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Discover 11,146 clinical trials near San Diego, California. Find research studies in your area.
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NCT01007435
This randomized, double-blind, parallel group study will assess the safety, disease remission, and prevention of structural joint damage in patients with early moderate to severe rheumatoid arthritis treated with tocilizumab as monotherapy or in combination with methotrexate, versus methotrexate alone. Patients will be randomized to receive either (A) tocilizumab (8 mg/kg iv every 4 weeks) plus placebo, (B) tocilizumab (8 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), (C) tocilizumab (4 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), or (D) placebo plus methotrexate (7.5-20 mg po weekly). Patients in groups C and D who have not achieved low disease activity at week 52 can receive tocilizumab 8 mg/kg iv every 4 weeks. Anticipated time on study treatment is 104 weeks.
NCT03227874
Metabolic syndrome is a combination of metabolic comorbidities associated with obesity, which include impaired glucose tolerance and regulation, hypertension, dyslipidemia, and increased cardiovascular disease risk. Metabolic syndrome is highly prevalent with the growing trend of obesity that characterizes the US, with 34% of adults 20 years of age and older meeting the criteria. The number of people with diabetes is expected to increase dramatically over the next decades, coinciding with rising obesity rates in many countries. Recent studies have highlighted the beneficial effects of apple and apple products in reducing the risk of chronic disease due to their rich content of fiber, nutrients and various phytochemicals. The primary objective of the proposed research is to determine the acute effect of consumption of 240 kcal servings of dried apples versus a lowfat/high fiber muffin on blood glucose, serum insulin, and fullness (satiety). The secondary objective of the proposed research is to determine the acute effect of consumption of dried apple versus a low-fat muffin on various cognitive domains. As with any organ, the brain requires nutrients to build and maintain its structure and function, in order to perform in a harmonious manner and avoid damage from aging. Epidemiological, clinical and basic research studies suggest protective effects of several classes of nutrients against cognitive decline and risk of dementia. Twenty five male and female participants between the ages of 20-45 years with a body mass index (BMI) between 18 and 25 will be recruited to participate in the study at San Diego State University. Each participant will consume both test foods, the dried apple and muffin, on two separate visits to the lab at least a week apart. The participants will come to each lab visit after a 10 hour overnight fast. After arriving at the laboratory, the participant's will complete a cognitive pre-test (Concussion Vital Signs Test Battery) consisting of eight short cognitive tests on a computer. Next After arriving at the lab, blood samples will be collected from warmed hands by finger-prick into large (250 microliter) heparinized Natelson tubes to obtain an ample blood collection for analysis of baseline plasma concentrations of glucose and insulin. The participants will then be given 5 minutes to consume the test food. Subsequent finger-prick blood samples will be collected at 15, 30, 45, 60, 90 and 120 minutes. The participants will also rate their feelings of fullness on a visual scale prior to consumption of the test food and every 15 minutes for two hours after consumption. After the completion of the finger-prick blood samples and satiety questionnaires the participants will complete a cognitive post-test which will be a different version of the cognitive pre-test battery. Concentrations of glucose will be assessed by a handheld glucose monitor as well as an enzymatic kit. Insulin will be assessed by ELISA or radioimmunoassay. Differences in all dependent variables between the trials will be determined using a repeated measures ANOVA and followed post-hoc when appropriate using paired T-tests to take advantage of the higher statistical power provided by paired comparisons. Data will be reported as means +/- SD. Significance will be selected at an alpha level of P \< 0.05. These data may be useful as finding a snack source that produces a lower glycemic response and a greater satiating effect could be valuable in dietary counseling for blood glucose maintenance. For the cognitive portion of this research, these data may be useful because there is considerable room for improvement and for expanding evidence-based knowledge on the link between nutrition and cognition.
NCT00335556
This phase II trial is studying how well combination chemotherapy, radiation therapy, and/or surgery work in treating patients with high-risk kidney tumors. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
NCT00437060
This clinical trial is looking at brain function in young patients receiving methotrexate for acute lymphoblastic leukemia. Learning about the long-term effects of methotrexate on brain function may help doctors plan cancer treatment.
NCT00106938
The study is being conducted to demonstrate the non-inferiority of carotid artery stenting (CAS) using the Emboshield® Embolic Protection System with the Xact® Carotid Stent System to carotid endarterectomy (CEA) for the treatment of asymptomatic extracranial carotid atherosclerotic disease.
NCT00988442
This study tested a system of nursing telephone support to determine if it improves adherence to antiretroviral therapy (ART) in at-risk, treatment-experienced people.
NCT02748902
The purpose of this study is to determine if ingenol mebutate 0.05% gel is safe and effective in treating common warts on the hands.
NCT00883909
ARI103094 is a follow-up study in adult male subjects who have received investigational product (either dutasteride or placebo) in the REDUCE Study (REduction by DUasteride of prostate Cancer Events), ARI40006, A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer. There are 2 parts to this REDUCE Follow-Up Study, Part A and Part B: * REDUCE Follow-Up Study, Part A, is a 2 year observational study which will follow eligible subjects for 2 years after completion of the 4 Contact in the REDUCE study. Eligible subjects for Part A, the 2 Year Observational Study fall into 3 groups as follows: (1) REDUCE subjects who completed treatment with investigational product (dutasteride or placebo) through the REDUCE 4 Year study visit \[Visit 10\], (2) REDUCE subjects who developed prostate cancer, were withdrawn from investigational product and participated in Prostate Cancer follow-up until the REDUCE 4 Year study visit \[Visit 10P\] or (3) REDUCE subjects who were withdrawn from investigational product and participated in observational phone follow up until the REDUCE 4 Year phone call after withdrawing from IP (expected Visit 10). The objective of this observational study for eligible REDUCE subjects is to collect and summarize data on prostate cancer (the incidence of newly diagnosed prostate cancers and changes in prostate cancer diagnosed during the REDUCE study) and serious adverse events (SAEs) for 2 years beyond the prospectively planned 4 year double blind, placebo-controlled study, REDUCE. * REDUCE Follow-Up Study, Part B, is for collection of cancer positive prostate biopsy tissue blocks/slides from subjects who were diagnosed with prostate cancer in the REDUCE study.
NCT00513565
This study will be conducted in healthy volunteers to investigate the effect of single dose GSK561679 on the changes of brain activation, as it compares to an active comparator, lorazepam.
NCT01920633
This is a single visit study in which people with Down syndrome aged 12-30 will attend the clinical center to undergo assessments to evaluate their eligibility for potential enrollment in the future BP27832 Phase II clinical study which will evaluate the efficacy, safety and tolerability of RG1662. Study participants may withdraw from this study at any time and for any reason.
NCT01502514
The intent of this clinical study is to answer the questions: 1. Is the proposed treatment safe 2. Is treatment effective in improving the disease pathology of patients with Heart Disease as assessed by a series of measurements indicating improvement, stability, or degradation of a patient's cardiovascular function and exercise capacity?
NCT00833235
This is a multi-center, prospective, controlled, observational study of the natural history of patients with dry eye disease.
NCT02609841
This study assesses serum potassium and cardiac rhythm trends in subjects with end stage renal disease (ESRD) who are on 3 times weekly maintenance hemodialysis for at least 60 days. Dialysate K (relative potassium concentration in dialysate) must be stable for 2 weeks prior to enrollment.The number of subjects on 3K or higher dialysate will be limited to 60, with the remainder of the subjects on 1K or 2K dialysate.
NCT00931801
The purpose of this Phase IV pilot study is to evaluate the safety, tolerability, and satisfaction of a nucleoside analog reverse-transcriptase inhibitors (NRTI)sparing regimen for participants fully suppressed on an atazanavir/ritonavir based highly active antiretroviral therapy (HAART)regimen plus emtricitabine/tenofovir (Truvada). Several pharmacologic factors support this concept including the favorable drug interaction between atazanavir and raltegravir. Participants will be randomized to either continue on their current regimen or one of two study arms (atazanavir 300mg plus ritonavir 100mg daily plus raltegravir 400mg twice daily or atazanavir 300mg twice daily plus raltegravir 400mg twice daily). Participants will be followed for 48 weeks for safety, tolerability, and satisfaction. After baseline, the participants will have six clinic visits for evaluation and labs.
NCT01858389
This is a Phase 2 study of oral dacomitinib given every 12 hours over days 1-4 of each two-week cycle to patients with Non-small cell lung cancer. The study includes two groups of patients, those whose tumor has a documented T790M mutation, and those without this mutation. All patients will receive repeated cycles of dacomitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met.
NCT02675855
The objective of the study is to compare the efficacy of weekly GrafixPRIME® administration to an Active Comparator in patients with chronic DFUs in a randomized, single-blind study.
NCT00659178
The purpose of this study is to identify a dose of SB-485232 which is safe, tolerable and biologically active when used in combination with pegylated liposomal doxorubicin (Doxil) in patients with epithelial ovarian cancer. This study will use a standard treatment regimen of pegylated liposomal doxorubicin (Doxil) in combination with rising doses of SB-485232. The dose selected from this study will be used in a future studies to evaluate the efficacy of this combination.
NCT02287350
As part of the Pediatric Research Equity Act (PREA) commitment, the objectives of the study are to characterize the pharmacokinetic (PK) profile and to determine the safety and tolerability of diclofenac potassium oral solution in pediatric subjects experiencing mild to moderate acute pain.
NCT01353677
This is a multi-institution, non-randomized, prospective pilot study to evaluate the feasibility of collecting quality of life (QOL) data on a large cohort of pediatric and adult allogeneic Hematopoietic stem cell transplantation (HCT) recipients.
NCT01723423
The MROC Study seeks to evaluate and compare from the patient's point of view the leading options for breast reconstruction after mastectomy. This study will help patients, physicians, payers and policy makers better understand the various surgeries available for breast reconstruction. Although many women choose reconstruction, the number of options as well as their pros and cons can make decision making difficult and stressful. From this research, we hope to learn more about what works best for patients undergoing these operations.
