The “Clinical Trials Act” was enacted in April 2018. We considered the current issues and future correspondence to conduct clinical studies in accordance with the Clinical Trials Act in the future. ...This Questionnaire survey was carried out with 409 doctors and dentist concerning diagnosis and treatment of cancer at Showa University Hospitals, East Hospital, Fujigaoka Hospital, Fujigaoka Rehabilitation Hospital, Northen Yokohama Hospital, Karasuyama Hospital, Dental Hospital, Koto Toyosu Hospital, Toyosu Clinic Preventive Medicine Center, Clinial Research Institute of Clinical Pharmacology and Therapeutics, Institute of Molecular Oncology from March 1 to March 12, 2018. We obtained responses from 214 of the 409 doctors who received the questionnaire （response rate: 52％）. The doctors who replied to the questionnaire were working in diagnosis and treatment departments associated with the treatment of cancer. Also, approximately 60％ of those were research principal investigator or sub investigator. Many doctors cannot understand the meaning of “specified clinical trials” as used in this Act; they expected establishment of a support system by the support department of Showa University. A certified review board is needed to review “specified clinical trials” in this Act; 97％ of Questionnaire respondents had the opinion to establish such a board at Showa University. Furthermore, a certified review board would need evaluations from technical experts to review clinical trials, and 55％ of respondent answered that they would cooperate for the cooperation request. It was shown that doctors at Showa University need information on the procedures of “specified clinical trials”, and there is immediate necessity for the establishment of a support system for doctors and dentists who conduct clinical studies.
HOW TO IMPLEMENT CLINICAL RESEARCH MONITORING TAKENOSHITA, Sachiko; RYU, Kakei; YAMAZAKI, Taigi ...
Journal of The Showa University Society,
2018, Volume:
78, Issue:
6
Journal Article
Peer reviewed
Open access
In clinical studies with the invasive intervention, it is necessary to monitor for quality assurance research according to the guidelines for human research. One of the present problems is that only ...a few researchers can perform monitoring due to the lack of experience. We obtained opportunities to monitor some clinical studies conducted in anesthesiology; we were able to carry out risk-based monitoring in collaboration with the principal investigator. In clinical research, it is not only the science that is significant, but also the ethical and safety viewpoints are very important. Thus, we checked informed consent, data, randomization and serious adverse effects in the monitoring. Further, we recommended the use of a worksheet to avert lack of data. We performed the monitoring immediately after entry of the first subject, at the entry of half of the subjects and after the end of the study of the final subject. Between the monitor and the principal investigator, consistently good communication was established, which led to not only education of the monitor but also it provided know-how for the principal investigator regarding monitoring. We would like to contribute to quality assurance by using monitoring as one support for clinical studies.
Vacuolar myelopathy (VM) is known to be a neurological complication in patients with acquired immunodeficiency syndrome (AIDS). In autopsy-based studies, VM was reported in approximately 20-50% of ...patients with AIDS. It manifests in various says, mainly presenting as a painless spastic paraparesis with a sensory ataxia. We present a rare case of VM after bone marrow transplantation (BMT) in a patient without AIDS. A 50-year-old man developed weakness in the lower legs, leg muscle atrophy, and difficulty in walking 86 days after BMT. The patient died from septic shock on day 309. The autopsy revealed intralamellar vacuolation in the spinal white matter, which was compatible with VM.
The objectives of this study are to analyze the dynamic behavior and to evaluate the maximum response of two-storied traditional wooden buildings against pulse-like ground motions. It was found from ...shaking table test and simulation analyses of two-storied wooden frames that structural properties cause the interactive effects between the first and second story, asymmetric restoring force characteristic, and uplift motion of column base. Based on the experiment, we suggest the simplified evaluation method of maximum deformation which is evaluated from equivalent natural period of building, period and displacement of input pulse wave using response spectrum.
We evaluated the influence of previous treatments on the parametric discrepancies between dose-volume histograms (DVHs) and dose-function histograms (DFHs) generated based on
Tc-GSA SPECT images of ...hepatocellular carcinoma (HCC) patients treated with stereotactic body radiation therapy (SBRT).
Twelve patients underwent SBRT at 30-40 Gy. Registration between planning CT and SPECT/CT images was performed, and DFH parameters were calculated as follows: Fx=(sum of the counts within the liver volume receiving a dose of more than x Gy/sum of the counts within the whole liver volume) ×100. The discrepancy between Fx and Vx (Dx) was also calculated.
The number of previous treatments for lesions other than SBRT-treated lesions (≥2 vs. <2) exhibited a significant influence on the absolute values of D
, D
, and D
(p<0.05).
Previous treatment significantly influences the parametric discrepancy between DFH and DVH.
In a phase I trial at Showa University Clinical Research Center, we found an elevation of serum transaminases in healthy male volunteers hospitalized for 9 days. We report the cases in whom ...controlled energy intake attenuated the elevation of transaminase values which seemed to be caused by excessive energy intake. Both aspartate transaminase （AST） and alanine transaminase （ALT） values at day 8 were significantly elevated compared with those at day 1 in the group who took the 2,500kcal/day diet for the whole period （cohorts 1, 2）. In contrast, serum AST and ALT values were not elevated in cohort 3 （2,200kcal/day diet for the whole period）, cohort 4 （2,500kcal/day diet switched to 2,200kcal/day diet at day 4） and cohort 5 （2,200kcal/day diet switched to 2,300kcal/day diet at day 4）. In conclusion, the elevation of serum transaminase values in hospitalized healthy male volunteers seemed to be induced by unbalanced excessive energy intake. The findings suggested that an adequate energy balance reduced the number of abnormal laboratory data unrelated to investigational drugs.
The patient was a 59-year-old woman on maintenance hemodialysis for unknown chronic renal failure from 2010. She recognized worsening skin itching from the beginning of 2014, and extensive exudative ...erythema appeared on the trunk and limbs and blisters on the palm and inside of the thigh in May. Therefore, she was to be admitted to our hospital at the beginning of June, but just before that, a fistula occluded. Thus, she was treated at another hospital and then transferred to our hospital. She started treatment with oral prednisolone (PSL) with a diagnosis of bullous pemphigoid from a skin biopsy and a high level of anti-BP180 antibodies. At first, she continued hemodialysis using a catheter, but it was removed because of catheter infection. With the improvement of her skin condition, she continued hemodialysis using a fistula from the fifth hemodialysis after being transferred. The patient was discharged at the end of June. There have been few reports of bullous pemphigoid in maintenance hemodialysis patients, so we report this case along with a review of relevant literature.
The dissolution rates of rare earth oxides and two types of rare earth containing functional materials into water, saline solution, and Gamble's fluid were measured in order to evaluate the ...biological effects of rare earth-containing functional materials. The tested materials were yttrium, lanthanum, cerium and neodymium oxides, and neodymium-boron-iron magnet alloy (NdBFe) and lanthanum-mish-metal-nickel-cobalt (LmNiCo) hydrogen-containing alloy. The dissolution rates of the rare earth oxides were very low, resulting in concentrations of rare earth elements in the test solutions of the order of ppb. In the most extreme case, Gamble's fluid dissolved 1,400 times more of the rare earth oxides than pure water. Fairly high concentration of neodymium were found in the dissolving fluids, which means that trace neodymium present as an impurity in each rare earth oxide dissolved preferentially. For yttrium oxide, the ratio of neodymium to yttrium that dissolved in the saline solution was greater than 78,000 to 1, taking into account the amount of each that was originally present in the yttrium oxide.
We report three cases of fusariosis that occurred during the treatment of acute leukemia, during the past 5 years at our institution. Case 1: A 70-year-old male with relapsed and refractory acute ...lymphoblastic leukemia (ALL) developed fever and multiple nodular lesions in both the lungs. Blood culture that was subsequently obtained revealed Fusarium species. Treatment with liposomal-amphotericin B (L-AMB) was ineffective, and the condition of the patient deteriorated rapidly leading to death. Case 2: A 28-year-old male with T-ALL developed echthyma gangrenosum (EG) ulcers on the scrotum during conditioning for transplantation. Antifungal therapy with L-AMB was ineffective, and later, itraconazole and micafungin (MCFG) were introduced. However, the engraftment was not achieved, and the patient died on day 27. Microbiological examination of EG samples collected on day 13 revealed infection by Fusarium species post mortem. Case 3: A 50-year-old male with blast crisis of chronic myeloid leukemia developed EG primarily on the trunk during chemotherapy. The patient died without any response to L-AMB and MCFG. A culture obtained from EG on day 19 yielded Fusarium species, post mortem. The prognosis of fusariosis is extremely poor. However, skin lesions such as EG may assist in the early diagnosis of the disseminated disease.
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