Teverelix is a potential treatment option for the prevention of acute urinary retention recurrence in men suffering from benign prostatic hyperplasia.

Purpose: To evaluate the efficacy and safety of teverelix in treatment naïve patients aged over 50 years with symptomatic benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS), and to explore teverelix' potential in preventing AUR secondary to BPH with the aim to inform a planned Phase 2 trial.

Methods: This Phase 2, multicenter, randomized, double-blind, placebo-controlled study involved BPH patients with an International Prostate Symptom Score (IPSS) ≥ 13 and uroflow < 13 mL/sec. After a 4-week single-blind placebo run-in, patients were randomized to receive teverelix 60 mg (n = 41) or placebo (n = 40) subcutaneously on day 1 and day 3.

A Model-Informed Drug Development Approach to Design a Phase 3 Trial of Teverelix Drug Product in Advanced Prostate Cancer Patients with Increased Cardiovascular Risk.

Teverelix drug product (DP) is a parenteral gonadotropin-releasing hormone (GnRH) antagonist that has been successfully tested in phase 2 trials for hormone-sensitive advanced prostate cancer (APC) and benign prostatic hyperplasia (BPH). In previous APC trials, teverelix DP was administered as intramuscular (IM) and subcutaneous (SC) injections, using a loading dose and (in a single trial) a maintenance dose. Our objective was to derive an optimal dosing regimen for phase 3 clinical development, using a pharmacometrics modeling approach.

Survival prediction in patients with gynecological cancer irradiated for brain metastases.

Background And Purpose: This large population-based, retrospective, single-center study aimed to identify prognostic factors in patients with brain metastases (BM) from gynecological cancers.

Material And Methods: One hundred and forty four patients with BM from gynecological cancer treated with radiotherapy (RT) were identified. Primary cancer diagnosis, age, performance status, number of BM, presence of extracranial disease, and type of BM treatment were assessed.

Efficacy, tolerability, and safety of teverelix DP in patients with advanced prostate cancer: A multicenter, open-label, phase 2 trial.

Background: Teverelix drug product (DP) is a novel injectable gonadotropin-releasing hormone antagonist.

Methods: An adaptive phase 2, open-label, multicenter trial was conducted in patients with advanced prostate cancer to evaluate the efficacy and safety of a combined subcutaneous (SC) and intramuscular (IM) loading dose regimen of teverelix DP of 120 mg SC + 120 mg IM (Group 1; N = 9) or 180 mg SC + 180 mg IM (Group 2; N = 41) administered at a single visit, followed by 6-weekly SC maintenance doses of 120 mg (Group 1) or 180 mg (Group 2), up to Day 168. The primary endpoint was the proportion of patients achieving castration levels with serum testosterone <0.

Safety, Pharmacokinetic and Pharmacodynamic Evaluation of Teverelix for the Treatment of Hormone-Sensitive Advanced Prostate Cancer: Phase 2 Loading-Dose-Finding Studies.

Teverelix drug product (DP) is a gonadotropin-releasing hormone antagonist in development for the treatment of patients with prostate cancer in whom androgen deprivation therapy is indicated. The aim of this paper is to present the results of five Phase 2 studies that assessed the pharmacokinetics, pharmacodynamics, efficacy and safety of different loading dose regimens of teverelix DP. Five single-arm, uncontrolled clinical trials were conducted in patients with advanced prostate cancer.

Leveraging Physiologically Based Modelling to Provide Insights on the Absorption of Paliperidone Extended-Release Formulation under Fed and Fasting Conditions.

Paliperidone was approved by the US FDA in 2006 as an extended-release (ER) tablet (Invega) for the once-daily treatment of schizophrenia. This osmotic-controlled release oral delivery system (OROS) offers advantages, such as the prevention of plasma concentration fluctuation and reduced dosing frequency. The administration of the ER after a high-fat/high-calorie meal leads to increased maximum plasma concentration and area under the curve values by 60% and 54%, respectively.

What are the similarities and differences in lung cancer symptom appraisal and help-seeking according to smoking status? A qualitative study with lung cancer patients.

Objective: Lung cancer in never-smokers represents a growing proportion of patients. The relationship between smoking status, symptom appraisal and help-seeking behaviour is complex. Little is known about cancer symptom-related health behaviours according to smoking status.

How does safety netting for lung cancer symptoms help patients to reconsult appropriately? A qualitative study.

Background: Safety netting in primary care is considered an important intervention for managing diagnostic uncertainty. This is the first study to examine how patients understand and interpret safety netting advice around low-risk potential lung cancer symptoms, and how this affects reconsultation behaviours.

Methods: Qualitative interview study in UK primary care.

Acceptability of a standalone written leaflet for the National Health Service for England Targeted Lung Health Check Programme: A concurrent, think-aloud study.

Background: Many countries are introducing low-dose computed tomography screening programmes for people at high risk of lung cancer. Effective communication strategies that convey risks and benefits, including unfamiliar concepts and outcome probabilities based on population risk, are critical to achieving informed choice and mitigating inequalities in uptake.

Methods: This study investigated the acceptability of an aspect of NHS England's communication strategy in the form of a leaflet that was used to invite and inform eligible adults about the Targeted Lung Health Check (TLHC) programme.

Decision Support Tools for Low-Dose CT Lung Cancer Screening: A Scoping Review of Information Content, Format, and Presentation Methods.

Several countries mandate informed or shared decision-making for low-dose CT (LDCT) lung cancer screening, but knowledge is limited about the type of information and presentation techniques used to support decision-making in practice. This review aimed to characterize the content, format, mode, and presentation methods of decision support tools (DSTs) for LDCT lung cancer screening. DSTs reported within peer-reviewed articles (January 2000-April 2021) were identified systematically from PubMed, PsycInfo, EMBASE, and CINAHL Plus.

Ethnographic research as an evolving method for supporting healthcare improvement skills: a scoping review.

Background: The relationship between ethnography and healthcare improvement has been the subject of methodological concern. We conducted a scoping review of ethnographic literature on healthcare improvement topics, with two aims: (1) to describe current ethnographic methods and practices in healthcare improvement research and (2) to consider how these may affect habit and skill formation in the service of healthcare improvement.

Methods: We used a scoping review methodology drawing on Arksey and O'Malley's methods and more recent guidance.

Lung cancer symptom appraisal, help-seeking and diagnosis - rapid systematic review of differences between patients with and without a smoking history.

Background: Lung cancer is the leading cause of cancer death in the world. A significant minority of lung cancer patients have never smoked (14% in the UK, and ranging from 10% to 25% worldwide). Current evidence suggests that never-smokers encounter delays during the diagnostic pathway, yet it is unclear how their experiences and reasons for delayed diagnoses differ from those of current and former smokers.

Five-year Survival Prediction and Safety Outcomes with Enzalutamide in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer from the PREVAIL Trial.

Background: In the PREVAIL study, enzalutamide significantly improved clinical outcomes versus placebo in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC).

Objective: To evaluate long-term benefits and risks of enzalutamide in the final prespecified PREVAIL analysis.

Design, Setting, And Participants: We conducted a final 5-yr survival analysis of PREVAIL in men with chemotherapy-naïve mCRPC from the enzalutamide (n = 689) and placebo (n = 693) arms.

Adherence to prophylaxis in adolescents and young adults with severe haemophilia: a qualitative study with healthcare professionals.

to examine healthcare professionals' (HP) perceptions and experiences in relation to adherence to prophylactic treatment among young people living with haemophilia (YPH). All HPs in four haemophilia centres across England and Wales were invited to participate, and all HPs who agreed to take part ( = 6) were interviewed. Interviews were audio-recorded, transcribed and then analysed using Interpretative Phenomenological Analysis (IPA).

Effect of monitor positioning on visual attention and situation awareness during neonatal resuscitation: a randomised simulation study.

Objectives: To compare situation awareness (SA), visual attention (VA) and protocol adherence in simulated neonatal resuscitations using two different monitor positions.

Design: Randomised controlled simulation study.

Settings: Simulation lab at the Royal Alexandra Hospital, Edmonton, Canada.

The SURV1VE trial-sustained inflation and chest compression versus 3:1 chest compression-to-ventilation ratio during cardiopulmonary resuscitation of asphyxiated newborns: study protocol for a cluster randomized controlled trial.

Background: The need for cardiopulmonary resuscitation (CPR) is often unexpected, and the infrequent use of CPR in the delivery room (DR) limits the opportunity to perform rigorous clinical studies to determine the best method for delivering chest compression (CC) to newborn infants. The current neonatal resuscitation guidelines recommend using a coordinated 3:1 compression-to-ventilation (C:V) ratio (CC at a rate of 90/min and ventilations at a rate of 30/min). In comparison, providing CC during a sustained inflation (SI) (CC + SI) significantly improved hemodynamics, minute ventilation, and time to return of spontaneous circulation (ROSC) compared to 3:1 C:V ratio in asphyxiated piglets.

Adherence to prophylaxis in adolescents and young adults with severe haemophilia A, a qualitative study with patients.

Reported levels of adherence to prophylaxis among young people with haemophilia (YPH) vary widely and are predominately based on estimations made by healthcare professionals and parents. Reasons for (non)adherence among YPH in particular have not been evidenced. to examine experiences in relation to prophylaxis with YPH themselves, and barriers and facilitators to their adherence.

Ventilation Strategies during Neonatal Cardiopulmonary Resuscitation.

Approximately, 10-20% of newborns require breathing assistance at birth, which remains the cornerstone of neonatal resuscitation. Fortunately, the need for chest compression (CC) or medications in the delivery room (DR) is rare. About 0.

Chest compression during sustained inflation versus 3:1 chest compression:ventilation ratio during neonatal cardiopulmonary resuscitation: a randomised feasibility trial.

Background: Current neonatal resuscitation guidelines recommend 3:1 compression:ventilation (C:V) ratio. Recently, animal studies reported that continuous chest compressions (CC) during a sustained inflation (SI) significantly improved return of spontaneous circulation (ROSC). The approach of CC during SI (CC+SI) has not been examined in the delivery room during neonatal resuscitation.

High-sensitivity detection of cardiac troponin I with UV LED excitation for use in point-of-care immunoassay.

High-sensitivity cardiac troponin assay development enables determination of biological variation in healthy populations, more accurate interpretation of clinical results and points towards earlier diagnosis and rule-out of acute myocardial infarction. In this paper, we report on preliminary tests of an immunoassay analyzer employing an optimized LED excitation to measure on a standard troponin I and a novel research high-sensitivity troponin I assay. The limit of detection is improved by factor of 5 for standard troponin I and by factor of 3 for a research high-sensitivity troponin I assay, compared to the flash lamp excitation.

Efficacy and Safety of Enzalutamide vs Bicalutamide in Younger and Older Patients with Metastatic Castration Resistant Prostate Cancer in the TERRAIN Trial.

Purpose: Enzalutamide significantly prolonged median progression-free survival vs bicalutamide in chemotherapy naïve men with metastatic castration resistant prostate cancer in the TERRAIN (Enzalutamide versus Bicalutamide in Castrate Men with Metastatic Prostate Cancer) trial. In this post hoc analysis we investigated the influence of age on the efficacy and safety of enzalutamide vs bicalutamide in this population.

Materials And Methods: Patients were randomized 1:1 to enzalutamide 160 mg per day or bicalutamide 50 mg per day.