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NCT00139282
Age-Related Macular Degeneration (AMD) is a degenerative eye disease of the retina that causes a progressive loss of central vision. AMD is the leading cause of blindness among adults age 50 or older in the Western world. AMD presents in two different types: "dry" and the more severe "wet" form. Wet AMD is caused by the growth of abnormal blood vessels in the macula. Squalamine lactate is an investigational drug that may prevent the growth of these abnormal blood vessels. This study will evaluate the safety and efficacy of Squalamine lactate in the treatment of AMD in patients, the exact number of which will be determined based on data from the sponsor's ongoing Phase 2 trials. The trial objective is to evaluate the safety and efficacy of two doses of Squalamine lactate for Injection administered as intravenous infusions weekly for 4 weeks followed by maintenance doses every 4 weeks through week 104 compared with the safety and efficacy in the control group.
NCT00460967
SUMMARY Age-related macular degeneration (AMD) is the leading cause of late onset visual impairment and legal blindness in people 65 years of age or older in the United States. It is a heterogeneous clinical entity in which retinal degeneration occurs predominantly in the macula in the context of aging and leads to impairment primarily of central visual acuity. The degenerative retinal eye disease occurs in two forms - a non-exudative "dry" form and an exudative "wet" form which in an individual patient may also represent stages of the disease. Non-exudative AMD accounts for 80-90% of AMD cases and it involves a constellation of clinical features that can include drusen, pigment clumping and/or retinal pigment epithelium (RPE) dropout, and geographic atrophy. Because of the overwhelming numbers of "dry" AMD subjects, the cumulative impact of this vision loss is significant. There is no effective therapy for maintaining or improving vision associated with dry AMD. The only therapy for persons with dry AMD is an oral supplement containing high doses of antioxidants and zinc, which was tested by the National Eye Institute in a large, multi-center, double-masked, sham-controlled clinical trial1. This antioxidant therapy was shown to modestly retard the progression of dry AMD from an intermediate stage to the advanced stages and confirmed the benefit of antioxidant therapy in this disease. There is currently no FDA-approved therapy for the treatment of subjects with dry AMD. Recently, the MIRA-1 modified per protocol population showed the effectiveness of Rheopheresis which is an application of selective therapeutic apheresis, namely double filtration plasmapheresis (DFPP) using a specifically designed filter for plasma filtration in subjects with non-exudative AMD. At one year the study reported with statistical significance (1) approximately a one line vision improvement in the Rheopheresis group versus no change in the Sham group and (2) 28% of subjects randomized to the active treatment gaining at least one line vision versus only 9% of subjects randomized to the sham treatment. With a total of 300 subjects with dry AMD and visual acuity of 20/40-20/100 inclusive, the current investigation plans to prove the effectiveness of the Rheopheresis treatment on a larger scale. Each subject will receive a series of 8 treatments (either active treatment or sham treatment in a 2:1 ratio) for a period of approximately 2.5 months. In addition, a post-treatment ophthalmic evaluation will be performed 2 weeks after the 8th treatment (approximately 3 months after the baseline visit) and at the 6, 9 and 12 month visits. Comparing the one-year proportions of at least a 10-letter gain in ETDRS LogMar BCVA from baseline, the current investigation will show the effectiveness of Rheopheresis treatment (compared to sham treatment) for treating dry AMD subjects. Other secondary effectiveness endpoints, including mean changes and proportions of BCVA better than 20/40 at one year, will be analyzed to support the main investigation.
NCT00354094
The purpose of this study is to assess the long term (up to 2 years) safety and tolerability of \[S,S\]-Reboxetine in patients with pain after shingles.
NCT00134485
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. To evaluate the efficacy and safety of torcetrapib/atorvastatin compared to atorvastatin alone in patients with heterozygous familial hypercholesterolemia
NCT00198094
The primary objective for the study is to test the hypothesis that sertraline plus alprazolam XR will result in superior early stabilization of primary care PD patients versus sertraline/placebo over a 12-week treatment period. The secondary objectives of the study are a) to assess withdrawal symptoms during alprazolam XR taper (weeks 5-7 of the 12-week trial) and after discontinuation, b) to compare physical health outcomes, medical services utilization, and cost-effectiveness of the two study interventions across the 12-week treatment period and subsequent three month maintenance treatment with sertraline alone, and c) to assess whether early co-administration of sertraline/ alprazolam XR will result in greater maintenance of treatment response than sertraline/placebo over the three months following the 12 week acute treatment program.
NCT00231946
The study is designed to investigate the activity of the hormone drug leuprolide acetate in stabilizing cognitive function in mild-to-moderate AD patients.
NCT00185042
The purpose of this study is to learn if CS-505 is safe and effective for slowing down or possibly reversing the buildup of tissue, cells and fatty deposits (plaque) in the blood vessels of the heart (coronary artery atherosclerosis).
NCT00273338
The primary objective of this study is: * To evaluate the effect of DN-101 in combination with docetaxel (ASCENT regimen) on survival in metastatic androgen-independent prostate cancer The secondary objectives of this study are: * To determine the effect of the ASCENT regimen on the rate of thromboembolic events (blood clots) * To determine the effect of the ASCENT regimen on prevention of skeletal-related events (fractures) * A Separate sub-study will be conducted at selected study sites in North America to determine the population PK of DN-101.
NCT00306254
To study the safety and effectiveness of several doses of PD 0348292 compared to enoxaparin in preventing blood clots in the lungs or deep leg veins of patients after knee surgery
NCT00289302
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles through three or four leads (soft insulated wires) that are inserted through the veins to the heart. People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating, may be in need of an electronic device called an implantable cardioverter defibrillator (ICD). An ICD is implanted surgically just under the skin in the upper chest area and it sends a strong electrical impulse, or shock, to the heart to return it to a normal rhythm. If the heart is beating too slowly or at an abnormal rhythm, an ICD can also pace the heart to return the heart to its normal rhythm. The InSync ICD device can change the timing of when the left and right ventricles of the heart are paced to beat. The purpose of this study is to monitor the long-term performance of the InSync ICD Model 7272 and the InSync Marquis 7277 systems for cardiac resynchronization therapy (CRT).
NCT00128531
The purpose of this study is to look at the efficacy and safety of leuprolide acetate in patients with prostate cancer.
NCT00236132
The main goal of the pectus multicenter outcomes study is to document the utility of PEx repair in improving health and quality of life and to test the prevailing belief that the two predominant surgical procedures currently in use for PEx repair are essentially equivalent in terms of long-term outcomes. We believe the uncertainty about the impact of PEx on cardiopulmonary function is due to part to the fact that the previous studies have not measured the physiological parameters mostly likely affected by the defect. A protocol to test this was developed. Thus, we propose to use these measures as well as conventional output of progressive exercise test to examine cardiopulmonary function before and after surgical repair of PEx within the context of the original study.
NCT00120172
Currently there is no one standard of care for older patients with metastatic colorectal cancer. The study will examine the tumor response to capecitabine, oxaliplatin, plus bevacizumab. The study will also gather information on the usefulness and side effects of this treatment combination.
NCT00190866
To assess the efficacy of Duloxetine compared with placebo in the treatment of pain in patients with Fibromyalgia syndrome, with or without major depressive disorder.
NCT00054678
The MyoCell™ implantation using the MyoCath™ delivery catheter system may have the potential to add a new dimension to the management of post-infarct deterioration of cardiac function in subjects with congestive heart failure. Based on pre-clinical studies, implantation of autologous skeletal myoblasts may lead to replacement of non-functioning myocardial scar with functioning muscle and improvement in myocardial performance. Preliminary data in human subjects suggest skeletal myoblast implantation at the time of CABG may lead to the same effects. In principal, myoblast implantation by catheter delivery may offer the same therapeutic benefit. The present clinical study is to be conducted primarily to evaluate the safety of MyoCell™ implantation using the MyoCath™ delivery system and secondarily to evaluate the effect on regional myocardial function post treatment.
NCT00090012
The purposes of this study are to determine: * The effectiveness of olanzapine as compared to quetiapine in treating and preventing the recurrence of a variety of symptoms of schizophrenia and schizoaffective disorder in patients who are obese or overweight. * The safety of olanzapine as compared to quetiapine.
NCT00041626
There is a need for more treatment options for patients with recurrent squamous cell cancer of the head and neck (SCCHN). These tumors usually have a variety of genetic defects that include disruption of the p53 pathway, a pathway that would ordinarily work to prevent the development of tumors. In this study the transfer of the p53 gene to tumor cells using a modified adenovirus (INGN 201) in combination with chemotherapy (cisplatin and fluorouracil) will be compared to chemotherapy with cisplatin and fluorouracil in patients who have failed surgery and radiotherapy.
NCT00049764
The purposes of this study are to determine: 1. Whether drotrecogin alfa (activated) helps children with severe sepsis survive their condition more often or recover faster than children who do not receive drotrecogin alfa (activated). 2. Whether drotrecogin alfa (activated) minimizes long term disabilities associated with severe sepsis. 3. The side effects that might be associated with drotrecogin alfa (activated) administration to children with severe sepsis.
NCT00002168
The purpose of this study is to compare the safety and effectiveness of two anti-HIV drug combinations when given to HIV-infected patients who have never been treated with anti-HIV drugs. One drug combination is stavudine (d4T) plus didanosine (ddI) plus Crixivan. The other combination is Retrovir (AZT) plus Epivir (3TC) plus Crixivan.
NCT00098046
Varicella zoster virus causes chickenpox in children and shingles in adults. Chickenpox is usually a self-limiting illness characterized by fever and a rash. Serious complications can include secondary bacterial infections, pneumonia, and encephalitis. Anti-viral treatment is not a standard of care in immunocompetent children, but is recommended whenever a risk of complication exists. This study will evaluate the safety and blood levels of a new formulation of famciclovir in children 1-12 years of age.
