Loading clinical trials...
Loading clinical trials...
Discover 12,794 clinical trials near Los Angeles, California. Find research studies in your area.
Showing 6181-6200 of 12,794 trials
NCT03527810
The subject will undergo standard pre-operative preparation. Subjects will be evaluated for the presence of bothersome GERD symptoms by GERD questionnaires and use of Proton-Pump Inhibitor (PPI) medications. Those eligible will be approached at their preoperative appointment about participation in the study and consent will be reviewed with subject. Signed consent will be collected from the subject prior to entry into the operating room. After induction of anesthesia, the subject will be randomized to sleeve gastrectomy with or without interrogation of the hiatus. The SG will be performed as per standard approaches already described. In those randomized to interrogation, the hiatus will be opened posteriorly with preservation of the phreno-esophageal ligament where possible, as per standard described techniques. Dissection into the mediastinum will be stopped if no hernia is seen or when appropriate intra-abdominal length of 2 cm of esophagus is created. Once opened, the Hiatal Surface Area (appendix B)17 will be measured, calculated and recorded and when possible, a photo taken of the area. Repair of the crura will then be performed around the sizing tube used to create the sleeve with enough space to allow a 5 mm instrument to be easily inserted. Permanent sutures will be placed posterior to the esophagus. Subjects will be recovered and be discharged per standard protocol. Evaluation for reflux will be conducted pre-operatively and then 3, 6, 12 and 24 months (+/- 30 days) after surgery or on demand if symptoms occur between follow up periods. Many groups advocate the use of PPI for the first 30 days after bariatric surgery - accordingly assessments of reflux will not occur until 3 months post operatively when most groups stop prophylactic PPI use. A visit within the first 30 days after surgery (+/- 15 days) should occur to evaluate for potential complications of surgery.
NCT02198794
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of SD-809 in reducing the severity of abnormal involuntary movements of moderate to severe tardive dyskinesia. The purpose of part B is to establish the durability of effect of SD-809 following 1-week period of randomized withdrawal (SD-809 and placebo), followed by 12 weeks of maintenance with SD-809.