Insights into Early Interactions on Innovative Developments with European Regulators.

Introduction: The European Medicines Agency Innovation Task Force (ITF) acts as early point of contact for medicine and technology developers to enable innovation during early drug development stages through ITF briefing meetings.

Aim: To reflect on the current pace of innovation and to assess the potential of ITF stakeholder interactions, a comprehensive analysis of the ITF briefing meetings held between 2021 and 2022 was conducted with a focus on individual questions raised by the developers and the related feedback provided by the European regulators.

Methods: Questions raised during ITF briefing meetings were extracted and categorised into main and sub-categories, revealing different themes across the whole medicine development process such as manufacturing technologies, pre-clinical developments, and clinically relevant questions.

Few-cycle laser pulse characterization on-target using high-harmonic generation from nano-scale solids.

We demonstrate high-harmonic generation for the time-domain observation of the electric field (HHG-TOE) and use it to measure the waveform of ultrashort mid-infrared (MIR) laser pulses interacting with ZnO thin-films or WS monolayers. The working principle relies on perturbing HHG in solids with a weak replica of the pump pulse. We measure the duration of few-cycle pulses at 3200 nm, in reasonable agreement with the results of established pulse characterization techniques.

Sub-100 fs all-fiber polarization maintaining widely tunable laser at 2 µm.

An all-fiber polarization maintaining (PM) laser tunable over 170 nm via Raman soliton self-frequency shift (SSFS) delivering sub-100 fs pulses with a central wavelength ranging from 1880 to 2050 nm is presented. The 40 MHz laser emits power ranging from 15 to 34 mW with pulse duration as short as 80 fs. It is based on exclusively commercially available standard fibers and has been designed to produce sub-100 fs pulse durations over the whole spectral range without the need for adjusting neither nonlinearities nor dispersion.

Health-related behaviors and weight-related outcomes within sibling pairs: A systematic review.

Background: Siblings reciprocally contribute to mutual social and physical development. The aim of this review was to examine the health-related behaviors and weight-related outcomes within child-sibling pairs and to determine how these factors vary by sibling composition.

Methods: Following the PRISMA guidelines, a systematic review of studies published since 2000 obtained from MEDLINE, CINAHL, PubMed, Cochrane Reviews, Web of Science, PsycINFO, Health and Wellness, and Science Direct was performed.

Mid-infrared frequency domain optical parametric amplifier.

We report on an optical architecture delivering sub-120 femtosecond laser pulses of 20 µJ tunable from 5.5 µm to 13 µm in the mid-infrared range (mid-IR). The system is based on a dual-band frequency domain optical parametric amplifier (FOPA) optically pumped by a Ti:Sapphire laser and amplifying 2 synchronized femtosecond pulses each with a widely tunable wavelength around 1.

College Students' eMental Health Literacy and Risk of Diagnosis with Mental Health Disorders.

Background: This study investigated college students' eMental health literacy (eMHL), knowledge of common mental disorders and risk of being diagnosed with a mental health disorder and compared their knowledge of mental disorders and concurrent risk of diagnosis with high and low eMHL; Method: A total of 123 college students completed an online survey through Amazon's Mechanical Turk (MTurk). Data were analyzed using descriptive statistics and chi-square tests; Results: eMental health literacy scores were higher when students had a history of prior mental health problems, were female, and graduate students. College students with high eMHL were more likely to recognize symptoms, recommend professional help, and be at lower risk for common mental health disorders compared to low eMHL students; Conclusions: eMHL was associated with mental health status and demographic variables.

Initial experience, feasibility, and technical development with an electromagnetic navigation assistance in percutaneous pelvic bone cementoplasty: retrospective analysis.

Objectives: To assess the feasibility and technical outcomes of pelvic bone cementoplasty using an electromagnetic navigation system (EMNS) in standard practice.

Materials And Methods: Monocentric retrospective study of all consecutive patients treated with cementoplasty or reinforced cementoplasty of the pelvic bone with EMNS-assisted procedures. The endpoints were periprocedural adverse events, needle repositioning rates, procedure duration, and radiation exposure.

Multi-gigahertz femtosecond pulses from linear and nonlinear propagation of a phase-modulated laser.

We propose and demonstrate a non-mode-locking approach to generating multi-gigahertz repetition rate, femtosecond pulses in burst mode by shaping a continuous-wave (CW) seed laser in an all-fiber configuration. The seed laser at 1030 nm is first phase modulated and de-chirped to low-contrast, ∼2 ps pulses at a 17.5 GHz repetition rate, then carved to bursts at a 60 kHz repetition rate, and finally shaped to <2 ps clean pulses by a Mamyshev regenerator.

Percutaneous alcohol embolization and vertebroplasty of a T2 aggressive vertebral hemangioma with prior embolization of dangerous arterial anastomoses.

Aggressive vertebral hemangiomas usually exhibit extraosseous expansion that can result in spinal cord or radicular compression.1 In symptomatic cases, treatment by alcohol embolization and percutaneous vertebroplasty has been reported as feasible, safe, and effective with long-term benefits on neurological symptoms.2 Safety rules before vertebral alcohol embolization include preoperative spinal cord vascularization mapping and opacification through bone needles to assess the absence of dangerous intratumoral anastomoses.

Delivering Services to Older Persons Experiencing Homelessness: Providers' Perspectives of What Does and Does Not Work.

Older people with experiences of homelessness (OPEH) tend to experience more complex health, social, and psychological issues than people experiencing homelessness at younger ages. Simultaneously, many housing resources (e.g.

The "Eiffel Tower" technique: novel long-axis sacroplasty under electromagnetic navigation assistance; feasibility and descriptive study.

Objectives: To describe a novel long-axis multimodal navigation assisted technique - the so-called Eiffel Tower technique - aimed at integrating recent technological improvements for the routine treatment of sacral insufficiency fractures.

Materials And Methods: The long-axis approach described in the present study aimed at consolidating the sacral bone according to biomechanical considerations. The purpose was (i) to cement vertically the sacral alae all along and within the lateral fracture lines, resembling the pillars of a tower, and (ii) to reinforce cranially with a horizontal S1 landing zone (or dense central bone) resembling the first level of the tower.

High-power nonlinear amplification of an ultrafast electro-optic frequency comb with flexible GHz repetition rate.

We report on an all-fiber 200 W widely tunable GHz electro-optic (EO) frequency comb operating in the nonlinear regime. The EO comb pulses at 1030 nm are initially pre-compressed to sub-2 ps, then power amplified to 2.5 W, and finally boosted to 200 W in a newly designed large-mode-area, Yb-doped photonic crystal fiber.

Extraction of cement leakages and malpositioned spindles complicating percutaneous interventions: why, when and how?

Objectives: Cement leakages in soft tissues are a common occurrence during cementoplasty. They may cause chronic pain, and thus treatment failure. Spindle malposition during reinforced cementoplasty may cause vascular, nerve or cartilage injury.

Reinforced cementoplasty for pelvic tumour lesions and pelvic traumatic fractures: preliminary experience.

Objectives: Pelvic bone pathological lesions and traumatic fractures are a considerable source of pain and disability. In this study, we sought to evaluate the effectiveness of reinforced cementoplasty (RC) in painful and unstable lesions involving the pelvic bone in terms of pain relief and functional recovery.

Methods: All patients with neoplastic lesion or pelvic fracture for whom a pelvic bone RC was carried out between November 2013 and October 2017 were included in our study.

Efficient few-cycle Yb-doped laser oscillator with Watt-level average power.

So far, the operation of ultrafast bulk laser oscillators based on Yb-doped gain materials and directly emitting few-cycle pulses have been restricted to low optical-to-optical efficiencies and average output powers of only a few milliwatt. This performance limitation can be attributed to the commonly-applied standard collinear pumping scheme in which the optical pump is transmitted through a dichroic mirror whose spectral transmission and dispersion properties severely perturb the oscillating pulse when its optical spectrum extends towards the pump wavelength. In this study, we report on a novel pumping scheme relying on cross polarization that overcomes this challenge.

Rescue technique for trapped bone needle in cement cast.

Avascular necrosis, or Kummel disease, is a potential complication of vertebral compression fractures. It is believed to arise as a result of a failed fracture healing process,1 2 leading to the formation of an air or fluid filled cavity within the vertebral body.3 Percutaneous vertebroplasty seems to provide both pain relief and increased spinal stability in avascular necrosis.

Polarization-independent pulse retrieval based on frequency resolved optical switching.

We demonstrate experimentally that the frequency resolved optical switching (FROSt) method is independent of the polarization direction of the pulse to be characterized. In this perspective, it is employed to characterize two or three co-propagating pulses linearly polarized in orthogonal directions, enabling to retrieve simultaneously their temporal intensity and phase profiles together with their group delay. This technique is also applied to track a simple nonlinear process involving different polarization states: type-I second harmonic generation (SHG).

Electro-optic comb pumped optical parametric oscillator with flexible repetition rate at GHz level.

We present a gigahertz (GHz)-repetition-rate optical parametric oscillator (OPO) pumped by an electro-optic comb at 1.03 µm, delivering sub-picosecond signal pulses across 1.5-1.

Onyx injection by direct puncture for presurgical embolization of a C2 hypervascular metastasis from a thyroid cancer.

Surgery for spinal hypervascular lesions, such as hemangioma or metastases from thyroid or renal cancer, may be challenging because of the risk of massive blood loss.1 To overcome this limitation, presurgical embolization has gained acceptance to reduce this risk.2 However, some configurations, such as the origin of a radiculomedullary artery close to the vessels feeding the lesion or when the lesion is supplied by vessels feeding an eloquent territory, may limit the possibility of presurgical embolization, especially with microparticles.

High-power amplified spontaneous emission pulses with tunable coherence for efficient non-linear processes.

We report on a detailed study of an amplified spontaneous emission source operated in a pulsed regime with particular attention paid to the influence of high-intensity chaotic temporal events on the generation of nonlinear processes. To this aim, we have developed a monolithic high-power fiber system delivering partially coherent pulses of adjustable coherence. We also have demonstrated a non-linear method to characterize the stochastic properties of the source mitigating the bandwidth limitation of linear techniques.

Reliability and accuracy of time-resolved contrast-enhanced magnetic resonance angiography in hypervascular spinal metastases prior embolization.

Objectives: Preoperative embolization of hypervascular spinal metastases (HSM) is efficient to reduce perioperative bleeding. However, intra-arterial digital subtraction angiography (IA-DSA) must confirm the hypervascular nature and rule out spinal cord arterial feeders. This study aimed to evaluate the reliability and accuracy of time-resolved contrast-enhanced magnetic resonance angiography (TR-CE-MRA) in assessing HSM prior to embolization.

Interim Results of a Phase 1-2a Trial of Ad26.COV2.S Covid-19 Vaccine.

Background: Efficacious vaccines are urgently needed to contain the ongoing coronavirus disease 2019 (Covid-19) pandemic of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). A candidate vaccine, Ad26.COV2.

Single-shot phase-matching free ultrashort pulse characterization based on transient absorption in solids.

The frequency-resolved optical switching (FROSt) method developed for ultrashort pulse characterization is implemented for single-shot measurements. In this basic demonstration, the delay axis of the spectrogram is spatially encoded by the pump beam having a small incident angle with the photoexcited material. We present the calibration procedure for spectrograms acquired in single-shot and the temporal characterization of 44 fs pulses with central wavelength at 800 nm both in scanning and single-shot FROSt configurations.