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Discover 23,476 clinical trials near Baltimore, Maryland. Find research studies in your area.
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NCT00216060
Risedronate is an orally administered pyridinyl bisphosphonate that is 36 times more potent than pamidronate and 72 times more potent than clodronate. Four randomized, double-blind trials have been carried out in patients with postmenopausal osteoporosis. In 2 of these studies, vertebral fracture incidence was reduced by a daily dose of 5 mg risedronate by up to 65% and 49% relative to placebo after 1 and 3 years, respectively. In these trials, risedronate improved lumbar spine, femoral neck, and femoral trochanter bone mineral density (BMD) at 6 months. In addition, preclinical studies have shown that risedronate is more potent than pamidronate and clodronate in inhibiting adhesion of prostate cancer cells to bone and preventing tumor cell invasion. The incidence of osteoporosis in prostate cancer patients has been well established; therefore, it is advantageous to assess the efficacy of oral bisphosphonate therapy.
NCT01435499
The primary objective of this study is to evaluate the safety and feasibility of administering an allogeneic GM-CSF-secreting lethally irradiated whole melanoma cell vaccine ("melanoma GVAX"), alone or in combination with low dose cyclophosphamide (CPM), for the adjuvant treatment of patients with surgically resected stage IIB-IV melanoma. Secondarily, the investigators will assess in vitro correlates of anti-melanoma immunization by melanoma GVAX, including serological and cellular immune responses in patients treated with either the vaccine alone or the vaccine given with low dose CPM.
NCT01546519
This is a Phase Ib, open-label, multiple-center, multiple-dose study designed to evaluate the pharmacokinetics and safety of vismodegib in patients with advanced solid malignancies (including hepatocellular carcinoma and lymphoma) that are refractory to standard therapy or for whom no standard therapy exists.
NCT00003590
RATIONALE: Drugs used in chemotherapy such as hydroxyurea use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well hydroxyurea works in treating patients with unresectable benign meningioma.
NCT00955825
The purpose of the study is to assess the efficacy and safety of 300 IR sublingual tablet of grass pollen allergen extract compared to placebo in adult patient with allergic rhinoconjunctivitis.
NCT02287246
To study post-operative efficacy of Exparel® for pain control in patients undergoing any Urogynecology surgery involving the posterior vaginal wall using a randomized, double-blinded placebo controlled trial.
NCT01103284
This study will look at the treatment effect of DiaPep277 on preservation of beta-cell function, as defined by meal-stimulated secretion of insulin. DiaPep277 is a peptide that changes the way the immune system behaves, stopping its attack on the beta-cells. Adults (\>20 years) with newly diagnosed (\<6 months) type 1 diabetes will be treated with 10 injections of DiaPep277 or Placebo over a 2-year treatment and follow-up period.
NCT02178540
The purpose of this actual use human factors (HF) study is to validate the approved US TOBI Podhaler Instructions for Use (IFU), by establishing that the IFU effectively communicates the information necessary to achieve safe and effective use of the Podhaler device.
NCT00754325
The purpose of this study is to find out what effect the combination of fulvestrant (Faslodex) and dasatinib (Sprycel) has on advanced breast cancer compared to fulvestrant alone.
NCT00717249
This study compares the performance of an investigational contact lens to a currently marketed lens.
NCT00642902
To evaluate the safety and tolerability of atacicept and to explore if atacicept reduces central nervous system inflammation in subjects with relapsing multiple sclerosis (RMS) as assessed by frequent magnetic resonance imaging (MRI). This study is randomised. Study medication is administered via subcutaneous (under the skin) injections.
NCT01305408
The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.
NCT00464061
The purpose of this study is to assess efficacy and safety of volinanserin in the population of patients complaining of sleep maintenance insomnia. The objective of the substudy is to assess glycemic control in the subgroup of patients with type II diabetes mellitus.
NCT00531622
The main purpose of this study is to evaluate the efficacy of saredutant 100mg once daily in combination with escitalopram 10mg once daily compared to saredutant placebo in combination with escitalopram 10mg once daily in patients with major depressive disorder. This study also includes a double-placebo group (saredutant placebo in combination with escitalopram placebo).
NCT00263042
The primary objective is to show whether rimonabant reduces the risk of a heart attack (MI), stroke, or death from an MI or stroke in patients with abdominal obesity with other cardiovascular (CV) risk factors. The secondary objective is to show whether rimonabant reduces the risk of MI, stroke, CV death, or CV hospitalization in these patients.
NCT02630563
The study is planned to be conducted in 2 parts. The first part (open label, multi-center, non-controlled) of the study will estimate a dose that would provide a mycophenolic acid (MPA) exposure in pediatric participant that is comparable to that achieved in adult liver transplant participants receiving the approved dose of mycophenolate mofetil (MMF, CellCept). The second part (open-label, multi-center, single-arm Phase IV study) of the study will provide the pharmacokinetics, efficacy and safety profile of the proposed dose in the immediate post-transplant period. This study will be conducted at two centers based in the United States of America. Twelve pediatric transplant participants receiving a first liver allograft from a cadaveric or living donor will be enrolled in this study. Stable pediatric liver transplant participants who are at least 6 months post-transplant and who were already receiving stable dose of MMF in combination with cyclosporine will be enrolled into the study. Participants should have received stable MMF dose according to center practice for at least seven days in order to get steady state pharmacokinetics (PK). Participants also should have received stable concomitant doses of cyclosporine (for at least 2 days) and corticosteroids per center practice. Participants will be aged between 9 months and 12 years, with at least 6 participants greater than or equal to (\>/=) 9 months and less than (\<) 36 months, of whom at least 2 will be \<24 months.
NCT02345421
The objective of this study is to determine the frequency of Lysosomal Acid Lipase Deficiency (LAL D) by lysosomal acid lipase (LAL) enzyme activity assay in patients who are considered to be at risk.
NCT01318941
This study will describe the long-term safety and effectiveness, treatment patterns,and patient reported quality of life associated with ranibizumab treatment in routine clinical practice for all approved indication included in the local product label.
NCT00291161
Background: Partners in Dementia Care (PDC) is a care coordination and support service intervention for veterans with dementia and their family caregivers, delivered through partnerships between VA medical centers and local Alzheimer's Association Chapters. PDC was designed to be a feasible and practical intervention to integrate health, community, and support services. PDC has a standardized protocol for care coordination and support services, including guidelines for care plan assessment, care plan development and implementation, ongoing monitoring, and reassessment. It also offers a structured training curriculum for providers and an operations manual for uniform implementation. Objectives: The primary objective was to test the impact of PDC on outcomes for veterans with dementia and family caregivers. Two specific research objectives and corresponding hypotheses were addressed: 1. To test the impact of PDC on three categories of outcomes: psychosocial well-being outcomes (patient and caregiver effects); health care service use (patient effects only); and health care cost (patient effects only). HI:PDC, compared to usual care, will improve psychosocial well-being for patients with dementia and their caregivers. H2:PDC, compared to usual care, will reduce health care service use for patients with dementia. H3:PDC is preferred to usual care based on cost-benefit analyses. H4:The PDC intervention will be more effective in improving psychosocial well-being and reducing health care service use for patients and caregivers dealing with more severe patient impairment (e.g., cognitive status, functional status, and level of problem behaviors). 2. To evaluate the impact of PDC on role and intra-psychic strains caused by dementia and its care (patient and caregiver effects). H5a:PDC, compared to usual care, will decrease patient role and intra-psychic strain. H5b:PDC, compared to usual care, will decrease caregiver role and intra-psychic strain. H6:The PDC intervention will be more effective in decreasing role and intra-psychic strains for patients and caregivers dealing with more severe patient impairment (e.g., cognitive status, functional status, and level of problem behaviors).
NCT00400478
This is a randomized, open label, phase III study to evaluate the ability of rituximab maintenance therapy to prolong event-free survival in aggressive NHL. Patients will be screened after successful standard induction therapy (CR or Cru following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8 cycles). Patients will be followed until an event occurs as defined in the protocol. To evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who have achieved a complete remission after appropriate first-line therapy, measured by event-free survival (EFS), 440 patients with DLCBL or follicular NHL grade 3 (220 per arm) will be recruited.
