Background: Re-revision of the Ethical Guidelines for Clinical Study (EGCS) in Japan is planned in 2013. It is important to ascertain the current situation of physicians' understanding to conduct clinical trials. It seems that the difference in regulatory processes between commercial and non-commercial clinical trials has caused significant confusion for physicians in conducting clinical trials in Japan.
This survey was undertaken in order to improve awareness of the differences between both types of clinical trials. Furthermore, this survey examined whether it was effective to promote about clinical trials under newly introduced regulatory guidelines and to examine the subsequent willingness of physicians to conduct such clinical trials.
Methods: From 24^th March to 24^th April 2009 inclusive, a questionnaire survey was conducted targeting 286 physicians working at Shiga University of Medical Science Hospital. A follow-up survey was conducted among 109 participants at a lecture about clinical trials on 8^th July 2009.
Results: Physicians who had prior knowledge of the regulations, purposes, or support systems for commercial and non-commercial clinical trials responded positively that they were more likely to conduct clinical trials, while physicians who had no prior knowledge of them responded negatively. Both groups reported that their daily working pressures and cumbersome regulatory processes prevented them from conducting clinical trials.
Conclusion: Japanese physicians lack knowledge and information about clinical trials, leading to negative perceptions and reduced willingness to conduct such studies. Thus, the introduction of any strict and complex regulations should be approached carefully when the environment for clinical trials has not yet been established.

Surgical results in eight octogenarians who were operated upon for abdominal aortic aneurysms were compared to those of 42 patients under 80 years of age. Seven of eight octogenarians were operated on an emergency basis, and four of them were ruptured aneurysms. The size of the ruptured aneurysms was over 6cm in all cases of both groups. Postoperative complications occurred more frequently and postoperative mortality were significantly higher in octogenarians than in patients under 80. Early surgical intervention is recommended for elderly cases with large abdominal aortic aneurysms.

A 51-year-old woman, who had undergone mitral valve replacement with the Starr-Edwards ball valve 21 years ago, was hospitalized with cardiac failure. Preoperative cineangiograms showed delay of the ball movement during the early diastolic phase. Re-replacement of the mitral prosthetic valve with a CarboMedics prosthetic valve and tricuspid annuloplasty was successfully performed. The postoperative period after the initial implantation of the Starr-Edwards ball valve is the longest among patients reported in Japan. The cause of prosthetic valve insufficiency may have been granulomatous hyperplasia on the valve seat.

Objective: The purpose of this study was to confirm the effect of feeding Okara fermented by Bacillus coagulans on cecum microflora in rat. Method: Three groups of SD rat of 8 weeks old were used in the experiment. The experimental animals were fed control diet, 2% okara diet, 2% fermented okara diet in each group for two weeks. The experimental diet and water were provided ad libitum. Food intake was measured every day. After 24 hours fast, we performed drawing blood with heparin after the experimental period. After drawing blood, several organs were removed for measuring their weight. In addition, we removed cecum after drawing blood about each three groups and studied their microflora. We also measured about plasma albumin, ALT, AST, ALP, LDH, total cholesterol, triacylglycerol, glucose, and cytokine level. Result: Bifidobacteria of cecum and blood IFN-g levels significantly increased in the fermented okara group. The total cholesterol level in blood significantly decreased. Conclusion: Okara fermented by Bacillus coagulans had an influence on not only intestinal microflora but also the immune system in rat, suggesting that the fermented okara can expect development as functional materials.

BACKGROUND/AIMS: This study aimed to predict sustained viral response (SVR) to low-dose pegylated interferon (PEG-IFN) plus ribavirin of elderly and/or cirrhotic patients with genotype 2 hepatitis C virus (HCV) using viral response within 2 weeks. METHODS: Low-dose PEG-IFN-α-2b plus ribavirin was administered to 50 elderly and/or cirrhotic patients with genotype 2 HCV for 24 weeks. The dynamics of HCV RNA and HCV core antigen levels within 2 weeks were measured. RESULTS: The patients' median age was 66 years. There were 21 male and 29 female patients. The median baseline HCV RNA level was 5.7 log IU/mL. Rapid viral response was achieved in 17 patients (34%), SVR in 28 (56%), and two (4%) discontinued treatment. Univariate analysis of factors contributing to SVR showed significant differences for sex, baseline virus level, and response within 4 weeks. When 40 fmol/L was set as the cutoff value for the core antigen level at 1 week, the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy for predicting SVR were 93%, 75%, 84%, 88%, and 85%, respectively. CONCLUSIONS: Low-dose PEG-IFN plus ribavirin was a safe and cost-effective treatment for elderly and/or cirrhotic patients with genotype 2 HCV, and the viral response within 2 weeks was a useful predictor of SVR.
Aged* ; Female ; Genotype* ; Hepacivirus* ; Hepatitis C* ; Hepatitis* ; Humans ; Interferons* ; Liver Cirrhosis ; Male ; Ribavirin* ; RNA ; Sensitivity and Specificity

BACKGROUND/AIMS: The present study aimed to clarify whether virological response within 2 weeks after therapy initiation can predict a null response to pegylated interferon alpha-2b plus ribavirin therapy in patients with high viral load genotype 1b hepatitis C. METHODS: The participants consisted of 72 patients with high viral load genotype 1b. The dynamics of viral load within 2 weeks were measured. RESULTS: Significant differences between null responders and nonnull responders were noted for interleukin (IL)-28B genotype, amino acid 70 substitution, alpha-fetoprotein, low-density lipoprotein cholesterol, hyaluronic acid, and viral response. The area under the curve (AUC) for the receiver operating characteristic curve of the hepatitis C virus (HCV) RNA level decline at 2 weeks (AUC=0.993) was the highest among the factors predicting the null response. When the cutoff value for the HCV RNA level decline at 2 weeks was set at 0.80 log, the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy in predicting a null response were 82%, 96%, 82%, 96%, and 94%, respectively. In comparison, values for the non-TT and mutant type of amino acid 70 substitution were similar to those for HCV RNA level decline at 2 weeks. CONCLUSIONS: Virological response at 2 weeks or the combination of IL-28B and amino acid 70 substitution are accurate predictors of a null response.
Administration, Oral ; Adult ; Aged ; Antiviral Agents/*administration & dosage ; Area Under Curve ; Drug Therapy, Combination ; Female ; Genotype ; Hepatitis C, Chronic/*drug therapy/genetics ; Humans ; Injections, Subcutaneous ; Interferon-alpha/*administration & dosage ; Male ; Medication Adherence ; Polyethylene Glycols/*administration & dosage ; Prospective Studies ; RNA, Viral/metabolism ; Recombinant Proteins/administration & dosage ; Ribavirin/*administration & dosage ; Treatment Outcome ; Viral Load ; Young Adult