Risultati per: Cardio-oncology: rivista open access

Introduction
The PRaG regimen, which consists of hypofractionated radiotherapy combined with a programmed cell death-1/programmed cell death ligand-1 (PD-1/PD-L1) inhibitor and granulocyte-macrophage colony stimulating factor (GM-CSF), has been demonstrated to have a survival benefit in patients with advanced solid tumours who have failed at least two lines of treatment. Nonetheless, lymphopenia poses an impediment to the enduring efficacy of PD-1/PD-L1 inhibitor therapy. Adequate lymphocyte reserves are essential for the efficacy of immunotherapy. Coupling the PRaG regimen with immunomodulatory agents that augment the number and functionality of lymphocytes may yield further survival benefits in this cohort of patients.

Objective
The aim of this study is to investigate the effectiveness and safety of a meticulously thymalfasin-controlled PRaG regimen in patients with advanced and chemotherapy-resistant solid tumours.

Methods and analysis
The study has a prospective, single-arm, open-label, multicentre design and aims to recruit up to 60 patients with histologically confirmed advanced solid tumours that have relapsed or metastasised. All eligible patients will receive a minimum of two cycles of the PRaG regimen comprising thymalfasin followed by maintenance treatment with a PD-1/PD-L1 inhibitor and thymalfasin for 1 year or until disease progression. Patients will be monitored according to the predetermined protocol for a year or until disease progression after initiation of radiotherapy.

Ethics and dissemination
The study protocol was approved by the Ethics Committee of the Second Affiliated Hospital of Soochow University, on 25 November 2022 (JD-LK-2022-151-01) and all other participating hospitals. Findings will be disseminated through national and international conferences. We also plan to publish our findings in high-impact peer-reviewed journal.

Trial registration number
NCT05790447.

Stroke, Ahead of Print.

Objective
This randomised trial aimed to address whether endoscopic variceal ligation (EVL) or propranolol (PPL) is more effective at preventing initial oesophageal variceal bleeding (EVB) in patients with hepatocellular carcinoma (HCC).

Design
Patients with HCC and medium-to-large oesophageal varices (EVs) but without previous EVB were randomised to receive EVL (every 3–4 weeks until variceal eradication) or PPL (up to 320 mg daily) at a 1:1 ratio. Long-term follow-up data on EVB, other upper gastrointestinal bleeding (UGIB), non-bleeding liver decompensation, overall survival (OS) and adverse events (AEs) were analysed using competing risk regression.

Results
Between June 2011 and April 2021, 144 patients were randomised to receive EVL (n=72) or PPL (n=72). In the EVL group, 7 patients experienced EVB, and 30 died; in the PPL group, 19 patients had EVB, and 40 died. The EVL group had a lower cumulative incidence of EVB (Gray’s test, p=0.009) than its counterpart, with no mortality difference (Gray’s test, p=0.085). For patients with Barcelona Clinic Liver Cancer (BCLC) stage A/B, EVL was better than PPL in reducing EVB (p

A report from the nonprofit research organization RAND estimated that by 2028, about 1.6 million people in the US with mild cognitive impairment due to Alzheimer disease will wait an average of more than 1.5 years to see a dementia specialist, such as a neurologist or geriatric psychiatrist. These wait times are 3 times longer in rural areas.

BackgroundThe escalating prevalence of mental health issues among university students is alarming, particularly as many do not receive necessary mental health interventions. While existing qualitative research has shed light on the perceived barriers students face accessing mental health care, our study explored the experiences of healthcare professionals who interact with these students. Our aim is to enhance the understanding of students’ accessibility to mental health care.MethodsBetween June 2022 and January 2023, we conducted semi-structured interviews with 23 professionals from university services, NHS general practice, crisis teams and psychological services in London. Data analysis was carried out concurrently with data collection, utilising reflexive thematic analysis and abductive analysis principles. The concept of ‘candidacy’ was instrumental in deciphering the ongoing phenomena observed in the data.ResultsOur findings indicate that students’ access to appropriate mental health care is intricately linked to their evolving social context, the structure, and pressures of the local health system. Professionals highlighted variability in students’ perceptions of what health issues warranted medical attention. The students who made it to a professional’s service were often those with more resources and better relationships to leverage. Once in the system, the actions professionals took were heavily influenced by their specific roles and expertise, available resources, but also by their service’s relationship with other organisations, and the types of support students deemed acceptable.ConclusionsThe concept of candidacy offers a useful lens to view university students’ access to mental health support. Access appears to be an increasingly intricate task for students, given the fragmented service landscape, surging demand for mental health care and the challenges of emerging adulthood. Our research suggests that mere policy shifts promoting increased use of mental health services may not yield better outcomes for students without holistic consideration of inter-service relationships and available resources.

BackgroundModern open science initiatives have implications for qualitative researchers, particularly in relation to ‘open’ data.AimWe describe the process of data-sharing for a qualitative interview study, to make transparent our thinking and decision-making around open data for our particular project.MethodsThe initial project aimed to explore perspectives of young adults on what precipitates and maintains feelings of loneliness among this age group. Participants did not necessarily need to discuss personal experiences of loneliness. 27 virtual interviews were conducted with young adults between 18 and 25 years.Results26 participants consented to make their anonymised transcripts available via the Irish Qualitative Data Archive; 24 transcripts were archived. One excluded transcript contained very rich descriptions of niche social activities and rare life events that could identify the participant. However, redacting these details meant that there was scant information left, and what was left was divorced from the rich context in which it was provided. For a further transcript, the participant had a relatively rare combination of demographic characteristics. These, combined with the detailed discussion of participants’ own characteristics and activities in the interview, meant that risk of identification of the participant was too great, even if access was restricted to educational and research use. Interestingly, one participant (whose transcript was archived) used no identifying information that definitively merited redaction or replacement, suggesting that even when participants consent to data archiving, this might shape the way in which they engage with the interview.ConclusionsData-sharing is more complex than ‘open’ or ‘closed’. Purposeful consideration of the why and how of data-sharing can support researchers to make optimal use of participant data while being mindful of the ways in which data sharing can shape the context of qualitative data collection.

The US Supreme Court’s decision in the Dobbs v Jackson Women’s Health Organization case allows individual states to determine access to abortion. Since the decision, 14 states have prohibited abortion at any gestational age.

JAMA Oncology is committed to publishing influential original research, opinions, and reviews that advance the science of oncology and improve the clinical care of patients with cancer.

This review examines the race and ethnicity of participants enrolled in pediatric studies conducted in response to written requests from the US Food and Drug Administration (FDA) for which pediatric exclusivity was granted between 2001 and 2021.

Introduction
Oesophageal cancer (OC) has higher morbidity and mortality rate than most other malignancies. The standard treatment for unresectable locally advanced oesophageal squamous cell carcinoma (OSCC) is concurrent chemoradiotherapy, with tumour regression observed in a proportion of patients after treatment, but prognostic improvement remains limited. Immunotherapy in combination with chemotherapy (CT) has been shown to be efficacious as the first-line treatment of advanced OC and neoadjuvant therapy. Therefore, we conducted a prospective, two-arm, randomised, unblinded phase II study to explore the efficacy of camrelizumab in combination with CT versus chemoradiotherapy for the conversion of unresectable advanced OSCC.

Methods and analysis
All participants meeting the inclusion criteria will be enrolled after signing an informed consent form. Patients with clinically cT4b or spread to at least one group of lymph nodes with possible invasion of surrounding organs and unresectable locally advanced squamous carcinoma of the thoracic segment of the oesophagus will be included in the study. Patients with suspected distant metastases on the preoperative examination will be excluded from this study. Patients eligible for enrolment will be grouped by centre randomisation according to the study plan. Patients will undergo radical surgery after completion of two cycles of chemotherapy (CT) combined with camrelizumab induction therapy or concurrent chemoradiotherapy if assessed to be operable. Patients evaluated as inoperable will be scheduled for a multidisciplinary consultation to determine the next treatment option. The primary endpoint is the R0 resection rate in patients undergoing surgery after treatment. Secondary endpoints are the rate of major pathological remission, pathological complete response rate, overall survival, progression-free survival and adverse events for all patients.

Ethics and dissemination
Ethical approval was obtained from the ethics committees of Fujian Medical University Union Hospital (No. 2022YF039-02). The findings will be disseminated in peer-reviewed publications.

Trial registration number
NCT05821452.

Introduction
In opioid therapy for cancer pain, opioid-induced nausea and vomiting (OINV) occur in 20%–40% of patients during initial opioid treatment or increasing opioid doses. OINV result in failure to achieve pain relief due to poor opioid adherence. Therefore, antiemetics are used to prevent OINV, but their efficacy and safety in this context have not yet been fully elucidated. Olanzapine is a promising antiemetic for the prophylaxis of chemotherapy-induced nausea and vomiting.

Methods and analysis
This single-arm, single-centre exploratory study will evaluate the prophylactic antiemetic efficacy and safety of 5 mg olanzapine in patients with cancer pain who are withholding initial regular opioid therapy. Thirty-five patients will be enrolled. The primary endpoint is the proportion of patients achieving complete control (CC) of OINV during 5 days of opioid treatment. CC was defined as the absence of emetic episodes, no need for rescue medication to treat nausea, and minimal or no nausea (3 or less on an 11-point categorical scale). Secondary endpoints include the complete response, defined as no emetic episodes and no use of rescue medication during the overall assessment period, the time from opioid initiation to first emetic episode, the time from opioid initiation to first rescue antiemetic administration, and adverse events graded by Patient-Reported Outcome (PRO) Common Terminology Criteria for Adverse Events (CTCAE) version 1.0 and CTCAE version 5.0.

Ethics and dissemination
This study protocol was approved by National Cancer Center Hospital Certified Review Board. The results will be used as preliminary data to conduct a validation study.

Trial registration number
Japan Registry of Clinical Trials (jRCT) jRCTs031220008.

Background
People living with HIV (PLWH) are more likely to develop hypertension and diabetes than people without HIV. Previous studies have shown that HIV stigma, discrimination and exclusion make it difficult for PLWH to access care for hypertension and diabetes.

Objectives
This study aimed to explore the lived experiences of PLWH with comorbid hypertension or diabetes to access hypertension and diabetes care in southern Ethiopia.

Design
We conducted a qualitative study using a semistructured interview guide for an in-depth, in-person interview.

Settings
From 5 August to 25 September 2022, PLWH with comorbid hypertension or diabetes were purposefully selected from five primary healthcare (PHC) facilities in the Wolaita zone of southern Ethiopia.

Participants
A total of 14 PLWH with comorbid hypertension or diabetes who were receiving antiretroviral therapy from PHC were interviewed. Among them, 10 were women, and 4 were men.

Methods
In-person, in-depth interviews were conducted. Qualitative data analysis software (NVivo V.12) was used to assist with the data organisation, and Colaizzi’s (1978) inductive thematic analyses were conducted to explore key concepts.

Result
This study yielded two main themes: Theme 1: barriers to accessing care as individual barriers to access (low awareness of non-communicable diseases, misperceptions, lack of health insurance and cost of treatment); healthcare system barriers (shortage of supplies, drugs and equipment; long wait times; lack of integrated services; absence of routine screening and lack of respect from providers); community barriers (lack of support from families, friends and the community) and stigma and discrimination access to hypertension and diabetes. Theme 2: accessibility facilitators (support from family, friends and organisations; health insurance coverage).

Conclusion
PLWH recommended that access to services can be improved by service integration, awareness-raising activities, no user fee charges for hypertension and diabetes care and routine screening.

Introduction
Sarcopenia is the age-associated loss of muscle mass and strength. Nicotinamide adenine dinucleotide (NAD) plays a central role in both mitochondrial function and cellular ageing processes implicated in sarcopenia. NAD concentrations are low in older people with sarcopenia, and increasing skeletal muscle NAD concentrations may offer a novel therapy for this condition. Acipimox is a licensed lipid-lowering agent known to act as an NAD precursor. This open-label, uncontrolled, before-and-after proof-of-concept experimental medicine study will test whether daily supplementation with acipimox improves skeletal muscle NAD concentrations.

Methods and analysis
Sixteen participants aged 65 and over with probable sarcopenia will receive acipimox 250 mg and aspirin 75 mg orally daily for 4 weeks, with the frequency of acipimox administration being dependent on renal function. Muscle biopsy of the vastus lateralis and MRI scanning of the lower leg will be performed at baseline before starting acipimox and after 3 weeks of treatment. Adverse events will be recorded for the duration of the trial. The primary outcome, analysed in a per-protocol population, is the change in skeletal muscle NAD concentration between baseline and follow-up. Secondary outcomes include changes in phosphocreatine recovery rate by 31P magnetic resonance spectroscopy, changes in physical performance and daily activity (handgrip strength, 4 m walk and 7-day accelerometry), changes in skeletal muscle mitochondrial respiratory function, changes in skeletal muscle mitochondrial DNA copy number and changes in NAD concentrations in whole blood as a putative biomarker for future participant selection.

Ethics and dissemination
The trial is approved by the UK Medicines and Healthcare Products Regulatory Agency (EuDRACT 2021-000993-28) and UK Health Research Authority and Northeast – Tyne and Wear South Research Ethics Committee (IRAS 293565). Results will be made available to participants, their families, patients with sarcopenia, the public, regional and national clinical teams, and the international scientific community.

Protocol
Acipimox feasibility study Clinical Trial Protocol V.2 2/11/21.

Trial registration number
The ISRCTN trial database (ISRCTN87404878).

Objectives
This study aimed to explore the experiences of multidisciplinary medical teams in implementing humanistic palliative care within the oncology ward.

Design
Purposive and snowball sampling methods were used in this qualitative study, which involved conducting semistructured interviews to gather personal experiences from members of multidisciplinary medical teams providing humanistic palliative care in the oncology ward.

Setting
The research was conducted in the oncology ward of a tertiary hospital located in Foshan, China.

Participants
Participants included 4 doctors, 12 nurses and 2 medical social workers who form the multidisciplinary medical team responsible for delivering humanistic palliative care to patients with cancer in oncology wards.

Results
Phenomenological qualitative analysis yielded 3 main themes and 9 subthemes. The identified themes were as follows: (1) conceptual change, (2) concrete actions and (3) facilitators and barriers to the implementation of humanistic palliative care.

Conclusion
The findings suggest a need for strengthening humanistic consciousness among multidisciplinary palliative care teams working in oncology wards, although there has been a gradual improvement in humanistic care behaviours. Furthermore, facilitators and barriers coexist in the implementation of humanistic palliative care. Efforts should be directed towards refining mechanisms that promote humanistic palliative care, fostering the enthusiasm of healthcare professionals, conducting systematic training to enhance their humanistic care abilities and striving for improvements in the quality of medical services for the benefit of both patients and their families.

Circulation, Volume 149, Issue 9, Page 725-726, February 27, 2024.

Circulation, Volume 149, Issue 9, Page 727-728, February 27, 2024.