The research is being done to determine if an investigational drug called "TS23" is safe and effective for the treatment of patients with an ischemic stroke that do not meet the criteria for standard treatments to remove the clot. The best dose of TS23 for these patients is unknown. Prior studies have shown that TS23 works without increasing safety concerns.
The goal of this study is to get the highest possible quality of life restuls for individuals suffering lower-limb impairment after suffering a stroke. This will be done by examining three different modern carbon fiber ankle-foot orthosis (AFO) options targeting the rehabilitation of individuals post-stroke. The study seeks to achieve the best AFO prescription that maximizes the mobility and satisfaction of the particpant.
A study in the United States that looks at the safety and effectiveness of Pradaxa Pellets in children aged 3 months to less than 12 years who need treatment of a blood clot or who have had a blood clot and are at risk of developing another blood clot. This study is for children prescribed Pradaxa oral pellet as a standard of care.
Research visits will occur when your child starts taking Pradaxa Pellets and at 6 weeks, 3 months, 6 months, and 12 months. During those visits questions about your child's medical history and current medication and health during the study will be asked.
This study is designed to learn more about how nivolumab and ipilimumab, with or without cabozantinib effects the growth and spreading of head and neck cancer. If decided to take part in this study, participants will go through a screening period, treatment period, and follow-up period. During the screening period following signing of consent form participants will be evaluated for screening criteria and determined if they qualify for the study. During treatment period participants will be randomly assigned to either receive the combination of two immunotherapy drugs, nivolumab and ipilimumab for up to 2 years, or the two immunotherapy drugs with an additional targeted drug, cabozantinib, for up to 2 years unless your cancer gets worse or the side effects of the treatment become too severe. In the follow up period the side effects will be observed by the study team every 3 to 4 months for 2 years after treatment. The most common risks and discomforts expected in this study are diarrhea, nausea, vomiting, tiredness, weight loss, loss of appetite, changes in taste or voice, redness, pain or peeling of palms and soles, and high blood pressure which may cause blurred vision. There may not a benefit from joining the study. The head and neck cancer may improve while on this study but it may not, and it may even get worse. It will also help inform how well this combination treatment works at curing this type of cancer. The study results may be used to help others in the future.
The primary objective of this study is to demonstrate the safety and effective use of Stryker's PEEK Customized Implants in patients receiving craniofacial (head and facial) surgery. Other objectives include using a CT scan to assist surgeons with providing a solution to complex and simple reconstruction challenges and reducing them to a single or two-stage procedure, thereby minimizing the overall surgery time and limiting the number of surgeries. Patient questionnaires and health information will be used during the study to demonstrate the safety and effectiveness of the implants. We will be enrolling ages 4 - 75 years old.
This is a prospective, longitudinal, multicenter, nonrandomized observational study to obtain research quality data across key outcome measures in people with Cystic Fibrosis who are ineligible and/or not taking a approved CFTR modulator and who are not receiving an investigational therapy.
Participants will be seen at study sites for research visits to include spirometry, patient reported outcomes (PROs), and blood collections on Day 0, Day 90 (3 months), Day 180 (6 months), and Day 360 (12 months). Participants will complete home spirometry as well during this period.
This study will assess an adjunctive treatment for major depressive disorder (MDD) called Aticaprant. Adults with MDD that are currently on an antidepressant but continue to experience prominent anhedonia may qualify.
This is a research study to evaluate the safety and effectiveness of Niyad (nafamostat mesylate) as a blood thinner used during continuous renal replacement therapy (CRRT). CRRT is a standard treatment much like dialysis that is used to temporarily take the place of kidney function when one's kidneys are injured. Like your kidneys, CRRT helps to clean your blood and remove waste products.
Niyad is experimental which means that it is being tested and is not approved by the United States Food and Drug Administration (FDA). There is no guarantee that you will receive direct benefit as a result of your participation in this study. Possible benefits of Niyad include preventing your blood from clotting the dialysis filter so that the CRRT machine works more effectively and it also may reduce your need for a transfusion. The study results may help people in the future.
Participation voluntary and is expected to last up to 28 days. The length of time you may be exposed to Niyad is up to 7 days and safety assessments may last up to 28 days.
There will be no additional cost to you for procedures required in this research study. All routine clinical care that you would have undergone without participation in the study, including testing and procedures, will be billed to you/your insurance company. All study-related tests and procedures will be paid for by the Sponsor.
Some insurance plans will not pay for these services for people taking part in research studies. You will be responsible for any charges that your insurance does not cover including co-payments and deductibles.
While cigarette smoking is detrimental to health and a known risk factor for cancer, e-cigarettes are thought to be less harmful but not entirely risk-free, and less is known about e-cigarette use and changes to health. The purpose of the present study is to evaluate changes in health that may occur when people stop using e-cigarettes. Participants who use e-cigarettes (and who never smoked, smoked in the past, or currently smoke) will be recruited to participate in a laboratory session followed by a week of abstaining from any nicotine use. Throughout the study, participants will provide biological samples for analysis of DNA damage, immune functioning, inflammation, and respiratory functioning at the MUSC Charleston campus. Results will provide insight into the health benefits of quitting vaping.
This is a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 versus placebo on top of standard of care in subjects with Progressive Pulmonary Fibrosis (PPF) over 52 weeks. Subjects will participate in the study for up to 58 weeks, inclusive of a Screening Period of up to 4 weeks, a 52-week Treatment Period, and a 2-week Follow-up Period that includes a Follow-up telephone call (TC) 2 weeks post final dose. Up to 300 eligible subjects will be randomized in a 2:1:2 ratio to 1 of 3 treatment arms: AP01 100 mg twice daily (BID), AP01 50 mg BID, or placebo BID (8 mL; two 4 mL blow-fill-seal [BFS] ampoules BID).