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NCT01070836
The primary objective of this study is to demonstrate that the incidence of progressive multifocal Leukoencephalopathy (PML) in natalizumab-treated participants who do not have detectable antibodies to John Cunningham virus (JCV) (antibody negative) is lower than in participants who have detectable antibodies to JCV (antibody positive). The secondary objectives of this study are to: Estimate the incidence of PML in natalizumab-treated participants who are anti-JCV antibody negative and anti-JCV antibody positive, based on a meta-analysis of data obtained from this study and other data sources; Define the prevalence of anti-JCV antibody in relapsing multiple sclerosis (MS) participants receiving natalizumab within the TYSABRI Outreach: United Commitment to Health (TOUCH) Prescribing Program; Determine changes in anti-JCV antibody status over time.
NCT02033551
This is an extension study to evaluate the safety of Veliparib monotherapy or in combination with Carboplatin plus Paclitaxel or modified Folinic Acid/Fluorouracil/Irinotecan (FOLFIRI) in subjects with solid tumors.
NCT02778438
REINVENT is a non-interventional, multi-center, research network-based cross-over study evaluating the potential utility of a telehealth platform in improving the efficiency of clinical trials. The study aims to enroll 30 subjects from primary care practices coordinated through a single main study site. Potential subjects will be screened and randomized (1:1) at Visit 1 into a 2-period crossover design study where 4 standard cognitive outcome measures are administered at Visits 2 (Day 30 ±7) and 3 (Day 90 ±7), either remotely or during an in-person visit.
NCT00264615
Pharmacokinetic (PK) study to characterize changes in serum concentrations in epilepsy patients when switching from LAMICTAL immediate-release to extended-release and vice versa.
NCT00404924
This study is being carried out to assess if adding ZD6474 to best supportive care (BSC) is more effective than best supportive care alone, for the treatment of patients with non-small cell lung cancer, whose disease has recurred after previous chemotherapy and an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI). ZD6474 is a new anti-cancer drug in development that works in a different way to standard chemotherapy drugs. It targets the growth of new blood vessels to a tumour and thereby might slow the rate at which the tumour may grow. Early studies indicate that ZD6474 has a positive effect on the time that a tumour may take to progress to a further stage. Approximately 930 patients will take part in this study. It will be conducted in hospitals and clinics in North and South America, Europe and Asia.
NCT00312377
This large phase III clinical study is studying the effect of vandetanib (ZACTIMA) in treating non-small cell lung cancer (NSCLC). Vandetanib is a new type of agent that targets the blood supply to a cancer tumour (through it's anti-vascular endothelial growth factor receptor (VEGFR) properties) and the tumour cells themselves (through it's anti-endothelial growth factor receptor (EGFR) actions). This study will look at the effects of vandetanib in lung cancer patients who have had their cancer re-appear after treatment with standard chemotherapy. This clinical study will test if the vandetanib anti-VEGF and anti-EGFR characteristics can deliver longer improved progression free survival and improved overall survival than docetaxel (Taxotere) alone. All patients participating this clinical study will receive treatment with docetaxel, a commonly used treatment for recurrent non-small cell lung cancer. In addition, some patients will also receive vandetanib (ZACTIMA), an anti-EGFR / anti-VEGF agent. Recent clinical research shows that vascular endothelial growth factor receptor (VEGFR) inhibition, when used with standard chemotherapy, can lead to increased survival in advanced non-small cell lung cancer (NSCLC) patients. Other research shows that epidermal growth factor receptor (EGFR) inhibitors, like erlotinib (Tarceva) can also increase overall non-small cell lung cancer survival by killing tumour cells and stopping them from dividing.
NCT01884532
The purpose of this clinical study is to evaluate blood metal ion levels as a function of time of implantation for the ASR-XL MoM system.
NCT01807949
The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.
NCT00261365
The purpose of this study is to identify candidate markers predictive of response and/or serious toxicity to BMS-734016 (MDX-010).
NCT01474135
This is a double-masked, randomized, controlled study assessing the safety and ocular hypotensive efficacy of two AR 12286/travoprost fixed-dose combination products compared to Travatan® Z in patients with elevated intraocular pressure
NCT00419276
To determine if following total knee replacement, putting local anesthetic-or numbing medication-for five days through a tiny tube next to the nerves that go to the knee will decrease the time that patients need to spend in the hospital.
NCT02201524
Study B7451005 is a Phase 2 study which will assess the efficacy and safety of PF-04965842 in patients with moderate to severe psoriasis. The study will include three PF-04965842 groups (200 mg daily, 400 mg daily and 200 mg twice daily) and a placebo group. The treatment period will be 4 weeks in duration and will be followed up by a 4 week follow up period.
NCT00884546
To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-833923 administered alone, in combination with lenalidomide plus dexamethasone, or in combination with bortezomib in subjects with relapsed or refractory multiple myeloma.
NCT01904773
This is a two-part, randomized, multi-center, blinded study in adolescents with Tourette's Disorder. There will be an up to 21-day screening period in which subject eligibility will be determined. In Part 1 of the study, the safety, tolerability and pharmacokinetics of AZD5213 will be assessed during a 1- week period. In Part 2 of the study, the safety, tolerability, and preliminary efficacy of two doses (depending on tolerability in Part 1 of the study) of AZD5213 and placebo will be assessed through six consecutive four-week crossover periods. Each subject will receive both AZD5213 and placebo. A follow-up vist will take place at 14 (±) 7 days following the last dose of study drug.
NCT00006429
This is a trial to test whether treadmill training can be used to improve the "walking" of patients with partial spinal cord injury. While on the treadmill, patients will be partially supported through the use of a specially designed harness attached to an overhead lift (also called Body Weight Supported Treadmill Training, BWSTT). Patients who enroll in this study will be randomly assigned to either the experimental group, which receives 12 weeks of this specialized treadmill training with regular physical therapy, or to the control group, which receives 12 weeks regular physical therapy. The ability of the patients to "walk" will be measured before and after treatment as well as 6 and 12 months later, using standard tests that examine mobility independence and speed of ambulation. The trial takes place across five sites in the US and Canada. Patients eligible for this trial will have had a traumatic spinal cord injury within 8 weeks of trial entry.
NCT01584557
The purpose of this study is to evaluate the short term efficacy and safety of tolvaptan in subjects hospitalized for worsening heart failure who have volume overload and one of the following: renal insufficiency, or hyponatremia or inadequate response to diuretic therapy. The primary variable for assessing efficacy will be self-assessed 7-point dyspnea score at 8 and 16 hours.
NCT00057018
An individual suffering a stroke or other brain injury may lose function on one side of the body (partial paralysis). As the individual shifts activities to favor the unaffected side, the problem worsens. Constraint induced (CI) therapy forces the individual to use the neglected arm by restraining the good arm in a sling. This study examines the effectiveness of CI therapy for improving arm motion after stroke.
NCT02084628
This is an open-label, multi-center study involving babies 0-2 months of age who have liver problems (pathology) and need to have their liver and possibly, the bile ducts imaged using magnetic resonance imaging and injection of a contrast agent (dye). This agent is called Eovist. It has been marketed since 2004 and used in many countries all over the world. The baby will have blood tests before and after the imaging is done to make sure that there are no unexpected findings before and after the imaging. Also 3 blood samples up to 8 hours after the injection will be obtained in order to measure how much of the dye is in the blood. The baby will have an intravenous line which can be used for the blood samples and will not need to be stick for the blood samples. Several radiologists will evaluate the images. The family doctor will be contacted to find out what was the diagnosis and treatment after the results of the MRI were known. Six months after the study, the parent(s)/legal guardian(s) will be contacted to make sure the that baby did not have any problems, especially with the skin, joints and eyes.
NCT01070823
The primary objective is to define the prevalence of serum anti-JCV antibody in relapsing multiple sclerosis (MS) participants receiving Tysabri® (natalizumab) or being considered for such treatment. Secondary objectives are to analytically validate the anti-JCV antibody assay in a plasma matrix and to determine changes in anti-JCV antibody status over time.
NCT01338779
The purpose of this multi-center (observational) registry study is to establish a database of clinical and laboratory information that may help to identify any unique characteristics of tolerant participants that differ from participants who reject their kidney after discontinuing immunosuppressive drugs.