Raleigh, NC Paid Clinical Trials

The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart procedure compared to the current standard of care. Read Less

Robotic lower limb exoskeletons aim to improve or augment limb functions. Automatic modulation of robotic assistance is very important because it can increase the assistive outcomes and guarantee safety when using exoskeletons. However, this automatic assistance adjustment is challenging due to person-to-person and day-to-day variations, as well as the time-varying complex human-machine-interaction forces. In recent years, human-in-the-loop optimization methods have been investigated to reduce participants' metabolic costs by providing personalized assistance from robotic exoskeletons. However, metabolic cost measure is noisy and the experimental protocol is usually relatively long. In addition, the influence of exoskeleton control on this human state in terms of energetic cost is unclear and indirect. More importantly, the optimization by reducing metabolic cost is found to affect human gait patterns and cause undesired outcomes. In this study, new evaluation measures other than metabolic cost will be investigated to optimize the assistance from a powered hip exoskeleton based on a reinforcement learning method. It is hypothesized that the new reinforcement learning-based optimal control approach will produce personalized torque assistance, reduce human volitional effort, and improve balance and other performance during walking tasks. Both participants without and with neurological disorders will be included in this study. Read Less

Lower limb amputees rely on their prosthetic to remain active and lead an independent life. In recent years, measuring residual muscle activity has been used to interpret a user's intent and thereby modulate prosthesis control. However, little knowledge is held on how residual muscle activity differs from non-amputated muscle. The research team will analyze and compare neuromuscular physiology in non-amputee individuals and amputees' non-amputated and residual muscles across functional tasks to better understand how amputees control their muscles. Such information will inform design of modern prosthesis controllers. Read Less

This international multi-center registry is used to collect existing information and outcomes for patients undergoing an operation for treatment of injuries to the brain including the blockage of blood flow to an area of the brain, an abnormal ballooning of an artery, abnormal tangling of blood vessels, abnormal formation of blood vessels, tearing of vein, and bleeding in the brain. This information is used to help predict outcomes that undergo an operation for treatment of the above-listed brain injuries. Additionally, the information is used to compare techniques and devices' effects on technical and clinical outcomes. Read Less

Human development as a species has been strongly associated with the ability to dexterously manipulate objects and tools. Unfortunately, current therapy efforts typically fail to restore fine manual control after stroke. The goal of this study is to evaluate a new intervention that would combine targeted electrical stimulation of selected nerves with use a soft, pneumatically actuated hand exoskeleton to enhance repetitive practice of independent movements of the fingers and thumb in order to improve rehabilitation of hand function after stroke. The investigators will recruit stroke survivors in the subacute phase of recovery (2-9 months post-stroke). These participants will be involved in a 5-week intervention involving 15 training sessions. During these sessions, participants will train independent movement of the digits of the paretic hand. Evaluation of motor control of the paretic hand will occur prior to initiation of training, at the midpoint of the training period, after completion of training, and one month later. Read Less

Prospective, multi-center, non-randomized, open label, clinical study intended to provide data to demonstrate safety and performance of the SoundBite Crossing System XS Peripheral. Read Less

This study is to characterize the safety and tolerability of an investigational drug called DONQ52 and consists of a single ascending dose part (Part A) and a multiple ascending dose part (Part B) in well-controlled celiac disease patients. Read Less

The Savella Pregnancy Registry is a US based registry designed to monitor pregnancies exposed to Savella (milnacipran HCI). This is an observational, exposure-registration and follow-up registry designed primarily to estimate the prevalence of major congenital anomalies, and secondarily to estimate the prevalence of recognized spontaneous abortions, stillbirths, induced abortions, minor congenital anomalies, and any serious adverse pregnancy outcomes among pregnancies exposed to Savella as well as adverse outcomes observed during the first year of life in off-springs born from these exposed pregnancies. Live offspring are followed from birth until age one. The Savella Pregnancy Registry is sponsored by AbbVie (formerly Actavis PLC, Forest Laboratories Inc., and Allergan) and managed by Syneos Health. Read Less

The study objective is to evaluate real world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System in patients at standard risk for adverse events from carotid endarterectomy Read Less

This three-group randomized double-blind placebo-controlled trial (N=180) will evaluate the impact of combination zonisamide and bupropion on the process of switching from combustible cigarettes (CCs) to an e-cigarette. There will be a data collection period of at least five days to obtain baseline information on the use of combustible cigarettes. All participants enrolled in the study will receive a JUUL e-cigarette at Visit 2 for ad libitum use. After the first week of e-cigarette use (at Visit 3), participants will be given bupropion (150 mg each morning for days 1-3, then 300 mg daily) with either zonisamide (100 mg daily) or placebo (group 1 and group 2 respectively), or placebo for both medications (group 3) in addition to continued use of the e-cigarette. At each visit, participants will receive enough study drugs (or placebos) and e-cigarettes to last until their next study visit. The combination of zonisamide and bupropion use will continue until Visit 6 (7 weeks of treatment), and e-cigarette use will continue until the end of treatment (Visit 7). Read Less

The primary objective of this study is to evaluate the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery. All patients with a qualifying POAF event, who decline randomization, will be offered the option of enrollment in a parallel registry that captures their baseline risk profile and their treatment strategy in terms of anticoagulants or antiplatelets received. These patients will also be asked to fill out a brief decliner survey. Read Less

This phase III trial studies how well letrozole with or without paclitaxel and carboplatin works in treating patients with stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body which in turn may stop the growth of tumor cells that need estrogen to grow. Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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. It is not yet known whether giving letrozole alone or in combination with paclitaxel and carboplatin works better in treating patients with low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum compared to paclitaxel and carboplatin without letrozole. Read Less