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NCT00390455
This randomized phase III trial studies fulvestrant and lapatinib to see how well they work compared to fulvestrant and a placebo in treating postmenopausal women with stage III or stage IV breast cancer that is hormone receptor-positive. Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes. Lapatinib may stop the growth of breast cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether fulvestrant is more effective with or without lapatinib in treating breast cancer.
NCT00475605
This is an observational study to assess the long-term safety of Protopic® Ointment for the treatment of atopic dermatitis. Patients whose ages are/were \< 16 years at the time of first tacrolimus ointment exposure are eligible to participate. No drug is distributed during this observational trial.
NCT02965456
The objective of this study was to evaluate the efficacy, safety, and tolerability of a once daily topical application of IDP-121 Lotion compared with its vehicle (IDP-121 Vehicle Lotion) in participants with moderate to severe acne vulgaris (acne) (that is, acne having an Evaluator's Global Severity Score \[EGSS\] of 3 \[moderate\] or 4 \[severe\]).
NCT00754221
This is a study to investigate the long-term safety and effectiveness \[S,S\]-Reboxetine in relieving the symptoms of Fibromyalgia in patients.
NCT00710567
Specific Aims The aims of this trial are to evaluate the safety and effectiveness of the DuraHeart™ LVAS in patients with advanced heart failure who require LVAS support as a bridge to cardiac transplantation. Study Population The patient population for this trial consists of patients with end stage heart failure awaiting cardiac transplantation. Patients must be listed for transplant with UNOS with status 1A or 1B. All patients who meet the eligibility criteria may be included in the study regardless of gender, race or ethnicity. Study Design This is a multi-center, prospective, single arm study in which the lower one-sided confidence interval exceeds the performance goal. Enrollment is expected to occur within an 18-month time period at up to 40 centers. All patients will be followed for all endpoints for 6 months while on DuraHeart™ LVAS support, or until cardiac transplantation or death, whichever occurs first. For those patients who remain on support after 180 days, survival and device reliability data will continue to be collected on a regular basis. If patients are transplanted, survival at day 30 post cardiac transplantation will also be assessed.
NCT01914393
This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the preceding studies, D1050301, D1050325, and D1050326
NCT00235495
The goal of the trial is to determine whether human albumin, administered within 5 hours of symptom onset, improves the 3-month outcome of subjects with acute ischemic stroke.
NCT01578707
The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapy results in a clinically significant improvement in progression free survival (PFS) as compared to treatment with ofatumumab in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
NCT00341705
The Second Multicenter Hemophilia Cohort Study (MHCS-II) will evaluate and prospectively follow approximately 4500 persons with hemophilia who were exposed to hepatitis C virus (HCV). The vast majority will have been infected with HCV, and approximately 1/3 will have been infected with human immunodeficiency virus (HIV). Primary objectives are to quantify the rates of liver decompensation, hepatocellular carcinoma, and non-Hodgkin lymphoma and to evaluate candidate clinical, genetic, virologic, serologic and immunologic markers that are likely to be on the causal pathway for these conditions. Candidate clinical and laboratory markers will be examined longitudinally to define changes over time and their relationships to one another. Collaborative studies will focus on genome scanning and evaluation of candidate genetic loci for susceptibility or resistance to HCV and HIV infections or to the diseases that result from these infections. Additional studies will identify response and complication rates of various anti-HCV and anti-HIV regimens in the setting of comprehensive clinical care of persons with hemophilia.
NCT00452335
The primary purpose of this study is to evaluate the safety and efficacy of lubiprostone in a pediatric population with constipation, including the pharmacokinetics of lubiprostone, in a subset of patients.
NCT01993875
To evaluate the pharmacodynamics and tolerability of a liquid formulation of lubiprostone, as compared to matching placebo, when administered orally to subjects with chronic idiopathic constipation. Additionally, liquid formulation pharmacokinetics, including a comparison of fed and fasted pharmacokinetics, of the liquid formulation will be performed in a subset of subjects.
NCT01844115
The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone relative to placebo in the treatment of generalized anxiety disorder (GAD).
NCT01766401
NCT00036790
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Motexafin gadolinium may increase the effectiveness of doxorubicin by making tumor cells more sensitive to the drug. PURPOSE: Phase I trial to study the effectiveness of combining motexafin gadolinium with doxorubicin in treating patients who have recurrent or metastatic cancer.
NCT00626028
The primary purpose of this study is to compare the number of participants with reversible pulmonary hypertension (vasoreactivity) due to nitric oxide for inhalation and oxygen as compared to 100% oxygen.
NCT01915368
The investigators will conduct a proof-of-concept study to provide preliminary evidence of efficacy of physical exercise dose on ambulatory function in adults undergoing sub-acute stroke rehabilitation.
NCT02228460
Primary Objective: To assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and exploratory efficacy of GZ/SAR402671 in enzyme replacement therapy treatment-naïve adult male participants diagnosed with Fabry disease.
NCT00722553
The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and folic acid, is effective in the treatment of advanced or metastatic bladder cancer. The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this patient population. Additionally, this study includes the collection of blood samples to investigate the pharmacokinetics (PK) of pralatrexate in this patient population (PK is the activity of a drug in the body over a period of time, including how the drug is absorbed, distributed in the body, localized in the tissues, and excreted from the body).
NCT01969695
This is a Phase 1, open-label, multicenter, extension study. Subjects with non-Hodgkin's lymphoma (NHL) (excluding chronic lymphocytic lymphoma \[CLL\], small lymphocytic lymphoma \[SLL\], and mantle cell lymphoma \[MCL\]) who completed a prior ABT-199 study, or were active and assigned to ABT-199 when the study was completed, may roll over into this extension study. Subjects will receive ABT-199 during this study.
NCT02066961
The purpose of this study is to describe patterns in disease management and to describe clinical outcomes, as well as to identify factors influencing physician treatment decisions including reason(s) for treatment choices and trigger(s) for treatment changes and to document healthcare resource utilization used to manage treatment-related complications.