Clinical implications of the BARI 2D and COURAGE trials: the evolving role of percutaneous coronary intervention.

Clinical Trial

Work that is the report of a pre-planned clinical study of the safety, efficacy, or optimum dosage schedule of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques in humans selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. While most clinical trials concern humans, this publication type may be used for clinical veterinary articles meeting the requisites for humans. Specific headings for specific types and phases of clinical trials are also available.

Early Termination Of Clinical Trials

Earlier than planned termination of clinical trials.

Clinical Trials As Topic

Pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.

Diskectomy, Percutaneous

Percutaneous excision of a herniated or displaced intervertebral disk by posterolateral approach, always remaining outside the spinal canal. Percutaneous nucleotomy was first described by Hijikata in Japan in 1975. In 1985 Onik introduced automated percutaneous nucleotomy which consists in percutaneous aspiration of the nucleus pulposus. It is carried out under local anesthesia, thus reducing the surgical insult and requiring brief hospitalization, often performed on an outpatient basis. It appears to be a well-tolerated alternative to surgical diskectomy and chymopapain nucleolysis.

Controlled Clinical Trials As Topic

Clinical trials involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicines, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trials are characterized as RANDOMIZED CONTROLLED TRIALS AS TOPIC.