Jefferson Valley, New York

Simulated Conversation Training for Mental Healthcare Providers to Improve Care for Transgender and Gender Nonconforming Individuals

Phase I: In order to assess feasibility and measure success in development, the team will recruit 20 providers in training from multiple sites around the United States to utilize the Intake Module to determine if the product changes provider knowledge. SIMmersion and their collaborators successfully used this methodology in a prior SBIR Fast-Track proposal to train health care providers in suicide assessment skills (R44 MH114710). Hypothesis: The investigative team hypothesizes that there will be a positive gain score on the knowledge assessment for a majority of the participants after interacting with the training simulation for one hour. Outcome Data: Demographics: Participants will complete a demographic questionnaire related to age, sex, race, ethnicity, area of licensure, years of experience, prior training experience and experience with TGNC populations. Usage Data: Each participant will be asked to complete the simulated conversation within the module a minimum of two times. The program will automatically store their usage data. Product Evaluation: Upon completion of the post-test knowledge assessment, participants will be asked to provide feedback related to the usefulness, feasibility, scalability, appropriateness, ability to practice, and engagement level of the simulation using Likert scales (0-10) and open-ended questions. Phase II: Control Group: Students randomized to the control group will be given an electronic copy of the Guidelines for Psychological Practice with Transgender and Gender Non-Conforming People (APA, 2015) and asked to take notes in the pdf document. The amount of time students spend on the document and note-taking will be recorded and notes will be analyzed for content. As an incentive, the participants in the control group will be given access to TTACS after they complete the post-intervention assessment. Educational Intervention: The educational intervention will be TTACS, the training program with simulated roleplays. Each participant will be asked to schedule 10 hours of time to utilize the simulation. In order to ensure all participants adhere to the minimum intervention requirements, each will be asked to schedule training time with a member of the research team. Participants will attend an initial training session where each participant will receive a short orientation about the product and its capabilities. Participants will attend an initial training session at one of two sites Psychology Department at Towson University or SIMmersion's office in Columbia, MD based on participant preference. Subsequent training sessions may be completed at Towson, SIMmersion or can be completed individually. Participants will receive confirmation emails the day before a scheduled session and a phone call to reschedule any missed sessions. While the program will be set up as a ready-to-use training package, prior research efforts have shown that requiring participants to utilize the training product in a computer lab provides consistent compliance rates which lead to a more accurate evaluation of the product's efficacy. However, given the demanding nature of practicing students' schedules, requiring all intervention usage at our two sites may be difficult for participants. The research team anticipates that the proposed method will accommodate for participant schedules while still ensuring intervention compliance. Demographic Collection: All training participants will complete a questionnaire designed to gather background information on demographic characteristics and other important characteristics. Information collected will include age, gender, race, program enrollment, prior exposure/training in working with TGNC individuals, and current coursework. This data will permit between-group comparability during subsequent data analysis. Performance Improvement Assessment Using Standardized Patient Methodology (H1-H4). The skills test will consist of two Standardized Patient (SP) testing stations, as described above. Each station is set up in 30-minute units. Prior to counseling each SP, participants will have 5 minutes to review scenario instructions. This will provide background information on the client's previous encounters with the clinician, if any. Then, the participant will have 25 minutes to work with the SP. Ten SPs will be recruited and trained by the staff at Towson University and Dr. Mastroleo. Training will be conducted in 3-hour sessions and include scenario, demonstration role-plays and/or videotapes, observed script practice sessions, group discussion of the character they are portraying and the questions that may be asked. They will also be taught how to time and score (using the checklist) the sessions.Dr. Mastroleo has been training SPs for intervention trials for the past 10 years and is well equipped to do so for this project. Methods to Ensure Reliability of Standardized Patient Performance: All SP interactions will be audio recorded for review and further evaluation. The research team will review the first 5 tapes of each SP and every 5th tape thereafter to ensure the SPs are following the script and scenario protocol. It is the researchers' experience that 10-20% of SPs are not able to follow the script despite extensive training. Utilizing this review methodology identifies these SPs immediately so they can be replaced with SPs that can adhere to the study protocols. Training Experience Questionnaire: Upon completion of the post-intervention SP encounters, each participant in the intervention arm will be asked to complete a Training Experience Questionnaire (TEQ) which will allow them to evaluate TTACS using a series of 5-point Likert scale questions and open-ended prompts. The research team anticipates that participants will indicate agreement or strong agreement on the TEQ that the product is (H5) an acceptable training tool (i.e., easy-to-use, realistic, relevant) and contributes to their skill development.

Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products

All Medtronic market-released leads and all market-released IPG, ICD and CRT devices are eligible to be included in this study.

Synbiotic Compound to Reduce Symptoms of Schizophrenia

A total of n=68 participants with schizophrenia or schizoaffective disorder who have residual psychotic symptoms which are of at least moderate severity will be randomized. Intestinal inflammation will be assessed through the measurement of antibodies to Saccharomyces cerevisiae, gliadin, Candida albicans as well as high-sensitivity C-Reactive protein and Pentraxin-3. The duration of the trial is 14 weeks: after a 2-week placebo run in, the participants will be randomized to receive the synbiotic compound or identical-appearing placebo over the 12 weeks of the randomized phase. The synbiotic compound is a quality-tested product, Probio-Tec ABCG-Stick-25, manufactured by ChrHansen which contains 4 strains of probiotic microorganisms - Bifidobacteria BB-12, Lactobacillus casei, Lactobacillus acidophilus, and Lactobacillus rhamnosus - and the prebiotic, inulin, a fructan-containing polysaccharide which has been shown to increase the level of non-pathogenic bacteria in the gastrointestinal tract. All participants will also be maintained on a stable regimen of psychiatric medications prescribed by their treating psychiatrist.

A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab as a 1L treatment for patients with mNSCLC whose tumors express PD-L1.

Integrity Implant System Post Market Clinical Follow-Up Study

The Study Objective is to confirm the performance, safety and clinical benefit of the Integrity Implant System when used for rotator cuff tear augmentation (with or without repair). The clinical success will be evaluated by absence of rotator cuff re-tear. Performance and clinical benefits will be evaluated by functional outcomes measured using standard scoring systems such as the American Shoulder and Elbow Surgeons Shoulder Score (ASES), Constant-Murley Score (CMS), Patient Satisfaction, EQ-5D-5L, Single Assessment Numeric Evaluation (SANE), Visual Analogue Scale (VAS) and rotator cuff repair outcomes measured using MRI evaluation for repair integrity, quality, tendon tissue thickness and regeneration. Safety of the Integrity Implant System will be assessed by monitoring the frequency and incidence of adverse events. The Primary Endpoint shall confirm the Performance of the Integrity Implant System when used for rotator cuff augmentation (with or without repair). Performance will be evaluated by an adequately powered analysis of retear rates seen by MRI at 12-months after surgery.

Sequential Multiple Assignment Randomized Trial for Bipolar Depression

This is a comparative effectiveness study to address the critical questions of how best to treat people with bipolar disorder who have a major depressive episode: how to get them well, provide second-line treatment when they don't initially get well, and keep them well after they get well. This is a multisite Sequential Multiple Assignment Randomized Trial (SMART) comparative effectiveness design. Investigators will recruit 2726 participants who have BD with a current major depressive episode. In Stage 1, investigators will compare four treatment arms, including three FDA approved monotherapies and the most widely used, but understudied, treatment for BD major depressive episode (i.e., a non-FDA approved combination of an antipsychotic and antidepressant). In Stage 2, participants who do not remit will be re-randomized to treatments not used in Stage 1. Investigators will follow all participants for a total of 52 weeks. This study will be conducted in two phases, a feasibility phase and a full study phase. In the feasibility phase, investigators will recruit at 8 of the 19 study sites based on readiness and interest, to ensure the efficacy of the study design before launching the full study phase. Feasibility Aim 1: To ensure that 8 of the 19 selected sites can recruit, randomize, and retain participants. During the feasibility phase, the selected sites will recruit 133 participants, administer baseline assessments, randomize the participants (at baseline and again at 6-weeks for non-remitters), and conduct follow-up assessments at the end of Stage 1 (6-weeks) and the end of Stage 2 (12-weeks) and end of study (52 weeks or end of feasibility phase, whichever is sooner) and all other scheduled visits. Feasibility Aim 2: To refine and finalize all study standard operating procedures for the full-scale study. After Aim 1 is complete, any changes in standard operating procedures will be made as needed to be implemented in the full study phase. Full Scale Study Full-Scale Study Aim 1: To compare the effectiveness, tolerability, and safety of the four treatments for BD major depressive episodes. Hypothesis 1a: There will be significant differences across the Stage 1 treatments in the proportion of remitters at week 6 (primary endpoint, effectiveness) and in the average adverse event burden and suicidal ideation/behavior at week 6 (secondary endpoints, tolerability and safety). Hypothesis 1b: Among non-remitters of a given Stage 1 treatment (i.e., participants who do not remit by week 6), there will be significant differences across the three remaining Stage 2 treatments in the proportion of remitters at week 12 (primary endpoint, effectiveness) and the average side effect burden and suicidal ideation/behavior at week 12 (secondary endpoints, tolerability and safety). Full-Scale Study Aim 2: To characterize the effectiveness, tolerability, and safety of the 12 adaptive interventions for BD major depressive episodes embedded within the SMART design. Hypothesis 2: On average, there will be significant differences across the 12 embedded adaptive interventions in the proportion of remitters at week 12 (primary endpoint, effectiveness) and in the average side effect burden and suicidal ideation/behavior at week 12 (secondary endpoints, tolerability and safety). Full-Scale Study Aim 3: To determine individual-level characteristics that predict heterogeneity of treatment effect (HTE) across the 12 adaptive interventions for BD major depressive episodes embedded within the SMART design. Hypothesis 3a: Individual-level characteristics and symptoms assessed at baseline as well as symptom changes and side effect profiles at week 6 will predict HTE at weeks 12 and 52. Hypothesis 3b: Investigators hypothesize that an optimal personalized adaptive intervention will perform significantly better than the best aggregate embedded adaptive intervention identified in Aim 2 in terms of the proportion of remitters at week 12 (primary endpoint, effectiveness) and the side effect burden and suicidal ideation/behavior at week 12 (secondary endpoints, tolerability and safety).

Study to Assess the Efficacy, Safety, and Tolerability of NOC-110 in Adults with Refractory or Unexplained Chronic Cough

Approximately 325 participants will take part in the study. It is anticipated that up to 600 participants will be screened. Participation will be approximately 13 weeks.

A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT

Participants will be randomized 1:1 to cretostimogene grenadenorepvec after TURBT (Arm A) vs observation after TURBT (Arm B). Participants in Arm A will receive an induction course and then quarterly maintenance courses of cretostimogene through Month 13, if there is no disease recurrence. Disease status will be assessed using urine cytology, complete bladder visualization (e.g., cystoscopy), and directed TURBT/biopsy (if indicated) every 3 months for the first 2 years after randomization and then every 6 months for an additional year or until disease recurrence. Participants in Arm B who recur with IR-NMIBC after TURBT and observation will be offered treatment with cretostimogene as per the treatment schedule in Arm A.

A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy

Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents

Approximately 1800 adult participants with mCSPC will be assigned to one of two cohorts (550 HRRm and 1250 non-HRRm) and randomized in a 1:1 ratio to receive either Saruparib (AZD5305) with NHA or placebo with NHA. They will receive their assigned treatment and regular tumor evaluation scans until disease progression, or until treatment is stopped for another reason. All patients will be followed for survival until the end of the study. Independent data monitoring committee (DMC) composed of independent experts will be convened to confirm the safety and tolerability of Saruparib (AZD5305) + physicians choice NHA.