Collection and Analysis of Adherence Information for Software as a Medical Device Clinical Trials: Systematic Review.

Background: The rapid growth of digital health apps has necessitated new regulatory approaches to ensure compliance with safety and effectiveness standards. Nonadherence and heterogeneous user engagement with digital health apps can lead to trial estimates that overestimate or underestimate an app's effectiveness. However, there are no current standards for how researchers should measure adherence or address the risk of bias imposed by nonadherence through efficacy analyses.

Phase I trial of panobinostat in children with diffuse intrinsic pontine glioma: A report from the Pediatric Brain Tumor Consortium (PBTC-047).

Background: Diffuse intrinsic pontine glioma (DIPG) is a lethal childhood cancer with median survival of less than 1 year. Panobinostat is an oral multihistone deacetylase inhibitor with preclinical activity in DIPG models. Study objectives were to determine safety, tolerability, maximum tolerated dose (MTD), toxicity profile, and pharmacokinetics of panobinostat in children with DIPG.

Phase II Randomized Trial of Lenalidomide in Children With Pilocytic Astrocytomas and Optic Pathway Gliomas: A Report From the Children's Oncology Group.

Purpose: Children with low-grade glioma often require long-term therapy and suffer from treatment morbidity. Although targeted agents are promising, tumor targets often encompass normal developmental pathways and long-term effects of inhibition are unknown. Lenalidomide is an immunomodulatory agent with wide-ranging properties.

Evaluation of the effect of a Nursing System Framework on Nurse Sensitive Indicators, mortality and readmission in an NHS Trust.

Unlabelled: In 2018, an NHS Trust (UK) implemented an innovative Nursing System Framework (NSF). The NSF formalized a two-year strategy, which provided teams with clear aims and measurable objectives to deliver care. Failures of coordination of nursing services are well-recognized threats to the quality, safety and sustainability of care provision.

Response assessment in pediatric craniopharyngioma: recommendations from the Response Assessment in Pediatric Neuro-Oncology (RAPNO) Working Group.

Background: Craniopharyngioma is a histologically benign tumor of the suprasellar region for which survival is excellent but quality of life is often poor secondary to functional deficits from tumor and treatment. Standard therapy consists of maximal safe resection with or without radiation therapy. Few prospective trials have been performed, and response assessment has not been standardized.

Response assessment in paediatric intracranial ependymoma: recommendations from the Response Assessment in Pediatric Neuro-Oncology (RAPNO) working group.

Response criteria for paediatric intracranial ependymoma vary historically and across different international cooperative groups. The Response Assessment in the Pediatric Neuro-Oncology (RAPNO) working group, consisting of an international panel of paediatric and adult neuro-oncologists, neuro-radiologists, radiation oncologists, and neurosurgeons, was established to address both the issues and the unique challenges in assessing the response in children with CNS tumours. We established a subcommittee to develop response assessment criteria for paediatric ependymoma.

Single-dose pharmacokinetics and bioavailability of a novel extended duration transdermal buprenorphine solution in cats.

A novel transdermal buprenorphine solution (TBS) was developed for evaluation in order to make available an extended duration opioid analgesic for cats. Healthy adult cats were administered a single TBS dose of 10 mg (1.57-4.

Vaccine Side Effects Following COVID-19 Vaccination Among the Residents of the UAE-An Observational Study.

COVID-19 vaccines have proven to be very safe in the clinical trials, however, there is less evidence comparing the safety of these vaccines in real-world settings. Therefore, we aim to investigate the nature and severity of the adverse effects reported and the differences based on the type of vaccine received. A survey was conducted among 1,878 adult (≥18 years) COVID-19 vaccine recipients through online survey platforms and telephonic interviews during March to September 2021.

Joint EANM/SIOPE/RAPNO practice guidelines/SNMMI procedure standards for imaging of paediatric gliomas using PET with radiolabelled amino acids and [F]FDG: version 1.0.

Positron emission tomography (PET) has been widely used in paediatric oncology. 2-Deoxy-2-[F]fluoro-D-glucose ([F]FDG) is the most commonly used radiopharmaceutical for PET imaging. For oncological brain imaging, different amino acid PET radiopharmaceuticals have been introduced in the last years.

Dual mTORC1/2 inhibition compromises cell defenses against exogenous stress potentiating Obatoclax-induced cytotoxicity in atypical teratoid/rhabdoid tumors.

Atypical teratoid/rhabdoid tumors (AT/RT) are the most common malignant brain tumors of infancy and have a dismal 4-year event-free survival (EFS) of 37%. We have previously shown that mTOR activation contributes to AT/RT's aggressive growth and poor survival. Targeting the mTOR pathway with the dual mTORC1/2 inhibitor TAK-228 slows tumor growth and extends survival in mice bearing orthotopic xenografts.

Immune response of booster doses of BBIBP-CORV vaccines against the variants of concern of SARS-CoV-2.

Background: Booster doses for COVID-19 vaccinations are currently recommended and approved in many countries. However, we need more evidence on the immune response of individuals to booster doses of inactivated vaccines and the neutralizing effect against the variants of concerns of SARS-CoV-2.

Objective: To compare the fold reduction in antibody titers against the variants of concerns of SARS-CoV-2 between the primary doses and booster dose vaccine cohorts of inactivated BBIBP-CorV vaccine.

GD2-CAR T cell therapy for H3K27M-mutated diffuse midline gliomas.

Diffuse intrinsic pontine glioma (DIPG) and other H3K27M-mutated diffuse midline gliomas (DMGs) are universally lethal paediatric tumours of the central nervous system. We have previously shown that the disialoganglioside GD2 is highly expressed on H3K27M-mutated glioma cells and have demonstrated promising preclinical efficacy of GD2-directed chimeric antigen receptor (CAR) T cells, providing the rationale for a first-in-human phase I clinical trial (NCT04196413). Because CAR T cell-induced brainstem inflammation can result in obstructive hydrocephalus, increased intracranial pressure and dangerous tissue shifts, neurocritical care precautions were incorporated.

Clinical Trial Enrollment Among Adolescent and Young Adults with Primary Central Nervous System Tumors Treated at the Dana-Farber Cancer Institute.

In recent decades, the survival outcomes among adolescent and young adults (AYAs, 15-39 years) have not improved substantially, especially among AYAs with primary central nervous system (CNS) tumors. While this is likely multifactorial, low participation in clinical trials among AYAs is thought to be a critical contributing factor. In this study, we describe the pattern of clinical trial enrollment among AYAs with primary CNS tumors at our institution.

Liquid biopsy in gliomas: A RANO review and proposals for clinical applications.

Background: There is an extensive literature highlighting the utility of blood-based liquid biopsies in several extracranial tumors for diagnosis and monitoring.

Methods: The RANO (Response Assessment in Neuro-Oncology) group developed a multidisciplinary international Task Force to review the English literature on liquid biopsy in gliomas focusing on the most frequently used techniques, that is circulating tumor DNA, circulating tumor cells, and extracellular vesicles in blood and CSF.

Results: ctDNA has a higher sensitivity and capacity to represent the spatial and temporal heterogeneity in comparison to circulating tumor cells.

Pharmacokinetics of the disialoganglioside, G, a circulating tumor biomarker for neuroblastoma, in nonhuman primates.

Background:: The ganglioside G is a potential circulating tumor biomarker for the childhood cancer neuroblastoma. Interpreting the levels of a circulating tumor biomarker depends in part on a knowledge of the biomarker’s clinical pharmacology.

Methods:: We studied the plasma and cerebrospinal fluid (CSF) pharmacokinetics of the C lipoform of G in two nonhuman primates with indwelling subcutaneous CSF lateral ventricular reservoir systems.

COVID-19 Crisis Management: Lessons From the United Arab Emirates Leaders.

This study analyses the UAE leadership's approach in response to the COVID-19 crisis through the Organization for Economic Co-operation and Development's Strategic Crisis Management Framework. This framework analyzes the crisis management in three phases: the preparedness, the response to mitigate damage and the feedback mechanism after the crisis. The analysis showed that the key components of the UAE's crisis management included efficient and able governance, integrated utilization of public-private partnerships and a global workforce of excellence.

Phase 2 Study of Pomalidomide (CC-4047) Monotherapy for Children and Young Adults With Recurrent or Progressive Primary Brain Tumors.

Introduction: Treatment of recurrent primary pediatric brain tumors remains a major challenge, with most children succumbing to their disease. We conducted a prospective phase 2 study investigating the safety and efficacy of pomalidomide (POM) in children and young adults with recurrent and progressive primary brain tumors.

Methods: Patients with recurrent and progressive high-grade glioma (HGG), diffuse intrinsic pontine glioma (DIPG), ependymoma, or medulloblastoma received POM 2.

Characteristics of patients ≥10 years of age with diffuse intrinsic pontine glioma: a report from the International DIPG/DMG Registry.

Background: Diffuse intrinsic pontine gliomas (DIPG) generally occur in young school-age children, although can occur in adolescents and young adults. The purpose of this study was to describe clinical, radiological, pathologic, and molecular characteristics in patients ≥10 years of age with DIPG enrolled in the International DIPG Registry (IDIPGR).

Methods: Patients ≥10 years of age at diagnosis enrolled in the IDIPGR with imaging confirmed DIPG diagnosis were included.

Adolescent and young adult neuro-oncology: a comprehensive review.

Adolescent and young adult (AYA; ages 15-39) patients represent a population that experiences significant challenges in cancer care and research, exemplified by poorer clinical outcomes as well as unmet psychosocial and reproductive health needs. Despite central nervous system (CNS) tumors being one of the most common malignancies diagnosed in the age group, there is a clear paucity of AYA CNS tumor-specific publications, especially those related to the unique psychosocial and reproductive health needs of this population of patients. In this review, we examine various aspects of AYA oncological care including tumor biology, clinical outcome, clinical trials enrollment rate, site of care, unique psychosocial needs, and oncofertility.

Reirradiation practices for children with diffuse intrinsic pontine glioma.

Background: Diffuse intrinsic pontine gliomas (DIPGs) are a leading cause of brain tumor deaths in children. Current standard of care includes focal radiation therapy (RT). Despite clinical improvement in most patients, the effect is temporary and median survival is less than 1 year.