Methodological Insights on Biomarker-Based Patient Selection: A Review of Scientific Advice Procedures at the European Medicines Agency.

Biomarkers play a pivotal role in the selection and enrollment of trial participants. Particularly, predictive biomarkers help tailor medical care to individual patients; however, also prognostic biomarkers require consideration at the design stage. At the time of initiating a clinical trial, there may be uncertainty about whether a biomarker is predictive or prognostic, and the trial design may need to account for this.

Long-term hemodynamic responses and reverse remodeling after pharmacotherapy in HFpEF versus HFrEF: a systematic review and meta-analysis.

The acute response to therapeutic afterload reduction differs between heart failure with preserved (HFpEF) versus reduced ejection fraction (HFrEF), with larger left ventricular (LV) stroke work augmentation in HFrEF compared to HFpEF. This may (partially) explain the neutral effect of HFrEF-medication in HFpEF. It is unclear whether such differences in hemodynamic response persist and/or differentially trigger reverse remodeling in case of long-term afterload reduction.

Evaluating a Virtual Community-of-Practice as Implementation Strategy for the Needs Assessment Framework in Intellectual Disability Care: A Quasi-Experimental Multi-Methods Study.

Background: The Needs Assessment Framework (NAF) stimulates awareness of care staff to consider perspectives of clients with intellectual disabilities in decisions on involuntary care. We explored the effect of implementers' participation in a Virtual Community-of-Practice (VCoP) for designing implementation plans, on NAF implementation and staff awareness.

Method: A quasi-experimental design was used to compare implementation and awareness by care staff (n = 54) between organisations that implemented NAF with VCoP participation (N = 4) and organisations that implemented NAF as usual (N = 3).

Optimising diagnostics for hard-of-hearing infants: factors associated with successful MRI scanning without general anaesthesia.

Purpose: Scanning during infancy is often required in otology, preferably without general anaesthesia. This study aims to determine the success rate of MRI of the head without general anaesthesia for infants, and to identify predictors for a successful scan.

Methods: Data was extracted from the electronic patient file for patients who received MRI of the head without general anaesthesia between 01-01-2019 and 31-12-2022 at an age younger than 6 months.

Characterizing biomarkers of ageing in Singaporeans: the ABIOS observational study protocol.

Ageing is the primary driver of age-associated chronic diseases and conditions. Asian populations have traditionally been underrepresented in studies understanding age-related diseases. Thus, the Ageing BIOmarker Study in Singaporeans (ABIOS) aims to characterise biomarkers of ageing in Singaporeans, exploring associations between molecular, physiological, and digital biomarkers of ageing.

Enhanced CH emissions from global wildfires likely due to undetected small fires.

Monitoring methane (CH) emissions from terrestrial ecosystems is essential for assessing the relative contributions of natural and anthropogenic factors leading to climate change and shaping global climate goals. Fires are a significant source of atmospheric CH, with the increasing frequency of megafires amplifying their impact. Global fire emissions exhibit large spatiotemporal variations, making the magnitude and dynamics difficult to characterize accurately.

Non-thermal plasma as promising anti-cancer therapy against bladder cancer by inducing DNA damage and cell cycle arrest.

Bladder cancer often recurs, necessitating innovative treatments to reduce recurrence. We investigated non-thermal plasma's potential as a novel anti-cancer therapy, focusing on plasma-activated solution (PAS), created by exposing saline to non-thermal plasma. Our study aims to elucidate the biological effects of PAS on bladder cancer cell lines in vitro, as well as the combination with mitomycin C (MMC), using clinically relevant settings.

Ex vivo assessment of human neutrophil motility and migration.

Neutrophils are pivotal in orchestrating tumor-induced systemic inflammation and are increasingly recognized for their critical involvement in both the initiation and progression of cancer. A fundamental facet of neutrophil biology is their migratory capacity, which enables them to extravasate and infiltrate tumors in other tissues, where they carry out essential effector functions. Unraveling the intricate mechanisms of neutrophil motility and migration is crucial for comprehending immune responses and inflammatory processes, shedding light on their substantial contribution to cancer progression.

Fixation for Osteochondral Lesions of the Talus Leads to Successful Clinical Outcomes in 9 out of 10 Patients: a Systematic Review.

Importance: Osteochondral lesions of the talus (OLT) with an osteochondral fragment are amendable for fixation. Fixation aims to stabilize the osteochondral fragment while retaining the native cartilage. Though fixation for OLT is a promising treatment, no systematic overview of the literature on its efficacy and safety exists.

Discovery of a DNA methylation profile in individuals with Sifrim-Hitz-Weiss syndrome.

Pathogenic heterozygous variants in CHD4 cause Sifrim-Hitz-Weiss syndrome, a neurodevelopmental disorder associated with brain anomalies, heart defects, macrocephaly, hypogonadism, and additional features with variable expressivity. Most individuals have non-recurrent missense variants, complicating variant interpretation. A few were reported with truncating variants, and their role in disease is unclear.

Seasonal changes in bay water column properties and their influence on the distribution of dissolved and particulate substances along the south coast of Curaçao (Caribbean Sea).

As endpoints of watersheds, bays concentrate erosion- and human-derived substances such as dissolved inorganic nutrients and pollutants. We investigated the water movement and biogeochemistry of two bays in Curaçao: Piscadera Bay and Spaanse Water, during the dry (May 2022 and 2023) and wet seasons (November 2021 and 2023). Bay-ocean exchange was limited during the dry season, enhancing nutrient concentrations in the bays.

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.

Risk characterisation of chemicals of emerging concern in real-life water reuse applications.

Water reuse is a viable option to address temporal or structural water shortages. However, the ubiquitous presence of chemicals of emerging concern (CECs) in natural systems, especially the aquatic environment, represents a significant obstacle to water reuse and the receiving environment. Therefore, an extensive literature review was performed to identify current water reuse practices at field scale, reported types and levels of CECs and their associated risks for human and environmental health.

Prognostic value of manual versus automatic methods for assessing extents of resection and residual tumor volume in glioblastoma.

Objective: The extent of resection (EOR) and postoperative residual tumor (RT) volume are prognostic factors in glioblastoma. Calculations of EOR and RT rely on accurate tumor segmentations. Raidionics is an open-access software that enables automatic segmentation of preoperative and early postoperative glioblastoma using pretrained deep learning models.

Shortened SARS-CoV-2 viral RNA shedding in saliva during early Omicron compared to wild-type pandemic phase.

This study compared the dynamics of SARS-CoV-2 viral shedding in saliva between wild-type virus-infected and Omicron-infected household cohorts. Pre-existing immunity in participants likely shortens the viral RNA shedding duration and lowers viral load peaks. Frequent saliva sampling can be a convenient tool to study viral load dynamics.

Intersection between individual, household, environmental and system level factors in defining risk and resilience for children in Kenya's ASAL: A qualitative study.

Introduction: Children growing up in arid and semi-arid regions of Sub-Saharan Africa (SSA) face heightened risks, often resulting in poor developmental outcomes. In Kenya, the arid and semi-arid lands (ASAL) exhibit the lowest health and developmental indicators among children. Despite these risks, some children grow up successfully and overcome the challenges.

Anti-immune complex antibodies are elicited during repeated immunization with HIV Env immunogens.

Vaccination strategies against HIV-1 aim to elicit broadly neutralizing antibodies (bnAbs) using prime-boost regimens with HIV envelope (Env) immunogens. Epitope mapping has shown that early antibody responses are directed to easily accessible nonneutralizing epitopes on Env instead of bnAb epitopes. Autologously neutralizing antibody responses appear upon boosting, once immunodominant epitopes are saturated.

Strain-Induced Photochemical Opening of Ferrocene[6]cycloparaphenylene: Uncaging of Fe with Green Light.

We present the synthesis, structural analysis, and remarkable reactivity of the first carbon nanohoop that fully incorporates ferrocene in the macrocyclic backbone. The high strain imposed on the ferrocene by the curved nanohoop structure enables unprecedented photochemical reactivity of this otherwise photochemically inert metallocene complex. Visible light activation triggers a ring-opening of the nanohoop structure, fully dissociating the Fe-cyclopentadienyl bonds in the presence of 1,10-phenanthroline.

Salpingectomy With Delayed Oophorectomy Versus Salpingo-Oophorectomy in BRCA1/2 Carriers: Three-Year Outcomes of a Prospective Preference Trial.

Objective: To compare menopause-related quality of life (QoL) after risk-reducing salpingectomy (RRS) versus risk-reducing salpingo-oophorectomy (RRSO) until 3 years of post-surgery.

Design: A prospective study (TUBA study) with treatment allocation based on patients' preference. Data were collected pre-surgery and at 3 months, 1 and 3 years of post-surgery.

Recurrent glioblastoma in national guidelines on the diagnosis and treatment of gliomas: A matter of European practice variation.

Introduction: The optimal treatment for recurrent glioblastoma patients remains not well-defined in international guidelines. On top of that, the availability of national guidelines is uncharted.

Research Question: This study aimed to investigate the availability of national guidelines on the diagnosis and treatment of adult glioma throughout Europe, specifically focusing on recurrent glioblastoma.

The Role of Positron Emission Tomography Imaging in Breast Implant Illness.

Background: Explantation often alleviates symptoms in women with breast implant illness. However, persistent complaints in some cases may be linked to persistent silicone-induced inflammation from residual silicone particles. Positron emission tomography (PET) imaging could potentially detect this inflammation.

Comparison of sample characteristics of Wisconsin Alzheimer's Disease Research Center participants with the Wisconsin state population-An evaluation of the recruitment effort.

Introduction: Understanding how a research sample compares to the population from which it is drawn can help inform future recruitment planning. We compared the Wisconsin Alzheimer's Disease Research Center (WADRC) participant sample to the Wisconsin state population (WI-pop) on key demographic, social exposome, and vascular risk measures.

Methods: The WADRC sample included 930 participants.

BrainFit: improving executive and subjective cognitive functioning in late-life mood disorders - a double-blind randomized active-controlled study evaluating the effect of online cognitive training.

Introduction: Unipolar and bipolar mood disorders in older adults are accompanied by cognitive impairment, including executive dysfunction, with a severe impact on daily life. Up and till now, strategies to improve cognitive functioning in late-life mood disorders (LLMD) are sparse. Therefore, we aimed to assess the efficacy of adaptive, computerized cognitive training (CT) on executive and subjective cognitive functioning in LLMD.

Amyloid-related changes in fluency in patients with subjective cognitive decline.

Introduction: We examined semantic and phonemic fluency in individuals with subjective cognitive decline (SCD) in relation to amyloid status and clinical progression.

Methods: A total of 490 individuals with SCD (62 ± 8 years, 42% female, 28% amyloid-positive, 17% clinical progression) completed annual fluency assessments (mean ± SD follow-up 4.3 ± 2.

Psychometrics of Wearable Devices Measuring Physical Activity in Ambulant Children With Gait Abnormalities: A Systematic Review and Meta-analysis.

Objective: To evaluate psychometrics of wearable devices measuring physical activity (PA) in ambulant children with gait abnormalities due to neuromuscular conditions.

Data Sources: We searched PubMed, Embase, PsycINFO, CINAHL, and SPORTDiscus in March 2023.

Study Selection: We included studies if (1) participants were ambulatory children (2-19y) with gait abnormalities, (2) reliability and validity were analyzed, and (3) peer-reviewed studies in the English language and full-text were available.