This study evaluated the reliability and validity of the Forgotten Joint Score-12 (FJS-12)-a measure of patients' ability to forget their joints in daily life-in patients who underwent total ankle ...replacement (TAR) or ankle arthrodesis (AA).
Patients who underwent TAR or AA were recruited from seven hospitals. The patients completed the Japanese version of FJS-12 twice, at an interval of two weeks, at a minimum of one year postoperatively. Additionally, they answered the Self-Administered Foot Evaluation Questionnaire and EuroQoL 5-Dimension 5-Level as comparators. The construct validity, internal consistency, test-retest reliability, measurement error, and floor and ceiling effects were evaluated.
A total of 115 patients (median age, 72 years), comprising 50 and 65 patients in the TAR and AA groups respectively, were evaluated. The mean FJS-12 scores were 65 and 58 for the TAR and AA groups, respectively, with no significant difference between groups (P = 0.20). Correlations between the FJS-12 and Self-Administered Foot Evaluation Questionnaire subscale scores were good to moderate. The correlation coefficient ranged from 0.39 to 0.71 and 0.55 to 0.79 in the TAR and AA groups, respectively. The correlation between the FJS-12 and EuroQoL 5-Dimension 5-Level scores was poor in both groups. The internal consistency was adequate, with Cronbach's α greater than 0.9 in both groups. The intraclass correlation coefficients of test-retest reliability was 0.77 and 0.98 in the TAR and AA groups, respectively. The 95% minimal detectable change values were 18.0 and 7.2 points in the TAR and AA groups, respectively. No floor or ceiling effect was observed in either group.
The Japanese version of FJS-12 is a valid and reliable questionnaire for measuring joint awareness in patients with TAR or AA. The FJS-12 can be a useful tool for the postoperative assessment of patients with end-stage ankle arthritis.
•Body weight increases among Asian people living with human immunodeficiency virus following the initiation of antiretroviral therapy (ART).•Long-term weight gain following ART initiation depends on ...drug combination•The combination of dolutegravir plus tenofovir alafenamide (TAF)/emtricitabine is associated with the greatest weight gain.•TAF-containing regimens are associated with the greatest weight gain.
To investigate changes in weight following the initiation of antiretroviral therapy in treatment-naïve Asian people living with human immunodeficiency virus (PLWH).
This retrospective observational study evaluated adult treatment-naïve Asian PLWH who started antiretroviral therapy based on an integrase strand transfer inhibitor, a protease inhibitor or a non-nucleoside reverse transcriptase inhibitor at the AIDS Clinical Centre, Tokyo between January 2005 and February 2019. Patients were followed-up until October 2019. Multi-variate linear mixed-effects models were used to generate marginal predictions of weight over time. Predicted weight was reported at 3-month intervals until censoring or for 5 years after treatment initiation.
Five years after treatment initiation, average weight gain in PLWH who started on dolutegravir-, darunavir- and elvitegravir-based treatment was 5.3 kg, 4.1 kg and 4.6 kg, respectively, while those who started on raltegravir-, lopinavir- and atazanavir-based treatment gained an average of 1.9 kg, 2.1 kg and 2.3 kg, respectively. Average weight gain in PLWH who started treatment with the backbone drugs, tenofovir alafenamide, abacavir and tenofovir disproxil fumarateb was 4.1 kg, 3.0 kg and 3.0 kg, respectively, and those treated with dolutegravir plus tenofovir alafenamide/emtricitabine gained an average of 6.7 kg.
Antiretroviral-therapy-associated weight gain continued to increase for 5 years following treatment initiation. A combination of dolutegravir and tenofovir alafenamide/emtricitabine was associated with the greatest weight gain.
Adult-onset Still's disease (AOSD) is a rare systemic autoinflammatory disease which encompasses patients with heterogenous presentation and a wide range of clinical courses. In this study, we aimed ...to identify potential subgroups of AOSD and reveal risk factors for relapse.
We included a total of 216 AOSD patients who received treatment in nine hospitals between 2000 and 2019. All patients fulfilled the Yamaguchi classification criteria. We retrospectively collected information about baseline characteristics, laboratory tests, treatment, relapse, and death. We performed latent class analysis and time-to-event analysis for relapse using the Cox proportional hazard model.
The median age at disease onset was 51.6 years. The median follow-up period was 36.8 months. At disease onset, 22.3% of the patients had macrophage activation syndrome. The median white blood cell count was 12,600/μL, and the median serum ferritin level was 7230 ng/mL. Systemic corticosteroids were administered in all but three patients (98.6%) and the median initial dosage of prednisolone was 40mg/day. Ninety-six patients (44.4%) were treated with concomitant immunosuppressants, and 22 (10.2%) were treated with biologics. Latent class analysis revealed that AOSD patients were divided into two subgroups: the typical group (Class 1: 71.8%) and the elderly-onset group (Class 2: 28.2%). During the follow-up period, 13 of 216 patients (6.0%) died (12 infections and one senility), and 76 of 216 patients (35.1%) experienced relapses. Overall and relapse-free survival rates at 5 years were 94.9% and 57.3%, respectively, and those rates were not significantly different between Class 1 and 2 (p=0.30 and p=0.19). Time-to-event analysis suggested higher neutrophil count, lower hemoglobin, and age ≥65 years at disease onset as risk factors for death and age ≥65 years at disease onset as a risk factor for relapse.
AOSD patients were divided into two subgroups: the typical group and the elderly-onset group. Although the survival of patients with AOSD was generally good, the patients often experienced relapses. Age ≥65 years at disease onset was the risk factor for relapse.
Background The purpose of this study was to develop an internet-based Guided Self-Help CBT (iGSH-CBT) for Bulimia Nervosa (BN) / Binge Eating Disorder (BED) for Japanese patients and to test its ...feasibility. Methods A single-arm feasibility study. After baseline assessment, patients underwent a 16-week iGSH-CBT program, our Japanese adaption of the European-based Salut BN program. During the treatment period, weekly email support from trained counselors was provided. Evaluations were performed at baseline, after 8 weeks, at the end of the 16-week intervention, and at 2 months after treatment had ended. The primary outcome measure was the change in the weekly frequency of objective binging. Secondary outcomes were the change in the weekly frequency of objective purge episodes, responses on self-report questionnaires of the frequencies of binging and purging, psychopathological characteristics of eating disorders found on BITE, EDE-Q, EDI-2, HADS and EQ-5D, measurements of motivation, and completion of intervention (vs. dropout). Results Participants were 9 female outpatients with BN (n = 5) or BED (n = 4), of whom 8 (88.9%) attended the assessment at the end of the 16-week intervention. Mean age was 28 years (SD = 7.9). Percent change of the weekly frequency of objective binging was -4.40%, and at the end of the 16-week intervention 25% of the participants had achieved symptom abstinence. Conclusions No adverse events were observed during the treatment period and follow-up, and the implementation and operation of the program could be performed without any major problems, confirming the feasibility of iGSH-CBT for BN and BED for Japanese patients. Although no significant change was observed in the weekly frequency of objective binging, the abstinence rate from bulimic behaviors of those who completed the assessments was 25.0% at the end of treatment, and the drop-out rate was 11.1%. iGSH-CBT may be an acceptable and possibly even a preferred method of CBT delivery for Japanese patients with BN or BED, and our Japanese adaptation of Salut BN seems feasible. Trial registration UMIN, UMIN000031962. Registered 1 April 2018 - Retrospectively registered, Keywords: Bulimia nervosa, Binge eating disorder, Cognitive behavioral therapy, Internet-based Guided Self-Help CBT (iGSH-CBT), Online therapy
We conducted a phase Ib study to examine the safety of a combination of carbon-ion RT (CIRT) with durvalumab (MEDI4736; AstraZeneca) in patients with locally advanced cervical cancer. This was an ...open-label, single-arm study with a modified 3 + 3 design. Patients with newly diagnosed histologically proven locally advanced cervical cancer were enrolled. All patients received 74.4 Gy of CIRT in 20 fractions and concurrent weekly cisplatin (chemo-CIRT) at a dose of 40 mg/m
. Durvalumab was administered (1500 mg/body) at weeks two and six. The primary endpoint was the incidence of adverse events (AEs) and serious AEs (SAEs), including dose-limiting toxicity (DLT). All three enrolled patients completed the treatment without interruption. One patient developed hypothyroidism after treatment and was determined to be an SAE. No other SAEs were observed. The patient recovered after levothyroxine sodium hydrate treatment. None of the AEs, including hypothyroidism, were associated with DLT in the present study. All three patients achieved complete responses within the CIRT region concerning treatment efficacy. This phase 1b trial demonstrates the safety of combining chemo-CIRT and durvalumab for locally advanced cervical cancer in the early phase. Further research is required as only three patients were included in this study.
Purpose: Increased use of deep convolutional neural networks (DCNNs) in medical imaging diagnosis requires determinate evaluation of diagnostic performance. We performed the fundamental investigation ...of diagnostic performance of DCNNs using the detection task of brain metastasis.Methods: We retrospectively investigated AlexNet and GoogLeNet using 3117 positive and 37961 negative MRI images with and without metastasis regarding (1) diagnostic biases, (2) the optimal K number of K-fold cross validations (K-CVs), (3) the optimal positive versus negative image ratio, (4) the accuracy improvement curves, (5) the accuracy range prediction by the bootstrap method, and (6) metastatic lesion detection by regions with CNNs (R-CNNs).Results: Respectively, AlexNet and GoogLeNet had (1) 50 ± 4.6% and 50 ± 4.9% of the maximal mean ± 95% confidence intervals (95% CIs) measured with equal-sized negative versus negative image datasets and positive versus positive image datasets, (2) no less than 10 and 4 of K number in K-CVs fell within the respective maximum biases of 4.6% or 4.9%, (3) 74% of the highest accuracy with equal positive versus negative image ratio dataset and 91% of that with four times of negative-to-positive image ratio dataset, (4) the accuracy improvement curves increasing from 69% to 74% and 73% to 88% as positive versus negative pairs of the training images increased from 500 to 2495, (5) at least nine and six out of 10-CV result sets essential to predict the accuracy ranges by the bootstrap method, and (6) 50% and 45% of metastatic lesion detection accuracies by R-CNNs.Conclusions: Our research presented methodological fundamentals to evaluate diagnostic features in the visual recognition of DCNNs. Our series will help to conduct the accuracy investigation of computer diagnosis in medical imaging.
Endometriosis-related pain encompassing dysmenorrhea, dyspareunia, and chronic pelvic pain, reduces the quality of life in premenopausal women. Although treatment options for endometriosis alleviate ...this pain, approximately one-third of women still experience pain even after receiving treatment, indicating the need for novel approaches to pain relief in those women. The Angel Touch device (AT-04) is a portable magnetic fields irradiation device that incorporates a combination of mixed alternative magnetic fields at 2 kHz and 83.3 MHz. A phase III trial confirmed the efficacy and safety of AT-02, a prototype of AT-04, for pain relief in patients with fibromyalgia.
This is a phase III, multicenter, prospective, randomized, sham device-controlled, double-blind, parallel study. The participants will be premenopausal women aged > 18 years who have endometriosis-related pain with at least moderate severity. Considering dropouts, 50 participants have been deemed appropriate. Eligible women will be centrally registered, and the data center will randomly allocate them in a 1:1 ratio to the intervention and control groups. Women in the intervention group will receive electromagnetic wave irradiation generated by AT-04 and those who in the control group will wear a sham device for 16 weeks, and both groups will wear AT-04 for another 4 weeks. The primary outcome measure is the change in the Numeric Rating Scale score at 16 weeks compared with the baseline. Secondary outcome measures are efficacy for pelvic pain including dysmenorrhea and non-menstrual pain, and chronic pelvic pain not related to menstruation, dysmenorrhea, and dyspareunia, and improvement of quality of life during the study period. Safety will be evaluated by device defects and the frequency of adverse events. The study protocol has been approved by the Clinical Study Review Board of Chiba University Hospital, Chiba, Japan, and will be conducted in accordance with the principles of the Declaration of Helsinki and the Japanese Clinical Trials Act and relevant notifications.
This study aims to develop a novel method of managing endometriosis-related pain. The AT-04 is an ultralow-invasive device that can be used without inhibiting ovulation, suggesting potential benefits to women of reproductive-age. Trial registration number Japan Registry of Clinical Trials (jRCTs032230278).
Mitochondrial dysfunction causes maternally inherited deafness and diabetes (MIDD). Herein, we report improved glycemic control in a 47‐year‐old Japanese woman with MIDD using imeglimin without major ...adverse effects. Biochemical tests and metabolome analysis were performed before and after imeglimin administration. Blood glucose level fluctuations were determined. Sulfonylureas, dipeptidyl peptidase‐4 inhibitors (DPP4is), and sodium glucose transporter‐2 inhibitors (SGLT2i) were administered to evaluate the efficacy of their combination with imeglimin. Imeglimin decreased the HbA1c and ammonia levels and increased the time‐in‐range, C‐peptide reactivity, and glucagon level. Elevated citrulline and histamine levels were decreased by imeglimin. The hypoglycemic effect was not enhanced by imeglimin when combined with sulfonylurea or DPP4i, but the blood glucose level was improved when combined with SGLT2i. Imeglimin improved glucose concentration‐dependent insulin secretion and maximized the insulin secretory capacity by improving mitochondrial function and glutamine metabolism and urea circuit abnormalities by promoting glucagon secretion. Imeglimin could improve glycemic control in MIDD.
We studied the effect of imeglimin in a patient with maternally inherited diabetes and deafness (MIDD). Imeglimin potentially improves glucose concentration‐dependent insulin secretion and metabolism in MIDD. Imeglimin shows potential as a new treatment for MIDD.
Abstract
Context
The syndrome of inappropriate antidiuresis (SIAD) with euvolemic hyponatremia may occur in patients with pulmonary tuberculosis (PTB), but little is known about the clinical ...characteristics of SIAD-associated hyponatremia in PTB patients.
Objective
This study aimed to investigate the frequency and risk factors of hyponatremia in PTB patients.
Methods
In this retrospective chart review, we examined the incidence and severity of hyponatremia in PTB patients. Multivariate analysis was conducted to identify risk factors for hyponatremia in PTB patients.
Results
Of the 161 patients who were screened, after excluding patients with hyperglycemia and renal failure, we enrolled and analyzed data from 113 participants. Hyponatremia occurred in 40.7% patients (<135 mEq/L). Univariate analysis revealed that the presence of hyponatremia was associated with old age, female sex, low body mass index, high glycosylated hemoglobin, C-reactive protein (CRP), and N-terminal pro-brain natriuretic peptide. Multivariable analysis indicated that hyponatremia was strongly associated with old age (odds ratio, 1.06; 95% CI, 1.03-1.09 for every 1-year age increase) and CRP values (odds ratio, 1.15; 95% CI, 1.03-1.30 for every 1-mg/dL increase in CRP). For 86 patients with blood cortisol measurements, the cortisol level was significantly high in the hyponatremia group.
Conclusions
Hyponatremia was less frequently associated with hyperglycemia, heart failure, renal failure, and other diseases that cause euvolemic hyponatremia; thus, PTB patients may have euvolemic hyponatremia due to SIAD. Administration of hypertonic saline or fluid restriction should be considered in PTB patients with hyponatremia.
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