Search Results for: Come si esegue la raccolta delle urine delle 24 ore

Introduction
Autism spectrum disorder (ASD) is often accompanied by a variety of comorbidities. A high prevalence of patients has difficulties with food intake, which can lead to malnutrition, obesity and dyslipidaemia. Although several factors influencing dietary intake in this population have been investigated in the literature, the lack of standardised assessment protocols has led to heterogeneous results across studies. This study protocol describes the methodology used to assess nutritional aspects such as feeding problems, food intake and biochemical variables in children and adolescents with ASD.

Methods and analysis
The clinical protocol for nutritional screening in autism is a clinically based cross-sectional study design that focuses on the assessment of nutrition in children and adolescents with ASD aged 2 to under 19 years. Participants and caregivers are assessed in three clinical steps by a team of dietitians. Nutritional aspects are assessed, such as feeding behaviour (Brief Autism Mealtime Behavior Inventory, Children’s Eating Behavior Questionnaire), food intake (3 non-consecutive days of 24-hour food record), anthropometric measurements to calculate nutritional indicators according to WHO standards and blood samples (analysis of fasting glucose, triglycerides, total cholesterol and its subfractions). The data collected have the potential for descriptive and multivariate analyses to investigate associations among clinical, dietary difficulties, nutritional and biochemical variables.

Ethics and dissemination
The study protocol was approved by the institutional review board of the Federal University of Pelotas (CAEE: 94253518.0.0000.5317). The results will be disseminated through peer-reviewed publications and conferences.

Introduction
Accidental falls are a common geriatric syndrome that hinders healthy ageing in older adults. Older adults who live in nursing homes (NHs) are at a greater risk of accidental falls than those who reside in communities. Intrinsic capacity (IC) decline has been shown to be an independent influencing factor for fall risk. Moreover, healthy behaviour is a prerequisite for IC. Therefore, this study considers IC as a starting point, with an aim of developing, implementing and evaluating a low-administration-cost multidomain fall risk management intervention programme based on the Health Action Process Approach.

Methods and analysis
The target population includes older adults with declining IC in Chinese NHs. A random lottery method will be adopted to divide the 100 participants into the control group and intervention group. The project will be conducted in three parts over 24 weeks. In the first part, a fall risk management intervention pathway and programme will be developed with the theoretical and IC framework, which will be refined via the Delphi method. In the second part, a randomised controlled trial will be implemented. The control group will receive usual care and health education, and the intervention group will complete a three-stage process to complete fall risk management behaviour intention and behaviour maintenance. In the third part, follow-up will be conducted to clarify the maintenance effectiveness of the programme in fall risk management. Behaviour change techniques and an interactive handbook will be used to increase the feasibility of the programme. The primary outcomes will include the IC composite score (cognition, locomotion, vitality, sensation and psychology) and fall risk. The secondary outcomes will include gait and balance, strength, fall efficacy, fall prevention self-management, fall management behaviour stages and healthy ageing. The outcomes will be assessed at baseline, and then after 4 weeks, 16 weeks and 24 weeks in both groups. The effectiveness of the intervention will be analysed via linear mixed models on a range of outcomes.

Ethics and dissemination
The trial was approved by the Huzhou University Committee (No.2023-06-06). The results will be submitted for publication in a peer-reviewed journal and presented at conferences.

Trial registration number
NCT05891782.

Introduction
The prevalence of dementia is increasing, both worldwide and in China. This disease is associated with numerous restrictions for those affected but also for caregivers and society. Due to the limited effectiveness of pharmacological interventions, more research on non-pharmacological interventions is needed. For the non-pharmacological multimodal MAKS (M: motor training, A: activities of daily living training, K: cognitive training, S: social-communicative setting) intervention, positive effects on cognition, activities of daily living, and the occurrence of behavioural and psychological symptoms of dementia were identified in two randomised controlled trials in different settings in Germany. Thus, the German MAKS intervention was culturally adapted for China and will now be tested for its efficacy in Chinese nursing homes in a randomised controlled trial.

Methods and analysis
Participants will be residents of Chinese nursing homes in Shenyang, Nanjing and Dalian, fulfilling the ICD-10 criteria for Alzheimer’s dementia, the psychometric criteria for mild to moderate dementia (MMSE 10–23) and none of the exclusion criteria. With n=200, effects with an effect size of Cohen’s d=0.45 and a power of 1-β = 0.80 can be detected. Screening and data collection at baseline, t6 and t12 will be conducted via face-to-face contact by proxy raters in the nursing homes (i.e., trained nursing staff not involved in the intervention) and master students as external testers for the performance tests on cognition and activities of daily living. Participants will be randomly allocated to the intervention or control group. SinoMAKS (i.e., the Chinese version of the MAKS intervention) will be conducted at least three times a week for six months by trained MAKS therapists. The control group will receive care as usual for 12 months after baseline. Thus, the treatment phase is six months with follow-ups after six and 12 months after baseline. In the open phase, from t6 to t12, the nursing homes are free to offer SinoMAKS to the intervention group residents. In line with international guidelines, the primary population for analysis is the intention-to-treat sample. Global cognition (measured with the Addenbrooke’s Cognitive Examination-III) is the primary outcome. The hypotheses will be analysed using multiple linear regression with the outcome variables as dependent variables.

Ethics and dissemination
All procedures were approved by the Ethics Committee of the Medical Faculty of the Friedrich-Alexander-Universität Erlangen-Nürnberg (Ref. 24–162-B) and the Ethics Committee of the China Medical University (Ref. [2024]181). Written informed consent will be obtained from all participants or—if applicable—their legal representatives. Results will be published in peer-reviewed scientific journals and conference presentations.

Trial registration number
ISRCTN10262531.

In the Original Investigation titled “Effect of Vitamin D Supplementation on Psoriasis Severity in Patients With Lower-Range Serum 25-Hydroxyvitamin D Levels: A Randomized Clinical Trial,” published online on March 29, 2023, and in the May 2023 issue, there was an error in the Box. Under “Inclusion Criteria,” the value of “42 ng/mL” should be “24 ng/mL.” This article was corrected online.

In Reply We thank Endo and Kami for their comments and for raising these questions in response to our post hoc analysis of the psychiatric safety of semaglutide, 2.4 mg, for weight management in persons without known major psychopathology, as evaluated in the STEP 1, 2, 3, and 5 studies.

Campagna informativa Ifo, non sottovalutare sangue nelle urine

Stanno bene, per 24/enne cesareo urgenza in 28esima settimana

Introduction
Maternal undernutrition and infections during pregnancy may influence birth and long-term child development outcomes. Characterising the micronutrient, metabolomic and microbiome profiles of pregnant women and infants may elucidate the underlying biology of adverse birth outcomes and early child development in the first 1000 days.

Methods and analysis
The Enhancing Nutrition and Antenatal Infection Treatment (ENAT) study was a 2×2 factorial, randomised clinical effectiveness study conducted in Amhara, Ethiopia from August 2020 to June 2022. We cluster-randomised pregnant women (n=2399) to receive either a nutrition intervention (iron-folic acid (IFA), iodised salt and balanced energy-protein supplementation for women with mid-upper arm circumference

Introduction
Postoperative delirium (POD) is a frequent complication in elderly surgical patients, leading to increased morbidity and mortality. Previous studies have shown that noise isolation is associated with a reduced incidence of delirium in the intensive care unit (ICU). This trial aims to evaluate the impact of noise isolation using noise-cancelling headphones on the incidence of POD in elderly patients undergoing hip surgery.

Methods and analysis
In this randomised controlled trial, a total of 320 elderly patients will be randomised to a noise isolation group or a control group, in a 1:1 ratio and stratified by age (65-80 years or >80 years), type of surgery (fracture or non-fracture) and planned ICU admission (yes or no). For patients in the noise isolation group, noise-cancelling headphones will be used throughout anaesthesia and in the postoperative care unit or ICU. Patients in the control group will be routinely managed and exposed to the clinical environment. The primary outcome is the incidence of POD during 0-7 days after surgery or before hospital discharge, assessed using the 3 min Confusion Assessment Method or the Confusion Assessment Method for the Intensive Care Unit. The secondary outcomes include postoperative pain at 6, 24 and 48 hours after surgery; sleep quality on the first and second nights after surgery; incidence of nausea and vomiting within 48 hours postoperatively; and cognitive function and mortality at 30 days after surgery.

Ethics and dissemination
The trial was approved by the Ethics Committee of the First Affiliated Hospital of Soochow University (Approval No. 2024–054). The results of this trial will be submitted for peer review and publication in a scientific journal.

Trial registration number
Chinese Clinical Trial Registry (ChiCTR2400082211).

Introduction
The management of immunoglobulin A (IgA) nephropathy remains a topic of debate. Hydroxychloroquine and mycophenolate mofetil (MMF) are two immunosuppressive agents that have recently garnered increased attention among patients with IgA nephropathy in China. Several studies have shown the comparable efficacy between MMF and enteric-coated mycophenolate sodium (EC-MPS), with lower adverse event rates for EC-MPS. The present study aims to evaluate the efficacy and safety of EC-MPS combined with hydroxychloroquine as an immunosuppressive regimen for patients with high-risk progressive IgA nephropathy, despite receiving routine supportive treatment.

Methods and analysis
This study is a multicentre, prospective, randomised controlled, open-label, blinded endpoint trial. 96 patients diagnosed with IgA nephropathy and persistent proteinuria from 12 general hospitals in Shanxi Province of China will be recruited and randomly assigned to receive either EC-MPS plus hydroxychloroquine or hydroxychloroquine alone in a 1:1 ratio. We will compare the efficacy and safety of hydroxychloroquine combined with or without oral EC-MPS (720–1080 mg/day for 6 months, and tapered to 360–540 mg/day for another 6 months) on a background of supportive care. All enrolled patients will receive standard basic treatment to achieve optimum blood pressure and the maximum tolerated dose of ACE inhibitors or angiotensin receptor blockers. The primary outcome is the change in 24-hour urine protein at 6 months relative to baseline. Participants will be subject to regular follow-up for a duration of 12 months.

Ethics and dissemination
This study has received ethical approval from the Ethics Committee of Shanxi Medical University Second Hospital (No. 2024YX-481). A duly signed and dated informed consent form must be obtained from each participant or his/her legal guardian prior to any operational procedures related to the trial. The result of this study will be presented and published at international conferences and in scientific journals.

Trial registration number
ChiCTR2400093530.

Objective
The objective is to examine the correlation of anti-phosphatidylethanolamine (aPE) antibodies with premature birth. Premature birth is an important risk factor for infant mortality and subsequent development of mental, metabolic and cardiovascular diseases. However, the risk factors associated with preterm birth are not well understood. aPE antibodies are an anti-phospholipid autoantibody that is thought to be a factor in pathological pregnancy. However, aPE antibodies have not been included in the classification criteria for antiphospholipid syndrome. Therefore, we aimed to check the clinical significance of aPE antibodies in association with premature birth.

Design
We conducted a retrospective analysis of 442 pregnant women who had experienced at least one unexplained miscarriage and were tested for aPE antibodies and compared their clinical characteristics, coagulation indicators, immune biomarkers and pregnancy outcomes. Logistic regression analysis was employed to identify factors associated with premature birth.

Setting
Ruian City, Wenzhou, Zhejiang Province, China.

Participants
A total of 442 patients with ultrasound-confirmed intrauterine pregnancy from the Third Affiliated Hospital of Wenzhou Medical University between May 2018 and December 2022 were retrospectively selected and included in the study. The inclusion criteria were as follows: having been tested for aPE and having experienced at least one unexplained miscarriage. The exclusion criteria were as follows: (a) incomplete clinical records, (b) being positive for typical antiphospholipid antibodies (aPL, aβ2-GP1 and LA), (c) hormone or metabolic disorder, (d) lost to follow-up, (e) known clinical autoimmune diseases, (f) severe reproductive system infection or malformation, (g) fetal loss: pregnancy loss before 24 weeks and (h) multiple pregnancy. In this study, preterm birth was defined as birth before 37 weeks.

Primary and secondary outcome measures
We enrolled 442 patients in our study: 60 pregnancies with premature birth and 382 pregnancies with term birth.

Results
Our findings revealed that among the 442 participants, 13.6% had a premature birth (

Introduction
Perinatal depression and anxiety (PDA) is associated with a high risk of maternal mortality. Existing data shows that 95% of maternal mortality in low- and middle-income countries (LMICs) is due to resource constraints and negligence in addressing perinatal mental health (PMH). Research conducted in more developed countries has demonstrated the potential of artificial intelligence (AI) to assist in predicting, identifying, diagnosing and treating PDA. However, there is limited knowledge regarding the utilisation of AI in LMICs where PDA disproportionately affects women. Therefore, this study aims to investigate the role of AI in predicting, identifying, diagnosing and treating PDA among pregnant women and mothers in LMICs.

Methods and analysis
This systematic review will use a patient and public involvement (PPI) approach to systematically investigate the role of AI in predicting, identifying, diagnosing, and treating PDA among pregnant women and mothers in LMICs. The study will combine secondary evidence from academic databases and primary evidence from focus group discussions and a workshop and webinar to comprehensively analyse all relevant published and reported evidence on PDA and AI from the period between January 2010 and May 2024. To gather the necessary secondary data, reputable interdisciplinary databases in the field of maternal health and AI will be used, including ACM Digital Library, CINAHL, MEDLINE, PsycINFO, Scopus and Web of Science. The extracted data will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) framework, ensuring transparency and comprehensiveness in reporting the findings. Finally, the extracted studies will be synthesised using the integrative data synthesis approach.

Ethics and dissemination
Given the PPI approach to be employed by this study which involves multi-stakeholders including mothers with lived experience, ethical approvals have been sought from the University of Ghana and University of Alberta. Additionally, during the review process, to ensure that the articles included in this study uphold ethical standards, only peer-reviewed articles from reputable journals/databases will be included in this review. The findings from this systematic review will be disseminated through workshops, webinars, conferences, academic publications, social media and all relevant platforms available to the researchers.

PROSPERO registration number
PROSPERO (10/06/24) CRD42024549455.

Introduction
Elderly patients with impaired intrinsic capacity are at increased risk for delayed or suboptimal recovery from surgery. S-ketamine has been proven to improve postoperative recovery quality. However, limited trials are studying the postoperative recovery quality in elderly patients with impaired intrinsic capacity. Therefore, the objective of this study was to evaluate the impact of S-ketamine on the quality of recovery in elderly patients with impaired intrinsic capacity following total knee arthroplasty.

Methods and analysis
This is a single-centre, randomised, double-blind, placebo-controlled trial. Participants undergoing total knee arthroplasty will be randomly assigned in a 1:1 ratio to either the S-ketamine group (n=80) or the placebo group (n=80). The S-ketamine group will undergo an intravenous infusion of S-ketamine administered at a dosage rate of 0.2 mg·kg–1·h–1 for 1 hour. The placebo group will receive an intravenous saline infusion at an identical rate and duration. Postoperatively, the S-ketamine group will continuously infuse S-ketamine for 48 hours using a patient-controlled intravenous device, with a fixed rate of 0.01 mg·kg–¹·h–¹, a bolus dose of 0.02 mg·kg–¹, a lockout period of 10 min and a maximum infusion rate of 0.13 mg·kg–¹·h–¹. In contrast, the patient-controlled intravenous device for the placebo group will not contain S-ketamine. The primary outcome is the quality of recovery scores at 24 hours following total knee arthroplasty. Secondary outcomes encompass quality of recovery scores at 48 and 72 hours postoperatively, pain scores at rest and during movement, oral morphine equivalents, sleep quality assessments, depression scores, the Barthel Index and the time to meet discharge criteria.

Ethics and dissemination
Approval for the trial was granted by the Medical Ethics Committee of The Affiliated Hospital of Qingdao University (QYFYEC2024-74). Written informed consent will be obtained from each patient before enrolment. The results of this trial will be presented at scientific conferences and in peer-­reviewed scientific journals.

Trial registration number
ChiCTR2400087028.

Introduction
Out-of-hospital cardiac arrest is a public health concern with a high mortality rate. Hypoxic ischaemic brain injury is the primary cause of death in patients admitted to the intensive care unit (ICU) after return of spontaneous circulation (ROSC). Several systemic factors, such as hypotension, can exacerbate brain injuries. International guidelines recommend targeting a mean arterial pressure (MAP) of at least 65 mm Hg. Several observational studies suggest that a higher MAP may be associated with better outcomes, but no randomised trials have shown an effect of higher MAP. The ongoing METAPHORE (mean arterial pressure after out-of-hospital cardiac arrest) trial aims to compare a standard MAP threshold (MAP ≥65 mm Hg) with a high MAP threshold (MAP ≥90 mm Hg) to evaluate whether implementing a higher MAP threshold can improve neurological outcomes in patients admitted to ICU after cardiac arrest.

Methods and analysis
METAPHORE is a randomised, controlled, multicentre, open-label trial with a blinded primary outcome assessor, comparing two parallel groups of patients 18 years of age or older, receiving invasive mechanical ventilation for coma defined by a Glasgow Coma Score ≤8/15 after out-of-hospital cardiac arrest and sustained ROSC. Eligible patients are randomly assigned in a 1:1 ratio to either a MAP target threshold of 65 mm Hg or higher throughout the ICU stay (control group) or a MAP target threshold of 90 mm Hg or higher during the first 24 hours after randomisation, followed by 65 mm Hg or higher for the remainder of the ICU stay (intervention group). Both groups receive the same general care concerning post-cardiac arrest syndrome management according to international guidelines. The primary endpoint is the proportion of patients with a favourable neurological outcome as defined by a modified Rankin scale (mRS) of 0 to 3 measured on day 180 after inclusion by a psychologist blinded to the allocation of the intervention. Secondary outcomes are the proportion of patients alive at ICU and hospital discharge, at day 28 and day 180; proportion of patients alive at ICU discharge with a mRS of 0 to 3; the EuroQOL-5D-5L at day 180; the Clinical Frailty Scale at day 180; the number of ICU-free days, ventilator-free days, catecholamine-free days and renal replacement therapy-free days at day 28; the proportion of patients with acute kidney injury stage 3 and need for renal replacement therapy within ICU stay and proportion of patients with persistent need for renal replacement therapy at ICU discharge; and safety outcomes (cardiovascular, neurological, cutaneous, digestive and haemorrhagic complications within 7 days after inclusion). Subgroup analyses are planned according to initial cardiac arrest rhythm (shockable or non-shockable), chronic hypertension and Cardiac Arrest Hospital Prognosis score. Outcomes will be analysed on an intention-to-treat basis. Recruitment started in October 2024 in 27 French ICUs, and a sample of 1380 patients is expected by October 2027.

Ethics and dissemination
The study received approval from the national ethics review board on 8 February 2024 (Comité de Protection des Personnes Sud-Est V – 2023-A00257-38). Patients are included after informed consent has been obtained either from a proxy or through an emergency procedure. Results will be submitted for publication in peer-reviewed journals.

Trial registration number
ClinicalTrials.gov: NCT05486884.

Stroke, Ahead of Print. BACKGROUND:Rehabilitation is an efficacious method to improve poststroke motor dysfunction. Various rehabilitative techniques have become popular in this field of research. However, it has not been reported whether better outcomes can be achieved if rehabilitation training is conducted at the optimal time of the day.METHODS:A model of photothrombotic ischemic stroke was used in C57/BL6 mice, and poststroke 24-hour activity cycles were evaluated. We found an activity peak around Zeitgeber time (ZT)13 (21:00) and a trough around ZT20 (04:00) during the dark phase. In addition, we selected ZT6 (14:00) as the daytime training group (corresponding to the ZT13 training group, ZT20 training group, and ZT6 training group, respectively). The 3 groups underwent treadmill training for 4 weeks. Functional and histological recovery levels were compared among groups. In addition, bulk RNA sequencing analysis was used to explore the possible molecular mechanisms.RESULTS:The results showed that stroke-induced mice maintained a regular nocturnal locomotor rhythm with reduced amplitude. Motor recovery was greater in the ZT13 training group than in the ZT6 group, with a trend toward better outcomes at ZT13 than ZT20. The ZT13 group also showed superior neuronal survival and neurogenesis compared with ZT6, while improvements between ZT13 and ZT20 were less pronounced. Bulk RNA sequencing suggested that synaptic plasticity, calcium signaling, cAMP signaling, and MAPK signaling pathways contributed to neural repair differences between ZT13 and ZT6. In addition, the results showed a similar pattern of motor recovery in female and aged mice trained at ZT13 compared with ZT6, reinforcing the benefits of time-of-day training.CONCLUSIONS:In conclusion, rehabilitative training during the most active phase is beneficial for enhanced recovery outcomes. Our study suggests that rehabilitation should be conducted when the body is in an optimal physiological state—that is, a time-of-day-dependent rehabilitation strategy.