Pilot study to estimate the safety and effectiveness of hydroxyurea and methotrexate recurrent langerhans cell histiocytosis (LCH-HU-pilot)

This study was a non-blinded, multicenter, single-arm study. Recurrent (relapsed) LCH is defined as the appearance of new lesions or the enlargement of preexisting lesions due to LCH. In this study, all patients received hydroxyurea, and if the treatment response was unsatisfactory, methotrexate was added. The duration of treatment was 48 weeks. The primary endpoint was the rate of non-active disease achievement, which was 24 weeks after initiating hydroxyurea administration. No active disease is defined as the resolution of all the signs and symptoms related to LCH

Perioperative dynamics and significance of plasma-free amino acid profiles in colorectal cancer

Abstract Background For early detection of cancer, we have previously developed the AminoIndex Cancer Screening (AICS) system, which quantifies 6 plasma-free amino acids (PFAAs) in blood samples. Herein, we examined the usefulness of the AICS in patients with colorectal cancer (CRC) by comparing the preoperative and postoperative PFAA profiles. Methods Our study cohort consisted of 62 patients who had undergone curative resection for CRC at our cancer center, with no recurrence at the time of the study. Blood samples were collected from fasted patients within 1 week before the resection and at 0.5–6.5 years post-resection. Following plasmapheresis, the PFAA levels were measured via liquid chromatography/mass spectrometry, and the AICS values were computed (the higher the value, the greater the probability of cancer). Risk was calculated from the AICS value and ranked as A, B, or C, with rank C representing the highest risk. All patients in our study were rank B + C. Results The postoperative AICS value was lower than the preoperative value in 57 of the 62 patients; the rank was also lower postoperatively (49 patients, p < 0.001). The decline in both was stage-independent, even occurring in patients with right-sided tumors or poorly differentiated adenocarcinomas. For comparative purposes, the levels of 2 tumor markers (carbohydrate antigen 19–9 and carcinoembryonic antigen) were also examined; these were within the reference ranges in 70–80% of patients preoperatively and in 80–90% postoperatively. Conclusion We suggest that tumor-bearing conditions alter the PFAA profiles, which may be used to predict prognosis and monitor for recurrence in CRC patients after tumor resection. Trial registration This trial has been retrospectively registered at UMIN-CTR R000028005, Oct 06, 2016

Impact of the Clinical Trials Act 2018 on clinical trial activity in Japan from 2018 to 2020: a retrospective database study using new and conventional Japanese registries

Objective To clarify the impact of Japan’s Clinical Trials Act (CTA), which was enacted in April 2018, on subsequent clinical trial activity through an analysis of Japanese registry data.Design Retrospective database study.Setting We extracted information on clinical intervention studies registered between 1 April 2018 and 30 September 2020 in the conventional University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) and the new Japan Registry of Clinical Trials (jRCT). We collected and analysed information on registration dates, intervention types, funding, secondary sponsors and use of designated staff in multidisciplinary roles (research planning support, research administration, data management, statistical analysis, monitoring and auditing). The temporal trends in clinical trial activity after CTA enactment were examined.Results A total of 577 CTA-compliant specified clinical trials (ie, studies funded by pharmaceutical companies or studies evaluating the efficacy and safety of off-label drugs or devices in humans) were registered in the jRCT. During the same period, 5068 clinical trials were registered in the UMIN-CTR. The number of specific clinical trials increased immediately after the implementation of the CTA and stabilised in late 2019, whereas the number of clinical trials registered in the UMIN-CTR generally declined over time. Specified clinical trials that received industry funding and public grants were more likely to use designated staff in multidisciplinary roles.Conclusions The implementation of the CTA has not reduced the number of specified clinical trials, but has reduced the total number of intervention trials. The use of designated staff in multidisciplinary roles is associated with funding, secondary sponsors and multicentre studies. It was inferred that funding was needed to establish research infrastructure systems that support high-quality research

Gait Characteristics of Dynapenia, Sarcopenia, and Presarcopenia in Community-Dwelling Japanese Older Women: A Cross-Sectional Study

Age-related decline in skeletal muscle mass and function are risk factors for reduced walking ability. This study aimed to understand the characteristic gait parameters of presarcopenia (low muscle mass only), dynapenia (low muscle function only), and sarcopenia (low muscle mass and function), which have differing skeletal muscle characteristics. Skeletal muscle mass, grip strength, and gait parameters (walking speed, cadence, step length, step width, gait angle, foot angle, stance time, swing time, and double stance time) were evaluated in 307 older Japanese women. Low muscle function was determined by grip strength and normal walking speed. Participants were assessed and divided into the normal (60.9%, n = 187), presarcopenia (25.7%, n = 79), dynapenia (5.2%, n = 16), and sarcopenia (8.1%, n = 25) groups. When compared to the normal group, the sarcopenia group had significantly slower walking speed and shorter step length (p &lt; 0.05); the dynapenia group had significantly slower walking speed, smaller cadence, shorter step length, wider step width, and longer stance time (p &lt; 0.05); and the presarcopenia group showed no differences. Skeletal muscle function may therefore be more strongly related to reduced walking function in older adults than body composition factors. The decrease in walking function was most pronounced in older women with dynapenia

Relationship between Subjective Grip Strength and Physical Functioning among Community-Dwelling Older Women

This study investigated the relationship between subjective grip strength and physical function in community-dwelling older women. Subjective grip strength was assessed using a questionnaire, and physical function and body composition were compared between groups with strong and weak subjective grip strength. Additionally, the two groups were compared in those with mild cognitive impairment (MCI) and those with normal cognitive function, respectively. The results showed significant differences in grip strength (p p = 0.039), timed up-and-go (TUG) test (p = 0.027), maximal gait speed (p = 0.029), and skeletal muscle mass (p p p p = 0.041), CS-30 (p = 0.002), TUG (p = 0.014), gait speed (p = 0.006), and skeletal muscle mass (p = 0.003). Older adults with low subjective grip strength had lower physical function and skeletal muscle mass. However, no items showed significant differences between groups among older adults with MCI. Thus, subjective grip strength is an indicator of an overall decline in physical function and a reduction in skeletal muscle mass in older adults, and cognitive function should be considered when assessing subjective grip strength in older adults

Factors Influencing the Development of Mild Cognitive Impairment in Community-Dwelling People Aged 75 Years and Older

In Asia, including Japan, dementia incidence peaks in older adults over ≥75 years; it is therefore important to detect mild cognitive impairment (MCI), and prevent its onset in this age group. Our study hypothesized that physical and psychological status would be associated with MCI incidence among community-dwelling people aged 75 years and older. The study population comprised 291 such individuals. Participants with a Mini-Mental State Examination score of 28 or more were considered non-MCI, and those with a score of less than 28 and greater than 24 were considered to have MCI. Several other measures were also evaluated, including information about their current medical visits due to diseases, depressive symptom severity, various physical functions (trunk function, 30 s chair-stand test, one-legged stance test, timed up and go test time, 5 m walking time, grip strength, knee-extension strength, and toe-grip strength), and body composition (body fat and skeletal muscle mass). Participants suspected of having MCI had significantly shorter educational histories, higher rates of medical visits due to hypertension, and poorer balance abilities. The results suggest that these indices can be considered screening indicators for detecting MCI in people aged 75 years and older, which may be useful for planning intervention programs for this population