine as determined by the illness rate of viral acute gastroenteritis (AGE) during the inpatient stay.
NCT02547688
Preliminary data show that high flow nasal air has been shown to reduce promote heat exchange due to evaporation of nasal mucus by the air flow resulting in heat loss. It is unclear whether unidirectional nasal airflow is well tolerated in healthy individuals. The central hypothesis of this proposal is that dry high flow nasal air will be sufficiently tolerated in healthy adults.
NCT00944554
This study aims to determine if varenicline (Chantix®), currently used as a smoking cessation aid, will decrease the likelihood of relapse to smoking following a programmed lapse in the laboratory. The hypothesis is that varenicline will reduce the reinforcing effects of smoking and will delay or prevent relapse compared to placebo.
NCT01394185
Study participants received dronabinol (0, 120mg/day and 240mg/day) for 12 consecutive days in a randomized order. During each dronabinol maintenance period they were able to self-administer active or placebo cannabis using either a progressive ratio schedule or choice between cannabis and monetary alternative.
NCT01393964
The purpose of the study is to assess the concentration of Elotuzumab in Myeloma patients with very low kidney function including patients on dialysis.
NCT00893074
A subset of heavy marijuana users have trouble quitting marijuana use and the number of those seeking treatment for problems related to marijuana is increasing. The purpose of this research study is to investigate whether dronabinol can reduce withdrawal effects associated with stopping marijuana use, if dronabinol can reduce the rewarding effects of smoked marijuana, and whether there are any cognitive performance deficits associated with dronabinol doses that produce such effects.
NCT01156142
RATIONALE: Doxepin hydrochloride may be an effective treatment for oral mucositis pain in patients undergoing radiation therapy with or without chemotherapy. PURPOSE: This randomized phase III trial is studying doxepin hydrochloride to see how well it works compared to placebo in treating oral mucositis pain in patients with head and neck cancer undergoing radiation therapy with or without chemotherapy.
NCT01226628
The main purpose of this study to evaluate the safety and tolerability of CNTO 2476 administered subretinally (beneath the retina) using the iTrack Model 275 micro catheter in patients with visual acuity (acuteness or clearness of vision) impairment associated with the geographic atrophy (GA: partial or complete wasting away of retinal layer below the retina) manifestation of age-related macular degeneration (AMD: medical condition which usually affects older adults and results in a loss of vision in the center of the visual field \[the macula\] because of damage to the retina).
NCT01674361
This multicenter, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of bitopertin in combination with SSRI in participants with obsessive-compulsive disorder. Participants will be randomized to receive either bitopertin 30 milligrams (mg) or bitopertin 10 mg or placebo orally daily in addition to their background therapy with an SSRI. Participants will be allocated to one of two strata. Participants in Stratum 1 will start study drug on Day 1. Participants in Stratum 2 will receive placebo from Day 1 (placebo lead-in) and will then start study drug at the Week 2 visit. Participants in both strata will receive the study drug in addition to their background therapy with an SSRI until Week 16.
NCT00889564
The purpose of this study is to compare the safety and effectiveness of the HeRO Vascular Access Device in access challenged (e.g., catheter-dependent) hemodialysis patients. It is hypothesized the bacteremia rate associated with the HeRO device will be lower than a historical literature control of tunneled dialysis catheters.
NCT03240770
The investigators hypothesize that brief, daily application of HFA will increase the efficiency of clear aligner treatment by altering PDL metabolism without increasing pain or discomfort. The investigators will divide subjects into 5 groups changing clear aligners at different time intervals with or without HFA application for 5 minutes/day to assess the effect on: time intervals between aligners, cytokine activity, and pain perception.
NCT02222246
The goal of this pilot study is to improve emergency department (ED) pain management for adults with sickle cell disease. Sickle cell disease (SCD) is the most common genetic disorder in the United States, and occurs primarily among African Americans. Management of painful episodes associated with SCD, referred to as vaso-occlusive crises (VOC), is the most common reason for SCD patients to visit the ED. Currently, there is no standard approach to managing VOC pain in the ED that is widely accepted and used, and pain management for vaso-occlusive crisis in persons with SCD is very different between providers and not based on research. Many times, patients who come to the ED with sickle cell pain feel that they do not receive adequate pain control. If EDs could provide efficient, effective, safe, patient-centered analgesic management, it may be possible to improve pain management for adults with SCD experiencing a VOC. Guidelines for treating vaso-occlusive crises caused by sickle cell disease will soon be published by the National Heart, Lung and Blood Institute of the National Institutes of Health. These guidelines recommend patient-specific pain treatment protocols or a standardized pain management protocol for SCD when a patient does not already have a pain treatment protocol designed for them. The purpose of this pilot study is to compare these two ways to treat vaso-occlusive pain in the ED for adults with sickle cell disease, and to determine if a large randomized controlled trial is feasible and required.
NCT01895088
This is a 2 year follow up study to monitor the long term safety of the ACI 7000PDT in subjects who are still implanted with the ACI and have successfully completed the ACU-P08-020/020A studies.
NCT00381810
This is a Phase II/III open label, single-arm, multicenter, extension study to evaluate the safety and efficacy of rituximab when administered on a scheduled basis every 6 months over the course of 1 year with reassessment of response at 12 months. This study is open to participants previously enrolled in Genentech Study U2971g only.
NCT02471222
This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once daily at bedtime for the treatment of walking impairment in MS. ADS-5102 is designed to be administered once daily at bed time, ADS-5102 achieves higher plasma amantadine concentrations in the early morning, sustained throughout the afternoon, and lower concentrations in the evening when patients are sleeping. ADS-5102 is designed to deliver its primary treatment effect during the day, and potentially reduce the adverse events of immediate-release amantadine when the patient is asleep.
NCT00354965
Clinical research study to test amoxicillin and clavulanate tablet formulation for use in Acute Bacterial Sinusitis (ABS) in adolescent patients weighing at least 40 kilogram (kg) and no more than 16 years old. ABS is an acute bacterial infection of the sinus. The purpose of this study is to find out how children tolerate Augmentin XR and what happens to Augmentin XR in the body after it has been swallowed by children.
NCT01295346
The purpose of this study is to assess if putative brain injury biomarkers have utility as blood-based traumatic brain injury (TBI) diagnostic and monitoring tools. This will be accomplished by examining the relationships between potential serum-based TBI biomarkers and clinical measures of injury severity, occurrence of complications, and outcome, in subjects with mild or moderate TBI. The assay will be evaluated in a sample population of subjects over the age of 18 who have been referred to the health care provider for closed head injury evaluation.