Clinical trials

This study is trying to improve the hospital-to-home transition for people with heart failure who receive home care services. The study will test an intervention called I-TRANSFER-HF, which differs from usual care by combining early home health nurse visits and outpatient medical appointments. The study is interested in two questions: 1. Is I-TRANSFER-HF better than usual care at preventing heart failure patients from returning to the hospital within 30 days? 2. Are there parts of I-TRANSFER-HF that are easy or hard to implement in the real world? The researchers will answer these questions by testing the intervention among pairs of hospitals and home health agencies across the country. During the study, the hospital-agency pairs will be asked to implement I-TRANSFER-HF. The researchers will then compare the results from before and after I-TRANSFER-HF was adopted. They will also interview people from these hospitals and agencies to see how I-TRANSFER-HF is being implemented under real-world conditions.

This randomized controlled trial compares a novel psychotherapy, Engage \& Connect, with a Symptom Review and Psychoeducation intervention, tailored to reduce postpartum depression. The study includes 9-weeks interventions, delivered remotely. It will examine changes in social isolation, processing of social rewards and depression severity over 9 weeks of treatment.

Investigators will determine whether N-of-1 trials, as a pragmatic, participant-centered approach to medication optimization that can overcome key barriers of deprescribing, can lead to increased participant confidence regarding their preference to continue or discontinue beta-blockers in older adults with Heart Failure with Preserved Ejection Fraction (HFpEF).

During surgery that is done using a robot, the surgeon needs to put carbon dioxide gas into the belly to lift the belly wall. This is done so the surgeon can adequately see all the body organs and operate safely. Many surgeons currently use a standard pressure of 15 mmHg (a unit to measure pressure). However, many patients find the use of this pressure to be painful after surgery. New research has shown that using a lower pressure with a device called "AirSeal" can safely reduce pain and lead to faster recovery after surgery. The goal of this clinical trial is to learn if using a lower gas pressure with the AirSeal device during robotic surgery, compared to standard gas pressure with conventional devices, helps adults feel less pain and recover faster. The study includes adults aged 18 or older having robotic at New York-Presbyterian Hospital/Weill Cornell Medical Center. The main questions this clinical trial aims to answer are: 1. Does using lower gas pressure shorten the time people spend in the recovery room after surgery? 2. Does using lower gas pressure lead to less pain and reduce the need for pain medicine after surgery?

The goal of this pilot study is to understand and improve the shared decision-making process between people with advanced breast cancer and their providers regarding their care and treatment. As part of this study, the researchers will evaluate a decision support tool called COAST that was designed to support patients and providers in having meaningful conversations. The main questions it aims to answer are: 1. Can the COAST tool improve the quality of communication between patients and their oncology providers? 2. Is the COAST tool acceptable, appropriate, and easy to use at NYP-Weill Cornell Medicine, NYP-Brooklyn Methodist Hospital and NYP-Queens? Participants will be asked to fill out two surveys: one before they use the COAST tool and another about 2 - 4 weeks later. Some patients will also be invited for an interview.

This research project has three main goals: (1) To create a new screening tool that helps primary care doctors spot signs of neglect in older adults with dementia. (2) To design a support program that can be delivered both in person and through a mobile app on Android phones. (3) To run a clinical trial with three groups of participants to find out how effective the screening tool is on its own, and how effective it is when combined with the support program-compared to standard care. This current phase of the project focuses on parts of goals 1 and 2, as described below.

The goal of this early-stage study is to support the heart health of home health aides, a workforce that provides care for adults at home but whose own health has been historically poor. To do this, the study will use Life's Essential 8 (LE8), a program developed by the American Heart Association (AHA) that promotes cardiovascular wellness through education and lifestyle changes. The program has been adapted specifically for home health aides and will be delivered by trained "peer coaches," who are fellow home health aides who will help guide participants through the program. The main questions the study aims to answer are: * Will the LE8 intervention, which provides cardiovascular health education and support with positive thinking, be used by home health aides and do they like it? * Does the LE8 intervention actually improve home health aides' cardiovascular health after the intervention's conclusion compared to baseline? Participants will be paired with a trained peer coach and take part in the 10-week program over the course of 6 months. The program includes support for healthy behaviors and positive thinking, with the goal of making lasting improvements in cardiovascular health.

The aim of this study is to find out if using a certain kind of mesh can reduce the chances of hiatal hernias coming back after anti-reflux surgery. Participants undergoing antireflux surgery will be assigned to one of two groups, a group that has surgery with mesh, or a group that has surgery without mesh.

The goal of this study is to understand and improve the breast surgical decision-making process for young women newly diagnosed with breast cancer. As part of this study, the investigators will evaluate the impact and use a web-based tool called CONSYDER that is designed to provide useful information to young breast cancer patients. It is also meant to improve communication between young women and their surgeons with the purpose of helping patients make appropriate surgical decisions. Participants will complete surveys approximately within 1 week of the surgical consult and approximately 6 months after surgery. Patients who receive neoadjuvant chemotherapy will also be surveyed after the completion of neoadjuvant treatment but prior to surgery. Some patients will be invited for an interview after their surgery as part of the evaluation. A subset of patients/surgeons will also have their surgical consultation audio-recorded.

The goal of this clinical trial is to learn about the effects of fluconazole in patients who plan to start or are currently undergoing standard of care treatment and plan to dose-escalate an IL-23 therapy for their Crohn's disease. The main question it aims to assess is whether or not patient response to IL-23 therapies improve when simultaneously treated with fluconazole.

Project 1: The goal of this research project is to examine usability and acceptance of virtual reality (VR) applications and their efficacy with older adults. This highly innovative cross-site Stage 1 Intervention Development Project (NIH (National Institutes of Health) Stage Model) will apply the CREATE systematic approach to the design and evaluation of an immersive VR program, Cognitive Activity Social Technology (CAST), for older adults. The program will provide a suite of virtual cognitive, social and activity engagement applications; and allow for virtual interactions.

Individuals with stroke commonly experience both depression and cognitive difficulties. The goal of this study is to evaluate the efficacy of a treatment that combines a digital therapeutic (an iPad-based cognitive training program) with learning cognitive strategies. The hypotheses are that this treatment will improve cognitive skills, depression symptoms, daily function, and brain connectivity. In the short-term, the findings will inform the efficacy of the intervention and in the long-term, may support the use of the intervention to improve co-occurring cognitive and mood difficulties after stroke.

The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG, the use of two or more arterial grafts compared to a single arterial graft is associated with improved survival. Prospective event-driven unblinded randomized multicenter trial of at least 4,300 subjects enrolled in at least 25 international centers. Patients will be randomized to a single arterial graft (SAG) or multiple arterial grafts (MAG). Patients will be randomized in a 1:1 fashion between the two groups. Permuted block randomization with random blocks stratified by the center and the type of second arterial graft will be used to provide treatment distribution in equal proportion.

The purpose of this study is to see if a randomized controlled trial of ovarian vein and pelvic vein embolization versus venography alone could determine outcomes for women with chronic pelvic pain and pelvic varicose veins. The data gathered will assist in addressing changes in quality of life in patients who have ovarian/pelvic vein embolization versus no embolization.

The goal of this study is to improve the mental health of home health aides, a workforce that provides care for adults at home but whose own health has been historically poor. The main questions the study aims to answer are: * Will a health program called Living Healthy, which provides health education and support with positive thinking, be used by home health aides and do they like it? * Does Living Healthy actually improve home health aides' mood compared to what they usually do to take care of themselves? Participants in the study will get an 8-week health program called Living Healthy over 3 months. Some of the participants will also have a 'peer coach' who is another home health aide who's been trained to help them with the program and learn some ways to feel better. The study will compare the experiences of home health aides who get Living Healthy plus a peer coach with those who only get the Living Healthy program.

The purpose of the study is to examine the effect of Problem Adaptation Therapy for Pain (PATH-Pain) on cognitive functioning, depression and pain-related disability in 100 older adults with cognitive impairment, chronic pain, and depression. The study will test if PATH-Pain has better cognitive, affective, and functional outcomes than Attention Control Usual Care.

The purpose of the study is to see if using a diabetes app along with nutrition counseling from a registered dietitian nutritionist can help improve blood sugars and cholesterol levels, quality of life, physical activity, and food and beverage choices.

The goal of this Stage 1 (NIH Stage Model) Intervention Development cross-site project is to develop, using a user-centered design approach, and evaluate an innovative intelligent adaptive software package aimed at providing cognitive and social support and engagement to older adults with mild cognitive impairment (MCI). The system will be designed to adapt to the needs and abilities of the user. The investigator's goal is to develop a unique and highly innovative technology tool that can provide adaptive support to aging individuals with MCI, even as cognition might deteriorate further. Speech data collected as part of an embedded reminiscence feature will advance fundamental knowledge of how speech and language production data might serve as an early indicator of cognitive decline.

The goal of this clinical study is to evaluate the feasibility and acceptability of the Galleri multi-cancer early detection blood test in people with BRCA1 or BRCA2 gene changes who are at high risk for ovarian cancer. The study will also explore how well the test detects ovarian cancer or related precancerous conditions. The main questions it aims to answer are: * Is it feasible to incorporate the Galleri blood test into the care of people at high \* risk for ovarian cancer? * Is the Galleri blood test acceptable to participants? * How well does the Galleri blood test identify ovarian cancer or related precancerous conditions? Participants will: * Receive the Galleri blood test. * Complete questionnaires about their experience with the test. * Some participants will also complete an interview about their experiences and preferences. * Continue with their planned standard medical care, including surgery or follow-up visits, as appropriate.

This randomized controlled trial examines a 1-session, telehealth pain coping skills training (PCST) protocol with five 15-minute maintenance calls (Brief PCST-Community) adapted for women with breast cancer in medically underserved areas. Pain, health-related quality of life, and self-efficacy for pain management will be assessed at baseline and 10 and 15 weeks later.

Atopic dermatitis is well reported to have a significant impact on well-being in adolescents with atopic dermatitis, without clear recommendations for intervention. The investigators aim to identify an accessible, effective digital health intervention for these patients. The investigators hypothesize that regular use of a digital mindfulness meditation app will improve disease control and quality of life in adolescents with moderate to severe atopic dermatitis based on validated survey measures.

The goal of this clinical trial is to evaluate the impact of screening for elder neglect in older adults with dementia in primary care settings and the impact of an intervention for caregivers of older adults with dementia. The hypothesis of the study are: * Neglect screening in primary care will have a positive impact on outcomes including a decrease in presence of neglect at 6 months and other patient and caregiver outcomes * Neglect screening paired with a caregiving intervention will have a greater impact on these outcomes than screening alone Researchers will compare three groups of participants to find out how effective the screening tool is on its own, and how effective it is when combined with the support program, compared to standard care. Participants will be asked to: * attend primary care clinic visits * complete questionnaires * participate in the intervention * participate in a semi-structured interview

The goal of this clinical trial is to learn whether Pain Reprocessing Therapy (PRT) can help adults with knee pain after knee replacement surgery. The study is comparing PRT to usual care (the regular treatment people get after surgery) to see which works better for relieving pain. The main questions the study aims to answer are: 1. Does PRT help lower pain in people who have chronic knee pain after knee surgery? 2. How do the effects of PRT compare with usual care in terms of pain relief and other factors such as anxiety, depression, and sleep? 3. How does PRT impact the brain? Participants will: 1. Be randomly assigned to receive either PRT or usual care. 2. Complete questionnaires about their pain and health. 3. If in the PRT group, have eight weekly therapy sessions over video calls with a therapist. 4. If interested, may also take part in an optional EEG test to measure brain activity related to pain.

The goal of this clinical trial is to test a new community health worker-delivered program (Strengthening COnnections to Overcome Pain, or SCOOP) that teaches strategies for managing chronic pain and loneliness to older adults living in rural areas. The main questions it aims to answer are: 1. Does participating in SCOOP result in less pain interference with daily life? 2. Does participating in SCOOP result in decreased loneliness? 3. What is the level of participant engagement in SCOOP? Researchers will compare people who have participated in SCOOP with people who have not participated in SCOOP to see if SCOOP is helpful in decreasing pain interference and loneliness. Participants will: 1. Watch brief videos teaching strategies to manage pain and boost social connections. 2. Engage in up to 7 weekly coaching sessions with a community health worker. 3. Complete two telephone interviews about health, mental health, and functioning: one at baseline, and one 2 months later.

The goal of this clinical trial is to learn whether a one-time injection of a person's own concentrated fat (micro-fragmented adipose tissue, or MFAT) can reduce pain and improve function in adults (ages 18-80) with chronic tendinopathy - tendon pain lasting more than 3 months (for example, in the shoulder, elbow, hip, knee, or Achilles) - that has not improved with usual treatments such as physical therapy, cortisone shots, or platelet-rich plasma. The main questions it aims to answer are: * Does injecting a person's own concentrated fat into a painful tendon reduce tendon pain? * Does it improve how well the tendon works, how long does any improvement last, and is the procedure safe? This is a single-group study, so there is no separate comparison group; each participant's pain, function, and ultrasound results after treatment are compared with their own measurements taken before treatment. Participants will: * Have a one-time procedure in which a small amount of fat is removed from the abdomen by liposuction (under local numbing), concentrated, and injected into the painful tendon using ultrasound guidance. * Complete short pain and function questionnaires and have ultrasound imaging of the tendon at study visits. * Be followed for about 12 months, with a phone or video check-in 3-7 days after the procedure, a 2-week skin check of the fat-removal site, and visits at 6 weeks, 3 months, 6 months, and 12 months.