Exploring the Pharmacokinetics of Phenoxymethylpenicillin (Penicillin-V) in Adults: A Healthy Volunteer Study

This healthy volunteer study aimed to explore phenoxymethylpenicillin (penicillin-V) pharmacokinetics (PK) to support the planning of large dosing studies in adults. Volunteers were dosed with penicillin-V at steady state. Total and unbound penicillin-V serum concentrations were determined, and a base population PK model was fitted to the data.

Frequency of The Medical Disordrers and Life Satisfaction Among Geriatric Population of Hyderabad Sindh

Objectives: To determine the most common health-related disorders and life satisfaction among the geriatric population of Hyderabad Sindh. Material and Methods: This cross-sectional community-based study was conducted at department of Community Medicine of LUMHS Jamshoro on geriatric population of district Hyderabad. All the people of 60 years or over and either gender, were included in the study. The volunteer study contributors were pre-informed and approached at their convenient place and time. All study subjects were interviewed regarding their health disorders and life satisfaction. Following a written and informed consent, a self-structured questionnaire was filled by the study volunteers, in the presence of chief investigator under her guidance. All information was recorded via a structured study questioner. Results: Total 422 individuals were studied and their average age was 70.12+6.33 years. Out of 69.4% were males and 30.6% were females. Self-dependent individuals were 14.9%, pension dependents were 34.4%, and 50.7% had other sources of income. As per medical disorders, hypertension and diabetes were the most common health issues followed by vision problems, cardiac issues, dental caries, loss of teeth, osteoporosis, chronic pain, urinary incontinence, haemorrhoids, loss of appetite, stroke, loss of memory and sleeplessness. Health status was excellent in 5.7% of the patients, good health in 212(50.2%), fair health in 123(29.1%) and poor health status was found in 63(14.9%) of the patients. Conclusion: It was concluded that the geriatric population is at high risk of hypertension, GI-problem, liver disease, weight loss, Dental caries, vision problem, DM, obesity, stroke, lung disease, and Benign Prostrate hypertension. Most patients were unsatisfied with their life and this was mostly due to poor socio-economic. Keywords: Old age individuals, health, medical disorder

ILIVE Project Volunteer study. Developing international consensus for a European Core Curriculum for hospital end-of-life-care volunteer services, to train volunteers to support patients in the last weeks of life: A Delphi study

Background: Volunteers make a huge contribution to the health and wellbeing of the population and can improve satisfaction with care especially in the hospice setting. However, palliative and end-of-life-care volunteer services in the hospital setting are relatively uncommon. The iLIVE Volunteer Study, one of eight work-packages within the iLIVE Project, was tasked with developing a European Core Curriculum for End-of-Life-Care Volunteers in hospital. Aim: Establish an international consensus on the content of a European Core Curriculum for hospital end-of-life-care volunteer services which support patients in the last weeks of life. Design: Delphi Process comprising the following three stages: 1. Scoping review of literature into palliative care volunteers. 2. Two rounds of Delphi Questionnaire. 3. Nominal Group Meeting. Setting/participants: Sixty-six participants completed the Round 1 Delphi questionnaire; 75% (50/66) took part in Round 2. Seventeen participants attended the Nominal Group Meeting representing an international and multi-professional group including, clinicians, researchers and volunteer coordinators from the participating countries. Results: The scoping review identified 88 items for the Delphi questionnaire. Items encompassed organisational issues for implementation and topics for volunteer training. Three items were combined and one item added in Round 2. Following the Nominal Group Meeting 53/87 items reached consensus. Conclusion: Key items for volunteer training were agreed alongside items for implementation to embed the end-of-life-care volunteer service within the hospital. Recommendations for further research included in-depth assessment of the implementation and experiences of end-of-life-care volunteer services. The developed European Core Curriculum can be adapted to fit local cultural and organisational contexts.

Reinforcement Learning for Closed-Loop Propofol Anesthesia: A Human Volunteer Study

Research has demonstrated the efficacy of closed-loop control of anesthesia using the bispectral index (BIS) of the electroencephalogram as the controlled variable, and the development of model-based, patient-adaptive systems has considerably improved anesthetic control. To further explore the use of model-based control in anesthesia, we investigated the application of reinforcement learning (RL) in the delivery of patient-specific, propofol-induced hypnosis in human volunteers. When compared to published performance metrics, RL control demonstrated accuracy and stability, indicating that further, more rigorous clinical study is warranted.

AGILE: a seamless phase I/IIa platform for the rapid evaluation of candidates for COVID-19 treatment: an update to the structured summary of a study protocol for a randomised platform trial letter

Background There is an urgent unmet clinical need for the identification of novel therapeutics for the treatment of COVID-19. A number of COVID-19 late phase trial platforms have been developed to investigate (often repurposed) drugs both in the UK and globally (e.g. RECOVERY led by the University of Oxford and SOLIDARITY led by WHO). There is a pressing need to investigate novel candidates within early phase trial platforms, from which promising candidates can feed into established later phase platforms. AGILE grew from a UK-wide collaboration to undertake early stage clinical evaluation of candidates for SARS-CoV-2 infection to accelerate national and global healthcare interventions. Methods/design AGILE is a seamless phase I/IIa platform study to establish the optimum dose, determine the activity and safety of each candidate and recommend whether it should be evaluated further. Each candidate is evaluated in its own trial, either as an open label single arm healthy volunteer study or in patients, randomising between candidate and control usually in a 2:1 allocation in favour of the candidate. Each dose is assessed sequentially for safety usually in cohorts of 6 patients. Once a phase II dose has been identified, efficacy is assessed by seamlessly expanding into a larger cohort. AGILE is completely flexible in that the core design in the master protocol can be adapted for each candidate based on prior knowledge of the candidate (i.e. population, primary endpoint and sample size can be amended). This information is detailed in each candidate specific trial protocol of the master protocol. Discussion Few approved treatments for COVID-19 are available such as dexamethasone, remdesivir and tocilizumab in hospitalised patients. The AGILE platform aims to rapidly identify new efficacious and safe treatments to help end the current global COVID-19 pandemic. We currently have three candidate specific trials within this platform study that are open to recruitment. Trial registration EudraCT Number: 2020-001860-27 14 March 2020 ClinicalTrials.gov Identifier: NCT04746183 19 February 2021 ISRCTN reference: 27106947

No Clinical Symptom Experienced after Consumption of Berry Fruits with Positive RT-qPCR Signals of Human Norovirus

Human noroviruses (hNoVs) are the most important foodborne viruses, and soft berries are one of the most common food sources of hNoV outbreaks and contamination. This paper presents a human volunteer study in order to investigate the correlation between molecular detection results of hNoV in berries with the public health risks. The participants with diverse histo-blood group antigens (HBGAs) phenotypes were required to consume self-purchased berries and meanwhile submit aliquots of the products for reverse transcription-quantitative polymerase chain reaction (RT-qPCR) detection. As a result, none of the 20 participants reported any hNoV infection-like symptoms after six independent consumptions (120 consumptions in total). In contrast, within the 68 berry samples with >1% virus recoveries, 28 samples were detected to be positive for hNoV GI and/or GII (the positive rate at 41%). All of the positive signals were below the limit of quantification (<120 genome copies/g) except one fresh strawberry sample at 252 genome copies/g. It is expected that this study would contribute to the definition of quantitative standards for risk assessment purposes in the future.

Degenerative cervical spine changes among early career fighter pilots: a 5-year follow-up

IntroductionDegenerative changes of the cervical spine often cause disability and flight duty limitations among Finnish Air Force (FINAF) fighter pilots. We aimed to study the effect of +Gz exposure on degenerative changes in the cervical spine by comparing cervical MRIs of FINAF fighter pilots and controls.MethodsAt baseline, the volunteer study population consisted of 56 20-year-old FINAF male fighter pilots (exposure group) and 56 21-year-old Army and Navy cadets (control group). Both groups underwent MRI of the cervical spine at the baseline and after 5 years. Degenerative changes evaluated using MRI included intervertebral disc (IVD) degeneration (Pfirrmann classification), disc herniations, uncovertebral arthrosis, Schmorl’s nodes, Modic changes, spinal canal stenosis, kyphosis and scoliosis.ResultsThe degree of IVD degeneration in the whole cervical spine increased significantly in both populations with no between-group differences. The prevalence of disc herniations also tended to increase in both populations with no difference in the incidence over the follow-up. However, pilots proved to have more disc herniations at the baseline and at the follow-up. There were virtually no between-group differences in other assessed degenerative changes.DiscussionWe found that IVD degeneration and the prevalence of disc herniations increased at a similar rate for fighter pilots and non-flying military students when all cervical levels were summed up. The lack of difference may be explained by the relatively low cumulative +Gz exposure during the first 5 years of a pilots’ career.

Feasibility of Upper Gastrointestinal Examination in Home Care Setting with a Magnetically Assisted Capsule Endoscopy System: A Retrospective Study

The magnetic assisted capsule endoscope (MACE) with a hand-held magnetic field navigator (MFN) for upper gastrointestinal examination achieved satisfactory results in a healthy volunteer study. We evaluated the feasibility of upper gastrointestinal examination in the home care setting with the MACE system. Home care patients with upper gastrointestinal symptoms that received an MACE exam were enrolled in the study. MACE procedure time; completeness of observation of important anatomical landmarks; endoscopic diagnosis; patient tolerance during the procedure; and patient data, including age, sex, comorbidities, symptoms, body weight, and height, were retrieved from hospital information system for data analysis. A total of 16 participants were enrolled with a mean age 74.3 ± 15.4 years (47 to 99 years). One patient failed to swallow the capsule and was excluded. The average procedure time was 23.7 ± 10.0 min (14.1 to 42.5 min) to complete each endoscopic exam for the remaining 15 patients. The overall maneuverability in the esophagus, stomach, and duodenum was 93.75%, 87.5%, and 75%, respectively. Overall completeness in the aforementioned regions was 93.75%, 81.25%, and 75%, respectively. No severe adverse events were noted. The results clearly demonstrate the promise of using this MACE system to perform endoscopic examination outside the hospital for patients confined to the community and home.

Author Correction: Human volunteer study of the decontamination of chemically contaminated hair and the consequences for systemic exposure

An amendment to this paper has been published and can be accessed via a link at the top of the paper.