Collaborative approach in the development of high-performance brain-computer interfaces for a neuroprosthetic arm: translation from animal models to human control.

Our research group recently demonstrated that a person with tetraplegia could use a brain-computer interface (BCI) to control a sophisticated anthropomorphic robotic arm with skill and speed approaching that of an able-bodied person. This multiyear study exemplifies important principles in translating research from foundational theory and animal experiments into a clinical study. We present a roadmap that may serve as an example for other areas of clinical device research as well as an update on study results.

Prospective randomized trial of hepatic artery chemotherapy with cisplatin and doxorubicin, with or without lipiodol in the treatment of advanced stage hepatocellular carcinoma.

Purpose: This randomized study assessed the responses in hepatocellular carcinoma (HCC) to hepatic arterial doxorubicin plus cisplatin, with or without lipiodol.

Patients And Methods: Patients with unresectable and biopsy-proven HCC were treated with doxorubicin (30 mg/m) plus cisplatin (100 mg/m) without (Solution) or with (Lipiodol) emulsification every 2 months till tumor progression. Primary end point was response.

A multidisciplinary approach to honest broker services for tissue banks and clinical data: a pragmatic and practical model.

Background: Honest broker services are essential for tissue- and data-based research. The honest broker provides a firewall between clinical and research activities. Clinical information is stripped of Health Insurance Portability and Accountability Act-denoted personal health identifiers.

Explanations and unresolved issues pertaining to the development of the Nuclear Pharmacy Compounding Guidelines.

Objectives: To provide background information related to the development of the Nuclear Pharmacy Compounding Guidelines, to discuss regulatory complexities related to radiopharmaceutical compounding practice, and to summarize the gaps in the current compounding regulations for radiopharmaceuticals.

Data Sources: The Guidelines closely follow the provisions of section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the monographs and chapters related to pharmacy compounding in the United States Pharmacopeia (USP), and the recommended guidelines published by the American Society of Health-System Pharmacists.

Summary: The Food and Drug Administration Modernization Act (FDAMA) of 1997 established parameters under which the compounding of drug products is appropriate and lawful, but these criteria expressly do not apply to radiopharmaceuticals.

Evaluation of prescribing practices: risk of lactic acidosis with metformin therapy.

Background: The risk of lactic acidosis during metformin therapy is linked to specific and well-documented conditions that constitute contraindications or precautions to use of the agent. We conducted a retrospective evaluation of metformin use to determine whether prescribing practices are in accord with published contraindications and precautions.

Methods: All patients admitted to the hospital during a 6-month period who received at least 1 dose of metformin were identified through hospital pharmacy records.