An artificial intelligence (AI)-based approach to clinical trial recruitment: The impact of Viz RECRUIT on enrollment in the EMBOLISE trial.

BACKGROUND: EMBOLISE (NCT04402632) is an ongoing randomized controlled trial investigating the safety and efficacy of middle meningeal artery embolization for the treatment of subacute or chronic subdural hematoma (SDH). Viz RECRUIT SDH is an artificial intelligence (AI)-based software platform that can automatically detect SDH in noncontrast computed tomography (NCHCT) images and report the volume, maximum thickness, and midline shift. We hypothesized that the mobile recruitment platform would aid enrollment and coordinate communication and image sharing among the entire research team. MATERIALS AND METHODS: Patient enrollment in EMBOLISE prior to and after implementation of Viz RECRUIT SDH at a large comprehensive stroke center was compared along with the performance of the software platform. The EMBOLISE trial was activated on May 5, 2021, and Viz RECRUIT SDH was activated on October 6, 2021. The pre-AI cohort consisted of all patients from EMBOLISE to AI activation (153 days), and the post-AI cohort consisted of all patients from AI activation until August 18, 2022 (316 days). All alerts for suspected SDH candidates were manually reviewed to determine the positive predictive value (PPV) of the algorithm. RESULTS: Prior to AI-software implementation, there were 5 patients enrolled (0.99 patients/month) and one screen failure. After the implementation of the software, enrollment increased by 36% to 1.35 patients/month (14 total enrolled), and there were no screen failures. Over the entire post-AI period, a total of 6244 NCHCTs were processed by the system with 207 total SDH detections (3% prevalence). 35% of all alerts for suspected SDH were viewed within 10 min, and 50% were viewed within an hour. The PPV of the algorithm was 81.4 (CI [75.3, 86.7]). CONCLUSION: The implementation of an AI-based software for the automatic screening of SDH patients increased the enrollment rate in the EMBOLISE trial, and the software performed well in a real-world, clinical trial setting.

Intersection of Mental Health and Dysphonia: A Scoping Review.

OBJECTIVE: Previous research has indicated that voice disorders frequently co-occur with mental health disorders, which may influence voice treatment seeking behavior and effectiveness. Our goal is to characterize the existing literature on the relationship between voice disorders and mental health and to investigate nuances related to mental health and voice disorder diagnosis. DATA SOURCES: Ovid MEDLINE, ProQuest PsycINFO, and Web of Science. REVIEW METHODS: Using the PRISMA protocol, a scoping review was performed. Databases searched included: Ovid MEDLINE, ProQuest PsycINFO, and Web of Science. Our inclusion criteria were all adults seen in an outpatient setting for voice and mental health disorders, excluding those with a prior history of head and neck surgery, cancers, radiation, or developmental anomalies, and certain mental health disorders. Results were screened by two independent screeners for inclusion. Data were then extracted and analyzed to present key findings and characteristics. RESULTS: A total of 156 articles, with publication dates ranging from 1938 to 2021, were included in the analysis, with females and teachers being the most described population groups. The most frequently studied laryngeal disorders were dysphonia (n = 107, 68.6%), globus (n = 33, 21.2%), and dysphonia with globus (n = 16, 10.2%). The two most common mental health disorders found in the included studies were anxiety disorders (n = 123, 78.8%) and mood disorders (n = 111, 71.2%). The Voice Handicap Index was the most used tool to gather data on voice disorders (n = 36, 23.1%), while the Hospital Anxiety and Depression Scale was the most used tool to gather data on mental health disorders (n = 20, 12.8%). The populations studied within the included articles were predominately female and worked in educational occupations. Race and ethnicity was only reported for 10.2% of included articles (n = 16) and the most commonly studied race was White/Caucasian (n = 13, 8.3%). CONCLUSION: Our scoping review of the current literature on mental health and voice disorders reveals an intersection between the conditions. The current literature represents change over time in terms of terminology that recognizes the patient's individualized experience of mental health and laryngeal conditions. However, there is still a great deal of homogeneity in the studied patient populations in terms of race and gender, with patterns and gaps that require further investigation.

Primary Middle Meningeal Artery Embolization for a Chronic Subdural Hematoma After Non-Accidental Trauma in a Child: A Case Report.

Chronic subdural hematoma in children can be pathognomonic of abusive head trauma. Treatment options for these range from observation to surgical evacuation depending on clinical circumstance and presenting features, which can include mental status changes, headaches, focal neurologic deficits, or asymptomatic presentation. Standalone endovascular treatments represent an area of growing interest in the adult population as an effective treatment modality. However, embolization as a singular treatment approach has not been reported in the pediatric population. We report the first case of stand-alone middle meningeal artery (MMA) embolization of a chronic subdural hematoma as a sequela of abusive head trauma in a two-year-old child, resulting in complete resolution on non-contrast CT head at six months post embolization.

Understanding Nanoparticle Toxicity to Direct a Safe-by-Design Approach in Cancer Nanomedicine.

Nanomedicine is a rapidly growing field that uses nanomaterials for the diagnosis, treatment and prevention of various diseases, including cancer. Various biocompatible nanoplatforms with diversified capabilities for tumor targeting, imaging, and therapy have materialized to yield individualized therapy. However, due to their unique properties brought about by their small size, safety concerns have emerged as their physicochemical properties can lead to altered pharmacokinetics, with the potential to cross biological barriers. In addition, the intrinsic toxicity of some of the inorganic materials (i.e., heavy metals) and their ability to accumulate and persist in the human body has been a challenge to their translation. Successful clinical translation of these nanoparticles is heavily dependent on their stability, circulation time, access and bioavailability to disease sites, and their safety profile. This review covers preclinical and clinical inorganic-nanoparticle based nanomaterial utilized for cancer imaging and therapeutics. A special emphasis is put on the rational design to develop non-toxic/safe inorganic nanoparticle constructs to increase their viability as translatable nanomedicine for cancer therapies.

Antitumor Efficacy of Liposome-Encapsulated NVP-BEZ235 Combined with Irreversible Electroporation for Head and Neck Cancer.

Irreversible electroporation (IRE) kills tumor cells by the delivery of short pulses of strong electric fields. However, the field strength decreases with distance from the treatment center. When IRE cannot eradicate the entire tumor mass, the surviving tumor cells can regrow. NVP-BEZ235 is a dual PI3K/mTOR inhibitor that has been administered orally in clinical trials. However, its hydrophobicity and poor water solubility make NVP-BEZ235 difficult to deliver to target areas. To improve its pharmacokinetics and therapeutic efficacy, we have encapsulated NVP-BEZ235 in a liposome (termed as L-BEZ). Our current study focuses on the long-term antitumor efficacy of IRE and intratumoral injection of L-BEZ in HN5 head and neck cancer xenografts in nude mice. We compared in vitro efficacy, as well as the effect on tumor size and growth rate in vivo, between IRE alone, IRE + oral BEZ, and IRE + L-BEZ over the course of two months. All animals in the control group were sacrificed by day 36, due to excess tumor burden. Tumors treated with IRE alone grew faster and larger than those in the control group. IRE + oral BEZ suppressed tumor growth, but the growth rate increased to that of the controls toward the end of 21 days. Only IRE + L-BEZ eradicated the tumor masses, with no palpable or extractable tumor mass observed after two months. The combination of IRE and L-BEZ could effectively eradicate tumors and prevent recurrence.

Antitumor efficacy of liposome-encapsulated NVP-BEZ 235 in combination with irreversible electroporation.

Irreversible electroporation (IRE) is an emerging minimally invasive tumor ablation technique that delivers short pulses of strong electric fields and kills cancer cells by disrupting their cell membranes with the electric pulses. However, clinical studies report that more than 10% of local tumor recurrences occur at the original ablated site. NVP BEZ-235 (BEZ) is a dual PI3K/mTOR inhibitor that has substantial anticancer effects. However, the clinical trials of BEZ was not satisfactory because of its low bioavailability and high toxicity, which stemmed from the use of oral administration of high doses over a long period of time. In this research, we prepared a liposomal formulation of BEZ (L-BEZ) for intratumoral injection and studied its antitumor efficacy alone and in combination with IRE. We hypothesized that IRE could release BEZ from the liposomes and that the combination could decrease tumor viability. Our results show that IRE released BEZ from its liposomal encapsulation. The combination of L-BEZ and IRE killed more Hep3B tumor cells in vitro than did L-BEZ or IRE alone and also inhibited cancer cell proliferation in nude mice bearing Hep3B xenografts. Combination of chemotherapeutic agent loaded nanoparticles could enhance the antitumor efficacy of IRE.

Stimuli-Responsive Gold Nanoparticles for Cancer Diagnosis and Therapy.

An emerging concept is that cancers strongly depend on both internal and external signals for growth and invasion. In this review, we will discuss pathological and physical changes in the tumor microenvironment and how these changes can be exploited to design gold nanoparticles for cancer diagnosis and therapy. These intrinsic changes include extracellular and intracellular pH, extracellular matrix enzymes, and glutathione concentration. External stimuli include the application of laser, ultrasound and X-ray. The biology behind these changes and the chemistry behind the responding mechanisms to these changes are reviewed. Examples of recent in vitro and in vivo studies are also presented, and the clinical implications of these findings are discussed.