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NCT02181257
The primary aims of this study is to determine the efficacy and tolerability of Extracorporeal Photopheresis (ECP) for the treatment of either Refractory Bronchiolitis Obliterans Syndrome (BOS) patients (258 at cessation of enrollment April 7, 2022) or Newly Diagnosed (22 as of enrollment Hold February 2022) Bronchiolitis Obliterans Syndrome patients after lung transplantation. In compliance with the Centers for Medicare and Medicaid Services' (CMS) Coverage with Evidence Development (CED) decision, the study will collect specified demographic, comorbidity, treatment, and outcome data exclusively for Medicare beneficiaries who are treated with ECP for either refractory or New BOS.
NCT01694953
This is a multi-center natural history study of Mitochondrial NeurogastroIntestinal Encephalopathy (MNGIE). Patients will be followed over time to assess clinical symptoms. The investigators hope to learn more about the disease of MNGIE as well as develop useful measures of disease status for use in future clinical trials. Additional clinical centers will be listed as they become available.
NCT06269146
This study seeks to understand if the medication pramipexole improves social connectedness and functioning in adults (ages 18-50) who experience anxiety or depression. The study plans to enroll 108 participants total across two sites (University of California San Diego and New York State Psychiatric Institute). Pramipexole will be given in a 6-week randomized, double-blind, placebo-controlled trial. Social reward processing will be assessed using measures of brain function (fMRI), behavior, and self-report at baseline and week 6. Knowledge gained from this study will help determine the therapeutic potential of targeting the dopamine system to remediate social disconnection as an anxiety and depression intervention.
NCT05351554
A Randomized, Double-blind, Placebo-controlled, Study with an Open-label Cohort.
NCT06286319
The objective of this feasibility study is to evaluate continuous temperature monitoring, oxygen (O2) concentration and ventilation with positive end expiratory pressure (PEEP) to keep lungs cooled at 4-8 degrees Celsius, with continuous O2 concentration of 100% and inflated with a PEEP of 8-10 during the entire cold ischemic period.
NCT05305118
This project will focus on a novel approach to stabilizing blood pressure (BP) during inpatient rehabilitation after acute SCI. After SCI, people have unstable blood pressure, ranging from too low (orthostatic hypotension) to too high (autonomic dysreflexia). Unstable BP often interferes with performing effective physical rehabilitation after SCI. A critical need exists for the identification of safe, practical and effective treatment options that stabilize BP after traumatic SCI. Transcutaneous Spinal Cord Stimulation (TSCS) has several advantages over pharmacological approaches: (1) does not exacerbate polypharmacy, (2) can be activated/deactivated rapidly, and (3) can be applied in synergy with physical exercise. The study team is asking the key question: "What if applying TSCS earlier after injury could prevent the development of BP instability?" To facilitate adoption of TSCS for widespread clinical use, the study team plans to map and develop a parameter configuration that will result in an easy to follow algorithm to maximize individual benefits, while minimizing the burden on healthcare professionals. This project will provide the foundational evidence to support the feasible and safe application of TSCS in the newly injured population, thereby overcoming barriers to engagement in prescribed inpatient rehabilitation regimens that are imposed by BP instability.
NCT05673811
A phase IIb, open-label, randomized study of Nab-Paclitaxel and Gemcitabine and plus/minus VCN-01 in Patients with Metastatic Pancreatic Cancer
NCT02496585
The purpose of this study is to find out what effects, good and/or bad, the drug nintedanib in combination with steroids, has on the lungs. Furthermore, such treatments' side effects will be studied together with quality of life. In addition, the investigators would like to determine whether they can find markers in the blood which predict worsening lung injury.
NCT05257408
The primary objectives of this study are to evaluate progression-free survival (PFS) by blinded independent central review (BICR) and overall survival (OS) (evaluated independently, as dual primary endpoints) in patients treated with intermittent regimen of Relacorilant in combination with nab-paclitaxel compared with patients treated with nab-paclitaxel monotherapy.
NCT03223753
This randomized clinical phase III trial studies how well web-based physical activity intervention works in improving long term health in children and adolescents with cancer. Regular physical activity after receiving treatment for cancer may help to maintain a healthy weight and improve energy levels and overall health.
NCT06934096
This is a three-cohort, randomized, double-blinded , sham-controlled, single-center, early feasibility research trial to determine whether organ-specific biologic effects on platelet activity and coagulation are achievable through selective ultrasound of the spleen utilizing low-energy (diagnostic-level) insonification. * Group 1: Focused insonification at center of the spleen. * Group 2: Prolonged duration insonification at center of the spleen * Group 3: Prolonged duration insonification across the spleen. Participants will receive 30 minutes of sham stimulation in the randomized group that is assigned to them, followed by active stimulation within the same group. Blood biomarkers (local and systemic) will be measured before and at several timepoints after stimulation to measure the molecular and cellular effects of the device
NCT03861702
This is a phase II, single-arm, open-label, clinical study to investigate the efficacy and tolerability of a combination of liposomal irinotecan (nal-IRI) with oxaliplatin, leucovorin, and 5-fluorouracil (FOLFOX-nal-IRI) for treatment of patients with locally advanced pancreatic carcinoma (LAPC).
NCT06629766
This study aims to assess the effect of age of the male partner and the reproductive ability of sperm prepared via sperm selection devices (Zymot) compared to routine embryologist selected sperm after density gradient centrifugation (DGC) preparation for intracytoplasmic sperm injection (ICSI) in patients undergoing in vitro fertilization treatment (IVF) of their infertility.
NCT05281601
This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of AZD7442 administered intramuscularly (IM) or intravenously (IV) in pediatric participants aged ≥ 29 weeks GA to \< 18 years.
NCT06930339
The Registry will be designed to gather information over 3 years. This important health economic information will help to establish the value of the PoNS Device on key therapeutic outcomes. These outcomes will include: disease-associated injury risks (i.e., falls), onset of new comorbidities and/or worsening/improvement of existing medical condition(s) (other than gait deficit/impairment), need for new pharmacological/non-pharmacological intervention or increase/decrease of ongoing pharmacotherapy or other non-pharmacological intervention, increase/decrease of in patient/outpatient hospital and/or office visits or stays, side effects. By participation in the Registry, patients and physicians will be providing Helius with access to information about medical history, medical diagnoses, clinical symptom presentations, vocational information, medications, pharmacologic and non-pharmacologic prescriptions, hospitalization and healthcare visits, and any reported therapy's adverse events.
NCT05811364
The objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease.
NCT02026271
This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex for production of human IL-12. IL-12 is a protein that can improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor. The main purpose of this study is to evaluate the safety and tolerability of a single tumor injection of Ad-RTS-hIL-12 given with oral veledimex.
NCT04870112
This study has 2 parts: dose finding and dose confirmatory. In Part 1, the dose finding phase of the study, there will be 3 or more dosing levels to find out what dose of durvalumab administered as an infusion under the skin acts similarly to durvalumab administered into a vein. 24 participants with Non-Small Cell Lung Cancer will be enrolled for a 12 month treatment period and 3 months follow up In Part 2, the dose confirmation phase of the study, participants will receive the dose of durvalumab identified in Part 1 of the study. The goal of Part 2 will be to learn more about the way that the body processes durvalumab when administered as an infusion under the skin. Approximately 90 participants with Non-Small Cell Lung Cancer will be enrolled; additionally, up to 10 participants with Small Cell Lung Cancer (who will receive concurrent chemotherapy) will be enrolled for a 12 treatment period and a 3 month follow-up period. AstraZeneca has decided to stop further enrollment and the study was terminated when all patients in Part 1 (Phase I) completed their last study visit. No safety issues or clinical concerns however, have been identified for this study. Part 2 (Phase II) was not initiated.
NCT05479721
The LITMUS Imaging Study is a prospectively recruited, observational study of patients with histologically characterised non-alcoholic fatty liver disease (NAFLD). It aims to evaluate the diagnostic performance of imaging biomarkers (ultrasound elastography and magnetic resonance biomarkers) against NAFLD histological scores in a cross-sectional analysis and the natural history of NAFLD in a longitudinal study.
NCT02990481
1. To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) of TRK-950 as single agent 2. To establish the dose of TRK-950 recommended for future phase 2 studies