Over 200 humans have been treated with myoblast transplantation for heart muscle repair since June 2000. Bioheart sponsored percutaneous delivery studies began in May 2001 in Europe. Approximately one third of the patients have exhibited substantial improvement in left ventricular ejection fraction (LVEF) of over 30% and two heart failure class improvements. Over 80% of the patients have exhibited one heart failure class improvement with moderate improvement of LVEF. Clinical trials seem to demonstrate a marked reduction in emergency hospitalizations in myoblast treated patients. Many years of careful studies have lead to randomized controlled studies that are enrolling patients now at numerous centers worldwide. A firm conclusion on the safety and efficacy of myoblast transplantation cannot be determined until these randomized studies are completed. Final results from randomized controlled studies should be available soon. (J Geriatr Cardiol 2006;3:165-7.)

Feeding and dietary regimes ; Respiratory ; morbidity aspects ; Acute ; Malaria

The effects of acupuncture on functional regulation of biological systems have been studied extensively. The most interesting feature of acupuncture is the bidirectional regulatory ability to restore homeostatic values of body systems from either up or down states, which was found by Chinese biomedical researchers several decades ago, and has recently been observed by peers internationally. Acupuncture can produce two physiological response patterns, an immediate short-term response or/and a long-lasting response. The bidirectional regulatory effects of acupuncture are rarely observed under physiological states (normal homeostasis), rather, they are usually observed under pathological states (abnormal homeostasis) with long-lasting response patterns. This suggests that the effects of acupuncture under pathological states are different from the mechanisms under normal physiological states. This is important for understan-ding and developing acupuncture therapy, and also gives insight into understanding the biological control process itself. The present paper reviews the experimental literature and discusses the four conditions that produce bidirectional regulation of acupuncture, i.e. the inherent properties of the target systems, the functional states of the target system, the acupoint characteristics, and the stimulation parameters. Finally, two hypotheses are proposed to explain the mechanisms of bidirectional effects of acupuncture. The possible peripheral mechanism is that acupuncture can stimulate different types of peripheral nerve fibers to produce opposite regulatory effects; and the possible central mechanisms is that acupuncture might activate the adaptive control process of the central nervous system to restore homeostatic balance.

STUDY DESIGN: Lumbar disc degeneration and segmental instability of the lumbar spine are causes of low back pain. Disc degeneration causes specific changes of the intervertebral disc, and could affect anatomic variations of end plate and vetebral body. However, the exact relationship between degenerative changes of the intervertebral disc and segmental motion characteristics is not known. It is known that radial tears of the annulus fibrosus initiate or accompany degenerative process of nucleus pulposus and the motion segment. It is hypothesis of this study that the existence of radial tear in the annulus fibrosis affects 3 dimension motion characteristics of motion segment. For the purpose, the degree of intervertebral disc degeneration is newly classified by existence of radial tear. Then, the resulting biomechanical motions are investigated. OBJECTIVES: To investigate effects of disc degeneration by the classification on kinematic motions of the motion segment from human lumbar spine and to suggest a quantified method to determine spinal instability in vivo. MATERIALS AND METHODS: A total of 60 spinal motion segments from human lumbar spine was used for this study. To measure 3 dimensioal motion of the motion segments, Vicon system(Oxford, England) with 3 cameras reflective markers and VAX station was used. 6 kinds of pure moments(flexion, extension, right and left axial rotation, and right and left lateral bending) were applied to the motion segments using dead weight for each loading step. At the end of test(maximum loading), motion segments were frozen for anatomical study. For making clear the degree of the degeneration of the disc, a new classification based on MRI results was used: Grade 1 is a normal young disc without tear; Grade 2 is a normal aging disc without radial tear; Grade 3 is a degenerative disc with radial tear; and Grade 4 is a severely degenerative disc with radial tear and other degeneration such as showing decreased disc height. RESULTS: The upper lumbar specimens with radial tears has increased flexion motions as compared to the normal group. Also, the right and left axial rotation in radial tear group increased as compared to the normal group. However, there were no statistical differences in other motions. For the lower lumbar specimens, there were no significant differences in measured motions in all directions between the normal and radial tear groups CONCLUSIONS: These results suggests that the segmental motions are affected by radial tear in the intervertebral disc. Thus, the radial tear in the annulus fibrosus of lumbar intervertebral disc could cause the instability of lumbar spine. Further research is required to determine the relationship between other structural changes and biomechanical characteristics, and future studies should include in vivo investigations to correlate these findings to patients'symptoms.
Aging ; Classification ; Fibrosis ; Humans ; Intervertebral Disc ; Intervertebral Disc Degeneration ; Low Back Pain ; Magnetic Resonance Imaging ; Spine

No abstract available.
Blood Donors* ; Female ; Humans ; Pregnancy ; Pregnancy Trimester, Third* ; Pregnancy*

The equivalence margin is the largest difference that is clinically acceptable between the test (or experimental) drug and the active control (or reference) drug. This paper discusses the scientific principles, along with the regulatory issues, that need to be addressed when determining the equivalence margin for the biosimilar product. The concept of assay sensitivity is introduced, and the ways to ensure assay sensitivity in the equivalence trial are emphasized. A hypothetical example is presented to show how an equivalence margin is determined. The regulatory agency should carefully assess if the equivalence margin of the biosimilar product was determined using a scientifically valid and clinically relevant approach, not subject to selection bias. This is important because the consumer risk of erroneously declaring equivalence when in fact it is not must be controlled conservatively low in the approval of any biosimilar products.
Dietary Sucrose ; Selection Bias

Boney metastasis may lead to terrible suffering from debilitating pain. The most likely malignancies that spread to bone are prostate, breast, and lung. Painful osseous metastases are typically associated with multiple episodes of breakthrough pain which may occur with activities of daily living, weight bearing, lifting, coughing, and sneezing. Almost half of these breakthrough pain episodes are rapid in onset and short in duration and 44% of episodes are unpredictable. Treatment strategies include: analgesic approaches with "triple opioid therapy", bisphosphonates, chemotherapeutic agents, hormonal therapy, interventional and surgical approaches, steroids, radiation (external beam radiation, radiopharmaceuticals), ablative techniques (radiofrequency ablation, cryoablation), and intrathecal analgesics.
Activities of Daily Living ; Analgesics ; Breakthrough Pain ; Breast ; Cough ; Diphosphonates ; Lifting ; Lung ; Neoplasm Metastasis ; Prostate ; Sneezing ; Steroids ; Stress, Psychological ; Weight-Bearing

Forty-one Korean immigrants in Washington, D.C. (of the United States) metropolitan area over age 60 were interviewed using the Diagnostic Interview Schedule (Korean version) with additional questions about culture-specific somatic symptoms identified in previous research with Korean populations. The lifetime and current prevalence were 29.27 percent and 14.63 percent, respectively, for major depression; 9.76 percent and 2.44 percent for generalized anxiety disorder; and 9.76 percent and 7.32 percent for somatization disorder. The lifetime and current rates of co-occurrence of major depression and somatization disorder were 25 percent and 33.33 percent. Subjects who met criteria for depression were more likely to experience culture-specific Korean somatic symptoms than subjects who did not meet those criteria.
Aged ; Aged, 80 and over ; Depression/*epidemiology ; District of Columbia/epidemiology ; *Emigration and Immigration ; Female ; Human ; Korea/ethnology ; Male ; Middle Age ; Prevalence ; Psychophysiologic Disorders/*epidemiology

PURPOSE: This study was performed to assess efficiency and stability of astigmatic change by incision size after cataract surgery. METHODS: This work was designed as a retrospective, comparative, nonrandomized interventional study. A total of 121 cases of cataract surgery were reviewed in 98 patients performed by one surgeon at the Oregon Eye Institute in Eugene, OR, USA with 3-year follow-ups. All procedures were performed with the temporal approach of self-sealing incisions. The serial change in surgically induced astigmatisms were examined in all cases of three groups: Group A, cartridge injection of a foldable IOL through a 2.5 mm self-sealing incision; Group B, cartridge injection of a foldable IOL through a 3.0 mm self-sealing incision; Group C, cartridge injection of a foldable IOL through a 3.5 mm self-sealing incision. Keratometric data were obtained preoperatively, and 3 weeks, 3 months, 6 months, 9 months, 12 months, 24 months and 36 months postoperatively. Polar value analysis was performed to calculate the surgically induced astigmatism. RESULTS: The astigmatic change decreased over time in Group B (P<0.05). The other groups tended to remain in induced astigmatism. All groups showed anticlockwise torque at 3 weeks following surgery. Group B showed a decrease in deviation, but the other groups showed increases in their torque value at postoperative 12 months (P<0.05). CONCLUSIONS: The 3.0 mm incision size correlated with the least surgically induced astigmatism.
Retrospective Studies ; Phacoemulsification ; Lens Implantation, Intraocular ; Humans ; Cornea/*surgery ; Cataract Extraction/*adverse effects/*methods ; Astigmatism/*etiology