New York

Researchers are evaluating the safety, tolerability, and effectiveness of CYB003, a Deuterated Psilocin Analog, compared to a placebo when added to current antidepressant treatment in adults with moderate to severe Major Depressive Disorder (MDD). This Phase III trial focuses on participants aged 18 to 85 years who have had inadequate response to a stable antidepressant dose, aiming to better understand how CYB003 might improve depressive symptoms. Participants receive oral doses of CYB003 or matching placebo along with manualized psychological support provided by trained facilitators. The treatment period includes multiple dosing sessions with monitoring and assessments throughout. Placebo is used as a comparator to evaluate the combined safety and efficacy of CYB003 in this population. During the study, participants undergo evaluations using the Montgomery-Åsberg Depression Rating Scale (MADRS) at several time points, including screening, baseline, and multiple days up to the end of treatment at Day 42. Researchers monitor symptoms, side effects, and overall safety. Participants provide informed consent and are assessed regularly to track changes in depression severity and any adverse events over the course of the study.

This research aims to find out which type of video is most effective in increasing the uptake of the HPV vaccine. It compares informational videos that explain HPV and the vaccine, personal story videos featuring individuals sharing their own HPV experiences, and a combination of both types. The study focuses on parents of children aged 11 to 17 who have not yet received the HPV vaccine. Participants will be shown different types of videos: an informational animation covering HPV disease and vaccine safety, personal narrative videos tailored to match the participant's race, ethnicity, and gender, or a combination of both. The personal stories are edited to be several minutes long and designed to resonate with each viewer. The study does not involve a drug or medical procedure but uses behavioral interventions through video viewing. During the study, researchers will track how many participants receive the HPV vaccine over a 9-month follow-up period. Participants must complete surveys and watch the assigned videos on their own device. The study observes vaccine uptake as the main outcome and excludes those whose children are already vaccinated or who do not complete study requirements. Overall, the study investigates how video content can influence vaccine decisions among parents.

Researchers are investigating the drug bezuclastinib in an open-label, two-part Phase 2 study for patients with Advanced Systemic Mastocytosis (AdvSM), including Aggressive Systemic Mastocytosis (ASM), Systemic Mastocytosis with an Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL). The study aims to evaluate the safety, effectiveness, and how the drug behaves in the body for these serious conditions. Bezuclastinib is given orally as tablets taken continuously in 28-day cycles. The study has two parts: Part I focuses on identifying safe and tolerable doses of bezuclastinib over 18 months, while Part II evaluates its effectiveness by measuring the objective response rate and confirming the relationship between drug exposure and response during another 18-month period. Participants will undergo assessments including clinical evaluations, laboratory tests, and monitoring of their disease status to determine treatment effects and safety. Researchers will track the drug's impact on the disease and patient health throughout the study, which involves continuous treatment and follow-up over the specified time frames.

Researchers are evaluating the safety and effectiveness of elenestinib (BLU-263) combined with symptom-directed therapy (SDT) compared to placebo plus SDT in people with indolent systemic mastocytosis (ISM) whose symptoms are not well controlled by SDT alone. This Phase 2/3 randomized, double-blind, placebo-controlled study includes participants with ISM and smoldering systemic mastocytosis, and also involves groups for pharmacokinetic studies and participants who previously received a selective KIT inhibitor. The study is divided into multiple parts. Parts 1 and 2 enroll participants with ISM who will receive either elenestinib oral tablets or placebo alongside their symptom-directed therapy. Participants from Part 2 may continue into Part 3, which is an open-label extension where all receive elenestinib. Part K enrolls participants with ISM who have prior experience with selective KIT inhibitors. The study tracks treatment effects and safety over time. Participants will be monitored for up to 5 years, with assessments including the number of treatment-emergent adverse events, changes in symptom scores measured by the ISM-Symptom in Assessment Form, and overall safety monitoring. Evaluations occur at baseline, 13 weeks, 49 weeks, and throughout the long-term follow-up. The study also includes detailed tracking of symptom control and adverse events to evaluate the impact of treatment on participants' health and quality of life.

Researchers are investigating the smallest effective dose of 131I-apamistamab to prepare patients with severe sickle cell disease (SCD) for a bone marrow transplant. This is the first use of 131I-apamistamab, an investigational drug not yet approved by the FDA, in advanced SCD patients undergoing allogeneic stem cell transplant. The study aims to replace the usual conditioning regimen, which includes chemotherapy, total body irradiation, and an antibody called Campath, to avoid long-term side effects like secondary cancers and infertility. Participants will receive 131I-apamistamab through intravenous infusion as part of a non-myeloablative conditioning regimen before stem cell transplant. The antibody dose will be at least 0.5 mg/kg but may be adjusted based on target radioactivity. Alongside this, patients may receive Campath via IV and Sirolimus orally to suppress the immune system. Total body irradiation, typically part of conditioning, is being eliminated in this study to reduce side effects. Before treatment, patients will undergo red blood cell exchange transfusion to lower Hemoglobin S levels and will have dosimetric imaging to monitor drug absorption. During the study, participants will be monitored for graft failure 42 days after transplantation. Assessments include clinical evaluations, imaging, laboratory tests, and medication level monitoring. The study enrolls 24 patients aged 12 to 50 years with advanced sickle cell anemia who have an HLA-matched sibling donor. Safety and effectiveness will be closely followed through the transplant and post-transplant periods to determine the minimum effective dose of this investigational treatment.

This research aims to explore how a dietary supplement called the Insulin Balance Formula can support healthy insulin levels and affect weight, fatigue, and sugar cravings. It is designed for generally healthy adults who want to maintain balanced insulin and achieve overall health goals. The study uses a single-arm observational design where participants serve as their own controls to gather initial data on the supplement's effects and safety. Participants will follow a 30-day protocol taking three capsules of the Insulin Balance Supplement daily, ideally one before each meal or all at once for convenience. They start with one capsule to check tolerance and may take the supplement on an empty stomach or with food. The formula includes berberine, beta alanine, zinc citrate, folate, and fenugreek extract, combined to target insulin resistance and support weight management. Throughout the study, participants will complete assessments including waist circumference measurements, the PROMIS Sleep Disturbance Scale, carbohydrate craving questionnaires, and hunger and fatigue ratings after meals. These evaluations occur at the start and end of the study, with some repeated randomly during the 30 days. Participants are encouraged to provide honest feedback while maintaining their usual diet and avoiding new supplements. The study monitors safety and collects data to guide future research on nutritional support for insulin balance and metabolic health.

Researchers are evaluating the clinical performance of the 3M17 Filtek17 Supreme Flowable Composite for dental restorations in Class IV cavities and veneers. This study focuses on the use of flowable resin composites, which offer advantages like better cavity adaptation and simpler techniques compared to traditional paste composites. The study aims to provide clinical data on this product's effectiveness using an updated Fe9de9ration Dentaire Internationale (FDI) modified score published in 2023. Participants will receive dental restorations using the 3M17 Filtek17 Supreme Flowable Composite, which contains specific resin and filler materials designed for these procedures. The study includes at least 50 Class IV restorations and 25 veneers, with veneers applied as pairs on contralateral teeth. Follow-up visits will occur at 7 days, 6 months, 12 months, and 24 months after the procedure, using the FDI modified score to assess restoration quality. During the study, researchers will collect clinical data and photographs before treatment and at each follow-up to evaluate the restorations. Assessments will be conducted by two calibrated evaluators separate from the operator. The primary outcome measured is the survival of the treated dental sites over 24 months. Participants must attend all scheduled follow-ups and maintain good oral hygiene for accurate evaluation throughout the study period.

Researchers are evaluating the use of psilocybin, a 5-HT2A receptor agonist, to help people quit smoking in this multi-site, double-blind, randomized clinical trial. This study focuses on adults with tobacco use disorder who have struggled to quit smoking despite multiple previous attempts. The trial aims to compare the effects of psilocybin against niacin as a placebo, with both groups also receiving cognitive behavioral therapy (CBT) to support smoking cessation. Previous studies have shown promising results for psilocybin, but this study will provide a more rigorous test across diverse participant groups and multiple research sites. Participants will be randomly assigned to receive two sessions of either oral psilocybin (30 mg initially and then 30 or 40 mg one week later) or oral niacin (150 mg initially and then 150 or 200 mg one week later). Both groups will receive CBT alongside the drug sessions. Niacin is used as an active placebo to mimic some physical effects without the psychedelic impact. The treatment sessions are one week apart, and the study involves 66 participants across four research sites experienced in psilocybin research. Throughout the 12-month study, participants will be closely monitored for smoking cessation using biochemical tests to confirm abstinence from smoking. Researchers will assess the primary outcome of biologically-confirmed 7-day point-prevalence abstinence at 12 months. Additional cognitive and psychological evaluations will explore how psilocybin may influence smoking behavior and withdrawal anticipation. Participant health will be carefully monitored through interviews, physical exams, ECGs, and lab tests to ensure safety during the trial.

Researchers are studying the safety and effectiveness of 67Cu-SAR-bisPSMA in men with metastatic castrate resistant prostate cancer that expresses PSMA. This Phase I/IIa trial focuses on participants whose cancer has progressed despite androgen deprivation therapy and prior treatments with androgen receptor pathway inhibitors. The study aims to understand how the drug distributes in the body, determine safe dosing levels, and evaluate treatment responses over several years. Participants receive two drugs: 64Cu-SAR-bisPSMA for imaging and dosimetry, and 67Cu-SAR-bisPSMA for treatment. The study includes a dose escalation phase to find the maximum tolerated or feasible dose of a single 67Cu-SAR-bisPSMA dose over 8 weeks, followed by a recommended dosing phase with two doses over 14 weeks. Imaging with PET/CT scans using 64Cu-SAR-bisPSMA helps model dosimetry for the therapeutic 67Cu-SAR-bisPSMA. The treatment is given under close monitoring to assess safety and response. During the study, participants undergo PET/CT scans, blood tests, ECGs, and vital sign monitoring at various times up to 5 years to track drug distribution, treatment effects on prostate specific antigen levels, radiographic cancer response, and any side effects. Safety is closely followed through laboratory results and adverse event reporting. Participants are monitored for long-term tolerability and treatment outcomes, with study involvement lasting up to five years.

Researchers are investigating the use of Ga-68-DOTATATE PET/MRI scans in diagnosing and managing patients with somatostatin receptor-positive central nervous system (CNS) tumors, mainly meningiomas, but also including other tumors like esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma, and certain brain metastases from systemic cancers. This study aims to determine if Ga-68-DOTATATE PET/MRI can better distinguish tumor recurrence from post-treatment changes, improving diagnosis and treatment planning. The investigation builds on prior pilot data showing promising results in detecting residual tumor and additional lesions not visible on MRI alone. Participants with meningioma who are planning surgery will have a Ga-68-DOTATATE PET/MRI scan combined with their standard care MRI before surgery for research purposes. Up to two additional follow-up PET/MRI scans may be performed as part of standard care. For patients with other somatostatin receptor-positive CNS tumors, PET scans may be added to their routine MRI to assess disease extent. When necessary, 1.5 Tesla MRI combined with PET/CT fusion imaging may be used instead of 3 Tesla MRI. During the study, participants will undergo these imaging procedures and clinical evaluations over time to assess the usefulness of Ga-68-DOTATATE PET/MRI in their care. Researchers will follow participants longitudinally, up to 10 years, to evaluate whether the scans provide additional clinical benefit in monitoring tumor status. Safety monitoring and diagnostic assessments will be conducted throughout the study to ensure accurate and informative results.