Patients

Researchers are evaluating the "One All" curriculum, which uses the sport Ultimate Frisbee to improve mental health resilience among young tribal people in two communities in South India. The study aims to see if this intervention is feasible and acceptable while assessing its effectiveness in building resilience and mental well-being. The research involves young tribal adults aged 12 to 25 years from Gudalur in Tamil Nadu and BR Hills in Karnataka. The intervention includes a three-year curriculum delivered by trained community facilitators who adapt the program to fit local needs. Participants attend two or more sessions each week, each lasting about one and a half hours. Sessions involve warm-up activities, drills, ultimate frisbee games with modified rules, and group discussions called spirit circles. The program focuses on developing skills such as self-management, social awareness, empathy, identity building, and conflict resolution. Participants undergo assessments before the program starts, after 12 months, and after 18 months. These include questionnaires measuring resilience (Child Youth Resilience Measure and Connor-Davidson Resilience Scale), mental health (GHQ12), and self-efficacy. Researchers will track attendance and reflections from sessions but will not access medical records. The study involves a baseline interview collecting socioeconomic data and assigns participants codes to protect privacy. Total participation lasts at least 18 months to evaluate outcomes.

This research aims to evaluate a 5-session cognitive behavioral program called 1MoreStep, designed for Black women living with HIV who have experienced intimate partner violence in the past two years. The study focuses on teaching skills to access personal and external strengths, safety strategies, knowledge about HIV care and stigma, communication skills to handle stigma, and addressing barriers to HIV care. It also examines the program's acceptability and feasibility among participants. Participants are randomly assigned to either the 1MoreStep intervention or an equal attention control group. The intervention includes seven group sessions and one individual session held weekly, led by experienced facilitators from the Black community. Sessions cover topics such as safety planning, HIV care engagement, stigma communication, and goal setting using cognitive behavioral skills. The control group attends weekly support group sessions that cover general health topics important to Black women living with HIV but not directly related to the intervention's goals. Throughout the study, participants complete assessments at baseline, 3 months, and 6 months to measure changes in safety strategies and HIV care engagement. Measures include surveys, medical record reviews, and interviews to evaluate treatment acceptance, session attendance, and participant experiences. The study spans approximately 6 months post-baseline, with follow-up surveys and qualitative interviews to explore program fit and barriers to participation.

This research aims to monitor participants who previously received TSC-100 or TSC-101 T-cell receptor engineered T-cell (TCR-T) therapies in the TSCAN-001 study. The goal is to assess the long-term safety and efficacy of these investigational treatments over a 15-year period following their administration, focusing on people treated for conditions such as AML, ALL, and MDS. Participants will not receive any new study drug during this long-term follow-up study. Instead, they will be observed after completing the initial TSCAN-001 trial, while continuing any other cancer treatments as necessary. Monitoring will include a period lasting 15 years from the date of their original TCR-T cell therapy. During the study, participants will be evaluated for treatment-emergent adverse events to assess safety and tolerability. Researchers will also monitor overall survival, relapse-free survival, and progression-free survival over the 15 years. This observational study involves regular assessments to track long-term outcomes without administering additional investigational treatments.

Researchers are evaluating the use of CD19 CAR-T cell therapy in adult patients newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). This open-label, multicenter study aims to assess how effective and safe this treatment is for this specific group of leukemia patients. Additional goals include studying how the CAR-T cells grow and persist in the body, as well as their effect on B-cell levels. Participants will receive an intravenous infusion of CD19 CAR-T cells at a dose of 2 x 10^6 CAR+ T cells per kilogram of body weight. The study includes approximately 50 adult patients and is designed as a single-arm trial without a comparison group. The treatment is administered once, followed by monitoring and evaluation periods. During the study, patients will be closely monitored for treatment response and safety. Key assessments include measuring the complete molecular response rate 28 days after infusion and tracking outcomes such as leukemia-free survival, overall survival, and relapse incidence over two years. Patients will undergo blood tests, genetic testing, heart function evaluations, and be observed for any infections or other health changes. Participation involves signing informed consent and agreeing to contraception measures if of childbearing potential.

Researchers are investigating the use of hyperbaric oxygen (HBO) therapy to improve umbilical cord blood (UCB) stem cell transplant outcomes for blood and lymph gland cancers such as AML, NHL, Hodgkin Disease, and myelodysplastic syndrome. UCB transplant has advantages like easier access and lower risk of infections and graft versus host disease, but challenges include limited stem cell doses and problems with homing, where stem cells lodge in the bone marrow. This study aims to see if HBO given before transplant can improve homing and engraftment by reducing a hormone that may impair this process. Participants in this randomized phase II trial will be assigned to either receive hyperbaric oxygen therapy or no additional intervention before their UCB transplant. HBO therapy involves breathing 100% oxygen in a pressurized chamber at 2.5 times normal atmospheric pressure. The study compares time to neutrophil recovery and other blood count and transplant success measures within 100 days after transplant between the two groups. Participants will be monitored closely with blood tests to track recovery and engraftment, including neutrophil and platelet counts and donor cell presence. Safety assessments and evaluations of transplant outcomes will occur regularly during the first 100 days post-transplant. The study runs until June 2027 and aims to provide important information on whether HBO therapy improves transplant success and immune recovery.

Researchers are evaluating the safety and feasibility of two genetically engineered donor-derived T cell therapies, TSC-100 and TSC-101, in patients with acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or acute lymphoblastic leukemia (ALL) who are undergoing allogeneic peripheral blood stem cell transplantation. This Phase 1, multi-center, open-label umbrella study is designed to assess these treatments combined with the standard of care, compared to the standard of care alone, following hematopoietic cell transplantation (HCT) from haploidentical donors or matched unrelated donors (MUD or MMUD). The study focuses on patients positive for HLA A*02:01 and aims to determine the optimally tolerated dose and preliminary efficacy of these T cell therapies. Participants receive either TSC-100 or TSC-101 based on their HLA type and minor antigen positivity, or standard of care alone. The treatments are administered intravenously alongside standard reduced intensity conditioning regimens such as fludarabine with cyclophosphamide and total body irradiation, or other institutional protocols. Dose escalation follows an interval 3+3 design to evaluate safety and tolerability, with up to two doses given. Once the recommended phase 2 dose is identified, additional patients may be enrolled at that dose level. Supportive care and infectious prophylaxis are provided per institutional guidelines. During the study, participants will undergo safety evaluations including monitoring for dose-limiting toxicities and adverse events over a two-year follow-up period. Researchers will assess disease-free survival, relapse rates, overall survival, and immune responses to the therapies at various intervals up to two years. Participants must consent to mandatory procedures such as bone marrow biopsies and blood sampling for research and agree to long-term follow-up for up to 15 years if receiving the investigational T cell infusion. The study involves careful monitoring and comparison of outcomes between treatment and control groups to evaluate the investigational therapies' potential.

Researchers are evaluating a new approach to improve care coordination between hospitals and primary care for patients aged 75 or older who have suffered a hip fracture. The study focuses on osteoporosis treatment using zoledronic acid infusions combined with vitamin D and calcium supplements to prevent further fractures. The trial aims to test if ambulant nurses assisting general practitioners (GPs) can increase the number of patients receiving recommended annual zoledronic acid infusions over three years after their fracture. Participants receive an initial infusion of zoledronic acid 5 mg at the hospital after their femoral neck fracture and are then followed in one of two ways based on their region. In intervention regions, ambulant nurses support GPs with administering zoledronic acid yearly for three years. In control regions, patients receive usual care where GPs are responsible for follow-up and annual infusions guided by discharge summaries. The study is designed as a cluster randomized controlled trial with regions assigned to intervention or control groups. During the study, patients from both groups are asked to complete a questionnaire after one year, reporting if they received zoledronic acid as recommended. The main outcome is whether patients are offered treatment at the one-year follow-up. The trial includes safety monitoring and data collection over three years, with an estimated total of 200 patients to account for mortality. It seeks to establish practical procedures for nurse-assisted osteoporosis treatment in primary care settings to improve patient care continuity after hospital discharge.

Researchers are evaluating an Acceptance and Commitment Therapy (ACT)-based intervention aimed at reducing psychological symptoms and increasing psychological flexibility among parents of children with medical complexity. These parents often face ongoing stress from managing their child's chronic, complex health conditions and uncertainty about the prognosis. This pilot randomized controlled trial addresses a gap in studies on ACT for Chinese parents in local communities to help them better manage caregiving-related stress and emotions. The study involves two groups: one group receives the ACT-based intervention consisting of four weekly face-to-face sessions, each lasting two hours and including a question-and-answer period. The sessions cover topics such as understanding ACT, stress and struggles, role play, mindfulness exercises, and applying personal values to actions. The other group has the option to join usual community social or health care services available to parents of children with medical complexity. Participants will be assessed at the start and after four weeks using the Chinese versions of the Depression Anxiety Stress Scale and a psychological flexibility measure. The study will monitor changes in psychological symptoms and flexibility. Parents will participate in scheduled sessions and complete questionnaires, with the trial lasting four weeks of intervention plus assessments. The research team will observe feasibility and preliminary effects of the ACT intervention to inform future studies.

Carpal tunnel syndrome (CTS) is a common nerve compression disorder affecting the wrist, caused by pressure on the median nerve within the carpal tunnel. Researchers are evaluating the use of ultrasound (US) and nerve conduction studies (NCS) as tools to help diagnose CTS, plan treatment, and monitor patients over time. This study focuses on how ultrasound can assist in understanding nerve changes and anatomical variations related to CTS. Participants will undergo high-resolution, real-time ultrasound imaging of both wrists using a 12 MHz linear array transducer. The ultrasound examinations will take place before surgery and again three months after surgery. This imaging approach aims to measure various nerve parameters such as size, blood flow, and movement, offering a non-invasive and quick method to support diagnosis and follow-up. During the study, patients will receive ultrasound assessments at specified times and clinical evaluations for CTS. Researchers will measure the sensitivity of ultrasound in diagnosing CTS during surgery. The study involves monitoring changes in the median nerve and surrounding structures to help improve diagnosis and management. Participation includes imaging visits and clinical follow-up over a period encompassing pre- and post-surgical assessments.

Researchers are evaluating how virtual care options in Primary Care can better meet the needs and preferences of Veterans. This study aims to improve understanding of the benefits and costs of different visit types, such as face-to-face, telephone, and video appointments, by using surveys and interviews with Veterans and their Primary Care physicians (PCPs). The study will test a new approach called the Advancing Decisions about Virtual Service Encounters (ADViSE) intervention to help Veterans and PCPs make better-informed decisions about care options. The ADViSE intervention includes sending personalized interactive text messages to Veterans for 6 months, guided by a library of messages developed in earlier research. PCPs will also receive coaching sessions twice during the intervention. The study uses a stepped wedge cluster randomized controlled trial design, gradually introducing the intervention to different care teams in random order. Each Veteran will have a 6-month intervention period compared to a 6-month control period before the intervention. Participants will engage in surveys and receive text messages while their healthcare use and outcomes are monitored over time. Researchers will assess Veterans' perceptions of healthcare value, satisfaction, preferences for virtual care, types of healthcare encounters, and various health measures such as blood pressure and cancer screenings. The study will also look at healthcare costs and time and travel expenses for Veterans, comparing data from before and after the intervention to understand its impact.