Manhattan

Researchers are collecting and storing tissue and blood samples from patients with various types of cancer to help create better models for studying cancer and testing new cancer drugs. This observational study focuses on patients with hematopoietic and lymphatic system neoplasms, malignant solid tumors, metastatic malignant solid tumors, and recurrent malignant solid tumors. The goal is to procure biological tissues and materials to develop preclinical cancer models for future laboratory analysis. During the study, tumor tissue and blood samples are collected during medical procedures required for the patients cancer treatment. These samples are then preserved using methods such as xenograft models, where tissues are transplanted to another species, or in vitro cell cultures. This process allows for future scientific study without additional invasive procedures beyond routine clinical care. Participants will be involved in routine clinical procedures during which tissue and blood samples are collected. Researchers will store these specimens and monitor their use in creating cancer models over a period of up to five years. The main outcome measured is the successful procurement and storage of tissue and blood specimens for research purposes. Participation will continue as long as samples can be collected during clinical management, with no additional treatment or interventions required specifically for this study.

Researchers are evaluating whether a data coaching process called Out of School Time Coach OST-Coach can increase physical activity among children, improve their perceived motor skills, and encourage staff to promote physical activity more effectively. This randomized controlled trial aims to see if targeted data coaching helps children in after-school programs engage in more physical activity and enhances staff practices compared to standard methods. The study involves two groups one receiving the OST-Coach intervention and the other continuing standard practice. The OST-Coach intervention includes four data coaching sessions throughout the academic year following the steps of investigate, design, practice, and reflect. During these sessions, site leaders receive customized data reports and set goals to improve child physical activity, motor competence, and staff behavior. The control group only receives data reports without coaching. Participants are children enrolled in elementary-level after-school programs. Researchers will measure child physical activity through observation and surveys about motor skills, while staff behavior will be observed and surveyed to assess physical activity promotion. Feedback is provided four times during the year. The main outcome is child physical activity tracked over one year, with staff behaviors and perceived motor competence also evaluated. The study runs from September 2025 to July 2026 with no masking.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.

Researchers are studying adults with depression and anxiety to understand how nature-based physical activity affects these conditions. The study involves licensed therapists and their clients and aims to see how a 10-week outdoor walk-and-talk therapy program might change depression and anxiety symptoms. The project also looks at how participating in nature-based activities impacts physical activity levels and mental health. Ten therapists will be trained to carry out the study, then each will recruit six adult clients diagnosed with depression or anxiety. Clients will be randomly placed in either the intervention group, which will participate in weekly outdoor walk-and-talk therapy sessions and set goals for more outdoor activity, or the control group, which will receive educational materials and access to the intervention after 10 weeks. Both groups will use a Fitbit and the NatureDose app to track activity and time spent in nature. Participants will complete surveys about their depression and anxiety symptoms before and after the 10-week program. Therapists will keep weekly logs of therapy sessions, and clients will log their nature-based activities. At the end, clients will fill out satisfaction surveys, and therapists will be interviewed. The study measures include participation in therapy, therapist support, acceptability of the program, physical activity, time spent in nature, and self-efficacy for physical activity and nature engagement.

Researchers are evaluating a phase III trial comparing shorter chemotherapy-immunotherapy without anthracycline drugs to the usual chemo-immunotherapy for treating early-stage triple negative breast cancer TNBC. This study aims to see if the shorter treatment works as well as the usual anthracycline-containing treatment. The trial also assesses patient-reported outcomes like fatigue and physical function, as well as safety and survival measures. It involves participants with specific stages of TNBC and includes detailed evaluations of tumor response and immune markers. Participants are randomly assigned to one of two treatment groups. One group receives paclitaxel, carboplatin, and pembrolizumab followed by doxorubicin, cyclophosphamide, and pembrolizumab, then surgery, with possible pembrolizumab after surgery. The other group receives docetaxel, carboplatin, and pembrolizumab prior to surgery, with possible pembrolizumab after surgery. Blood samples may be collected throughout the trial for research purposes. During the study, participants undergo surgery after chemotherapy-immunotherapy. They are followed every six months for two years, then annually up to five years. Assessments include breast cancer event-free survival, pathological response, distant relapse-free survival, overall survival, adverse events, and patient-reported fatigue and physical function. Quality of life and other patient-reported symptoms are also evaluated. Specimens are banked for future research. The total participation may last up to five years from registration.

This research investigates how a mobile app called Flourish may affect the well-being of students. It aims to understand whether access to the Flourish app increases positive feelings, reduces loneliness, and improves a sense of belonging. The study compares three groups to evaluate if the app alone or combined with a human buddy leads to better well-being outcomes over existing school resources. Participants are randomly assigned to one of three groups a waitlist control group continuing with regular school resources and given external mental health information a group using the Flourish app twice weekly for six weeks and a group using the app twice weekly while also engaging with a buddy. The Flourish app includes a science-based digital toolkit and an AI chatbot designed to support student well-being. During the six-week period, participants complete four brief online surveys measuring mood, loneliness, social support, mindfulness, resilience, life satisfaction, and relationships with the Flourish buddy if applicable. These assessments occur at the start, throughout, and at the end of the study. Researchers monitor well-being changes and enrollment intentions to understand how the app and social support influence student flourishing.

Researchers are evaluating the addition of pembrolizumab, an immunotherapy drug, to usual chemotherapy for patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer that has been completely removed by surgery. This phase III trial aims to compare disease-free survival and overall survival between different treatment approaches, including chemotherapy alone and chemotherapy combined with pembrolizumab. The study also assesses quality of life, side effects, and the impact of tumor markers on outcomes. Patients are randomly assigned to one of two active treatment groups. One group receives standard chemotherapy every 21 days for 4 cycles followed by pembrolizumab given intravenously every 21 days or every 6 weeks for up to 17 cycles. The other group receives chemotherapy combined with pembrolizumab during the initial 4 cycles, followed by pembrolizumab alone for additional cycles. Chemotherapy regimens include combinations of cisplatin, carboplatin, pemetrexed, gemcitabine, or paclitaxel. A previous group receiving chemotherapy alone followed by observation is closed. Participants undergo various assessments including echocardiograms, MRIs, CT scans, and blood sample collections during the trial. They complete quality of life questionnaires and are monitored regularly for disease recurrence, side effects, and survival for up to 10 years. Follow-up visits occur every 3 months for 2 years, then every 6 months for years 2 to 4, and annually thereafter, providing long-term monitoring of treatment effects and safety.

This trial investigates how well cabozantinib works when combined with two immunotherapy drugs, nivolumab and ipilimumab, in treating patients with rare genitourinary tumors that have spread from their original site. These cancers include various rare bladder, kidney, penile, and urethral cancers. The study aims to measure how effectively this combination can shrink tumors and improve survival, while also assessing safety and collecting tissue for further research. Participants receive cabozantinib pills daily on specific schedules during treatment cycles. Nivolumab and ipilimumab are given intravenously on set days during early cycles, with nivolumab continued alone afterward. Treatment cycles repeat every 21 days initially and then every 28 days for up to two years, unless the cancer worsens or side effects become unacceptable. Patients may undergo scans like CT, MRI, PETCT, and bone scans, as well as blood and urine tests throughout the study. During the study, patients have regular imaging and lab tests to evaluate tumor response and monitor health. Follow-up continues every two months for up to five years after treatment to assess outcomes such as tumor shrinkage, progression-free survival, overall survival, and side effects. The research team also supports tissue banking and evaluates treatment effects on bone disease. Safety and quality of life are monitored closely throughout this time.

Researchers are evaluating treatments for adults with newly diagnosed multiple myeloma, a type of plasma cell cancer. This phase III trial compares a four-drug combination including daratumumab, bortezomib, lenalidomide, and dexamethasone to a three-drug combination without bortezomib. The study aims to find out if adding bortezomib improves overall and progression-free survival, response rates, and patient quality of life while monitoring side effects and disease markers like minimal residual disease MRD. All participants first receive a standard induction therapy with daratumumab, lenalidomide, and dexamethasone over about 9 cycles of 28 days each. After this, patients are randomly assigned to one of two consolidation and maintenance treatments one group receives bortezomib along with the other drugs for consolidation followed by maintenance with daratumumab and lenalidomide the other group receives consolidation and maintenance without bortezomib. Treatments are given by subcutaneous injection or orally at specified days and cycles. Patients are followed long-term for up to 15 years after study entry. During the trial, patients undergo regular assessments including blood and urine tests, bone marrow biopsies, and imaging scans like PETCT to measure disease status and treatment response. Patient-reported outcomes on symptoms like neuropathy and quality of life are also collected. Safety is closely monitored through adverse event reports. Follow-up visits occur every 3 months initially, then less frequently over time to track survival and health outcomes.

Researchers are studying whether repeated transcranial magnetic stimulation rTMS can help treat stuttering in adults. The study aims to find out if this treatment causes changes in brain activity and if those changes lead to reduced stuttering. This pilot study focuses on adults who stutter and involves brain imaging and behavioral tests to understand the effects of rTMS. Participants will receive 10 sessions of rTMS delivered at 10 Hz for 10 minutes each, targeting the left inferior frontal gyrus, a brain area involved in speech. Before treatment, structural and resting-state functional MRIs will be taken to guide the precise placement of the stimulation coil. The treatment is given over 10 days, with one group receiving this intervention. Participants will visit the lab three times before treatment to complete tests including resting-state EEG recordings, eye tracking during speech tasks, and speech sample recordings. After the treatment sessions, they will return twice for follow-up tests to assess changes in brain connectivity and speech behavior. The study measures brain activity changes and behavioral improvements in stuttering immediately after treatment and one week later.