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Discover 13,954 clinical trials near San Diego, California. Find research studies in your area.
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NCT00862082
The current understanding of PR104 justifies the evaluation of PR104 with sorafenib in patients with hepatocellular carcinoma. These include: * Hypoxia. Hepatocellular Carcinoma (HCC) is likely to demonstrate a level of hypoxia sufficient to activate PR104 to its active metabolites PR104H and PR104M. In addition, in preclinical models, sorafenib has been demonstrated to increase the degree of hypoxia in tumors following treatment. * Non-overlapping toxicity. PR104 and sorafenib do not share major toxicities. It is anticipated that both drugs can be administered at their full single agent dose when used in combination. * Aldo-keto reductase 1C3 (AKR1C3). HCC has been shown to express high levels of AKR1C3 which should lead to selective activation of PR104 within both hypoxic and oxic HCC cells. * Preclinical data. The use of sorafenib and PR104 alone and in combination in a hepatocellular carcinoma model demonstrates activity of PR104 as a single agent and increased activity when PR104 and sorafenib are used in combination. The current study will provide an estimate of the activity of PR104 in subjects with HCC. This information will prove valuable in defining the future clinical development of PR104, and in determining if PR104 has sufficient activity in HCC to warrant a larger phase III registration study in this indication. Primary objectives * Phase I: Determine the maximum tolerated dose (MTD) of PR104 when used in combination with standard dose sorafenib * Phase II: Estimate the response rate (RR) of PR104/sorafenib \[Note: Phase II was never initiated\] Secondary objectives * Evaluate survival * Evaluate Progression Free Survival (PFS) * Evaluate time to progression (TTP) * Evaluate safety * Evaluate the pharmacokinetics (PK) of sorafenib, PR104 and PR104 metabolites * Collect diagnostic biopsy samples for the determination of aldo-keto reductase 1C3 * Collect plasma samples for assessment of potential biomarkers of tumor hypoxia
NCT00005977
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have non-Hodgkin's lymphoma or acute lymphocytic leukemia.
NCT00043927
This study will gather and compare data about the effectiveness and safety of two different treatments for extensive Small Cell Lung Cancer (SCLC) in patients who have not received previous chemotherapy. One treatment will use an investigational drug in combination with an FDA approved chemotherapy. The other treatment will use a combination of two FDA approved chemotherapy drugs.
NCT01621399
The purpose of this study is to determine if product 55394 is safe and efficacious for the treatment of bacterial vaginosis.
NCT00019422
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Lobradimil may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of carboplatin and lobradimil in treating children with brain tumors that have not responded to previous treatment.
NCT00594425
This multicenter study will be divided into 2 phases. The first phase will be an open label, dose-escalation phase, while the second will be a blinded, randomized, vehicle-controlled, parallel-group, dose-response phase. The second phase will only start if the first phase succeeds in establishing well tolerated dose(s). Patients with moderate to severe acne vulgaris in the face will be included.The results from part 2 has been presented in the result section.
NCT01077960
In Serono Study 24380, the antecedent protocol to Study 25373, patients were randomly assigned in a 3.0-to-1.0 ratio to Groups A and B. All patients in Group A received recombinant human growth hormone (Serostim®) 4 mg daily (the "induction" phase) for the first 12 weeks, and then were re-randomized to receive either placebo or Serostim 2 mg on alternate days (roughly equivalent to 1 mg daily) during Weeks 12-36 (the "maintenance" phase). All patients in Group B initially received placebo from baseline to Week 24, and then received Serostim® 4 mg daily from Weeks 24 to 36 (Grunfeld, 2007). In the follow-up Study 25373, any subject who was enrolled in Serono Study 24380 and was assigned to Group A, who fully completed all study visits without a major protocol violation, was eligible to enroll to receive re-treatment with Serostim at a dose of 4 mg daily for 12 weeks. During study 25373, safety was monitored by recording of adverse events and measurement of urinalysis and laboratory blood tests to assess fasting glucose, fasting insulin, and routine biochemistry and hematology parameters. At Week 12 or at the time of study termination, subjects underwent re-assessment of body composition via anthropometry measurements and dual photon absorptiometry (DXA) scanning. In addition, at study termination, measurements of insulin-like growth factor I (IGF-I), insulin-like growth binding protein 3 (IGFBP-3), fasting lipid profile, and oral glucose tolerance testing were obtained.
NCT00411385
This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa-2b (alb-IFN)in combination with ribavirin compared with peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic hepatitis C, genotype 2/3 who are IFNa treatment naive.
NCT00873158
The purpose of this study is to compare two treatments for adhesive capsulitis.
NCT00583830
The purpose of this study is to evaluate the efficacy (disease response) and safety of mapatumumab in combination with carboplatin and paclitaxel as first line therapy in subjects with advanced non-small cell lung cancer (NSCLC).
NCT00003203
RATIONALE: Drugs used in chemotherapy, such as carboplatin and vincristine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining carboplatin and vincristine with radiation therapy followed by adjuvant chemotherapy may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy followed adjuvant chemotherapy in treating young patients who have newly diagnosed high-risk CNS embryonal tumors.
NCT00002816
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase III trial to compare the effectiveness of combination chemotherapy in treating children who have relapsed acute lymphoblastic leukemia.
NCT00208494
The purpose of this study is to compare the performance of artificial hips with metal heads and metal sockets to artificial hips with ceramic heads articulating with metal socket components. The success of the total hip arthroplasty (THA) will be based upon all of the following clinical and radiographic criteria being met at the two-year evaluation: (1) the patient's clinical results as measured using modified Harris Hip evaluation rating system, and the absence of a complication that requires the surgical removal or replacement of a component; and (2) radiographic findings at study endpoint (i.e., two years follow-up). Clinical and radiographic success at two (2) years postoperative is required for the study hip to be deemed successful.
NCT00109733
The primary objective is to evaluate the efficacy and safety of two different dose regimens of r-hGH (Saizen®) in subjects with childhood-onset growth hormone deficiency (COGHD) during the transition phase from childhood to adulthood.
NCT00732940
The purpose of this study is to test the safety and tolerability of repeated subcutaneous (SC) doses of belimumab in subjects with SLE.
NCT00005609
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have Waldenstrom's macroglobulinemia.
NCT00005992
RATIONALE: Vaccines made from a person's peripheral stem cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
NCT01858415
The TriPollar is intended for non invasive treatment of facial wrinkles and rhytides. This study was designed in order to evaluate the safety and efficacy of the TriPollar.
NCT00227786
RATIONALE: Stop-smoking plans suggested by physicians may help patients quit smoking. Studying how physicians give stop-smoking treatment as family doctors may increase the chance of smokers receiving such treatment. PURPOSE: This randomized clinical trial is studying physicians' practice patterns to see if regular feedback to the physician increases the chance of adult smokers receiving stop-smoking treatment.
NCT00992719
The purpose of this study is to evaluate the safety of a 2009 H1N1 influenza vaccine in pregnant women and to determine how their body reacts to different strengths of the vaccine. Two strengths of the H1N1 influenza vaccine will be tested. Since it is not known if the response to the vaccine in pregnant women is the same or different than in non-pregnant women, the study also includes a group of women who are not pregnant for comparison. Participants include 200 pregnant women and 100 non-pregnant women ages 18-39. Study procedures include physical exams, several blood samples and maintaining a memory aid to document daily temperature and side effects for 8 days following vaccination. Participants will be involved in study related procedures for about 6 months.
