Pooled clinical trial analyses evaluating outcomes of HER2-low vs HER2-0 expression in patients with metastatic breast cancer following chemotherapy.

The therapeutic importance of subsetting patients with HER2-negative breast cancer according to their tumors' cellular HER2 expression (e.g., HER2-low vs.

Outcomes of patients aged ≥26 years with relapsed or refractory B-cell acute lymphoblastic leukemia in ZUMA-3 and historical trials.

Brexucabtagene autoleucel (brexu-cel) is an autologous anti-CD19 CAR T-cell therapy approved in the USA and European Union (EU) for adults with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL; aged ≥26 years in EU). Here, outcomes for patients with R/R B-ALL aged ≥26 years in ZUMA-3 treated with brexu-cel were compared with historical standard-of-care (SOC) therapy. After median follow-up of 26.

Historic Clinical Trial External Control Arm Provides Actionable GEN-1 Efficacy Estimate Before a Randomized Trial.

Purpose: To inform continued development of the novel immune agent GEN-1, we compared ovarian cancer patients' end points from a neoadjuvant single-arm phase IB study with those of similar historic clinical trial (HCT) patients who received standard neoadjuvant chemotherapy.

Methods: Applying OVATION-1 trial (ClinicalTrials.gov identifier: NCT02480374) inclusion and exclusion criteria to Medidata HCT data, we identified historical trial patients for comparison.

Intercalation and reactions of CO under single layer graphene/Ni(111): the role of vacancies.

We use synchrotron radiation-induced core level photoemission spectroscopy to investigate the influence of vacancies, produced by ion bombardment, on monolayer graphene/Ni(111) exposed to CO at pressures ranging from ultra-high vacuum (10 mbar) up to near ambient (5.6 mbar) conditions. CO intercalates at a rate which is comparable to the one observed in absence of defects and reacts the Boudouard reaction producing additional carbon atoms and CO.

Real-World Data as External Controls: Practical Experience from Notable Marketing Applications of New Therapies.

Introduction: Real-world data (RWD) can contextualize findings from single-arm trials when randomized comparative trials are unethical or unfeasible. Findings from single-arm trials alone are difficult to interpret and a comparison, when feasible and meaningful, to patient-level information from RWD facilitates the evaluation. As such, there have been several recent regulatory applications including RWD or other external data to support the product's efficacy and safety.

Medical residents' mental distress in the COVID-19 pandemic: An urgent need for mental health care.

Purpose: Medical residents' mental health is currently an issue of concern for medical educators worldwide. The COVID-19 pandemic has raised the greatest concerns given the psychological effects of this scenario on medical residents on the frontlines of the pandemic. To assess the psychological impact of the COVID-19 pandemic on physicians in residency training, the collective symptoms of burnout, depression and anxiety are used to identify the residents' beliefs and clinical practices related to COVID-19 patients and their behaviors concerning disease prevention.

Exploring the Potential of External Control Arms created from Patient Level Data: A case study in non-small cell lung cancer.

Randomized controlled trials (RCTs) are the gold standard for evaluation of new medical products. However, RCTs may not always be ethical or feasible. In cases where the investigational product is available outside the trial (e.

Bioconcentration factors for hydrocarbons and petrochemicals: Understanding processes, uncertainty and predictive model performance.

Fish bioconcentration factors (BCFs) are often used to assess substance-specific bioaccumulation. However, reliable BCF data are limited given the practical challenges of conducting such tests. The objectives of this paper are to describe nine rainbow trout studies performed in our lab using tailored dosing and test designs for obtaining empirical BCFs for 21 test substances; gain insights into the structural features and processes determining the magnitude and uncertainty in observed BCFs; and assess performance of six quantitative structure property relationships (QSPRs) for correctly categorizing bioaccumulation given current regulatory triggers.

Effects of More-Affected vs. Less-Affected Motor Cortex tDCS in Parkinson's Disease.

: To evaluate therapeutic potential of different montages of transcranial direct current stimulation (tDCS) in Parkinson's Disease (PD) patients with asymmetric motor symptoms. : Fourteen patients with asymmetric PD underwent, while on treatment, seven separate sessions including electrophysiological and clinical evaluation at baseline and after anodal, cathodal and sham tDCS of the primary motor cortex (M1) of the two hemispheres. Changes in motor cortical excitability were evaluated by transcranial magnetic stimulation (TMS).

Alternatives to in vivo tests to detect endocrine disrupting chemicals (EDCs) in fish and amphibians--screening for estrogen, androgen and thyroid hormone disruption.

Endocrine disruption is considered a highly relevant hazard for environmental risk assessment of chemicals, plant protection products, biocides and pharmaceuticals. Therefore, screening tests with a focus on interference with estrogen, androgen, and thyroid hormone pathways in fish and amphibians have been developed. However, they use a large number of animals and short-term alternatives to animal tests would be advantageous.

Hazard evaluation of diisononyl phthalate and diisodecyl phthalate in a Japanese medaka multigenerational assay.

Reproductive and developmental effects of diisononyl phthalate (DINP) and diisodecyl phthalate (DIDP) were evaluated in a Japanese medaka (Oryzias latipes) multigeneration protocol. Each phthalate was administered via fish flake diets at a concentration of 20 microg/g (1 microg/g fish/day). Two controls were included, untreated and acetone carrier.

A proposed multigeneration protocol for Japanese medaka (Oryzias latipes) to evaluate effects of endocrine disruptors.

Definitive data on reproductive impairment of chronically exposed populations may be required to assess the appropriateness of the existing test methods for hazard identification and prioritization of endocrine modulators. Multigeneration toxicity testing protocols for wildlife receptors are lacking. To help address this gap we describe a multigeneration fish assay using the freshwater fish, Japanese medake (Oryzias latipes).

[Multiple coronary aneurysms of an atherosclerotic nature in a patient with an abdominal aortic aneurysm: presentation of an anatomo-clinical case].

We describe the case of a 71-year-old man with history of inferior wall myocardial infarction and abdominal aortic aneurysm surgically treated. The patient, admitted to hospital for chest pain, after 24 hours suddenly dead for ventricular fibrillation and cardiac arrest. Chest X Ray, echocardiogram and Computed Tomography had shown a very large paracardiac mass.

Seminal plasma of spinal cord injured men inhibits sperm motility of normal men.

Purpose: Seminal plasma was investigated as a contributor to the poor sperm motility of spinal cord injured men.

Materials And Methods: Seminal plasma of spinal cord injured men was mixed with sperm of normal men and vice versa. Sperm motility was analyzed at 5 and 60 minutes after mixing.

Bilateral epidermoid cysts of the testis.

We present a case of bilateral testicular epidermoid cysts. These lesions were identified in a 22-year-old male who had previously experienced mild testicular trauma. Management consisted of inguinal exploration and wedge resection on one side and transscrotal exploration and excision on the other.

Squamous cell carcinoma of the prostate: a transformation from adenocarcinoma after the use of a luteinizing hormone-releasing hormone agonist and flutamide.

We report a primary squamous cell carcinoma of the prostate that developed in a 57-year-old man, 3 years after treatment with leuprolide and flutamide for Stage D1 adenocarcinoma of the prostate. This is the first case that describes this transformation from adenocarcinoma to squamous cell carcinoma following the use of luteinizing hormone agonists.

[X-syndrome: a pending problem].

The aim of the study was to evaluate the debated question of the pathogenesis of Syndrome X. Twelve consecutive patients with Syndrome X underwent high-dose dipyridamole echocardiographic test. Angina and ischaemic ST depression occurred in all patients, without impairment of regional wall-motion.

[Systemic thrombolysis in acute myocardial infarct. The physiopathological bases, current status, problems and prospects].

Thrombolytic therapy of acute myocardial infarction has been demonstrated to recognize occluded coronary arteries, reduce infarct size and left ventricular dysfunction, and improve the survival. Intravenous thrombolysis is now accepted as the best way, with the same results but less organisational problems in comparison with the intracoronary treatment. In these present study a particular reading of the thrombolytic method is proposed, based on the Knowledge of the patho physiology of coronary artery disease, and on data found in the literature concerning the effectiveness, problems and perspectives of this treatment.

[A comparative evaluation between streptokinase and r-TPA in limiting the myocardial damage during an acute myocardial infarct. An echocardiographic study].

Once the experience of GISSI I was concluded, the as yet unresolved problem of the choice of one fibrinolytic agent in preference to others emerged. In the present study, the authors used echocardiography in order to compare streptokinase with r-TPA in order to limit myocardial damage in acute myocardial infarction in 33 patients, average age 64.6 years.

[Prevalence of hyperkinetic ventricular arrhythmias in an ambulatory population of nonprofessional athletes. A study controlled by ambulatory electrocardiography].

Hyperkinetic ventricular arrhythmia being the main cause of electrical destabilization and hence fatal tachy-arrhythmias, we have studied, by Holter test, the prevalence of these arrhythmias in ambulatory non-professional athletes and compared it with a homogeneous group of sedentary subjects in order to evaluate if sports, even if not in athletic competitions, represent a potential risk for sudden death. The results show the prevalence of hyperkinetic ventricular arrhythmias to be similar in the two groups and not related to sports.