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Filter by:This exploratory study will compare the efficacy of the fixed-dose combination (FDC) of aclidinium bromide and formoterol fumarate once daily in the morning and placebo once in the evening vs. the FDC once daily in the morning and formoterol fumarate once in the evening vs. formoterol fumarate twice daily. The study will assess pulmonary function and symptoms in patients with moderate to severe COPD.
RATIONALE: Gene-modified lymphocytes may stimulate the immune system in different ways and stop tumor cells from growing. High-dose aldesleukin may stimulate lymphocytes to kill tumor cells. Vaccines made from a gene modified virus and a person's dendritic cells may help the body build an effective immune response to kill tumor cells. Giving gene-modified lymphocytes together with high-dose aldesleukin and vaccine therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gene-modified lymphocytes together with high-dose aldesleukin and vaccine therapy works in treating patients with progressive or recurrent metastatic cancer.
The purpose of this study is to: - assess the effectiveness of lenalidomide for the treatment of patients with relapsed and or refractory peripheral T-cell lymphomas; and, - assess the safety of lenalidomide. There are reports suggesting a therapeutic benefit of thalidomide in patients with refractory and/or relapsed Non-Hodgkin's Lymphoma's (NHL) which have led to the formal investigation of lenalidomide in the treatment of relapsed NHL's.
This is a clinical trial in patients with Metabolic Syndrome and Dyslipidemia to study the effects of MK0767 on triglycerides.
An exploratory, open-labeled study of participants with Pompe disease, who had previously received Myozyme® (alglucosidase alfa) treatment, to evaluate the efficacy, safety and clinical benefit of 2 Immune Tolerance Induction (ITI) regimens in combination with Myozyme®. Eligible participants who were then receiving Myozyme® therapy were enrolled into the study, and were followed for a minimum of 18 months on-study (a 6-month ITI treatment module and a 12-month follow-up module on Myozyme® alone). Eligible participants were followed for a minimum of 18 months on treatment or, if a participant was <6 months of age at the time of enrollment, until the participant was 2 years of age. Both cross-reacting immunologic material (CRIM)-negative and CRIM-positive participants were eligible for Regimen A depending if they met the required criteria. Regimen B, however, was limited to CRIM-negative participants.
This phase I trial is studying the side effects of decitabine when given together with or without interferon alfa-2b, and the best dose of interferon alfa-2b, in treating patients with unresectable or metastatic solid tumors. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as interferon alfa-2b, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether decitabine is more effective when given with or without interferon alfa-2b in treating solid tumors.
The purpose of the study is to evaluate the performance of the Discover cervical Artificial disc in the treatment of degenerative disc disease in one level of the cervical spine.
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the M2a- Taper™ Hip System
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the M2a- 38™ Hip System
Adhesion formation is a result of abdominal and pelvic surgery and is a cause of such diseases as chronic pain syndrome, bowel obstruction and infertility. Both patients and surgeons suffer when adhesions are encountered, since the surgery becomes more intense, lengthy, and complicated. Seprafilm® has been shown to limit the formation of adhesions in gynecologic and abdominal surgery. Limited data is available on the effectiveness of Seprafilm® in the prevention of abdominal wall and pelvic adhesions at the time of cesarean section. Adhesions at the time of repeat cesarean make the surgery frustrating and complex, with difficult lysis of adhesions being the cause of morbidities such as bladder damage, increased blood loss, and longer operating times. The objective of this definitive project is to define the extent of reduction of adhesion formation of Seprafilm® when used at the time of primary cesarean section. Women undergoing primary cesarean section will be randomized for Seprafilm® application, and the incidence and grade of adhesions at repeat cesarean will be determined.