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Discover 22,668 clinical trials near New York, New York. Find research studies in your area.
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NCT04343573
The investigators are doing this study to find out whether proton craniospinal radiation therapy (proton CSI) or partial photon radiation therapy is more effective at preventing leptomeningeal metastasis from worsening. The proton CSI targets the entire space containing the CSF, brain, and spinal fluid. The partial photon radiation therapy treats only areas where the patient is having symptoms, such as the entire brain or part of the spine. The investigators also want to find out if proton CSI improves the symptoms patients may be experiencing because of the leptomeningeal metastasis. In addition, the investigators will compare the side effects of proton CSI and partial photon therapy. Patients undergoing proton beam RT will receive their treatment at the New York Proton Center in New York, NY. As part of the New York Proton Consortium, MSK has contracted for its faculty to treat patients at the New York Proton Center. If it is unfeasible for patients to get treated at NYPC, patients will have the decision to get treated at ProCure in Summerset, NJ.
NCT06450639
The purpose of this study is to assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of satralizumab, a humanized anti-interleukin-6 receptor (aIL-6R) monoclonal antibody, in ambulatory and non-ambulatory participants with DMD age ≥ 8 to \< 18 years old receiving corticosteroid therapy.
NCT04800367
The overarching goal of the research program is to define optimal treatment for premenopausal women with clinically significant fracture syndromes that require medical therapy. The investigators hypothesize that romosozumab will be associated with improvements in bone mass and microarchitecture in premenopausal women, and also that the responses and response rates will exceed those observed in premenopausal women treated with teriparatide. The investigators will test this hypothesis in this phase 2 study of 30 premenopausal women with idiopathic osteoporosis (IOP) who will receive 12M of romosozumab 210 mg monthly followed by 12M of denosumab 60 mg SC q6M. Aim 1 will define the within-group effects of this regimen. Aim 2 will compare results from participants treated with romosozumab-denosumab to the investigator's well-characterized historical controls treated with teriparatide followed by denosumab.
NCT04863495
This is a longitudinal study with regular quantitative assessments of all participants every six months for 3 years. The quantitative portion of the study will recruit couples, consisting of individuals over the age of 65 who are in a committed relationship. Both members of the couple must be willing to participate at baseline. The assessment is in two parts. In the first part, each member of the couple will be asked the following: demographic information, mental health history, self-reported physical and emotional health, measures of emotional and mental health, personality, relationship and attachment style, social support and self-efficacy. Then each member of the study couple will be asked a series of questions to determine whether they consider themselves a caregiver. If they do, individuals will be asked to respond to additional caregiver questionnaires. Follow-ups will occur every six months for the study couples for a total of three years from the baseline visit. Each visit, the entire assessment except for demographic questions, will be re-administered to each individual in the couple. At the end of each questionnaire battery, individuals will be screened for cognitive impairment and those who are in the middle to advanced stages of dementia will no longer participate. Recruitment will end when 600 individuals (300 couples,150 couples at each site) are enrolled in the longitudinal portion of the study. All study visits will be conducted virtually via Zoom or WebEx video conferencing. Analyses will be conducted to determine the association between changes in dyadic relationship and changes in mental health and cognitive outcomes, to elucidate how relationship characteristics impact health and well-being as perceived by each member of the dyad.
NCT07128589
This clinical study aims to evaluate the clinical performance of 3M™ Filtek™ Supreme Flowable Composite in class IV and veneer indication. Follow-ups of 7 days, 6, 12, and 24 months will be conducted following an Fédération Dentaire Internationale (FDI) modified score (2023). A minimum of 50 Class IV and 25 veneers will be included in the evaluation. Research data and pictures will be provided for each patient pre-op and at 7 days (baseline, 6 months, 12 months and 24 months. Evaluation will be conducted by two calibrated evaluators different from the operator according to FDI clinical criteria.
NCT06668493
The primary purpose of this trial is to evaluate the safety \& tolerability of Nadofaragene Firadenovec in subjects with LG-UTUC. To help with this evaluation, a safety lead-in period will be conducted for the first 6 subjects. Complete response is at 3 or 6 months defined as absence of any UTUC in the renal pelvis.
NCT04422132
The purpose of this study is to compare urinary and bowel side effects of hypofractionated radiotherapy in 20 treatments (4 weeks) to ultra-hypofractionated radiotherapy in 5 treatments (2 weeks) for prostate cancer that has returned after prostatectomy. The investigators are also interested in looking at time to progression and the quality of life (health scores).
NCT05425641
This study is a randomized, factorial experiment using the basic Science of Behavior Change (SOBC) approach to efficiently test the effects of four distinct behavior change techniques (BCTs), goal setting, action planning, self- monitoring and feedback, thought to engage one key behavioral mechanism of action (MoA) for improving daily walking by at least 1000 steps per day in persons who have been objectively verified as sedentary and are at risk for cardiovascular disease.
NCT03808337
This study is being done to determine if stereotactic body radiotherapy (SBRT) when delivered to all sites of disease in participants with 1-5 metastases will increase the length of time before participants' disease gets worse.
NCT05897619
This study aims to assess the feasibility and acceptability of the Maya Perinatal Cognitive Behavioral Skills App, a novel app for pregnant and postpartum individuals experiencing difficulties with mood, anxiety, or stress. Participants will complete the 12-module app to learn evidence-based strategies previously shown to help manage mood and anxiety. Assessments will include app feedback questionnaires, feedback interviews, a daily symptom tracker, and symptom measures. The study investigators hypothesizes that participants will find content to be helpful in developing skills to manage anxiety and mood difficulties during the perinatal period, and that the app interface, session structure, and pacing will be acceptable and feasible for this population. It is further hypothesized that increased Maya Perinatal Cognitive Behavioral Skills App use, engagement, and satisfaction will be associated with lower self-reported anxiety and mood symptoms.
NCT03067181
This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Chemotherapy drugs, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors.
NCT06799221
The purpose of this program is to provide access to obe-cel treatment for adult patients with ALL who have undergone leukapheresis and had obe-cel manufactured from their blood cells but the product is deemed OOS (does not meet the specifications to be used commercially). The target patients for this study have limited options for treatment and repeat blood sampling is not feasible. The main aims of this study are (1) to provide adult patients with ALL with access to obe-cel and (2) to describe the safety profile of obe-cel (including CRS, ICANS, serious infections, secondary cancers, and any side effects) within the first 45 days after infusion of OOS obe-cel. This study is a single-arm, open-label, multicenter expanded access program (EAP). The patient population included in this EAP will be adult patients diagnosed with recurring or refractory ALL who were prescribed obe-cel as part of their standard of care and are eligible for use under the approved local prescribing information. To be in the study, patients must provide informed consent, be at least 18 years of age, have a confirmed diagnosis of ALL, be medically fit and stable to receive obe-cel, have had commercial obe-cel prescribed by their treating physician as per standard of care, and for whom remanufacturing is not clinically appropriate. Patients cannot be in the study if they have a history of severe immediate allergic reaction to any drugs or metabolites of similar chemical classes as obe-cel, are a pregnant woman, or are receiving treatment in another study. All data will be collected from information routinely recorded in the medical record. There is no formal hypothesis testing. Data will be analyzed descriptively (numbers, percentages and ranges, etc.).
NCT06888921
The goal of this clinical trial is to learn if the experimental antibody COM701 delays the progression of ovarian cancer in participants with Relapsed Platinum Sensitive Ovarian Cancer. It will also learn about the safety of COM701. The main questions the trial aims to answer are: * Does COM701, when used as a maintenance treatment, stop or slow the progression of ovarian cancer? * Does COM701 delay the time to needing a new anti-cancer treatment? * What side effects do participants have when taking COM701? Participants will: * Visit the clinic once every 3 weeks during which the study treatment will be administered intravenously * Undergo various tests and procedures to monitor general health throughout the trial including physical examinations, vital sign measurements (heart rate, blood pressure, breathing, and body temperature), weight measurements, electrocardiography (ECG), blood and urine tests and pregnancy tests if relevant. * Undergo various tests and procedures to assess disease response throughout the trial including tumor imaging by CT scans or MRI to assess the tumor, its location, and size, and the testing of a sample of tumor tissue (from a prior biopsy or a fresh biopsy if feasible, to evaluate tumor response to treatment and to measure levels of tumor markers,
NCT05033028
Treatments for opioid addiction exist, but effectiveness is compromised when subjects use illicit opiates during treatment. Reuse rates during treatment can be high, and reducing illicit opiate use during treatment has thus recently become a major NIDA policy goal. The 5-minute battery indicates the numerical probability that a patient will reuse illicit opiates within the next 7-10 days.
NCT06999733
The Sponsor is developing KB801, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector engineered to deliver functional full-length human nerve growth factor (NGF) to the corneas of people with Stage 2 or 3 neurotrophic keratitis (NK) via topical application. This is a Phase 1/2, multicenter, double-masked, placebo-controlled study to evaluate the safety, tolerability, and preliminary efficacy of KB801 in these subjects.
NCT06022809
The HIV diagnosis rate among African-born Black women is the highest of all Black individuals living in the US. Correct and consistent use of condoms and use of pre-exposure prophylaxis (PrEP) are two effective means of decreasing HIV risk among women, but they remain suboptimal among Black women. The specific aims of this study are: 1. To culturally adapt two widely utilized, evidence-based HIV prevention interventions originally designed for US born Black women (Sister-to-Sister (S2S) and Sisters Informing Sisters about Topics on AIDS (SISTA)) for use by African-born women. To ensure the interventions resonated with African culture, they were given new names. The adapted S2S program was renamed as 'Dada Kwa Dada' (DKD), and the SISTA adaptation as 'DADA.' In Swahili and various other languages across East and West Africa, 'dada' means 'sister'. 2. To conduct a randomized controlled comparative effectiveness trial (RCT) to determine the effectiveness of adapted versions of S2S versus SISTA on increasing condom use and PrEP uptake among African-born women. This study compares the effectiveness of an individual versus a group-level intervention to increase pre-exposure prophylaxis (PrEP) uptake, condom use, and HIV testing and decrease the incidence of HIV and other sexually transmitted infections (STIs).
NCT07098988
This is an exploratory, signal finding, randomized, placebo-controlled, blinded, multi-center Phase 2b trial of the anti GDF-15 antibody Visugromab (CTL-002) versus Placebo, combined with Immunochemotherapy (ICT: Pembrolizumab, Pemetrexed, Carboplatin) in the first-line treatment of participants with newly diagnosed metastatic non-squamous NSCLC. The trial consists of 3 Parts, a non-randomized Safety-run-in part (Part A) and the subsequent randomized Ph2b trial with 2 treatment arms. After the treatment of 15 participants with visugromab at the expansion dose, an interim safety and preliminary efficacy analysis will be conducted (Part B), followed by the treatment of the remaining participants (Part C).
NCT05319314
Study ICT-GCC19CART-US-001 (CARAPIA-1) is a Phase 1 study evaluating the safety, tolerability, clinical activity, pharmacokinetics and pharmacodynamics of GCC19CART in subjects with relapsed or refractory metastatic colorectal cancer.
NCT07434869
This study is for people who have had a lung transplant and developed a condition called chronic lung allograft dysfunction (CLAD), which is a type of chronic rejection. Doctors often treat CLAD with a procedure called extracorporeal photopheresis (ECP), but it can take up to six months to know if the treatment is working. The goal of the study is to find early signs (biomarkers) that show whether ECP is helping, so patients can get the right care sooner. For participants in the study, small blood samples will be collected at three points during ECP treatment and, for some participants, two MRI scans of the lungs will be performed-one before starting ECP and one after finishing treatment. The MRI uses a safe contrast dye to help us see changes in lung blood flow and tissue. Investigators will also look at certain immune cells in the blood. This is not a study of a new drug or treatment-participants will receive the same ECP therapy their doctor already recommended. The study will help researchers understand how ECP works and identify markers that predict who benefits most. There is no direct benefit to participants, but participation may help improve care for future lung transplant patients.
NCT07434973
The purpose of this trial is: * To investigate whether cannabidiol (CBD), compared to placebo, can reduce the severity of attenuated psychotic symptoms in individuals at clinical high risk for psychosis. * To confirm the safety of CBD in individuals at clinical high risk for psychosis. The trial is a randomised, double-blind, placebo-controlled, multi-centre, international clinical trial. Individuals meeting clinical high risk for psychosis criteria will be recruited for the trial intervention component of the trial. Participants are randomised to treatment with oral CBD 300mg (oral solution 100 mg/mL) twice daily, or a matching placebo, for 104 weeks. By using a battery of clinical outcome assessments, the trial will be able to assess several biomarkers to predict clinical outcomes and response to treatment with CBD. Participants will be invited to provide blood samples, stool samples, cerebrospinal fluid samples (if aged 18 years or over) and complete neuroimaging assessments. Individuals who are not found to have mental illness as defined by DSM-5 criteria will be recruited to a healthy control group, to validate the biomarker component of the trial. Additionally, a control group of healthy volunteers will be recruited who will not take the trial intervention to aid calibration between datasets from sites acquiring MRI data and to inform and validate any possible multivariate signature associated with the CHR-P state, course or outcome by understanding how these measures are different in controls. Healthy controls will also be used for secondary case-control comparisons. Healthy controls will undergo clinical and biomarker assessments only.
