Phase 2 trial results look promising, although immunosuppression is required.
Search Results for: Gestire la colica renale nel setting delle cure primarie
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Tumori, nuovo paradigma di cure con l'immunoterapia neoadiuvante
Con terapia prima del bisturi meno recidive in diverse neoplasie
Tumori, nuovo paradigma di cure con l'immunoterapia neoadiuvante
Con terapia prima del bisturi meno recidive in diverse neoplasie
Principal investigators experience of COVID-19 therapeutic clinical trials in Japan: a qualitative study
Objective
During the COVID-19 pandemic, many clinical trials were conducted to identify effective COVID-19 therapeutics. However, while a large amount of resources was invested and significant numbers of patients participated, this did not necessarily have an impact on clinical practice. To face these issues, initiatives such as the 100 Days Mission have been set out globally. Yet, limited data exist on the context surrounding the implementation of clinical trials at a national level during a health emergency. The study explored experiences and perceptions of principal investigators in conducting clinical trials for COVID-19 therapeutics in Japan.
Design
A qualitative study was conducted using semistructured interviews. The obtained data were inductively analysed using thematic analysis.
Setting and participants
We interviewed 15 principal investigators between September and November 2022 who conducted investigator-initiated clinical trials on the development of COVID-19 therapeutics in Japan.
Results
Three themes were generated: structural barriers, fragmented efforts and limited evidence generation. Structural barriers and fragmented efforts comprised four subthemes: individual, institutional, interinstitutional and policy/regulatory levels. Structural barriers at all levels included (1) limitations of individual capabilities, (2) the double burden of clinical practice and research, (3) inefficient interinstitutional collaboration and (4) regulatory frameworks and available resources that interrupt stakeholders’ actions, leading to limited evidence generation despite the fragmented efforts of principal investigators and other stakeholders.
Conclusions
This study illustrated that the efforts of Japanese principal investigators did not necessarily pay off in identifying therapeutics. A strategic and systematic approach for an improved national clinical trial ecosystem must be sought during the interpandemic period to overcome structural barriers in harmonisation with the global stakeholders.
Theory-based chatbot for promoting colorectal cancer screening in a community setting in Hong Kong: study protocol of a randomised controlled trial
Background
Colorectal cancer (CRC) is the third most common cancer and the second leading cause of cancer mortality worldwide. Despite the organised CRC screening programme, the uptake rate of the population-based CRC screening was still low. Thus, we will conduct a randomised controlled trial in a community setting to evaluate the effectiveness of a theory-based chatbot in promoting CRC screening uptake.
Methods and analysis
A total of 500 eligible participants will be randomly assigned to a WhatsApp Messenger-initiated chatbot outreach group or a standard text reminder group at a ratio of 1:1. The intervention group will deliver Chinese culturally tailored education texts and videos developed based on the Health Belief Model and the Trans-Theoretical Model. The control group will deliver a standard text reminder of information about the Hong Kong organised CRC screening programme. In addition to the baseline assessment and postintervention assessment, all subjects will be followed up for 3 months and 6 months, respectively. The primary outcome will be the CRC screening uptake rate at the 3 month and 6 month follow-up. The secondary outcomes will be the intention to undergo CRC screening uptake, time interval to participate in and complete screening after recruitment, and reasons for not participating in screening at the 3 month and 6 month follow-up. Quantitative data will be analysed using Student’s t-test, Pearson’s 2 test or Fisher’s exact test. Qualitative data will be analysed by thematic analysis.
Ethics and dissemination
Ethical approval of this trial was granted by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (2022.614). Written informed consent will be obtained from study participants before enrolment. The findings will be disseminated through peer-reviewed journals.
Trial registration number
The study was registered on clinicaltrials.gov (NCT06192862).
All'Irccs Candiolo nuovo studio su sarcomi dei tessuti molli
Il progetto ‘Matilde’ per cure sempre più personalizzate
All'Irccs Candiolo nuovo studio su sarcomi dei tessuti molli
Il progetto ‘Matilde’ per cure sempre più personalizzate
[Articles] Global outbreaks of respiratory syncytial virus infections from 1960 to 2025: a systematic review and meta-analysis
RSV outbreaks have contributed significantly to global morbidity since the 1960s, with increasing reports over time. While the CFRs have decreased, they remain high in certain subgroups based on age, genotype, and outbreak setting. The pooled attack rate remains substantial, particularly in healthcare settings involving RSV-B genotypes and among immunosuppressed populations. This meta-analysis underscores the importance of targeted vaccination and treatment strategies for controlling RSV outbreaks worldwide in the future.
Incidence, progression and predictors of chronic kidney disease among adult HIV/AIDS patients on antiretroviral treatment in comprehensive specialised hospitals in the Amhara Region, Ethiopia, 2022: a multi-centre retrospective follow-up study
Objective
To assess the incidence, progression and predictors of chronic kidney disease among adult patients living with HIV/AIDS who are receiving antiretroviral therapy.
Design
An institution-based, multicentre retrospective follow-up study was conducted among a randomly selected sample of 535 adult patients. Data were entered into Epi Data version 4.6.0 and analysed using STATA version 14.0. A Cox proportional hazards regression model was fitted to identify independent predictors of chronic kidney disease incidence. Variables with p
Development and preliminary evaluation in community mental health teams of a cervical screening informed-choice tool for women with severe mental illness in England: a mixed-method study
Objectives
Women with severe mental illness (SMI) face barriers to cervical cancer screening, leading to lower participation and poorer outcomes. This research aimed to develop and test an informed-choice tool to help women with SMI make informed decisions about screening attendance.
Design
The tool was developed using a realist review of physical health interventions and a systematic review of informed-choice tools for people with SMI. A mixed-methods approach informed its development. Usability and acceptability were assessed through semistructured interviews and the think-aloud method with service users (n=18), clinicians (n=16) and key informants. A preliminary proof-of-concept (n=25) evaluated the impact on decisional conflict—the uncertainty around making value-sensitive choices.
Setting and participants
Conducted in two National Health Service (NHS) Mental Health Trusts (urban and rural). Participants included women with SMI accessing secondary mental healthcare, clinicians and service user groups. A key informants’ group guided clinical content.
Intervention
A cervical screening informed-choice leaflet and an accompanying video.
Results
The tool was usable and acceptable, especially for women overdue or never screened. It may reduce decisional conflict and increase screening uptake, potentially improving survival. An National Institute for Health and Care Research (NIHR)-funded feasibility trial (Improving uptake of cervical screening in people with severe mental illness (OPTMISE)) is underway. The current UK government guidance on Support for people who find it hard to attend cervical screening due to having a mental health condition or having experienced trauma or abuse is based on this research.
Conclusions
Future research may involve further assessments of the real-world impact of the tool and its adaptation to other health-related decisions.
Association between loneliness and depression, anxiety and anger during the COVID-19 pandemic: a nationwide population-based survey
Objectives
This study aims to determine the association between loneliness and depression, anxiety and anger with a representative sample of the general population in Korea, which are the most prevalent mental health problems during the pandemic.
Design
Cross-sectional study.
Setting
National survey across all 17 provinces in South Korea between December 2021 and January 2022.
Participants
We conducted a national survey on 2699 participants aged 19–84 years using proportional stratified sampling. Using the UCLA Loneliness Scale and standardised questionnaires for depression (Patient Health Questionnaire-9), anxiety (Generalised Anxiety Disorder-7) and anger (Patient-Reported Outcomes Measurement Information System-Anger), we explored the prevalence and association of loneliness with these mental health outcomes.
Primary and secondary outcome measures
Primary outcomes included the prevalence and co-occurrence of depression, anxiety and anger across different levels of loneliness.
Results
Of total, 20.7% and 2.1% experienced moderately high and high levels of loneliness, respectively. Among participants with high levels of loneliness, 11.8%, 5.9% and 11.8% had depression, anxiety and anger, respectively, and 28.7% of them had depression, anxiety and anger together. The adjusted prevalence of depression was 0.2 (95% CI 0.0 to 0.5), 8.2 (95% CI 6.7 to 9.7), 31.3 (95% CI 27.4 to 35.3) and 63.5 (95% CI 50.1 to 76.8) for low, moderate, moderately high and high levels of loneliness, respectively. Similarly, increased adjusted prevalence of anxiety and anger was observed ㅈwith higher levels of loneliness.
Conclusions
Lonely people have a higher risk of depression, anxiety and anger. Identifying individuals who may be vulnerable to loneliness is important for early intervention.
Is exposure to cement dust and heavy metals associated with reduced pulmonary function? A cross-sectional study among cement factory workers in Türkiye
Objectives
To assess the relation of exposure to cement dust and heavy metal (aluminium, cadmium and lead) exposures to pulmonary function among male cement plant workers. The study also aimed to evaluate dose–response relationships and prevalence and severity of respiratory symptoms among exposure categories compared with a control group.
Design
Cross-sectional study.
Setting
Secondary-level occupational health clinic in Ankara, Türkiye.
Participants
461 male non-smoking cement plant employees were included in total. Participants were categorised into packaging (n=101), milling (n=162) and office unexposed workers (n=198). Inclusion criteria were more than 70% work history in the cement industry and exclusion of pre-existing respiratory disease and missing data from the participants.
Interventions
Not applicable.
Primary and secondary outcome measures
Pulmonary function tests (forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1), FEV1/FVC and peak expiratory flow (PEF)) and urinary, cadmium and blood lead concentrations were measured. Lung function impairment was the primary outcome measure; secondary outcomes included metal exposure—pulmonary measure correlations.
Results
Significant negative correlations existed between FEV1 and urine aluminium (r=–0.622, p
Prevalence and determinants of unsuppressed HIV viral loads among children and adolescents living with HIV on antiretroviral therapy in Lubumbashi, Democratic Republic of the Congo: a retrospective cross-sectional study
Background
Despite global improvements in antiretroviral therapy (ART) access for children and adolescents living with HIV (CALHIV), a significant proportion continue to experience unsuppressed viral load (USVL). Limited studies focus on the factors contributing to USVL among CALHIV in the Democratic Republic of the Congo (DRC), especially in the context of evolving treatment landscapes. Understanding these determinants is crucial for enhancing ART outcomes.
Objective
This study aimed to determine the prevalence of USVL and identify factors associated with USVL among CALHIV receiving ART in Lubumbashi, DRC.
Design
A multicentre retrospective cross-sectional study was conducted. Data were gathered using an observational checklist based on assessing patient file data and entered into Microsoft Excel. Analysis was performed using STATA V.16. Variables with a p value of 0.20 from the bivariable analysis were included in a multivariable logistic regression model, and significant variables (p
Cost-effectiveness analysis of robotic exoskeleton versus conventional physiotherapy for stroke rehabilitation in Singapore from a health system perspective
Objectives
This study conducted a comprehensive probabilistic cost-effectiveness analysis comparing robotic exoskeleton therapy to conventional physiotherapy for stroke rehabilitation in Singapore, focusing on three patient groups categorised by their Functional Ambulation Category (FAC) scores.
Design
A probabilistic cost-effectiveness analysis was conducted alongside a non-randomised controlled study. Costs and Quality-Adjusted Life Years (QALYs) for both interventions were calculated and compared over a 6 month period.
Setting
The study was carried out at Alexandra Hospital, Jurong Community Hospital and St Luke’s Hospital in Singapore.
Participants
Individuals requiring inpatient gait rehabilitation from acute to subacute stages of stroke recovery, with FAC scores of 0–1, were included in the analysis.
Primary outcome measure
The primary outcome measure was QALYs, a composite measure combining the length and quality of life into a single value.
Results
Robotic exoskeleton therapy was found to be cost-effective compared with conventional physiotherapy across all patient groups, with Group 2 (FAC 0) showing the most favourable cost-effectiveness profile (incremental cost-effectiveness ratio (ICER): US$ 28 259.62 per QALY gained). The probabilistic sensitivity analysis demonstrated the robustness of the results, with QALY gains and the cost of the robotic exoskeleton having the largest impact on the ICER.
Conclusion
The findings suggest that robotic exoskeleton therapy is likely to be cost-effective for stroke rehabilitation in Singapore, particularly for patients with severe mobility impairments (FAC 0). The results have important implications for clinical practice, resource allocation and future research in the field of stroke rehabilitation in Singapore.
Trial registeration number
NCT05659121.
Association of triglyceride-glucose index with in-hospital outcomes in patients with acute myocardial infarction: a retrospective, single-centre, cohort study in China
Objectives
To investigate the association between triglyceride-glucose (TyG) index levels at hospital admission and the risk of in-hospital adverse events, including all-cause mortality, in patients with acute myocardial infarction (AMI). The primary hypothesis was that higher TyG index levels are associated with greater risk of adverse in-hospital outcomes.
Design
Retrospective cohort study.
Setting
Tertiary hospital inpatient care in China. The study included consecutively hospitalised patients with AMI between 1 August 2011 and 10 January 2022.
Participants
A total of 3458 patients with AMI were included. The mean age was 60.8 years, and 78.4% were men. Patients were excluded if they had incomplete data for TyG index calculation or outcome ascertainment.
Interventions
No therapeutic intervention was assigned; the study was observational. TyG index was calculated using fasting triglycerides and fasting plasma glucose levels at admission.
Primary and secondary outcome measures
The primary outcome was all-cause in-hospital mortality. Secondary outcomes included cardiogenic shock and fatal rapid arrhythmia. Outcomes were identified through standardised clinical records.
Results
Among 3458 patients, 375 (10.84%) died during hospitalisation, 236 (6.84%) developed cardiogenic shock and 147 (4.25%) experienced fatal rapid arrhythmia. After multivariable adjustment, higher TyG index levels were significantly associated with increased odds of all-cause mortality (OR, 1.27; 95% CI, 1.02 to 1.57; p
Smoking cessation in people with multiple sclerosis: qualitative study on the current practices and barriers for delivering assistance from the perspective of healthcare professionals in Germany
Objectives
Smoking is a well-established risk factor that exacerbates multiple sclerosis (MS) progression and increases disease activity. Smoking cessation promotion practices of MS clinicians are not meeting the needs of people with MS (pwMS). This study aimed to explore the current practices and barriers faced by MS clinicians in Germany.
Design
A qualitative study design, using semi-structured interviews and thematic analysis.
Setting
Interviews with participants were held online, via telephone or face-to-face at our institute in Hamburg, Germany.
Participants
We recruited eight neurologists and four MS nurses from hospitals, neurology practices and rehabilitation facilities in Germany via purposive and snowball sampling.
Results
We identified 27 codes across four themes: (1) knowledge: the 12 participants demonstrated a satisfactory general knowledge of the negative impacts of smoking on MS (2) current practice: significant variability was reported in the current practices, with some clinicians providing detailed advice while others merely assessing smoking status without further advice or assistance. (3) Barriers: key barriers identified included limited consultation time, perceived lack of patient motivation and insufficient availability of resources, like information material, for effective smoking cessation support. (4) Needs and wishes: participants wished for specific smoking cessation courses to which they could refer patients, as well as information material to use during patient counselling.
Conclusion
The study reveals considerable gaps in the consistency and comprehensiveness of smoking cessation support provided by MS clinicians in Germany. Addressing these gaps through targeted interventions, and improving the availability of information materials could enhance smoking cessation promotion for pwMS.