Bronx County

Researchers are evaluating the safety, tolerability, and effectiveness of CYB003, a deuterated psilocin analog, compared to a matching placebo as an additional treatment for people with Major Depressive Disorder (MDD). The study focuses on adults aged 18 to 85 who have moderate to severe depression and have not responded adequately to a stable antidepressant medication. This phase III trial aims to add knowledge about treating MDD by assessing CYB003 alongside current antidepressants and psychological support. Participants are randomly assigned to one of two groups. One group receives 16 mg of CYB003 in two dosing sessions spaced about three weeks apart, while the other group receives a placebo on the same schedule. All participants continue their current antidepressant treatments and receive manualized psychological support throughout the study. Those who do not respond to placebo may join a later extension trial to receive CYB003. Throughout the trial, participants undergo several assessments, including the Montgomery-Åsberg Depression Rating Scale (MADRS) at multiple time points from screening to 42 days after treatment begins. Other evaluations include the Beck Depression Inventory, Clinical Global Impression Scale, Generalized Anxiety Disorder scale, and Quality of Life questionnaire. Participants are monitored for safety, treatment response, and tolerability, with the total study period lasting around six weeks after dosing begins.

Cognitive impairment related to dementia is often missed in primary care, especially among older adults from minority and socio-economically disadvantaged populations. Researchers are evaluating the 5-Cog brief cognitive assessment, a quick, simple, and standardized tool that takes less than 5 minutes and addresses cultural and logistical barriers. This pragmatic cluster-randomized trial aims to test whether the 5-Cog paradigm improves detection of new cases of cognitive impairment and dementia care in older adults with cognitive concerns. The study involves 22 primary care clinics in Bronx and Indiana, enrolling about 6,600 patients aged 65 and older who report cognitive concerns. Participants receive either the 5-Cog battery combined with a clinical decision-making tool or enhanced usual care, which includes cognitive concern screening. The 5-Cog battery includes tests like Picture Memory Impairment Screen, Motoric Cognitive Risk Syndrome diagnosis, and Symbol Match. Primary care physicians receive results and decision support but use their clinical judgment in care decisions. Participants undergo cognitive concern screening before their appointments. Researchers will review new cognitive impairment diagnoses and improvements in dementia care within 90 days after the primary care visit using electronic medical records. Additional evaluations include tests for reversible causes, medication changes, specialist referrals, and social support. The study also examines the 5-Cog paradigm's implementation and cost-effectiveness, focusing on populations facing health disparities. Total participation duration varies by patient and clinic schedule.

Researchers are evaluating the use of XYOSTED as a testosterone replacement therapy in adolescent males aged 12 to under 18 years with primary or secondary hypogonadism, a condition where the body produces little or no testosterone. This Phase 3/4 open-label study aims to assess how well XYOSTED supports the continuation or start of puberty, along with its safety and the testosterone levels it maintains. Participants will receive XYOSTED injections at doses tailored to their weight and targeted pubertal stage. Dose adjustments will be made based on testosterone levels measured at specific intervals after dosing, with evaluations approximately every three months to reach the desired hormone levels. After completing the 52-week initial study period, participants may enter a 24-month extension to further monitor long-term safety and treatment effects. Throughout the study and extension, participants will undergo clinical examinations including pubertal staging, blood tests for testosterone and other labs, bone density scans, body composition assessments, and X-rays to monitor bone age. Researchers will track changes in puberty progression, bone health, body measurements, and hormone levels. Participants will attend regular clinic visits every six months during the extension phase to continue safety and pharmacokinetic evaluations.

Researchers are evaluating the use of letermovir to prevent cytomegalovirus (CMV) infection in children and adolescents who have received a kidney transplant and weigh less than 40 kilograms. This phase 1 study aims to understand how letermovir behaves in the body over time and to assess its safety and tolerability in this young population. Participants between 4 and 52 weeks after their kidney transplant will receive letermovir orally, either as tablets or pellets, or through a gastrostomy or nasogastric tube, for 7 consecutive days. The study is open-label and single-arm, focusing on weight-based dosing of letermovir. Throughout the study, researchers will monitor the drug levels in the body by measuring the area under the curve from dosing up to 24 hours on day 7. They will also track any adverse events up to 21 days and note if anyone stops the study drug due to side effects within 7 days. Participants will be assessed for kidney function stability and absence of CMV infection, with careful follow-up to evaluate the drug's safety and how well it is tolerated.

Researchers are evaluating new medicines to prevent infection with Human Immunodeficiency Virus Type 1 (HIV-1). This Phase 3 clinical trial aims to find out if taking MK-8527 once a month is as effective or better than a standard daily pre-exposure prophylaxis (PrEP) in preventing HIV-1 infection. The study also assesses the safety and tolerability of MK-8527. Participants are randomly assigned to one of two groups: one group takes 11 mg of MK-8527 once monthly plus a placebo daily pill matching FTC/TDF, and the other group takes 200 mg FTC/245 mg TDF daily plus a placebo monthly pill matching MK-8527. This treatment phase lasts up to approximately two years. Afterward, all participants receive open-label FTC/TDF daily for an additional 28 days. During the study, participants are closely monitored for HIV-1 infection, adverse events, and any discontinuation due to side effects over the two-year treatment period. The primary outcomes include the number of participants who acquire HIV-1 infection, experience any adverse events, or stop the study intervention because of adverse events. Follow-up and safety assessments continue through the entire treatment period to evaluate the medicine's performance and participant well-being.

Researchers are evaluating molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in adults who are at high risk. This trial focuses on people who may not be able to take certain other COVID-19 treatments due to availability or potential drug interactions. The study aims to compare molnupiravir with a placebo to understand if it reduces hospitalization, death, or medically attended visits related to COVID-19. Participants are randomly assigned to receive either 800 mg of molnupiravir or a matching placebo orally every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if it is clinically appropriate and available. The study is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. During the study, participants will be monitored for up to 29 days to track hospitalizations, deaths, and adverse events. Researchers will assess symptoms, viral levels, and any medical interventions related to COVID-19. Safety will be followed for approximately five months, including any side effects or reasons for stopping the study treatment. The total time commitment varies, with regular assessments and monitoring to understand the treatment's effects and safety.

Researchers are evaluating the safety and effectiveness of the DurAVR4 biomimetic valve compared to other commercially available transcatheter heart valves (THVs) in adults with severe native calcific aortic stenosis who require Transcatheter Aortic Valve Replacement (TAVR). This prospective, randomized, controlled, multicenter international study includes subjects determined by the local Heart Team to benefit from TAVR. The study also includes a separate group of patients with failed surgical bioprosthetic valves who need valve-in-valve TAVR and are considered high surgical risk. Participants will be randomized to receive either the DurAVR4 THV system or a control THV from the SAPIEN or Evolut series. Up to 1054 subjects will be enrolled in the main randomized cohort and followed for 10 years. Additionally, up to 446 low-risk subjects will be randomized in a continued access cohort. A separate nested registry will enroll up to 150 high-risk subjects needing valve-in-valve TAVR who will only receive the DurAVR4 THV. Treatments are delivered by transcatheter implantation, and the study compares these devices in real-world clinical settings. During the study, participants will undergo assessments including mortality, stroke, and cardiovascular hospitalizations over one year as primary outcomes. Secondary outcomes include mortality, disabling stroke, bleeding, vascular complications, and kidney injury within 30 days following the procedure. Participants will be monitored with imaging and clinical evaluations, and safety will be followed for up to 10 years in the main cohort and 5 years in the valve-in-valve registry. The study aims to provide long-term data on these heart valve devices and their impact on patient health.

Researchers are evaluating the safety, tolerability, and effectiveness of BNT113 combined with pembrolizumab compared to pembrolizumab alone as a first treatment for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that tests positive for human papillomavirus 16 (HPV16) and expresses the protein PD-L1. This Phase II/III trial includes patients whose tumors have a combined positive score of 1 or higher for PD-L1. The study is designed to generate important safety and efficacy data for these treatments in this patient group. The trial consists of two parts: Part A is a non-randomized safety run-in phase to confirm the safety and tolerability of BNT113 with pembrolizumab. Part B is a randomized phase comparing BNT113 combined with pembrolizumab versus pembrolizumab alone. Treatments are given by intravenous injection or infusion. Patients may receive treatment for up to 24 months. An optional pre-screening phase allows tumor samples to be tested centrally for HPV16 DNA and PD-L1 expression before entering the main trial. Participants will undergo regular assessments including monitoring for treatment-emergent adverse events, overall survival, and progression-free survival for up to 48 months. Researchers will also measure response rates and duration, disease control, and any dose adjustments due to side effects. Patients provide tumor tissue samples before treatment and are monitored closely throughout the study period. The trial aims to collect comprehensive data on safety, treatment effects, and patient outcomes over this extended follow-up.

Researchers are evaluating a culturally-tailored home-based physical activity program designed for Hispanic or Latino/Latina adolescent and young adult childhood cancer survivors. These survivors may face long-term effects like weight gain, fatigue, and reduced physical fitness after cancer treatment. The study aims to see if this culturally-relevant program can help increase physical activity and improve overall health compared to using a Fitbit tracker alone. The study has two stages. In Stage 1, 20 Latinx survivors participate in developing the intervention using Fitbit trackers, text messages, social media support, wearable activity devices, and interviews over 9 months. In Stage 2, 170 survivors who do not meet physical activity guidelines are randomized to either the intervention group, which includes Fitbit use, weekly goal-setting, peer support via social media and Zoom meetings, and optional activity partners, or a control group that only uses Fitbit trackers for 12 weeks. The intervention includes an intensive phase with weekly sessions followed by a 4-week maintenance phase. Participants will wear Fitbit trackers daily and engage in goal-setting, peer discussions, and physical activity reminders. Researchers will measure moderate to vigorous physical activity, sedentary time, and health-related quality of life over 12 weeks. Additional evaluations include physiological markers of heart and metabolic health and qualitative interviews to improve the program. The study lasts through the intervention phases with ongoing monitoring and support for participants.

Researchers are evaluating how different doses of galvokimig compare with a placebo in adults with moderate-to-severe atopic dermatitis, a chronic skin condition. This Phase 2 study aims to understand the relationship between the dose given and its effects on the condition, focusing on safety, how the drug moves through and acts in the body, and its overall impact on the disease. Participants will be randomly assigned to receive one of three different doses of galvokimig or a placebo during the initial treatment period. After 16 weeks, participants will either continue on the same dose or switch to a modified dose based on the study plan. Galvokimig and placebo are given as injections, and the study is designed to be double-blind, meaning neither participants nor researchers know who receives which treatment during the initial phase. During the study, participants will be regularly evaluated for changes in their eczema severity, itch intensity, and overall response to treatment using specific scales like the Eczema Area and Severity Index (EASI) and Peak Pruritus Numerical Rating Scale (PP-NRS). Safety is closely monitored through reports of adverse events up to week 58. The study lasts at least 16 weeks with ongoing assessments to track treatment effects and safety over time.