BACKGROUND: Along with the recent greater number of medical devices for the elderly in the market, there has been a parallel increase in the number of clinical trials for these devices. It is uncertain, though, whether the target population has the awareness and understanding of these clinical trials and the possible adverse events of the devices. METHODS: A total of 147 elderly subjects (mean age, 65.8+/-8.3 years; 39 males) responded to the questionnaire. A pilot study during the development of the questionnaire was conducted in 2009 with the actual survey taking place from June to November 2011. The questionnaire included 22 items-10 items on awareness and understanding of the clinical trial; 4 items on the understanding of adverse events; and 8 items on demographical characteristics. RESULTS: Of the responders, 62.5% had participated in at least one clinical trial and had heard about the clinical trials through a doctor, newspaper, or television. And 63.3% of the responders understood that the purpose of the trial was to show efficacy and safety for the medical device. There were significant differences on the awareness of the trial by gender and life level. However, there was no statistically significant difference in adverse events awareness. CONCLUSION: Although elderly subjects participate in clinical trials, it seems they do not receive enough information when involved in clinical trials of medical devices. In the future, before these trials are carried out, medical device companies need to ensure that they provide their elderly subjects with better education and information.
Aged ; Dietary Sucrose ; Health Services Needs and Demand ; Humans ; Hypogonadism ; Mitochondrial Diseases ; Periodicals ; Ophthalmoplegia ; Pilot Projects ; Surveys and Questionnaires ; Television

The authors have studied on the effect of digital pressure on eyeball under the surface anesthesia instead of other reducing agents of intraocular pressure and retrobulbar anesthesia in order to lower the intraocular pressure as a preoperative procedure of cataract extraction in 26 eyeballs of 24 patients and following results were obtained: 1. The authors had intraocular pressure lowered till averaging 10.8 mmHg (average 13.5 ~ 8.0 mmHg) of original pressure by ocular massage. 2. Massage on eyeball was thought to be a satisfactory preoperative procedure to perform cataract extractIon. 3. In operative complications, loss of vitreous and rupture of capsule were noticed 11.5% and 60% respectively. and it was thought to be caused by technical failure in surgeons. In view of this fact we could not find that the loss of vitreous was caused by intraocular pressure below 13.5 mmHg.
Anesthesia ; Cataract Extraction* ; Cataract* ; Humans ; Intraocular Pressure ; Massage* ; Preoperative Care ; Reducing Agents ; Rupture

OBJECTIVE: To investigate the difference of outcome variables and demographic features between traumatic and non-traumatic spinal cord injury (SCI) patients. METHOD: Medical records of 87 spinal cord injured patients were retrospectively reviewed. The patients were divided into traumatic and non-traumatic groups. The etiology, level and completeness of SCI were investigated. The functional evaluation was performed by Frankel's classification, American spinal cord injury association (ASIA) motor and sensory scores, and modified Barthel scores at the time of admission and discharge. Bladder function and emptying method were also investigated. RESULTS: Spinal cord injury of non-traumatic etiology was more likely to result in a incomplete injury and more prevalent in females. At admission, the ASIA motor and sensory scores and modified Barthel index of non-traumatic spinal cord injury patient were higher than those of traumatic patients. At discharge, same results were observed for ASIA motor and sensory scores, but the modified Barthel scores showed no difference between the two groups. The changes of the scores between time of admission and discharge showed no significant difference in the two groups. There was no significant difference of bladder type and bladder emptying method. CONCLUSION: This study suggest that favorable outcome in non-traumatic spinal cord injury patients might be due to better functional status at the time of admission and not due to the degree of recovery.
Asia ; Classification ; Female ; Humans ; Medical Records ; Retrospective Studies ; Spinal Cord Injuries ; Spinal Cord* ; Urinary Bladder

BACKGROUND: Numerous studies of safe, long term preservation for lung transplantation have been performed using ex vivo models or in vivo single lung transplantation models. However, a safe preservation time which is applicable for clinical use is difficult to determine. We prepared LPDG solution for lung preservation study. In this study we examined the efficacy of LPDG(low potassium dextran glucose) solution in 24-hour lung preservation by using a sequential bilateral canine lung allotransplant model. MATERIAL AND METHOD: Seven bilateral lung transplant procedures were performed using weight-matched pairs(24 to 25kg) of adult mongrel dogs. The donor lungs were flushed with LPDG solution and maintained hyperinflated with 100% oxygen at 10C degrees for a planned ischemic time of 24 hours for the lung implanted first. After sequential bilateral lung transplantation, dogs were maintained on ventilators for 3 hours: arterial resistance were determined if the recipients hourly after bilateral reperfusion and compared with pretransplant-recipient values, which were used as controls. After 2hours of reperfusion, the chest X-ray, computed tomogram and lung perfusion scan were performed for assessmint of early graft lung function. Pathological examinations for ultrastructural findings of alveolar structure and endothelial structure of pulmonary artery were performed. RESULT: Five of seven experiments successfully finished the whole assessments after bilateral reperfusion for three hours. Arterial oxygen tension in the recipients was markedly decrased in immediate reperfusion period but gradually recovered after reperfusion for three hours. The pulmonary artery and pulmonary vascular resistance showed singificant elevation(p<0.05 versus control values) but also recovered after reperfusion for three hours(p<0.05 versus immediate period value). The ultrastructural findings of alveolar structure and endothelial structure of pulmonary artery showed reversible mild injury in 24 hours of lung perservation and reperfusion. CONCLUSION: This study suggests that LPDG solution provides excellent preservation in a canine model in which the dog is completely dependent on the function of the transplanted lung.
Adult ; Animals ; Dextrans ; Dogs ; Humans ; Lung Transplantation ; Lung* ; Organ Preservation ; Oxygen ; Perfusion ; Potassium ; Pulmonary Artery ; Reperfusion ; Thorax ; Tissue Donors ; Transplants ; Vascular Resistance ; Ventilators, Mechanical

Vitamin B12 deficiency can cause myelopathy of subacute combined degeneration of lateral and dorsal column in spinal cord. When combined with compressive myelopathy, symptoms and signs of vitamin B12 deficient myelopathy could be masked. We experienced a case of forty-one year old man suffered from gait disturbance and decreased proprioception. Initially surgeons concluded his weakness resulted from myelopathy by C5-6 centrally herniated disk based on MRI and surgical decompression was performed. Gait disturbance slightly improved but decreased proprioception did not improve. Vitamin B12 deficiency was found and high signal intensity lesions were found in dorsal and lateral spinal column with review of pre-op MRI. After administration with vitamin B12 supplements, weakness and sensation of proprioception improved and follow-up MRI showed decreased signal intensity. We concluded the cause of his symptoms was combination of compressive myelopathy and vitamin B12 deficient myelopathy.
Decompression, Surgical ; Follow-Up Studies ; Gait ; Intervertebral Disc Displacement ; Masks ; Proprioception ; Sensation ; Spinal Cord ; Spinal Cord Compression ; Spinal Cord Diseases ; Spine ; Subacute Combined Degeneration ; Vitamin B 12 ; Vitamin B 12 Deficiency ; Vitamins

We describe a case of spontaneous bleeding from a branch of the right internal pudendal artery that resulted in massive scrotal swelling in a patient who had underwent primary percutaneous coronary intervention with the use of abciximab concurrent with conventional anticoagulation and dual antiplatelet therapies for the treatment of acute ST-segment elevation myocardial infarction. This unusual complication was promptly identified by percutaneous peripheral arteriography and successfully treated with gel-foam embolization.
Angiography ; Arteries* ; Hemorrhage* ; Humans ; Myocardial Infarction ; Percutaneous Coronary Intervention*

OBJECTIVE: There is a close relationship between the amount of hematoma and vasospasm in aneurysmal subarachnoid hemorrhage (SAH). Tissue plasminogen activator (t-PA) has been used as a safe agent to remove these hematoma. This study aims to find a benefit effect of the intracisternal t-PA use in the patients with massive SAH. METHODS: There were 25 patients who had been treated with intracisternal t- PA to remove the hematoma in the cases with massive SAH during recent 5 years. We enrolled the control group (N=25) which had same Fisher grade, Hunt-Hess grade, and age compared with t-PA treated group. And the prophylactic and therapeutic treatment modalities for vasospasm were the same in both groups except t-PA use. We compared the incidence of clinical vasospasm and delayed cerebral ischemia (DCI), Glasgow Outcome Scale (GOS) score after 3 months, mortality rate, clearance time of basal cisternal hematoma on CT, and the incidence of hydrocephalus and the number of ventriculo-peritoneal (V-P) shunt operation between two groups. Chi square test and independent t-test (SPSS version 12.0, p<0.05) were used in statistical evaluation. RESULTS: The incidences of clinical vasospasm and DCI had no significant difference between two groups (p=0.765, p=0.157). There were also no significant differences of GOS scores at 3months between two groups (p=0.657). However, the incidences of DCI resulted from clinical vasospasm were 11% (1/9) and 50% (4/8), and so there was 30.8% of risk reduction (95% CI, 0.136~0.695, p=0.015). Mortality rates were 8% (N=2) in t-PA treated group and 16% (N=4) in control group. The causes of death were not related to the vasospasm in t-PA group and were related to the vasospasm in 3 out of 4 in the control group. The mean clearance time of cisternal clot on CT after surgery was 3.24+/-1.56 days in t-PA group and 6.39+/-1.83 days in control group (p<0.001). The incidences of hydrocephalus were not different significantly between two groups (p=0.556) but the rate of V-P shunt operation in t-PA group (25%, 2/8) was lower than that in control group (60%, 6/10) (p=0.138). CONCLUSION: Intracisternal t-PA use in the patients with thick and massive SAH can lower significantly the incidence of the DCI caused by clinical vasospasm, and may decrease the mortality rate associated with clinical vasospasm, and may prevent V-P shunt operation resulted from post-hemorrhagic hydrocephalus. We assumed that t-PA use was effective especially in the patients with thick and massive SAH, and prospective randomized study was necessary.
Aneurysm* ; Brain Ischemia ; Cause of Death ; Glasgow Outcome Scale ; Hematoma ; Humans ; Hydrocephalus ; Incidence ; Mortality ; Risk Reduction Behavior ; Rupture* ; Subarachnoid Hemorrhage* ; Tissue Plasminogen Activator*

Synovial cysts of the lumbar spine are an uncommon cause of back and radicular pain. These cysts most frequently present as back pain, followed by chronic progressive radiculopathy or gradual onset of symptoms secondary to spinal canal compromise. Although less common, they can also present with acute spinal cord or root compression symptoms. We report of a case in which hemorrhaging into a right L2-3 facet synovial cyst caused an acute onset of back pain and radiculopathy, requiring surgical excision.
Back Pain ; Hemorrhage ; Radiculopathy ; Spinal Canal ; Spinal Cord ; Spine ; Synovial Cyst

STUDY DESIGN: The authors retrospectively analysed the recovery of clinical symptoms after surgical treatment of lumbar HIVD. OBJECTIVES: To investigate the incidence of clinical symptoms, the recovery rate and time after surgical treatment and the difference between L4-5 and L5-S1 lesion. SUMMARY OF LITERATURE REVIEW: There are many reports concerning the clinical result of surgical treatment for the HIVD. They usually describe the result as excellent, good, fair and poor. We can't get any information about the recovery rate and recovery time of each clinical symptom from the reports . MATERIALS AND METHODS: Thirty-eight patients were treated by one level open discectomy from march 1991 to december 1995, The clinical symptoms and signs including SLR, motor deficit, sensory deficit, change of DTR and severity of radiating pain were periodically followed up on the predesigned protocol. RESULTS: In preoperative examination, SLR was positive in 82%, motor deficit in 76%, sensory deficit in 74%, DTR change in 50%, and radiating pain in 100%. The recovery rate of SLR was 96.8%, motor deficit ; 93.6%, sensory deficit ,78.6%, DTR change ; 21% and radiating pain ,84.2%. The average recovery time of SLR was 3.4 months, motor deficit ; 1.9 months, sensory deficit ; 5.3 months, DTR change ; 4.1 months and radiating pain ; 3.2 months. Motor and sensory deficit was more frequent in L4-5 lesion but DTR change was usually noted in L5-S1 lesion. The recovery rate and time showed no great difference between the two level. CONCLUSIONS: The recovery rate was higher in SLR, motor deficit and radiating pain rather than sensory deficit and DTR change. The recovery time was fastest in radiating pain but variable nature was noted in sensory deficit. Above results may be helpful to explain the prognosis of the lumbar HIVD.
Diskectomy ; Humans ; Incidence ; Prognosis ; Retrospective Studies

BACKGROUNDS: The aim of this retrospective study was to compare patients treated for complicated peptic ulcers with special reference to the morbidity and the mortality rates and its determining factors according to the type of surgery. METHODS: From Jan. 1988 to May 1996, a total of 168 patients with complicated peptic ulcers underwent surgical treatment. Among them, 39 patients were lost during the follow up period and 10 cases were operated on due to pyloric obstruction, so we analyzed 119 cases according to the type of surgery (definitive or minimal). Definitive surgery means acid-decreasing procedures such as a gastrectomy or a truncal vagotomy with drainage procedure. Minimal surgery means life-saving procedures such as primary closure or bleeding vessel ligation. The type of operation was determined according to the preference of the individual consultant surgeons at our institute. RESULTS: There were 70 definitive and 49 minimal operations (6:4). The mean follow-up period was 20.6 months (range: 11-73 months). The risk factors affecting the morbidity and the mortality were comparable for both groups. In spite of little statistical significance, the results of definitive surgery were superior to those of minimal surgery in morbidity (15.7%:20.4%), mortality (0%:6.1%), recurrence (5.5%:12.2%), and Visick grading scale 1 & 2 (92.8%:81.6%). The determining factor affecting morbidity was the presence of combined disease (p=0.001) only; other factors such as age, anemia, leukocytosis, presence of preoperative shock, transfusion amount, and type of operation did not affect the morbidity rate. CONCLUSION: Considering that there were no differences in postoperative morbidity and mortality between definitive and minimal surgery, it is better to perform definitive surgery on patients who have no serious combined disease.
Anemia ; Consultants ; Drainage ; Follow-Up Studies ; Gastrectomy ; Hemorrhage ; Humans ; Leukocytosis ; Ligation ; Mortality ; Peptic Ulcer* ; Recurrence ; Retrospective Studies ; Risk Factors ; Shock ; Vagotomy, Truncal