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NCT00131313
This research study measures the safety and efficacy of the combination of three drugs that are approved, Nipent, Rituxan and Cytoxan in the treatment of Chronic Lymphocytic Leukemia (CLL). These drugs are being given together for investigational purposes as the specific combination of these three drugs has not been approved for treatment of CLL by the FDA.
NCT00088192
To provide Pegaptanib sodium injection to patients with subfoveal choroidal neovascularization (CNV) secondary to AMD, who are unable to participate in any of the Sponsor's other clinical studies with this drug for AMD, until such time as the patient's lesion is considered to have resolved or stabilized in the opinion of the treating ophthalmologist, or product becomes commercially available.
NCT00134225
The investigators hypothesize that non able-bodied participants with reported acute, sub-acute, or chronic symptoms of neck or back pain of a musculoskeletal origin will have magnetic resonance imaging (MRI), X-ray and blood parameters that do not demonstrate a statistical difference between "normal" (able-bodied) volunteers. Muscle pattern recognition (MPR) testing will show statistically different results between these groups. This statistically significant finding in MPR results will enhance a clinician's determination of clinical normality or abnormality. If this hypothesis is demonstrated, the MPR modality will be the first quantitative tool developed for assisting in the diagnosis of the presence or absence of a musculoskeletal dysfunction in a patient population. The availability of such an evaluation tool to a healthcare provider for patients with soft tissue, non-surgical neck or back complaints will substantially improve the accuracy of diagnosis and case management decisions.
NCT00215215
To compare outcomes over 12 months of treatment with antiepileptic drugs (AEDs) alone or vagus nerve stimulation (VNS) therapy plus AEDs in patients who have partial seizures refractory to at least two, but not more than five, AEDs.
NCT00064571
Unilateral vocal fold paralysis (UVFP) is caused by injury to the nerve to the affected vocal fold. The injury to the vocal fold makes the affected person's voice sound "breathy". Voice therapy is usually tried first, and, if unsuccessful, surgical treatment is considered. The standard surgical treatment is called vocal fold medialization and aims to bring the injured cord to the midline. An alternative surgical treatment, vocal fold reinnervation, aims to bring a new nerve supply to the injured vocal fold. The reinnervation operation, which has some potential advantages over the medialization operation also requires several months for final results to be gained. The goal of this multicenter, randomized clinical trial is to see which of the two surgical treatments produces a better outcome. In order to participate in this study patients with UVFP must meet all entry criteria and must be released from voice therapy by a speech-language pathologist. Information collected for the study (pre-surgery, and at 6 and 12 months after surgery) includes voice recordings, movies made of vocal fold function, airflow and pressure measurements of the voicebox, and an outcomes questionnaire.
NCT00045864
The purpose of this study is to determine the safety and effectiveness of combination therapy with Proleukin and Rituxan on patients with intermediate-and high- grade Non-Hodgkin's lymphoma.
NCT00023348
Primary Objectives: 1\) To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetic parameters for isoniazid and rifabutin. Secondary Objectives: 1. To determine risk factors for abnormal pharmacokinetic parameters for isoniazid and rifabutin. 2. To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the occurrence of toxicity attributed to antituberculous therapy. 3. To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the efficacy of TB therapy. 4. To define and correlate phenotypic INH acetylator status with the results of genotypic acetylator data obtained in the parent trial.
NCT00023400
Primary Objective: To define the impact of nelfinavir (given at 1250mg bid as part of a combination antiretroviral regimen) on peak levels and area under the curve for rifabutin and the rifabutin metabolite, 25-O-desacetyl rifabutin when rifabutin is given at 300 mg bi-weekly as part of tuberculosis chemotherapy. Secondary Objectives: To compare the pharmacokinetics of nelfinavir given twice daily at 1250 mg bid with twice-weekly isoniazid and rifabutin to the pharmacokinetics of nelfinavir 1250 mg twice-daily in historical HIV-infected patients not receiving isoniazid and rifabutin. To evaluate the correlation between pharmacokinetic parameters of rifabutin and 25-O-desacetyl rifabutin and the occurrence of toxicity attributed to rifabutin in patients with HIV-related tuberculosis. To define detailed pharmacokinetics of isoniazid given at 15mg/kg or 900 mg in patients with HIV-related tuberculosis. To attempt to derive optimal sampling times for nelfinavir and rifabutin pharmacokinetic studies.
NCT00046072
Sepsis is a serious condition where there is inflammation and damage to body tissue, usually caused by an infection. This infection can lead to decreased function of vital body organs and in some cases may lead to permanent health problems or death. Much of the injury is due to endotoxin, a harmful substance produced by certain types of bacteria. An endotoxin antagonist is designed to block the effects of endotoxin. This study is designed to study the safety and efficacy when treating patients with severe sepsis.
NCT00188838
To examine the impact of cognitive-behavioural therapy on both the episodic and functional outcome of bipolar disorder, in combination with pharmacotherapy. Primary Hypothesis is twofold: 1. Cognitive Behavioural Therapy will reduce the total symptom burden, as measured both by percentage of time spent ill (both syndromic and subsyndromal) and number of episodes, as compared to psychoeducation 2. Cognitive behavioural therapy will reduce social and occupational disability to a greater extent than psychoeducation.
NCT00082472
This study is intended to show whether inhaled chemotherapy can be added to a standard IV chemotherapy regime, to investigate the additional toxicities and to show initial evidence of efficacy of the combination.
NCT00034710
The purpose of this study is to gain initial information on the tolerability of high-dose capsaicin patches in patients with Painful Postherpetic Neuralgia. The study will also collect preliminary information on safety and efficacy.
NCT00100724
The purpose of this study is to assess the safety and immunogenicity of rPA102 vaccine given intramuscularly at 0 and 4 weeks over 2 dose ranges and 4 adjuvant levels.
NCT00230997
TRIAL SUMMARY: This is an open-label, 24-week, investigator initiated study to evaluate the safety and efficacy of galantamine (16 8 to 24 mg/day; flexible dosing) in the treatment of Dementia with Lewy bodies. The primary efficacy variables will be the NPI -12, the COGDRAS tests of attention and visuospatial orientation, and the ADCS-CGIC. The secondary efficacy variables will be the MMSE, ADCS-ADL-Inventory, ADAS-Cog, PSQI, and the use of concomitant rescue antipsychotic medication. PET scanning will be obtained on 10 patients at one site. An interim analysis will also be performed. Safety outcome measures will be adverse event reports, vital signs, physical examinations, ECG, laboratory parameters and the UPDRS (motor subscale).
NCT00017758
The purpose of this study is to find out whether certain anti-HIV drugs (efavirenz \[EFV\] and nelfinavir \[NFV\]) affect the amount of certain fat-lowering drugs (atorvastatin, pravastatin, and simvastatin) in the blood. Protease inhibitors (PIs), a type of anti-HIV drug, are known to cause increased lipids (fats) in the blood of HIV-infected patients. EFV also is known to increase blood fats. HIV-infected patients who take PIs and/or EFV may need to take fat-lowering drugs to correct this problem. So it is important to look at possible drug interactions when these drugs are taken together. This study will see if taking EFV or NFV, a protease inhibitor, affects the blood level of simvastatin, atorvastatin, or pravastatin (all fat-lowering drugs). To obtain results more quickly, the study population will be healthy HIV-negative volunteers.
NCT00078065
This trial is a phase II, randomized study of patients with multiple myeloma. All patients will receive Xcellerated T Cells, with or without prior fludarabine therapy. 15 patients in each study arm will be followed for 6 months.
NCT00087542
The primary objective is to demonstrate that the investigational new drug, ACP-103, is well tolerated by, and will not worsen parkinsonism in, patients with Parkinson's disease and psychosis. The secondary objectives are to determine whether ACP-103 will ameliorate psychosis in patients with Parkinson's disease and whether ACP-103 is safe in Parkinson's disease patients taking multiple anti-parkinsonian medications.
NCT00305630
Randomized controlled clinical trial of periocular corticosteroids as adjunctive therapy to photodynamic therapy (PDT) for patients with neovascular age-related macular degeneration (AMD). Patients undergoing PDT are randomized to either a periocular corticosteroid injection with 40 mg of triamcinolone acetonide or observation just prior to PDT. Patients are followed for 6 months. Primary outcome is leakage from choroidal neovascularization (CNV) at 3 months on fluorescein angiography.
NCT00073502
Multi-center, open-label, non-randomized Phase II study to evaluate the efficacy and safety of OSI-7904L in gastric and GEJ cancers. Those patients who do not derive clinical benefit after two cycles may be switched to a commonly used combination regimen.
NCT00094003
This study is to investigate the safety of NS-9 and to see how well it is tolerated in patients with cancer that has metastasized (spread) to the liver from another primary tumor. NS-9 is a drug developed to go to the liver to cause cell death specifically in tumor cells. This study is also set up to determine the best dose to use.