Regulatory workshop on standardisation of clinical procedures, endpoints and data robustness of human challenge studies - A stakeholder meeting report.

Inno4Vac, a public-private partnership funded by the IMI2/EU/EFPIA Joint Undertaking (IMI2 JU), brings together academic institutions, SMEs, and pharmaceutical companies to accelerate and de-risk vaccine development. The project has made significant strides in the selection and production of challenge agents for influenza, respiratory syncytial virus (RSV), and toxigenic Clostridioides difficile for controlled human infection model studies (CHIMs). A regulatory workshop held on March 20, 2024, addressed the standardisation of clinical procedures, ethical considerations, endpoints, and data integrity, highlighting the ongoing initiatives related to these CHIMs.

Viral Encephalitis after Hematopoietic Cell Transplantation: A Systematic Review.

Viral encephalitis is a rare but serious complication after hematopoietic cell transplantation (HCT). The nonspecific early signs and symptoms and rapid progression can make it difficult to diagnose and treat in a timely fashion. To better inform clinical decision making in post-HCT viral encephalitis, a systematic review of prior studies of viral encephalitis was performed, with the goal of characterizing the frequency of various infectious etiologies and their clinical course, including treatments and outcomes.

Tissue specific signature of HHV-6 infection in ME/CFS.

First exposure to various human herpesviruses (HHVs) including HHV-6, HCMV and EBV does not cause a life-threatening disease. In fact, most individuals are frequently unaware of their first exposure to such pathogens. These herpesviruses acquire lifelong latency in the human body where they show minimal genomic activity required for their survival.

A Systematic Review of Human Challenge Trials, Designs, and Safety.

Background: Few studies have assessed participant safety in human challenge trials (HCTs). Key questions regarding HCTs include how risky such trials have been, how often adverse events (AEs) and serious adverse events (SAEs) occur, and whether risk mitigation measures have been effective.

Methods: A systematic search of PubMed and PubMed Central for articles reporting on results of HCTs published between 1980 and 2021 was performed and completed by 7 October 2021.

Winner Winner Turkey Dinner! An Empirical Approach to Measuring Palatability and Satisfaction with Emergency Department Turkey Sandwiches.

Introduction: Despite their popularity in many EDs, little is known regarding perceptions of turkey sandwiches among patients. Given the importance of turkey sandwiches as a form of nutrition provided in EDs, we sought to quantify the composition and taste of ED turkey sandwiches through a quantitative assessment of turkey sandwiches by ED staff.

Methods: This was a blinded observational study performed at a tertiary, urban academic medical center in Boston, MA.

A retrospective review of implementation of an inhaled epoprostenol protocol in the emergency department.

Introduction: Inhaled epoprostenol is a selective pulmonary vasodilator that has shown a potentially broad number of applications in the management of critically ill patients. To date, the vast majority of the literature with regard to efficacy, indications for use, and adverse effects of inhaled epoprostenol is focused on use of this agent in critical care settings, with relatively little literature describing use of inhaled epoprostenol in the Emergency Department. This retrospective review sought to examine instances in which inhaled epoprostenol was administered in the Emergency Department of a tertiary-care, Level I trauma center following implementation of a clinical pathway for administration of this medication for cases of refractory hypoxemia, RV dysfunction, and refractory hypoxemia.

Segmental arterial mediolysis: a rare cause of an acute abdomen.

Segmental arterial mediolysis (SAM) is a nonatherosclerotic, noninflammatory and nonimmune arteriopathy of unknown aetiology. We present the case of a 43-year-old male who presented to the emergency department with abdominal pain. A computed tomography of abdomen and pelvis showed a narrow, hypodense superior mesenteric artery after the origin, raising the possibility of thrombus or vasculitis.

Pragmatic use of short-course radiotherapy, chemotherapy and surgery for stage IV rectal cancer with locally advanced or symptomatic primary tumours.

Introduction: We assessed management of patients with de novo metastatic rectal cancer, referred for radiotherapy to the rectum, who were candidates for short-course radiotherapy (SCRT) and chemotherapy, followed by resection of all disease. We assessed surgical outcomes, overall survival (OS) and progression-free survival (PFS).

Methods: Retrospective review of patients meeting criteria: (i) treatment with SCRT to rectum; (ii) locally advanced primary rectal cancer; and (iii) resectable distant metastases at diagnosis.

The surgical admission proforma: the impact on quality and completeness of surgical admission documentation.

Background: Inadequate medical documentation has been associated with a higher rate of adverse events and may have medicolegal consequences. An accurate admission note is critical as it is frequently referred to during inpatient stay, particularly when the patient is acutely unwell and during handover of care.

Aim: We set out to implement a surgical admission proforma and evaluate its impact on the quality of acute surgical admission notes.

Single access laparoscopic total colectomy for severe refractory ulcerative colitis.

Background: Single port laparoscopic surgery allows total colectomy and end ileostomy for medically uncontrolled ulcerative colitis solely the stoma site incision. While intuitively appealing, there is sparse evidence for its use beyond feasibility.

Aim: To examine the usefulness of single access laparoscopy (SAL) in a general series experience of patients sick with ulcerative colitis.

How manual therapy provided a gateway to a biopsychosocial management approach in an adult with chronic post-surgical low back pain: a case report.

Background: The management of patients with chronic post-surgical low back pain can be very challenging to surgeons, physiotherapists, and patients alike. Subsequent surgery is often associated with post-operative complications and even lower levels of success than the initial spinal surgery. Physiotherapy is often recommended as the first-line management, however, debate exists amongst physiotherapists regarding the optimal treatment strategy.

Retrospective case analysis of antiviral therapies for HHV-6 encephalitis after hematopoietic stem cell transplantation.

Human herpesvirus 6 (HHV-6) is one of the most common causes of encephalitis in allogeneic hematopoietic stem cell transplant (HCT) recipients and is associated with significant morbidity and mortality. There are no FDA-approved treatments specifically for HHV-6 encephalitis; HHV-6 disease is typically treated with CMV antivirals. A review of antiviral medications used to treat HHV-6 encephalitis was conducted by aggregating data from case reports found on PubMed.

Technical challenges and potential solutions for rectal and sigmoid tumours following previous radiation for prostate malignancy: A case series.

Introduction: The aftermath of pelvic radiotherapy for prostate cancer (PC) can pose a significant challenge for surgeons in the management of rectal and sigmoid tumours, resulting in extensive fibrosis and difficult anatomy. Higher rates of ureteric injuries and anastomotic leakage following anterior resection (AR) have been reported with no clear consensus for an optimal approach. We present three cases, each employing a different surgical approach tailored to the individual patient-specific and disease-specific factors.

Adaptation of an Intervention to Reduce Disparities in School HRQOL for Latino Childhood Cancer Survivors.

Objective: Survivors of childhood leukemia, especially those from low socioeconomic status households, often experience persistent neurocognitive and academic impairment. This study adapted an existing parent training intervention to improve outcomes for low-acculturated, Spanish-speaking Latino parents of children with leukemia and pilot tested that intervention for feasibility.

Methods: Semistructured interviews were conducted with a focus group of 20 Latino parents of children treated for leukemia.

The clinical dilemma of the persistent idiopathic pneumoperitoneum: A case report.

Introduction: Idiopathic pneumoperitoneum (IP) is a rare phenomenon which merits special attention. It is defined as free intraperitoneal air which is not caused by viscus perforation and does not require surgical intervention. It is generally considered a diagnosis of exclusion and often poses a genuine diagnostic dilemma.

Scope and Safety of Paediatric Surgery in a Model III Hospital.

Introduction Elective and emergency paediatric general surgery is performed in numerous hospitals but with differing exclusion and transfer thresholds. Recent national guidelines detail necessary surgical, anaesthetic and nursing resources for safe and efficient delivery of services. Methods A retrospective review of paediatric surgical admissions was performed from January 2015 to December 2016.

First pediatric experience of SL-401, a CD123-targeted therapy, in patients with blastic plasmacytoid dendritic cell neoplasm: report of three cases.

Background: Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a highly aggressive hematological malignancy with extremely poor outcome. The median overall survival for adult patients is 9-13 months. Pediatric patients are exceedingly rare with an unclear clinical course.

Digital Imaging and Communications in Medicine Whole Slide Imaging Connectathon at Digital Pathology Association Pathology Visions 2017.

As digital pathology systems for clinical diagnostic work applications become mainstream, interoperability between these systems from different vendors becomes critical. For the first time, multiple digital pathology vendors have publicly revealed the use of the digital imaging and communications in medicine (DICOM) standard file format and network protocol to communicate between separate whole slide acquisition, storage, and viewing components. Note the use of DICOM for clinical diagnostic applications is still to be validated in the United States.

Effective communication enhances the patients' endoscopy experience.

Background: Undergoing an endoscopy is a stressful experience for patients.

Aims: To audit the endoscopy pathway to improve patient satisfaction.

Methods: A prospective survey of endoscopy patients to identify system improvements that were then implemented.

Prevalence of and attitudes about concussion in Irish schools' rugby union players.

Background: Youth rugby players represent 45.2% (N = 69,472) of the Irish rugby union playing population. The risk and consequences of concussion injury are of particular concern in these young athletes, but limited epidemiological data exists.