Bronx County

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 paradigms 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 34 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 letermovir in children and adolescents under 18 years old who weigh less than 40 kilograms and have received a kidney transplant. The study aims to understand how letermovir behaves in the body over time and to assess its safety and how well participants tolerate it. This phase 1, open-label study focuses on cytomegalovirus CMV prevention in this specific pediatric transplant population. Participants who are between 4 and 52 weeks post-kidney transplant will receive letermovir either orally as tablets or pellets, or through a gastrostomy or nasogastric tube as pellets, for 7 consecutive days. The dosing is adjusted based on weight bands. This is a single-group study without a placebo or comparator arm. During the study, participants will be closely monitored through blood samples to measure drug levels and CMV DNA, including the primary outcome of the drug concentration area under the curve over 24 hours on Day 7. Safety will be assessed by recording any adverse events up to 21 days and study discontinuations due to adverse events up to 7 days. The study is expected to last until 2028 and includes assessments of kidney function stability and medication absorption tolerability.

Researchers are evaluating new medicines to prevent HIV-1 Human Immunodeficiency Virus Type 1 infection. This Phase 3 clinical study aims to determine if taking the drug MK-8527 once a month can prevent HIV-1 infection as well as or better than the standard daily pre-exposure prophylaxis PrEP. The study also assesses the safety and tolerance of MK-8527 in participants. Participants are randomly assigned to one of two groups. One group receives 11 mg of MK-8527 once monthly along with a daily placebo pill matching FTCTDF. The other group receives a daily dose of FTC245 mg TDF and a monthly placebo matching MK-8527. This treatment period lasts for approximately two years, followed by an additional 28-day period where all participants receive open-label FTCTDF daily. During the study, participants will undergo regular monitoring to check for HIV-1 infection and any adverse events. Researchers will track the number of participants who acquire HIV-1, experience side effects, or stop treatment due to side effects over the two-year period. Safety and adherence assessments will be conducted to evaluate the study treatments. The total participation time includes the two-year treatment phase plus the 28-day follow-up with open-label FTCTDF.

Researchers are evaluating molnupiravir, an oral medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in people at high risk of disease progression. The study focuses on adults with confirmed COVID-19 infection who are at increased risk due to age, medical conditions, or other factors. This is a Phase 3 randomized, placebo-controlled, double-blind clinical trial led by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive either molnupiravir or a matching placebo. Those in the molnupiravir group will take 800 mg orally every 12 hours for 5 days, totaling 10 doses. The same dosing schedule applies to the placebo group. Some participants may also receive remdesivir as part of standard care if clinically appropriate. During the study, participants will be monitored for up to 29 days to assess outcomes such as hospitalization, death, or medically attended visits related to COVID-19. Safety will be evaluated by tracking adverse events and discontinuation due to side effects. Researchers will also measure symptom relief, viral RNA levels, and other health indicators. The study is expected to continue until January 2031.

Researchers are evaluating the safety, tolerability, and therapeutic effects of BNT113 combined with pembrolizumab compared to pembrolizumab alone as a first-line treatment for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma HNSCC positive for human papilloma virus 16 HPV16 and expressing the protein PD-L1 with a combined positive score of 1 or higher. This is an open-label, multi-site, Phase IIIII clinical trial consisting of two parts an initial safety run-in phase and a randomized phase. In the safety run-in phase Part A, patients receive BNT113 in combination with pembrolizumab to confirm safety and tolerability at selected dose levels. The randomized phase Part B compares BNT113 combined with pembrolizumab against pembrolizumab monotherapy. Treatments are given by intravenous injection or infusion and continue for up to 24 months. An optional pre-screening phase allows tumor samples to be tested for HPV16 DNA and PD-L1 expression before the main trial screening. Participants will be closely monitored throughout the study. Assessments include safety evaluations, tumor response, and survival outcomes such as overall survival and progression-free survival. Tumor tissue samples must be provided for testing. Researchers will measure treatment-emergent adverse events, response rates, duration of response, and disease control. The study may last up to 48 months, with ongoing safety and efficacy monitoring during and after treatment.

Researchers are evaluating a culturally-tailored home-based physical activity program designed for Hispanic or LatinoLatina 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 the dose-response relationship of galvokimig compared with placebo in adults with moderate-to-severe atopic dermatitis AtD. The study focuses on participants who have had chronic AtD for at least one year and aims to assess how different doses of galvokimig impact the condition. This phase 2 trial is designed to better understand the drugs effects on symptoms and safety in this population. Participants are randomly assigned to one of several groups receiving different predefined doses of galvokimig or a matching placebo during an initial 16-week intervention period. After week 16, participants continue treatment with the same or a modified dose of galvokimig. The study uses a double-blind design to compare the effects of these doses on atopic dermatitis. During the study, participants will undergo regular assessments including the Eczema Area and Severity Index EASI, Investigator Global Assessment vIGA, and Peak Pruritus Numerical Rating Scale PP-NRS. Safety is monitored through reported adverse events up to week 58. The primary outcome is the percentage of participants achieving a significant improvement in EASI score at week 16. The total study duration extends beyond 16 weeks to include ongoing safety and response evaluations.

This study focuses on participants who have previously been treated with ciltacabtagene autoleucel cilta-cel, an autologous CAR-T therapy targeting B-cell maturation antigen BCMA used in multiple myeloma. The purpose is to collect long-term follow-up data to understand delayed adverse events and the long-term safety profile of cilta-cel over a period of up to 15 years after the last dose. Participants were originally treated in company-sponsored clinical trials evaluating cilta-cel. No treatment is administered during this follow-up study. Participants will be observed in two phases the first phase covers the initial 5 years after their last cilta-cel dose, and the second phase covers years 6 through 15 post-treatment. The study includes yearly safety evaluations involving review of adverse events, laboratory tests, and physical examinations including neurological assessments. Participants will be followed up at least once per year for up to 15 years to monitor for new or worsening medical conditions such as malignancies, neurological or autoimmune disorders, hematologic disorders, infections, and serious adverse events. The research team will also assess laboratory markers related to the CAR-T therapy, such as lentivirus presence and CAR transgene levels. This extended monitoring aims to provide a comprehensive safety profile of cilta-cel over the long term.

Researchers are studying the long-term safety and effects of ritlecitinib, an oral medicine, for children with severe alopecia areata, a condition that causes significant hair loss. This Phase 3 trial focuses on participants who completed previous Pfizer studies and have notable scalp hair loss or specific vaccination history. The study aims to understand how well ritlecitinib is tolerated and its impact on hair regrowth and quality of life over time. Participants will take ritlecitinib capsules once daily at home for up to three years. Those who previously received different doses of ritlecitinib will continue the same dose, while others will be randomly assigned to either a higher or lower dose. Dose adjustments and treatment continuation will be evaluated at specific months, with some participants switched to placebo if they do not meet efficacy criteria, though they remain in the study. During the trial, participants will attend 17 clinic visits and receive monthly phone calls. Researchers will monitor safety by tracking adverse events and assess effectiveness using tools like the Severity of Alopecia Tool SALT, eyebrow and eyelash assessments, and patient-reported outcomes on anxiety, depression, behavior, and quality of life. The study includes ongoing safety checks and measures cognitive function at select points, ensuring thorough evaluation throughout the three-year participation period.