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Discover 12,796 clinical trials near Florida. Find research studies in your area.
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NCT02042443
This randomized phase II trial studies how well trametinib or combination chemotherapy works in treating patients with refractory or advanced biliary or gallbladder cancer or that cannot be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving trametinib is more effective than combination chemotherapy in treating patients with biliary or gallbladder cancer.
NCT00408408
RATIONALE: 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. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving chemotherapy and bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known which chemotherapy regimen is more effective with or without bevacizumab in treating breast cancer. PURPOSE: This randomized phase III trial is studying six different chemotherapy regimens to compare how well they work with or without bevacizumab in treating women with stage I, stage II, or stage IIIA breast cancer that can be removed by surgery.
NCT00880399
This is a 6-week, randomised, multicenter, double-blind, placebo controlled, fixed dose parallel group study to assess the efficacy and safety of orvepitant (30 and 60 mg/day) versus placebo in subjects with a diagnosis of a Major Depressive Disorder, whose symptoms are considered moderate or severe. Following an initial screening visit, subjects fulfilling the study inclusion and exclusion criteria will enter a pre-treatment screening phase to permit evaluation of the laboratory and ECG assessments and to confirm eligibility for inclusion into the study. This screening phase will be a minimum of 7 days, but no longer than 21 days. At the completion of the screening period, eligible subjects will be randomised at the baseline visit to receive either orvepitant 30mg/day, orvepitant 60mg/day or placebo (equal chance of receiving any of the three possible treatments, i.e., a 1:1:1 ratio) for a six-week double-blind treatment phase. Those subjects randomised to receive placebo will receive study medication identical in appearance to that received by subjects assigned to receive orvepitant 30 or 60mg/day. Efficacy will be assessed via standard depression symptom and severity rating scales or questionaires. The Hamilton Depression Rating Scale (HAM-D) will be used as the primary measure. Secondary efficacy endpoints include the Quick Inventory of Depressive Symptomatology (QIDS-SR) and the Clinical Global Impression- Global Improvement and Severity of Illness Scale (CGI-I and CGI-S, respectively). Safety will be assessed by monitoring for adverse events (side effects) and through periodic laboratory evaluations (blood tests), vital signs assessments (e.g., blood pressure, heart rate, temperature) and heart function measurements (electrocardiograms, or ECGs).
NCT00394030
This study is an open-label study in healthy volunteers and in patients with Type 2 Diabetes Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the bloodstream after a single dose given at different injection sites, and the impact this medication has on various substances in the blood. Assessments include ECGs, vital signs, repeat blood sampling and monitoring of any side effects.
NCT02406235
The overall objective of this study is to assess turnaround time, pre-BRCA test onco-genetic counselling quality and satisfaction with a new onco-genetic BRCA testing model.
NCT01236768
The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.
NCT01395914
The administration of Anamorelin HCl in patients with Non-Small Cell Lung Cancer-Cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.
NCT02203032
The purpose of this study is to evaluate the efficacy and safety of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash) who had inadequate response to ustekinumab.
NCT01316939
A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A in maintaining remission over 52 weeks in adult subjects with Crohn's disease. Efficacy will be assessed by the Crohn's Disease Activity Index (CDAI) score. Eligible subjects will have achieved response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior GSK sponsored induction study. The primary endpoint will be proportion of subjects in remission at both Weeks 28 and 52. Safety will be assessed by recording of adverse events, clinical laboratory parameters including liver function tests, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work Productivity and Activity Impairment - Crohn's Disease (WPAI-CD) and disability.
NCT00981357
Inactivation of the FAAH (Fatty Acid Amide Hydrolase) enzyme has been shown to relieve pain and inflammation in animal studies. PF-04457845 has been shown to inactivate the FAAH enzyme in animals and healthy human volunteers. The purpose of this study is to evaluate whether PF-04457845 can inactivate the FAAH enzyme in patients experiencing pain due to OA and whether this results in these patients experiencing less pain.
NCT00309179
This study proposes to determine the safety of the administration of E7820 plus cetuximab and explore the MTD of the combination in a Phase Ib study. In addition, the efficacy of this combination will be explored in patients with colorectal cancer in the Phase II proof of concept phase of the study.
NCT00530894
The purpose of this study is to determine the safety and effectiveness of the device and delivery systems (transfemoral and transapical) in high risk, symptomatic patients with severe aortic stenosis.
NCT00857545
This randomized phase II trial studies OPT-821 and vaccine therapy to see how well they work compared with OPT-821 alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer that has decreased or disappeared, but the cancer may still be in the body. Biological therapies, such as OPT-821, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines may help the body build an effective immune response to kill tumor cells. It is not yet known whether OPT-821 is more effective with or without vaccine therapy in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer.
NCT00876889
The purpose of the study is to find out if the use of the drug Riluzole is both safe and improves outcome in patients with acute traumatic spinal cord injury (SCI).
NCT01340794
This phase II trial studies how well pazopanib hydrochloride works in treating patients with advanced or progressive malignant pheochromocytoma or paraganglioma. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
NCT00297206
Limited data are available on valaciclovir use in children and valaciclovir is not currently approved for use in pediatrics. The marketed formulation of valaciclovir is not ideal for use in pre-adolescent patients who may have trouble swallowing solid oral dosage forms. An extemporaneous suspension formulation of valaciclovir has been developed to expedite the provision of benefits to children similar to those from administration of valaciclovir solid formulations in adults.
NCT01559272
The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of a paliperidone palmitate 3-month formulation in patients with schizophrenia.
NCT01684423
The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. There will also be a check for bleeding and worsening of blood clots.
NCT02210325
This study will compare a single dose of oral solithromycin to the standard of care (intramuscular ceftriaxone plus oral azithromycin) in the treatment of patients with urogenital gonorrhea. A completed open-label Phase 2 study with single doses of solithromycin resulted in 100% microbiological eradication in male and female patients with uncomplicated urogenital gonorrhea.
NCT02724384
The purpose of this study is to evaluate the safety and preliminary efficacy of using electrical plasma to treat toenail fungus.