There are about 173942 clinical studies being (or have been) conducted in United States. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The aim of this clinical trial is to investigate the efficacy (by monitoring neovascularization and epithelial defects) of up to four doses of the investigational medicinal product (IMP) LSC2 topically administered on the target eye of patients with LSCD. Further, safety of the IMP during and after application will be investigated (by monitoring adverse events [AEs]).
The "North Carolina Clinical Genomic Evaluation by Next-gen Exome Sequencing, 2 (NCGENES 2)" study is part of a larger consortium project investigating the clinical utility, or net benefit of an intervention on patient and family well-being as well as diagnostic efficacy, management planning, and medical outcomes. A clinical trial will be implemented to compare (1) first-line exome sequencing to usual care and (2) participant pre-visit preparation to no pre-visit preparation. The study will use a randomized controlled design, with 2x2 factorial design, coupled with patient-reported outcomes and comprehensive clinical data collection addressing key outcomes, to determine the net impact of diagnostic results and secondary findings.
The goal of treatment with radiation therapy is to deliver as high of a dose as possible to the target (tumor), while minimizing the dose to the normal tissues where late-side effects can drastically affect patient quality of life.
This is a seven-cohort, double-blinded, randomized, sham-controlled feasibility trial to determine whether organ-specific biological effects are achievable through selective ultrasound of the spleen utilizing low-energy insonification.
This is a multi-center Phase II randomized study. We plan to enroll 78 patients with biopsy-proven hepatic-limited metastatic colorectal cancer deemed resectable after multi-disciplinary discussion. Eligible patients must have confirmed isolated liver metastases by radiographic imaging of the investigators' choosing. Imaging must include the chest, abdomen, and pelvis regardless of imaging modality chosen. Patients will be randomized to either the control arm or the experimental arm. The control arm will receive mFOLFOX6 every 2 weeks for 4 cycles concurrently with Nivolumab. The experimental arm will first be treated with 2 vaccinations of MVA-BN-CV301 given two weeks apart (Days -28, -14) concurrently with Nivolumab followed by 4 vaccinations of FPV-CV301 given two weeks apart concurrently with mFOLFOX6 and Nivolumab, which will again be administered every 2 weeks for 4 cycles (FPV-CV301, mFOLFOX6 and Nivolumab) After Cycle 4, patients will be re-evaluated for surgical resection by re-staging CT chest, abdomen and pelvis (C/A/P). Patients still considered resectable will undergo surgical resection with the goal of complete resection. Patients who cannot be completely resected will continue to be followed on study, and an additional appropriate candidate will be randomized to the corresponding arm. We will collect peripheral blood and tumor tissue at the time of surgical resection, if applicable, or by re-biopsy if resection is not possible. Post-operative therapy will begin when patients are deemed ready by their surgical oncologist team. Patients in the control arm will then undergo another 8 cycles of mFOLFOX6 with Nivolumab administered concurrently. Nivolumab will then be administered every four weeks. The experimental arm will receive the same post-operative regimen but including FPV-CV301 boosters given concurrently with mFOLFOX6 and Nivolumab. FPV-CV301 will then be administered every 12 weeks, and Nivolumab every 4 weeks. We will collect peripheral blood for evaluation of correlates upon the completion of therapy. The vaccination approach of initial immunization during the neoadjuvant period followed by FPV-CV301 boosters for two years postoperatively was chosen to optimize the induction of a long-lasting tumor-specific host response. Neoadjuvant vaccination will also allow for analysis of the tumor microenvironment in resection specimens. Post-therapy patients will be under surveillance per NCCN guidelines with repeat CEA every 3 months for 2 years followed by every 6 months for 1 year (total 3 years), repeat CT of the C/A/P every 3 months for 2 years followed by every 6 months for up to 1 year (total 3 years), and colonoscopy at one year with repetition based on findings at the time of the procedure.
Single arm phase I/II study of ixazomib and romidepsin in relapsed/refractory PTCL. Each cycle is 28 days. Patients will continue to receive therapy until progressive disease, unacceptable toxicity, or if any other withdrawal criteria are met. The phase I study includes three dose levels. The phase II study will include treatment with ixazomib and romidepsin at the MTD established in the Phase I study.
This pilot trial studies how well a diabetes prevention program with or without hunger training works in helping to lower breast cancer risk in obese participants. A diabetes prevention program involves learning about and receiving materials on different strategies to encourage weight loss, and hunger training involves learning how to recognize hunger. It is not yet known whether adding hunger training to a diabetes prevention program helps participants control their weight that could reduce the risk of some cancers.
The Acute Respiratory Distress Syndrome (ARDS) impacts one of every four patients requiring mechanical ventilation for respiratory support and carries a mortality rate of 40%. To diagnose ARDS, doctors currently use the Berlin definition, that requires chest radiographs and analysis of oxygenation in the blood (arterial blood gas). These tests are not available in areas of the world with constrained resources and may be unnecessarily invasive. A modification of the Berlin definition, using ultrasound and pulse oximetry (a small device that measures oxygen level non-invasively by clipping to the body, typically a finger), has been recently developed and tested in Kigali, Rwanda. This study will try to confirm the validity of the Kigali modification initially in Boston and Toronto and subsequently in other hospitals worldwide. If confirmed, this new definition could allow for faster recognition and potentially improved treatment of patients with ARDS and facilitate studies worldwide. The purposes of this study are: 1. To describe clinical characteristics and outcomes of patients diagnosed with ARDS according to the Berlin and Kigali definitions; 2. To determine how well chest radiograph and ultrasound of the chest are able to define ARDS, in comparison to chest computer tomography (CT).
This phase I trial studies the side effects and best dose of autologous dendritic cell-adenovirus CCL21 vaccine (CCL21-gene modified dendritic cell vaccine) combined with intravenous pembrolizumab, and to see how well they work in treating patients with stage IV non-small cell lung cancer. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving CCL21-gene modified dendritic cell vaccine with pembrolizumab may work better in treating patients with stage IV non-small cell lung cancer.
This multi-site study will test the efficacy of an intervention to train and equip pharmacists to provide naloxone, an overdose antidote, to patients using prescribed and illicit opioids, to improve opioid safety and prevent opioid-involved adverse events. The study will carry out a stepped-wedge, cluster randomized trial implemented over five waves, within two chain community pharmacies across four states with varying pharmacy-based naloxone distribution laws: Oregon, Washington, Massachusetts, and New Hampshire. Our specific study aims are to: 1) integrate two successful demonstration research projects into one cohesive educational program (MOON+), 2) evaluate the effectiveness of MOON + on naloxone-related outcomes, and 3) use mixed methods to further explore the impact and implementation of MOON+ and associated factors (e.g., state policy, store policy, region).