1.First-in-Human Trial of Photodynamic Therapy for Spinal Cord Malignant Astrocytoma: Study Protocol
Toshiki ENDO ; Yoshiharu TAKAHASHI ; Taketo NISHIZAWA ; Tatsuya SASAKI ; Aya SATO ; Shinjiro FUKAMI ; Satoshi MIYATA ; Jiro AKIMOTO
Neurospine 2024;21(4):1276-1282
Our extensive basic research on photodynamic therapy (PDT) application in models of intracranial malignant astrocytoma led to its clinical application for intracranial malignant astrocytoma in Japan. Having considered the safety and effectiveness of this pathology, we initiate a first-in-human clinical study of PDT for spinal cord malignant astrocytoma. This study has an open-label, single-arm design. The initial follow-up period is 12 months, at the end of which we will quantify survival after PDT for spinal cord malignant astrocytoma as primary objective. The secondary objective is to quantify the overall progression-free survival of treated patients and the percentage of patients surviving 6 months after PDT without recurrence. Twenty patients suffering from spinal cord malignant astrocytoma will be recruited. In particular, 10 of those should be newly diagnosed World Health Organization grade 4. After obtaining consent, each patient will receive a single intravenous injection of talaporfin sodium (40 mg/m2) 1 day before tumor resection. One day after completing tumor removal, the residual lesion and/or resection cavity will be irradiated using a 664-nm semiconductor laser with a radiation power density of 150 mW/cm2 and a radiation energy density of 27 J/cm2. The procedure will be performed 22–26 hours after talaporfin sodium administration. This study protocol has been reviewed and approved by the Certified Committee in the Japanese Ministry of Health, Labor, and Welfare University Hospital Medical Information Network Clinical Trials Registry (Japan Registry of Clinical Trials number, jRCT2021220040).
2.First-in-Human Trial of Photodynamic Therapy for Spinal Cord Malignant Astrocytoma: Study Protocol
Toshiki ENDO ; Yoshiharu TAKAHASHI ; Taketo NISHIZAWA ; Tatsuya SASAKI ; Aya SATO ; Shinjiro FUKAMI ; Satoshi MIYATA ; Jiro AKIMOTO
Neurospine 2024;21(4):1276-1282
Our extensive basic research on photodynamic therapy (PDT) application in models of intracranial malignant astrocytoma led to its clinical application for intracranial malignant astrocytoma in Japan. Having considered the safety and effectiveness of this pathology, we initiate a first-in-human clinical study of PDT for spinal cord malignant astrocytoma. This study has an open-label, single-arm design. The initial follow-up period is 12 months, at the end of which we will quantify survival after PDT for spinal cord malignant astrocytoma as primary objective. The secondary objective is to quantify the overall progression-free survival of treated patients and the percentage of patients surviving 6 months after PDT without recurrence. Twenty patients suffering from spinal cord malignant astrocytoma will be recruited. In particular, 10 of those should be newly diagnosed World Health Organization grade 4. After obtaining consent, each patient will receive a single intravenous injection of talaporfin sodium (40 mg/m2) 1 day before tumor resection. One day after completing tumor removal, the residual lesion and/or resection cavity will be irradiated using a 664-nm semiconductor laser with a radiation power density of 150 mW/cm2 and a radiation energy density of 27 J/cm2. The procedure will be performed 22–26 hours after talaporfin sodium administration. This study protocol has been reviewed and approved by the Certified Committee in the Japanese Ministry of Health, Labor, and Welfare University Hospital Medical Information Network Clinical Trials Registry (Japan Registry of Clinical Trials number, jRCT2021220040).
3.First-in-Human Trial of Photodynamic Therapy for Spinal Cord Malignant Astrocytoma: Study Protocol
Toshiki ENDO ; Yoshiharu TAKAHASHI ; Taketo NISHIZAWA ; Tatsuya SASAKI ; Aya SATO ; Shinjiro FUKAMI ; Satoshi MIYATA ; Jiro AKIMOTO
Neurospine 2024;21(4):1276-1282
Our extensive basic research on photodynamic therapy (PDT) application in models of intracranial malignant astrocytoma led to its clinical application for intracranial malignant astrocytoma in Japan. Having considered the safety and effectiveness of this pathology, we initiate a first-in-human clinical study of PDT for spinal cord malignant astrocytoma. This study has an open-label, single-arm design. The initial follow-up period is 12 months, at the end of which we will quantify survival after PDT for spinal cord malignant astrocytoma as primary objective. The secondary objective is to quantify the overall progression-free survival of treated patients and the percentage of patients surviving 6 months after PDT without recurrence. Twenty patients suffering from spinal cord malignant astrocytoma will be recruited. In particular, 10 of those should be newly diagnosed World Health Organization grade 4. After obtaining consent, each patient will receive a single intravenous injection of talaporfin sodium (40 mg/m2) 1 day before tumor resection. One day after completing tumor removal, the residual lesion and/or resection cavity will be irradiated using a 664-nm semiconductor laser with a radiation power density of 150 mW/cm2 and a radiation energy density of 27 J/cm2. The procedure will be performed 22–26 hours after talaporfin sodium administration. This study protocol has been reviewed and approved by the Certified Committee in the Japanese Ministry of Health, Labor, and Welfare University Hospital Medical Information Network Clinical Trials Registry (Japan Registry of Clinical Trials number, jRCT2021220040).
4.First-in-Human Trial of Photodynamic Therapy for Spinal Cord Malignant Astrocytoma: Study Protocol
Toshiki ENDO ; Yoshiharu TAKAHASHI ; Taketo NISHIZAWA ; Tatsuya SASAKI ; Aya SATO ; Shinjiro FUKAMI ; Satoshi MIYATA ; Jiro AKIMOTO
Neurospine 2024;21(4):1276-1282
Our extensive basic research on photodynamic therapy (PDT) application in models of intracranial malignant astrocytoma led to its clinical application for intracranial malignant astrocytoma in Japan. Having considered the safety and effectiveness of this pathology, we initiate a first-in-human clinical study of PDT for spinal cord malignant astrocytoma. This study has an open-label, single-arm design. The initial follow-up period is 12 months, at the end of which we will quantify survival after PDT for spinal cord malignant astrocytoma as primary objective. The secondary objective is to quantify the overall progression-free survival of treated patients and the percentage of patients surviving 6 months after PDT without recurrence. Twenty patients suffering from spinal cord malignant astrocytoma will be recruited. In particular, 10 of those should be newly diagnosed World Health Organization grade 4. After obtaining consent, each patient will receive a single intravenous injection of talaporfin sodium (40 mg/m2) 1 day before tumor resection. One day after completing tumor removal, the residual lesion and/or resection cavity will be irradiated using a 664-nm semiconductor laser with a radiation power density of 150 mW/cm2 and a radiation energy density of 27 J/cm2. The procedure will be performed 22–26 hours after talaporfin sodium administration. This study protocol has been reviewed and approved by the Certified Committee in the Japanese Ministry of Health, Labor, and Welfare University Hospital Medical Information Network Clinical Trials Registry (Japan Registry of Clinical Trials number, jRCT2021220040).
5.First-in-Human Trial of Photodynamic Therapy for Spinal Cord Malignant Astrocytoma: Study Protocol
Toshiki ENDO ; Yoshiharu TAKAHASHI ; Taketo NISHIZAWA ; Tatsuya SASAKI ; Aya SATO ; Shinjiro FUKAMI ; Satoshi MIYATA ; Jiro AKIMOTO
Neurospine 2024;21(4):1276-1282
Our extensive basic research on photodynamic therapy (PDT) application in models of intracranial malignant astrocytoma led to its clinical application for intracranial malignant astrocytoma in Japan. Having considered the safety and effectiveness of this pathology, we initiate a first-in-human clinical study of PDT for spinal cord malignant astrocytoma. This study has an open-label, single-arm design. The initial follow-up period is 12 months, at the end of which we will quantify survival after PDT for spinal cord malignant astrocytoma as primary objective. The secondary objective is to quantify the overall progression-free survival of treated patients and the percentage of patients surviving 6 months after PDT without recurrence. Twenty patients suffering from spinal cord malignant astrocytoma will be recruited. In particular, 10 of those should be newly diagnosed World Health Organization grade 4. After obtaining consent, each patient will receive a single intravenous injection of talaporfin sodium (40 mg/m2) 1 day before tumor resection. One day after completing tumor removal, the residual lesion and/or resection cavity will be irradiated using a 664-nm semiconductor laser with a radiation power density of 150 mW/cm2 and a radiation energy density of 27 J/cm2. The procedure will be performed 22–26 hours after talaporfin sodium administration. This study protocol has been reviewed and approved by the Certified Committee in the Japanese Ministry of Health, Labor, and Welfare University Hospital Medical Information Network Clinical Trials Registry (Japan Registry of Clinical Trials number, jRCT2021220040).
6.Dietary supplement use in elementary school children: a Japanese web-based survey.
Kazue ISHITSUKA ; Satoshi SASAKI ; Hidetoshi MEZAWA ; Mizuho KONISHI ; Maki IGARASHI ; Kiwako YAMAMOTO-HANADA ; Shoji F NAKAYAMA ; Yukihiro OHYA
Environmental Health and Preventive Medicine 2021;26(1):63-63
BACKGROUND:
A variety of dietary supplements are commercially available. However, the efficacy and safety of dietary supplement use in children are not well established. Understanding dietary supplement use is important for developing public health policy regarding dietary supplements. This study aimed to investigate the types of dietary supplements used and characteristics of dietary supplement users among Japanese elementary school children.
METHOD:
We conducted a cross-sectional web-based questionnaire study. Dietary supplement use, socio-demographics, and health-related behaviors were assessed through mother-reported questionnaire. Types of dietary supplements were identified based on ingredient using product barcodes and brand names. Multivariate logistic regression analysis was conducted to investigate the socio-demographics and health-related behaviors associated with supplement use.
RESULTS:
Among 4933 children, 333 (6.8%) were identified as dietary supplement users. The most common supplement was amino acids or protein (1.4%), followed by n-3 fatty acids or fish oil (1.0%), probiotics (1.0%), multivitamins (0.9%), multivitamin-minerals (0.8%), and botanicals (0.8%). Overall, any dietary supplement use was significantly associated with the highest frequency of sports participation (odds ratio [OR], 2.58; 95% confidence interval [CI], 1.65-4.02), highest household income (OR, 1.87; 95% CI, 1.13-3.10), highest maternal educational level (OR, 1.82; 95% CI, 1.31-2.52), and male sex (OR, 1.38; 95% CI, 1.09-1.75). The highest frequency of sports participation was significantly associated with higher odds of use of amino acids or protein (OR, 6.06; 95% CI, 1.78-20.6) and multivitamins (OR, 3.56; 95% CI, 1.11-11.5), compared to the lowest frequency of sports participation.
CONCLUSION
This study showed that Japanese children primarily use non-vitamin, non-mineral supplements. Non-vitamin, non-mineral supplements should thus be included in future studies aimed at monitoring dietary supplement use. We also found that dietary supplement use in children was associated with sports participation. Guidelines for dietary supplement use for children, in particular sport participants, are needed.
7.Relationship between maternal employment status and children's food intake in Japan.
Sachie MORI ; Keiko ASAKURA ; Satoshi SASAKI ; Yuji NISHIWAKI
Environmental Health and Preventive Medicine 2021;26(1):106-106
BACKGROUND:
Although long maternal working hours are reported to have a negative effect on children's dietary habits, few studies have investigated this issue in Japan. Healthy dietary habits in childhood are important because they may reduce the risk of future disease. Here, we examined the relationship between maternal employment status and children's dietary intake in 1693 pairs of Japanese primary school 5th and 6th graders and their mothers.
METHODS:
The survey was conducted using two questionnaires, a brief-type self-administered diet history questionnaire and a lifestyle questionnaire. The analysis also considered mothers' and children's nutrition knowledge, attitudes toward diet, and some aspects of family environment.
RESULTS:
Longer maternal working hours were associated with children's higher intake of white rice (g/1000kcal) (β 11.4, 95%CI [1.0, 21.9]; working ≥8h vs. not working), lower intake of confectioneries (g/1000kcal) (β -4.0 [-7.6, -0.4]), and higher body mass index (BMI) (kg/m
CONCLUSIONS
Longer maternal working hours were significantly associated with higher intake of white rice and lower intake of confectioneries, as well as higher BMI among children. Even when a mother works, however, it may be possible to improve her child's dietary intake by other means such as nutrition education for children or enhancement of food environment.
Adult
;
Child
;
Child Health/standards*
;
Diet/standards*
;
Diet Surveys
;
Employment
;
Female
;
Health Knowledge, Attitudes, Practice
;
Humans
;
Japan
;
Life Style
;
Male
;
Middle Aged
;
Mothers
;
Nutritional Status
;
Surveys and Questionnaires
8.Estimation of daily sodium and potassium excretion from overnight urine of Japanese children and adolescents.
Masayuki OKUDA ; Keiko ASAKURA ; Satoshi SASAKI
Environmental Health and Preventive Medicine 2020;25(1):74-74
BACKGROUND:
Estimates of daily sodium (Na) and potassium (K) excretion were explicitly biased when using equations for adults. We aimed to develop equations to estimate them using overnight urine from Japanese children and adolescents.
METHODS:
The subjects comprised 70 students aged 10.49-15.76 years: validation group, n = 34; and verification group, n = 36. Each subject performed two operations of overnight spot urine (U
RESULTS:
In validation, we formulated Na excretion (mg d
CONCLUSION
We obtained validated equations to estimate daily Na and K excretion with accessible variables such as Na, K, and Cr concentrations of overnight urine, body height and weight, and age for children and adolescents. When using the obtained equations, caution should be paid to small but definite biases and measurement errors.
Adolescent
;
Child
;
Creatinine/urine*
;
Female
;
Humans
;
Japan
;
Male
;
Potassium/urine*
;
Sodium/urine*
9.Treatment of Isolated Type Ic Lesion-Induced Aortic Regurgitation by External Suture Annuloplasty Alone
Minoru MATSUHAMA ; Satoshi ARIMURA ; Kenichi SASAKI ; Takashi KUNIHARA
Japanese Journal of Cardiovascular Surgery 2019;48(4):239-244
A diagnosis of active aortic valve endocarditis was made in a 52-year-old man who presented with fever and edema. Blood cultures were positive for Streptococcus gallolyticus subsp. pasteurianus. The infection was treated successfully using antibiotics and dental care, but a mobile vegetation-like structure on the aortic valve and severe aortic regurgitation, mainly due to aortic annulus dilatation, remained and required surgery. During the surgical procedure, the aortic valve leaflets were seen to be almost normal, and the regurgitation was found to be mainly due to aortic annulus dilation. Regurgitation could be managed with external suture annuloplasty alone, although a second session was necessary to reduce the annular size by one size. The annular size has been stable for over 1 year after surgery without re-operation of the aortic valve. This procedure not only reduces the operation time but also decreases the surgical stress and avoids the need for prosthetic valve replacement.
10.Improvement of the Ischemic Area after Surgical Treatment for Anomalous Origin of the Right Coronary Artery from the Pulmonary Artery
Minoru MATSUHAMA ; Satoshi ARIMURA ; Kenichi SASAKI ; Takashi KUNIHARA
Japanese Journal of Cardiovascular Surgery 2019;48(2):111-114
Anomalous origin of the right coronary artery from the pulmonary artery (ARCAPA) is a rare congenital coronary anomaly. Although asymptomatic in most cases, with the anomaly only being detected incidentally, surgical correction should be considered before onset of severe myocardial ischemia in such cases. Here, we present a 70-year-old man who was referred to our department due to chest pain on effort and was given a diagnosis of ARCAPA concomitant with mild aortic stenosis. As the symptoms and the degree of aortic stenosis deteriorated during follow-up, the patient underwent direct re-implantation of the right coronary artery into the ascending aorta and aortic valve replacement. The patient's postoperative course was uneventful, and the symptoms disappeared. Postoperative myocardial perfusion scintigraphy revealed improvement of the myocardial ischemic area.


Result Analysis
Print
Save
E-mail