|Acromegaly Safety Monitoring Program||An Acromegaly Safety Monitoring Program for Treating Patients with Pasireotide LAR who are in need of Medical Therapy (ACCESS Study)This study will provide acromegalic patients, for whom medical therapy is appropriate, access to paseriotide LAR while regulatory approval is sought.
Potential patients must:
-be age 18 or older
-have confirmed diagnosis of active acromegaly (caused by GH producing pituitary tumor)
-not be controlled by pituitary surgery or not be eligible or refuse surgery
|Controlled Trial of Deep Brain Stimulation (DBS) for Obsessive Compulsive Disorder (OCD)||The goal of this study is to complete the first definitive controlled trial of a neurosurgical procedure for a severe psychiatric illness. The study will compare the effects of three months of double-masked placebo versus active DBS on OCD severity.
Potential participants must:
-be between the ages of 18 and 75
-have OCD diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV)
-have persistence of sever symptoms and impairment for five years or more despite at least three first-line and two second-line treatments.
|DuraSeal Exact Spine Sealant System Post-Approval Study||This multi-center, non-randomized, two-arm, Post Approval Study will further evaluate the rate of postoperative CSF leaks in subjects who undergo a spinal procedure and receive DuraSeal Exact Spine Sealant for treatment of either an intentional or incidental opening of the dura compared to Control patients who receive other products and/or treatments to close the dura.
Subjects must be 18 years of age or older and have had a spinal procedure where a dural opening (whether intentional or incidental) occured and was treated with either:
-DuraSeal Exact Spine Sealant System (DuraSeal Sealant arm ONLY) or
- Any other method of sealing the dura with the exception of DuraSeal Sealant- either spinal or cranial (Control arm ONLY)
|Malignant Brain Tumors||A Multicenter Study of 5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Malignant Tumor in Patients with Newly Diagnosed or Recurrent Malignant Gliomas: A Safety, Histopathology, and Correlative Biomarker Study
This single arm trial is being conducted to establish the safety and efficacy of Gliolan® (5-ALA) in patients undergoing resection of newly diagnosed or recurrent malignant gliomas. The rationale for the study is that Gliolan® (5-ALA), as an adjunct to tumor resection, is safe and will provide surgeons with real-time visualization of malignant tumor.
|Responsive Neurostimulator System (RNS) Long Term Treatment Investigation||This study os designed to assess the ongoing safety and to evaluate the long-term effectiveness of adjunctive RNS therapy in reducing siezures that are refractory to two or more antiepileptic medications.