This phase III study is for participants with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is negative for a type of virus called human papilloma virus (HPV). If decided to participate in this study, participants will be receive either ficlatuzumab in combination with cetuximab, or placebo in combination with cetuximab. There are 3 Arms participants will be randomly assigned to: Arm 1 will receive ficlatuzumab (10mg/kg by intravenous (IV) infusion) and cetuximab (by IV infusion), Arm 2 will be given ficlatuzumab (20mg/kg by IV infusion) and cetuximab, and Arm 3 will receive placebo and cetuximab. The effectiveness of the 2 different ficlatuzumab groups (Arm 1 and Arm 2) will be compared at the first on-study scan, and the more successful Arm will began enroll more participants. This study is estimated to last approximately 5 years. Study drugs will be administered until disease progression or unacceptable toxicity, withdrawal of consent, death, or until the Sponsor terminates the study (whichever comes first). The main risk associate with the trial are swelling of your lower legs or arms, fatigue, shortness of breath, vomiting, diarrhea or constipation, bone pain, decreased appetite, anemia, high level of liver enzymes in your blood, dizziness, infusion reactions, cardiopulmonary arrest, pulmonary (lung) toxicity, skin reactions, inflammation of the mouth, low blood counts, liver problems, infection, headache, allergic reactions, and there may be unknown risks. This treatment can not guarantee the cancer will get better, since it may stay the same or get worse. What is discovered from this study may help other people in the future. The alternative to this study is not participating in this study and receiving HNSCC in patients who have previously received immunotherapy including chemotherapy with other treatment drugs or another clinical trial.
This is an NIH sponsored trial across the US where patients who have been or will be implanted with cervical vagus nerve stimulation (VNS) are then tested in a variety of ways to determine the activity of the VNS on different organs in their body. This will involve implantation for those who qualify, and then two trips to the University of Minnesota for more extensive testing. The device, implantation and travel are all at no cost.
This is a global, Phase 3b/4, randomized, open-label, efficacy assessor-blinded, multi-center study that will evaluate upadacitinib compared to dupilumab in adult subjects with moderate to severe AD and inadequate response to dupilumab after at least 6 months of current use. The study consists of a 35-day Screening Period; an 8-week randomized, open-label, efficacy assessor blinded treatment period for all participants (Period 1); a 24-week open-label, efficacy assessor-blinded extension period for all participants who finish Period 1 (Period 2) (total duration of Period 1 and Period 2 is 32 weeks); and a 30-day Follow-up visit.
The study will evaluate the effect of prophylactic intra-operative ventricular tachyarrhythmia ablation (VTA) at the time of left ventricular assist device (LVAD) implantation on post-implant total recurrent VTA events, after accounting for the competing risk of death, from discharge to an average follow-up of 18 months (with a minimum of 9 months) after LVAD implantation.
This study is for patients with hypertrophic cardiomyopathy (HCM). HCM is a condition where the heart muscle becomes abnormally thickened, which can sometimes block the blood flow out of the heart and results in the heart muscle working harder to pump blood to the body. Participants who have completed participation in a previous HCM study investigating the study drug, called aficamten (CK-3773274), will be eligible to participate in this study.
The study is done to collect long-term safety and tolerability data, including assessments of cardiac structure and function during chronic dosing with aficamten. Aficamten is a tablet taken by mouth. This is an open label study (the participants and study team will know the dose of aficamten taken at any given time). If your screening results show you are eligible to continue in the study, you will visit the research site for the "first dosing day" (Day 1), followed by visits at Weeks 2, 4, 6, 12, then every 12 weeks thereafter. Study related procedures include blood work, echocardiograms (ultrasound test of the heart), electrocardiogram (recording of heart's electrical activity), physical exams, and questionnaires. Risks associated with this study include shortness of breath, nausea, diarrhea, headaches and dizziness.
This is a double-blind, randomized, placebo-controlled study of CMTX-101 in pwCF who are 18 years of age or older and chronically infected with P. aeruginosa. This study will evaluate the safety and tolerability, PK, immunogenicity, reduction of pulmonary P. aeruginosa burden, and exploratory endpoints of CMTX-101 in up to 41 participants. This study has 2 parts.
This is a multi-center study that we have been invited to join that will evaluate the LVAD pump function in relation to adverse events. We are the 8th largest implanting center for LVADs in the United States and feel it is important to be a part of this.
The purpose of this study is to better understand tobacco outcomes using a commonly prescribed stop smoking medication (varenicline) and financial incentives for adults who also use cannabis. Varenicline is not FDA approved for e-cigarette cessation, but is FDA approved for cigarette cessation. We are also interested in how cannabis/marijuana and tobacco interact during a tobacco quit attempt. All participants will receive e-cigarette cessation treatment for 12 weeks. To qualify, participants must be between the ages of 18-40 and use both tobacco and cannabis. Participants do not need to be interested in quitting cannabis to qualify. This study is being conducted at three sites: the Medical University of South Carolina in Charleston, SC, Behavioral Health Services in Pickens, SC, and MUSC Lancaster
The purpose of this study is to better understand tobacco outcomes using a commonly prescribed stop smoking medication (varenicline) and financial incentives for adults who also use cannabis. Varenicline is not FDA approved for e-cigarette cessation, but is FDA approved for cigarette cessation. We are also interested in how cannabis/marijuana and tobacco interact during a tobacco quit attempt. All participants will receive e-cigarette cessation treatment for 12 weeks. To qualify, participants must be between the ages of 18-40 and use both tobacco and cannabis. Participants do not need to be interested in quitting cannabis to qualify. This study is being conducted at three sites: the Medical University of South Carolina in Charleston, SC, Behavioral Health Services in Pickens, SC, and MUSC Lancaster
The purpose of this study is to get feedback on an existing augmented reality (AR) software developed by researchers at Wayne State University (phase I) and then use the refined software, along with Prolonged Exposure (PE) therapy to treat Veterans and military personnel with posttraumatic stress disorder (PTSD).
AR involves wearing goggles through which you can see the real world, however virtual objects can be added to the environment (for example, like in the popular phone game Pokemon Go).
The technology was originally designed to help first responders, specifically police and firefighters, to overcome their avoidance of normal life situations caused by their trauma experience and PTSD. This includes a crowded party, a grocery store, a police roll call room and a fire station. This technology is now being expanded to include other common scenarios that military personnel and Veterans with PTSD may avoid.
This study will occur in 2 phases. Phase 1 will focus on getting feedback on the AR program from people who have completed PE therapy before to refine the technology. In phase 2, 40 Veterans and military personnel will be randomly selected to receive PTSD therapy + the refined AR technology or PE therapy alone.
This study is open to Veterans and active duty military personnel. All study activities will take place at the Ralph H. Johnson VA Health Care System and surrounding community-based outpatient clinics. This study is not open to civilians/non military personnel at this time.