In current practice, options for venous and lymphatic malformations remain limited. Recently an oral medication, sirolimus, has been found to benefit patients when taken once or twice a day for several months. Unfortunately there are many side effects associated with this medication, some of which can be severe including, neutropenia, oral ulcerations, and lab abnormalities. The purpose of this study is to determine if once weekly dosed sirolimus will be effective for the treatment of venous and lymphatic malformations. Additionally, the study will evaluate patient satisfaction and identify adverse effects. Participants will be on the medication for 6 months with an option to continue after this time period.
This study is for patients that have been diagnosed with non-small cell lung cancer. The purpose of this study is to compare the usual treatment alone to using pembrolizumab plus the usual treatment. The investigational drug in this study is pembrolizumab. This drug, pembrolizumab is already approved by the FDA for use in patients with more advanced lung cancer. Participants can expect to be on treatment for up to a year. Participants will be followed for up to 10 years after completion of treatment.
The study will test a computerized treatment with subjects ages 13-17 years who are interested in seeking treatment for alcohol and/or cannabis use. Follow-up assessments will be conducted at one- and three-months following treatment.
Cigarette smoking is a significant public health concern. Transcranial magnetic stimulation (TMS) is a non-invasive form of brain stimulation that has already displayed remarkable potential for producing novel, non-pharmacological interventions for depression and cigarette smokers. In this study, we will use brain MRI to guide TMS therapy for smoking cessation.
To assess comparable efficacy of aphasia therapy administered via telerehab (aphasia remote therapy; ART) to aphasia therapy administered in clinic (in-clinic therapy; I-CT).
Human subjects are being recruited for the proposed study to participate in usability testing for a virtual reality technology tool to be refined for assessment and prevention of risky sexual and substance use behaviors. Specifically, 15 adolescents, 15 young men, and 15 front line health care providers will participate in qualitative interviews and focus groups. Targeted enrollment is based on estimates from the existing clinical population treated by the local clinics from which participants will be recruited and the candidate's experience conducting clinical studies at these sites.
Phase 3 sample will include 20 adolescents, 20 young men, and 10 frontline health care workers. They will complete assessments/interviews, a brief emotion regulation skills training, and a simulation using a refined virtual reality tool.
This observational, multi-center cohort study of pediatric cardiac arrest management will contribute to a clinical CPR Learning Laboratory. The objectives of this study are to characterize the quality of CPR and post-cardiac arrest care delivered to children across a broad spectrum of hospitals, to determine the association between quantitative CPR quality measures (depth, rate, compression release, flow fraction) and survival to hospital discharge, and to determine the association of survival with site-specific post-cardiac arrest care (PCAC). The study will enroll pediatric cardiac arrests requiring chest compressions for ≥1 minute identified as part of standard clinical operations. The CPR quantitative measures, defibrillator data (when available), monitor data (when available), and post-arrest care will be de-identified and submitted to a central database.
This study will include volunteers diagnosed with a form of heart failure that is characterized by a weakened heart muscle that appears to be pumping in a normal manner. This condition is called "heart failure with preserved ejection fraction" or HFpEF. For these individuals, it has been determined that the health problems and symptoms experienced may be due to a significant increase in the pressure of one of the chambers of the heart. This pressure build-up causes a variety of symptoms, including tiredness, difficulty breathing, and reduced ability to exercise/walk.
This study is to help evaluate a new device (the "Satera Ablation System") designed to reduce the build-up of pressure described above. The Satera Ablation system is a catheter used to ablate or destroy the splanchnic nerve on one side of the body. The Sponsor believes by destroying this nerve there may be some reduction in the symptoms caused by HFpEF. The procedure using the Satera Ablation System will be performed in the catheterization lab and does not involve surgery. Participants will stay overnight in the hospital following the procedure for observation.
The length of subject participation in the study will be approximately 24 months and includes 5 office visits, 1 phone call and 2 procedures. Participants in this research study will be randomized to either the treatment group or the control group and have a 2:1 chance of receiving the research treatment with the Satera Ablation System at the time of randomization.
This study will help us learn more about how safe and effective the Satera Ablation System is in treating the symptoms of patients with HFpEF.
This is a study looking at the effects of Belimumab, a medication approved by the FDA to treat lupus, in people who have been recently diagnosed with lupus. It proposes that the early use of Belimumab may prevent long-term tissue damage from the disease. The study will last 2 years with clinic visits every 4 weeks.
This study is being done on patients who have heart failure, a condition where the heart muscle weakens and enlarges and cannot pump blood effectively. The purpose of this study is to assess the safety and effectiveness of a new device called the AccuCinch Ventricular Restoration System and compare it to treatment with standard heart failure medications alone. The AccuCinch Ventricular Restoration System consists of anchors, which attach to your heart muscle, sliders to connect the anchors and a thread like cord that goes through the anchors and is cinched to make your enlarged heart smaller so it can pump more efficiently. The device is implanted in one of the lower pumping chambers of the heart (called left ventricle). The study will have two groups, the treatment group in which participants undergo the device implant in addition to taking heart failure medications and the control group in which participants are treated with heart failure medications alone. Participation will last up to 5 years.