Jpn-003, Japan

A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK

A Study to Evaluate the Effect of Venetoclax on Participants Receiving a Covalent Bruton's Tyrosine Kinase Inhibitor (cBTKi) for First-line Chronic Lymphocytic Leukemia (1L CLL) to Achieve Deep Durable Remissions to Allow Off-treatment Period.

A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of ANX007 in Participants With Geographic Atrophy (GA)

A Dose Finding Study of Debio 4228 in Participants With Locally Advanced/Metastatic Prostate Cancer

Safety, Efficacy, and Frequency of Administration of VNX001 in the Treatment of Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS)

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.

SIBTime Phase II: Web Application for Typically Developing Siblings

An 8-week RCT will be conducted to evaluate the full-scale SIBTime program in a sufficiently powered randomized controlled trial evaluation (sample size = 160 parent/child dyads). SIBTime will be assessed in terms of its relevance, acceptability, cultural appropriateness, and efficacy. Participants will complete measures pre- and post- intervention selected to detect changes in parenting stress and adjustment, parent-child relationship, parents' self-efficacy and frequency of engagement in the targeted parenting strategies, and TD sibling behavior and adjustment. Information will also be collected on family demographics, consumer satisfaction, usability ratings, usage metrics, and recommendations for modifications to the program.

Impact of Two Dietary Interventions on Simple Carbohydrate Intolerance

This is a prospective cross over study. Participants who meet the study entry criterion, will be randomized to a specific dietary intervention: low FODMAP for a 3-week period or Limited Added Sugar for 3 weeks. After the initial study phase, participants will enter a 3 week break followed by a crossover to the other diet phase. Each participant will be randomized to either the low-FODMAP diet group (LFD) or the low added sugar diet group (LAS) for 3 weeks. All participants will be assigned to a nutrition intervention consisting of 2 one-hour counseling sessions (pre and post diet initiation) plus one 30 min telephone session at week 1 and 2 of the intervention for both diet groups. Macronutrients will not be restricted and both study diets will be ad libitum. Diet interventions will include administration of a 24 hour food recall and completion of the Comprehensive Nutrition Assessment Questionnaire in addition to comprehensive education of the assigned diet. Investigators will collect stool samples prior to intervention and post each diet intervention to assess initial microbiome composition as well as post intervention changes. Symptom data will be collected via an online survey link consisting of abdominal pain related questionnaires. Measures for child and parent will be requested at the time enrollment of the study and at the end of each diet phase. Animal studies indicate microbiome adjustment to an increase in dietary carbohydrate pool. It is difficult to capture this change in humans as the microbiome shift may not be evident by actual change in certain strains but by genomic adjustment. Investigators propose a metagenomic approach in combination with metabolomics to identify microbiome end products present as a result of changes in dietary carbohydrate intake by dietary elimination. Investigators will characterize shifts in metagenomic composition in response to dietary shifts using multivariate methods and linear mixed effects models. To address our hypothesis that FODMAP and low added sugar diets will affect microbial gene content in similar ways, investigators will compare metagenomic shifts relative to a baseline diet using multivariate models that control for subject, age, sex, diet order and potential confounding factors in PerMANOVA and distance-based redundancy analyses. Investigators will have 95% power to detect medium shifts in metabolic profiles among dietary groups (Cohen's D = 0.520). Investigators will use mixed effect linear models to measure enrichment for specific metabolic pathways and diet-driven shifts in specific metabolites over time while controlling for subject, age, sex, diet order, symptoms and potential confounding factors. In these repeated measures design, we will have 95% power to detect a small to medium effect of diet on a given metabolite (Cohen's D = 0.371). The Benhamini-Hochberg procedure will be applied to decrease the false discovery rate when running multiple tests (Yoav et al) It is also of interest to analyze how microbial gene content and metabolic profiles covary. Investigators will apply qualitative genetic methods of covariance matrix estimation to determine how metabolite profiles can be predicted by metagenomic content.

Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy

A Study of Dual-task Exercise Training to Prevent Falls Among Older Adults With Mild Cognitive Impairment

The primary aim of the study is to determine the comparative efficacy of two tai ji quan interventions (Dual-task tai ji quan, standard tai ji quan), relative to a stretching exercise control, in reducing the incidence of falls among community-dwelling older adults with mild cognitive impairment.