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Neonatal haemochromatosis, considered to be a gestational alloimmune liver disease (NH-GALD), is a rare but serious disease that results in fulminant hepatic failure. The recurrence rate of NH-GALD in a subsequent infant of a mother with an affected infant is 70%–90%. Recently, antenatal maternal high-dose intravenous immunoglobulin (IVIG) therapy has been reported as being effective for preventing recurrence of NH-GALD in a subsequent infant. However, no clinical trial has been conducted to date.
This is a multicentre open-label, single-arm study of antenatal maternal high-dose IVIG therapy in pregnant women with a history of documented NH in a previous offspring. The objective of this study is to evaluate the efficacy and safety of antenatal maternal high-dose IVIG therapy in preventing or reducing the severity of alloimmune injury to the fetal liver.
The clinical trial is being performed in accordance with the Declaration of Helsinki. The trial protocol was approved by the Clinical Research Review Board at four hospitals. Before enrolment, written informed consent would be obtained from eligible pregnant women. The results are expected to be published in a scientific journal.
28 October 2024, V.8.0.
jRCT1091220353.
To examine the relationship between weight loss and problems with oral intake in institutionalised older adults.
A 1-year longitudinal observational study.
Data were obtained from a prospective study conducted in three nursing homes and two long-term care facilities in Japan. Participants' problems with oral intake were assessed using items published in 2021 by the Japanese Ministry of Health, Labour and Welfare. Baseline and follow-up factors were compared between individuals who experienced a weight loss of 5% or more and those who did not. Separate multivariable logistic regression models were constructed for each oral intake assessment item to examine its independent association with weight loss of 5% or more, accounting for transitions in each item between baseline and the 1-year follow-up.
In total, 172 institutionalised older adults were included in the analysis. Among them, 57 (33.1%) participants experienced a weight decrease of 5% or more. The emergence of somnolence or clouding of consciousness during meals at the 1-year follow-up in participants without these signs at baseline was independently associated with a weight loss of 5% or more, after adjustment for baseline characteristics.
Recognising signs of somnolence or clouding of consciousness during meals may be useful for the early detection and prevention of weight loss in institutionalised older adults.
Early detection of individuals at risk is essential to prevent significant weight loss and its associated adverse outcomes. Recognising somnolence or clouding of consciousness during meals may enable earlier detection and intervention to prevent weight loss and improve the quality of care for older adults.
Strengthening the Reporting of Observational Studies in Epidemiology.
No patient or public contribution.
Atopic dermatitis (AD) is a chronic inflammatory skin condition that impairs the quality of life of affected paediatric patients and their families. Dupilumab, an antagonist of the shared alpha chain subunit of the cytokines interleukin-4 and interleukin-13, has revolutionised the management of moderate-to-severe AD by effectively targeting type 2 inflammation. However, live attenuated vaccines, including live attenuated influenza vaccines (LAIVs), are contraindicated during dupilumab therapy owing to limited safety data. This restriction poses challenges to immunisation strategies, particularly in paediatric populations. This study aims to evaluate the safety and efficacy of LAIV in paediatric patients with AD undergoing dupilumab therapy.
This multicentre, prospective, single-arm, open-label trial will enrol 50 paediatric patients aged 2–18 years with AD undergoing dupilumab treatment. The participants will receive intranasal LAIV, followed by a 25-week observation period after vaccination. The primary outcome is the proportion of participants with a four-fold or greater increase in haemagglutination inhibition titres against influenza strains A(H1N1), A(H3N2) and B at 4 weeks post vaccination. The secondary outcomes include the incidence of influenza and systemic or local adverse events, such as injection site reactions, fever and other influenza-like symptoms observed within 4 weeks of vaccination. Exploratory endpoints include the evaluation of immunosuppressive markers such as neutrophil counts, lymphocyte subsets and serum immunoglobulin G levels. Safety analyses will assess the frequency of each adverse event, whereas efficacy analyses will focus on immunogenicity and influenza incidence during the 25-week follow-up period. This study aims to provide critical safety and immunogenicity data to guide immunisation strategies in biologically treated paediatric patients with AD.
This study complies with the principles of the Declaration of Helsinki and received ethics approval from the Institutional Review Board of Chiba University Hospital as a specified clinical trial. Informed consent and assent will be obtained as appropriate based on the participants’ ages. These findings will be disseminated through peer-reviewed journals and scientific conferences to inform clinical vaccination strategies for biologically treated populations.
jRCTs031240442.
In October 2011, the Fukushima prefectural government started a thyroid ultrasound examination (TUE) as part of the Fukushima Health Management Survey following the Fukushima Daiichi Nuclear Power Plant accident. The proportion of examinees is an important factor when interpreting the results.
To construct models that assess the relationship between the proportion of non-examinees and the characteristics of eligible participants in the first-round to third-round TUEs. Using these models, estimate the number of thyroid cancer cases in the entire population for each survey, considering non-examinees.
Model-based estimation using cohort survey data.
Fukushima Health Management Survey from 2011 to 2017.
Children and adolescents aged 18 years or younger (363 342 individuals) who were identified through resident registration records, resided in Fukushima Prefecture at the time of the accident, and were eligible for each TUE.
Modelling the relationship between non-examinee status and individual characteristics, and estimating the number of cases in the entire population for each survey round.
The area under the receiver operating characteristic curve of the constructed models ranged from 0.815 to 0.905. In the first-round, second-round and third-round TUEs, 115, 70 and 30 cases were observed among 294 921, 258 771 and 208 955 examinees, respectively, whereas the estimated number of cases in the entire population including the non-examinees was 177.3 (95% CI 167.0 to 188.0), 126.3 (95% CI 106.3 to 150.2) and 49.7 (95% CI 35.8 to 71.9), respectively.
These estimates were higher than the actual number of observed cases because they considered non-examinees. Our model for non-examination showed a high discriminant accuracy and was considered to capture well the factors that resulted in non-examinees. This study’s findings provide valuable information for studies considering the number of potential thyroid cancer cases among non-examinees and may facilitate appropriate interpretation of reports and prospective survey outcome management.
by Daisuke Noguchi, Naohisa Kuriyama, Yuji Kozuka, Haruna Komatubara, Tatsuya Sakamoto, Takahiro Ito, Aoi Hayasaki, Yusuke Iizawa, Takehiro Fujii, Akihiro Tanemura, Yasuhiro Murata, Masashi Kishiwada, Shugo Mizuno
PurposeWe proposed a novel morphological classification for intraductal papillary neoplasm of the bile duct (IPNB) and evaluated its association with postoperative prognosis.
MethodsForty-two IPNB patients who underwent surgical resection were classified morphologically into three types—branched (n = 10), main duct (n = 26), and mixed (n = 6)—based on preoperative imaging features indicating cystic and/or bile duct involvement. Among them, 32 patients with evaluable specimens were further categorized pathologically into Type 1 (n = 10) and Type 2 (n = 22). Patient characteristics and postoperative outcomes were analyzed.
ResultsIntraepithelial neoplasia was more frequently observed in the branched type, whereas invasive carcinoma predominated in the main duct type. In the mixed type, a half of patients involved both intra- and extrahepatic bile ducts, and this type also showed the highest incidence of residual tumor. The mixed type had the poorest 5-year postoperative survival rate (50%), compared to 90% in the main duct type and 100% in the branched type. It also exhibited the highest 5-year recurrence rate (62%). Among IPNB patients with associated invasive carcinoma, tumor infiltration beyond the bile duct wall (p Conclusions
Our novel morphological classification of IPNB correlates with postoperative prognosis and may assist in preoperative planning of surgical strategies for IPNB patients.
by Mami Takahashi, Takeshi Shimamoto, Lumine Matsumoto, Yusuke Mitsui, Yukari Masuda, Hirotaka Matsuzaki, Eriko Hasumi, Chie Bujo, Keiko Niimi, Takako Nishikawa, Ryoichi Wada, Nobutake Yamamichi
This multicenter study aimed to elucidate the association between sleep duration and various lifestyle-related disorders in healthy adults in Japan. A total of 62,056 healthy participants (age: 49.4 ± 10.9 years) who received medical checkups from 2010 to 2020 were analyzed cross-sectionally and longitudinally. The mean sleep duration was 6.2 ± 1.0 h in men and 6.1 ± 1.0 h in women. The distribution of sleep duration showed that older people tended to sleep longer, which was clearly observed in men but not in women. Univariate analyses showed that older age, lower body mass index (BMI), habitual drinking, and habitual exercise were significantly associated with longer sleep duration. Multivariate analyses in men showed that sleep duration was positively associated with age, habitual exercise, serum triglyceride (TG), systolic blood pressure (SBP), and habitual drinking and negatively associated with BMI and hemoglobin A1c (HbA1c). Alternatively, in women, sleep duration was positively associated with habitual exercise and TG and negatively associated with BMI, high-density lipoprotein-cholesterol, HbA1c, and current smoking. During the follow-up period, 3,360 of 31,004 individuals (10.8%) developed obesity. The Cox proportional hazards model showed that shorter sleep duration was a significantly higher risk of obesity, and longer sleep duration might be a lower risk of obesity. On the other hand, 1,732 of 39,048 participants (4.4%) developed impaired glucose tolerance, and 6,405 of 33,537 participants (19.1%) developed hypertriglyceridemia. However, the Cox proportional hazards model did not show significant association between sleep duration and impaired glucose tolerance or hypertriglyceridemia. In conclusion, our large-scale cross-sectional study showed that sleep duration was positively associated with habitual exercise and TG and negatively associated with BMI and HbA1c, regardless of sex. Longitudinal analysis revealed that shorter sleep duration is a significant risk factor for obesity.by Oluwadamilare Akingbade, Ka Yi Hong, Oluwabukola Sharon Ayo, Adetutu Sefinat Alade, Moshood Akinwumi Lawal, Ibironke Elizabeth Somoye, Victoria Adediran, Olamide Sado, Ka Ming Chow
BackgroundBreast cancer (BC) remains a significant health burden globally, with high incidence and mortality rates, particularly in Nigeria. Chemotherapy, a common treatment modality for BC, often leads to various physical and psychological side effects, impacting patients’ quality of life. Despite the growing use of mobile health (mHealth) interventions to provide psychoeducational support, there is a paucity of evidence regarding their feasibility and acceptability among Nigerian women with BC.
ObjectiveTo develop and investigate the feasibility and acceptability of a mHealth psychoeducational intervention (mPEI) named the ChEmo Nurse Breast cancer Application (CENBA) programme.
MethodsA multi-centre, assessor-blinded, parallel-group pilot randomised controlled trial (RCT) was conducted at Lagos State University Teaching Hospital (LASUTH) and Lagos University Teaching Hospital (LUTH). Thirty women newly diagnosed with BC and undergoing chemotherapy were randomly assigned to an intervention or a control group. The intervention group received the CENBA programme, which included BC education, coping skills training, a discussion forum, and nurse-led consultations, delivered via a mobile application and phone calls over six weeks. The control group received standard care. Feasibility was assessed through consent, attrition, and completion rates, while acceptability was explored via qualitative interviews.
ResultsThe completion rate was 93.3%. Qualitative data indicated that participants found the intervention beneficial, particularly appreciating the educational content and the emotional support provided through the discussion forum and nurse consultations.
ConclusionThe CENBA programme was perceived as a feasible and acceptable mHealth intervention for providing psychoeducational support to Nigerian women with BC undergoing chemotherapy. These findings suggest that the CENBA programme could be a valuable tool in addressing the psychoeducational needs of this population, warranting further investigation in a full-scale RCT.
Trial registrationThis manuscript reports a feasibility study preceding the full trial, which was registered with the United States Clinical Trials registry (number NCT05489354).
FreshRSS 