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Discover 12,794 clinical trials near Los Angeles, California. Find research studies in your area.
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NCT03077165
Dose-response relationship study of S42909 on leg ulcer healing after oral repeated administration in patients with active venous leg ulcer.
NCT02462967
Study GT 026 is a Phase 2, multicenter, parallel group, North American, randomized, placebo controlled, double blind study. This study will enroll subjects with portal hypertension (HVPG greater than or equal to 6 mm Hg) who also have a liver biopsy with cirrhosis (Ishak stage 5 or 6), presumably due to NASH, excluding subjects with medium and large varices and those with decompensated cirrhosis. Subjects with portal hypertension and cirrhosis will be randomly assigned (1:1:1 ratio) to receive 1 of 3 treatment assignments including placebo, GR MD 02 in a dose of 2 mg/kg lean body mass, or GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 intravenous infusions. The primary endpoint analysis is the baseline adjusted change in HVPG at 1 year (53 55 weeks) in subjects treated with placebo as compared to subjects treated with GR MD 02 (2 mg/kg/week or 8 mg/kg/week). An esophagogastroduodenoscopy (EGD) with evaluation for varices, HVPG, and liver biopsy will be performed before the first infusion and after the final 26th dose of the investigational medicinal product (IMP). Additionally, subjects will undergo a FibroScan (if available) prior to the first infusion, at Infusion Visit 13, and 14 to 28 days following final 26th infusion, an methacetin breath test (MBT), will be performed if available at screening, at Infusion Visit 13, and 14 to 28 days after the final infusion, and blood will be collected for assessment of biomarkers. All subjects are to attend 2 postdose visits: the first will occur 14 to 28 days after the final dose administration and a second will occur 14 days following the first postdose visit. Subjects will be offered enrollment into a subsequent separate study, an open label extension study, if there is adequate tolerability and no safety issues or signs of clinical progression that would recommend discontinuation. Subjects who do not enroll in the open label extension study will be contacted via telephone every 6 months for 2 years and annually thereafter for a total of 4 years.
NCT00033514
RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Combining trastuzumab with erlotinib may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with erlotinib as first-line therapy in treating women who have metastatic breast cancer associated with HER2/neu overexpression.
NCT00572858
For unexplained reasons, young premenopausal women with heart disease have twice the rate of death compared to men of the same age. Animal experiments have shown that stress can reduce ovary function in females monkeys due to reductions in brain hormones. This stress and reduced brain hormone levels lead to low estrogen levels and can cause menstrual cycles to become irregular, leading to reductions in fertility. These monkeys are also more likely to develop heart disease. In order, to better understand this relationship the investigators would like to study estrogen levels in premenopausal women with heart disease. Premenopausal women who have recently undergone a study of their coronary (heart) arteries will have their blood hormone levels measured over one menstrual cycle. The investigators will correlate the blood hormone levels with coronary angiography results and with other markers of heart disease, such as a test that uses noninvasive, painless ultrasound waves to study the thickness of the arteries in the neck (carotid arteries). In addition blood cholesterol levels, blood sugar levels and other blood tests have been shown to correlate with heart disease will be measured. Another aim of the study is to evaluate a potential link between environmental stress and hormone levels. Each patient will be given multiple questionnaires to evaluate stress, anxiety and depression and the investigators will be measuring the stress hormone (cortisol) levels in saliva for additional information. The results of the study will further explore a possible link between low estrogen levels and heart disease in young premenopausal women and help pave the way for larger research studies to define better ways of preventing heart disease in these women.
NCT03189030
This study will evaluate the safety and tolerability of a personalized live, attenuated, double-deleted Listeria monocytogenes (pLADD) treatment in adults with metastatic colorectal cancer.
NCT02866994
This randomized comparative effectiveness trial examines the potential psychosocial and physical health-related benefits of sharing personal websites with other women with breast cancer, as well as with family and friends (PCO PLUS condition) versus sharing with family and friends only (PCO condition) in a sample of women with metastatic breast cancer.
NCT03446781
Subjects will be screened for study eligibility within 14 days prior to enrolling in this study. Subjects with 2 treatment areas (bilateral buttocks) with moderate or severe levels of cellulite as independently assessed by the subject using the Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS) and by the Investigator using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) will be eligible. The eligibility of the buttocks will be confirmed on Day 1. Once the eligibility of the buttocks is confirmed, subjects will be randomly assigned to a treatment group (EN3835 0.84 mg per buttock or placebo) in a 1:1 ratio within an investigational site. Each subject will receive a treatment course which consists of up to 3 treatment visits (sessions), separated by 21 days (ie, Days 1, 22, and 43). Each treatment visit will consist of 12 injections (0.3 mL per injection of EN3835 0.07 mg/injection or placebo; 0.84 mg in 3.6 mL per buttock) in each of the two buttocks for a total volume of 7.2 mL (1.68 mg). Selection of dimples to be treated in the buttocks will be at the discretion of the Investigator. End of study will occur at study day 71.
NCT02809053
This is a Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the statistical equivalence of efficacy, safety and immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in asymptomatic patients with Low Tumor Burden Follicular Lymphoma.
NCT02940886
Evaluate safety and efficacy of iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®) compared with iron sucrose (Venofer®), in subjects diagnosed with IDA.
NCT01248923
This is a Phase 1 study during which patients with relapsed or refractory multiple myeloma (MM) or plasma cell leukemia (PCL) will receive investigational study drug ARRY-520 and bortezomib, with or without dexamethasone, with granulocyte-colony stimulating factor (G-CSF) support. This study has 2 parts. In the first part, patients will receive increasing doses of study drug (2 dosing schedules will be evaluated) in combination with (1) bortezomib with G-CSF support or (2) bortezomib and dexamethasone with G-CSF support, in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Approximately 45 patients from the US will be enrolled in Part 1 (Active, not recruiting). In the second part of this study, patients will receive the best dose(s) and schedule(s) of study drug, in combination with bortezomib ± dexamethasone + G-CSF, determined from the first part of the study and will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 42 patients from the US will be enrolled in Part 2 (Active, not recruiting).
NCT02759016
Intravenous BI 836826 in combination with ibrutinib in relapsed/refractory Chronic Lymphocytic Leukemia (CLL) patients who have been pre-treated with at least one prior line of systemic therapy, and who are eligible for treatment with ibrutinib. Objectives of the trial are to determine the recommended Phase 2 dose of BI 836826, and to document the safety and tolerability of BI 836826 when given in combination with ibrutinib
NCT03342898
The main purpose of this study is to assess the immunogenicity and safety of the concomitant and sequential administration of yellow fever (YF) vaccine and tetravalent dengue vaccine (TDV) in healthy participants aged 18 to 60 years living in country non-endemic for both dengue and YF.
NCT02228564
Collect confirmatory evidence of the safety and effectiveness of the Balloon LIFESTREAM™ Stent Graft for the treatment of stenoses and occlusion in the iliac arteries.
NCT03511235
Medicare is requesting outcome data on patients who received Prolaris testing and were prescribed active surveillance (AS). In order to ensure appropriate patient care, it is important to understand how this added prognostic information influences the selection and durability of AS and corresponding clinical outcomes. To address this knowledge gap, this study will evaluate how frequently men with low disease-specific mortality (DSM) risk based on Prolaris CCR score and who meet NCCN low-risk criteria initially select AS (AS selection). This study also will assess how long Prolaris-tested men who initially select AS remain on this course before proceeding to definitive treatment (AS durability), and whether AS duration impacts biochemical recurrence (BCR) and metastasis risk in these men. This retrospective, observational and multi-site study will combine patient CCR scores with longitudinal clinical data to address these questions.
NCT01753739
This study will examine dose ranging characteristics of bepotastine besilate nasal spray compared to placebo nasal spray in 600 male or female subjects 12 years of age and older with active seasonal allergic rhinitis (SAR) and a demonstrated history of allergic sensitivity to Mountain Cedar pollen for at least 2 years prior to the study.
NCT00577161
BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and reduced delayed cardiotoxicity in animal models compared to reference standards. This cytotoxic agent has structural similarities to mitoxantrone as well as general similarities to anthracyclines (such as the tricyclic central quinoid chromophore7). This phase III study will compare the efficacy and safety of the combination BBR 2778, fludarabine, and rituximab with the combination fludarabine and rituximab in patients with relapsed or refractory indolent non-Hodgkin's lymphoma.
NCT02322333
This is a double-blind, placebo-controlled, randomized, multi-center study. Subjects agreeing to participate in the study and meet the entry criteria assessed at the screening visit, will begin a 28 day baseline period to confirm their diagnosis, as well as establish baseline migraine characteristics. During this baseline period, subjects will continue treating their migraines as usual, simply recording the information in a daily headache diary. Subjects who, after completing the baseline, continue to meet entrance criteria will be eligible to enter into the treatment phase and be randomized according to the Clinvest generated randomization schedule. Approximately 142 subjects (71 subjects per arm) will be randomized and enter the treatment phase receiving MLD10 or placebo in a 1:1 design at 6 United States sites. Diary assessments will collect study medication adherence, pain severity, headache symptoms, acute medication usage, and unusual symptoms. Serum samples will be collected and analyzed for ionized magnesium, electrolytes, and creatinine.
NCT00014222
RATIONALE: 1. . To compare the effects on breast cancer of three different combinations of drugs which are commonly used to treat this disease. 2. . It is not yet known which treatment regimen is most effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy given with or without epoetin alfa in treating women who have undergone surgery for stage I, stage II, or stage III breast cancer.
NCT02253992
The purpose of this study is to determine which doses of Urelumab and Nivolumab are safe and tolerable when they are given together.
NCT04419064
Chest radiography is the gold standard for confirming tracheal intubation. Bedside ultrasound can be a useful alternative. The investigators are conducting a multi-center, observational study from January 2019 to May 2020 (COVID-US Study) to determine the feasibility of tracheal and lung ultrasound in confirming endotracheal tube placement in the critically ill.
