Clinical ethics evaluation

BACKGROUND: The lack of harmonization of evaluation criteria by Ethics Committees in the European Union (EU) has led to inconsistent ethics reviews received by research sites participating in multicenter non-interventional studies. The European General Data Protection Regulation (GDPR) appears to be implemented at national level with a substantial degree of variance in interpretation. The European Reference Networks (ERNs) were struggling in setting an Informed Consent Form (ICF) for registries, allowing reuse of data for research purposes...

BACKGROUND AND OBJECTIVES: This study examines aortomesenteric angle (AMA) and distance (AMD), which are critical in superior mesenteric artery (SMA) syndrome. Addressing the scarcity of SMA cases, the research explores potential links with lower BMI and aims to establish normative data for diagnostic and predictive purposes, using contrast-enhanced computed tomography (CT) scans across various BMI and sex categories. METHODOLOGY: A retrospective quantitative cross-sectional study was conducted on 189 patients undergoing abdominal contrast-enhanced CT scans between December 2019 and December 2020...

BACKGROUND: Artificial intelligence (AI) chatbots, such as ChatGPT-4, have shown immense potential for application across various aspects of medicine, including medical education, clinical practice, and research. OBJECTIVE: This study aimed to evaluate the performance of ChatGPT-4 in the 2023 Taiwan Audiologist Qualification Examination, thereby preliminarily exploring the potential utility of AI chatbots in the fields of audiology and hearing care services. METHODS: ChatGPT-4 was tasked to provide answers and reasoning for the 2023 Taiwan Audiologist Qualification Examination...

INTRODUCTION: A prototype lateral flow device detecting cytokine biomarkers interleukin (IL)-1α and IL-1β has been developed as a point-of-care test-called the Genital InFlammation Test (GIFT)-for detecting genital inflammation associated with sexually transmitted infections (STIs) and/or bacterial vaginosis (BV) in women. In this paper, we describe the rationale and design for studies that will be conducted in South Africa, Zimbabwe and Madagascar to evaluate the performance of GIFT and how it could be integrated into routine care...

INTRODUCTION: Gait and mobility impairment are pivotal signs of parkinsonism, and they are particularly severe in atypical parkinsonian disorders including multiple system atrophy (MSA) and progressive supranuclear palsy (PSP). A pilot study demonstrated a significant improvement of gait in patients with MSA of parkinsonian type (MSA-P) after physiotherapy and matching home-based exercise, as reflected by sensor-based gait parameters. In this study, we aim to investigate whether a gait-focused physiotherapy (GPT) and matching home-based exercise lead to a greater improvement of gait performance compared with a standard physiotherapy/home-based exercise programme (standard physiotherapy, SPT)...

INTRODUCTION: Symptoms due to chemotherapy are common in patients with cancer. Cancer-related symptoms are closely associated with the deterioration of physical function which can be associated with decreased quality of life and increased mortality. Thus, timely symptom identification is critical for improving cancer prognosis and survival. Recently, remote symptom monitoring system using digital technology has demonstrated its effects on symptom control or survival. However, few studies examined whether remote monitoring would contribute to retaining physical function among patients with cancer...

INTRODUCTION: Video-electroencephalogram (EEG) with suggestion is widely considered the gold standard for diagnosing psychogenic nonepileptic seizures (PNES). However, ethical concerns and uncertainties persist regarding the most minimally invasive and least deceptive suggestion approach. MATERIALS AND METHODS: In an open-label randomized controlled trial, we evaluated the effectiveness of three suggestion methods (verbal suggestion, verbal suggestion with a tuning fork, and verbal suggestion with a cotton swab) during short-term video-EEG (STVEEG) recordings to induce PNES in children aged 5-18 years...

Phage therapy has re-emerged as a promising treatment for non-resolving infections. Given the lack of approved phage treatments, there is a need to establish a compassionate use pipeline. Here, we present a protocol for phage matching, treatment, and monitoring for compassionate bacteriophage use in non-resolving infections. We describe steps for consultation and request implementation, evaluating and comparing different aspects of phage activity, and phage production. We then detail procedures for multidisciplinary meetings, ethics approvals, phage therapy, and follow-up...

BACKGROUND: Therapeutic latency, lack of efficacy and adverse drug reactions are the major concerns in current antidepressant therapies. To overcome these treatment hurdles, add-on therapy to conventional antidepressant medications may lead to better therapeutic outcomes. The present randomised controlled trial has been planned to evaluate the efficacy and safety of add-on dextromethorphan to selective serotonin reuptake inhibitors (SSRIs) in major depressive disorder (MDD). METHODS AND ANALYSIS: A randomised, double-blind, add-on, placebo-controlled, group sequential design clinical trial will be conducted on patients with MDD who will be randomly assigned to the control and the test group in a 1:1 ratio...

INTRODUCTION: Cardiac rehabilitation (CR) delivered by rehabilitation specialists in a healthcare setting is effective in improving functional capacity and reducing readmission rates after cardiac surgery. It is also associated with a reduction in cardiac mortality and recurrent myocardial infarction. This trial assesses the feasibility of a home-based CR programme delivered using a mobile application (app). METHODS: The Rehabilitation through Exercise prescription for Cardiac patients using an Artificial intelligence web-based Programme (RECAP) randomised controlled feasibility trial is a single-centre prospective study, in which patients will be allocated on a 1:1 ratio to a home-based CR programme delivered using a mobile app with accelerometers or standard hospital-based rehabilitation classes...

OBJECTIVE: This scoping review aimed to identify manualised programs and practice suggestions to support children's health literacy, behaviors and emotions after a parental acquired brain injury. METHODS: A systematic search of five scientific databases (PsychINFO, MEDLINE, ProQuest, Scopus, Cochrane) and gray literature occurred. Inclusion criteria included: studies and gray literature published 1989 to 2023, in English, child populations with relationship to parental acquired brain injury, identifying manualised programs or practice suggestions via content analysis approach...

INTRODUCTION: The development of malignant tumors in patients with hydranencephaly is extremely rare. We describe the first case of testicular cancer that developed in the undescended testes of a long-term survivor of hydranencephaly. CASE PRESENTATION: A 32-year-old man with severe cerebral palsy due to hydranencephaly was referred to our department for the evaluation of a subcutaneous lump in the lower right abdomen. He was a long-term survivor of hydranencephaly...

BACKGROUND: Severe pneumonia (SP) stands as one of the most prevalent critical illnesses encountered in clinical practice, characterised by its rapid onset and progression, numerous complications and elevated mortality rates. While modern medical interventions primarily focus on symptomatic management such as anti-infective therapy and mechanical ventilation, challenges including high drug resistance and suboptimal therapeutic outcomes for certain patients persist. Dry cupping as an ancient practice with over a millennium of clinical use in China is renowned for its convenience and perceived clinical efficacy in various illnesses...

Effective and sustainable strategies are needed to address the burden of preventable deaths among children under-five in resource-constrained settings. The Tools for Integrated Management of Childhood Illness (TIMCI) project aims to support healthcare providers to identify and manage severe illness, whilst promoting resource stewardship, by introducing pulse oximetry and clinical decision support algorithms (CDSAs) to primary care facilities in India, Kenya, Senegal and Tanzania. Health impact is assessed through: a pragmatic parallel group, superiority cluster randomised controlled trial (RCT), with primary care facilities randomly allocated (1:1) in India to pulse oximetry or control, and (1:1:1) in Tanzania to pulse oximetry plus CDSA, pulse oximetry, or control; and through a quasi-experimental pre-post study in Kenya and Senegal...

OBJECTIVE: This study aimed to establish the association between HLA-A, B, DR genotypes and gastrointestinal variables in patients with SpA without inflammatory bowel disease (IBD). METHODS: Retrospective study of 91 patients with SpA and 401 healthy controls, with typing by Illumina Sequencing/PacBio and LIFECODES HLA-PCR/SSO multiplex sequencing technology. The presence of gastrointestinal symptoms was evaluated by administering a survey, and those who presented 2 or more symptoms were taken for clinical evaluation by rheumatology and gastroenterology, colonoscopy and histopathological study...

BACKGROUND: Pediatric airway management requires careful clinical evaluation and experienced execution due to anatomical, physiological, and developmental considerations. Video laryngoscopy in pediatric airways is a developing area of research, with recent data suggesting that video laryngoscopes are better than standard Macintosh blades. Specifically, there is a paucity of literature on the advantages of the C-MAC D-blade compared to the McCoy direct laryngoscope. METHODS: After Ethics Committee approval, 70 American Society of Anesthesiologists physical status 1 and 2 children aged 4-12 years scheduled for elective surgery under general anesthesia were recruited...

BACKGROUND: Rapid reduction of leukemic cells in the bone marrow during remission induction chemotherapy (RIC) can lead to significant complications such as tumor lysis syndrome (TLS). We investigated whether prephase steroid treatment before RIC could decrease TLS incidence and improve overall survival in pediatric patients with acute lymphoblastic leukemia (ALL). METHODS: Data were extracted from the Common Data Model databases in two tertiary-care hospitals in Seoul, South Korea...

BACKGROUND/AIMS: The aim of this study was to prospectively evaluate stereotactic body radiotherapy (SBRT) with robotic radiosurgery in hepatocellular carcinoma patients with macrovascular invasion (HCC-PVT). MATERIALS AND METHODS: Patients with inoperable HCC-PVT, good performance score (PS0-1) and preserved liver function [up to Child-Pugh (CP) B7] were accrued after ethical and scientific committee approval [Clinical trial registry-India (CTRI): 2022/01/050234] for treatment on robotic radiosurgery (M6) and planned with Multiplan (iDMS V2...

INTRODUCTION: Despite advances in immunomodulatory treatments of multiple sclerosis (MS), patients with non-active progressive multiple sclerosis (PMS) continue to face a significant unmet need. Demyelination, smoldering inflammation and neurodegeneration are important drivers of disability progression that are insufficiently targeted by current treatment approaches. Promising preclinical data support repurposing of metformin for treatment of PMS. The objective of this clinical trial is to evaluate whether metformin, as add-on treatment, is superior to placebo in delaying disease progression in patients with non-active PMS...

PURPOSE: The purpose of this study was to systematically review the reported performances of ChatGPT, identify potential limitations, and explore future directions for its integration, optimization, and ethical considerations in radiology applications. MATERIALS AND METHODS: After a comprehensive review of PubMed, Web of Science, Embase, and Google Scholar databases, a cohort of published studies was identified up to January 1, 2024, utilizing ChatGPT for clinical radiology applications...