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Filter by:Aim of the study is to test INNOGRAFT Heart Suite in a clinical setting, using a previously collected set of plasma samples from patients who underwent heart transplant and routinely or symptoms-based surveillance during the period 2016- 2019.
The primary objective of this study is to evaluate two pharmacotherapeutic approaches to sleep induction, both of which have been shown to be effective hypnotics, but may have unique side effect profiles. These profiles may have markedly different impacts on performance in a military setting. In this randomized, double-blind, placebo controlled study, the side effects of these drugs will be compared - suvorexant, a dual orexin receptor antagonist and zolpidem, a non-benzodiazepine gamma-aminobutyric acid (GABA) A agonist - in healthy controls comparable in age and gender to the target military population.
Background: Gene therapy is closely followed by the U.S. Food and Drug Administration (FDA). The FDA requires researchers to conduct long-term follow-up of people who have had the treatment. This study collects data on people who have had gene therapy and sends it to the FDA. The data does not include participants names. Objective: To contact current or past participants of gene therapy protocols at least once a year for up to 15 years to ensure they have not had any harmful side effects. Eligibility: People aged 18 and older who have had gene therapy in a National Cancer Institute study Design: Participants will give their address and telephone number. They will also give and the address and phone number of 1 or 2 other people who will know where they are. For the first year after gene therapy, participants will give blood samples 3 times (at 3, 6, and 12 months). For the next 4 years, they may have a physical exam and laboratory tests with a home physician. They will get a kit to mail in blood samples. Or they can visit the NIH Clinical Center. They will be asked if they have had any signs of neurological, autoimmune, or blood disorders, or any new cancers. For years 6 to 15, participants will be contacted yearly via phone or email and asked questions about their health. They may give blood samples. When the participant dies, if researchers think the death was caused by gene therapy, they will ask the participant s family to allow an autopsy. ...
About half of patients with ST-segment elevation myocardial infarction (STEMI) have multi-vessel lesions (> 50% diameter stenosis). But how to deal with the non-culprit vessels is still controversial. Previous studies have shown that flow fractional reserve (FFR)-guided revascularization on non-culprit vessels can further improve prognosis of such patients. However, FFR requires the use of pressure guidewire and special drugs such as adenosine to maximize induction of hyperemia forcoronary artery, which will increase the cost of operation and may cause additional risks. Quantitative flow ratio (QFR) is a novel angiography-based method for deriving FFR without pressure wire or induction of hyperemia. In present, there still are poor data about QFR-guided revascularization on non-culprit vessels in patients with STEMI. The purpose of this study is to compare the clinical effects of QFR-guided with angiography-guided revascularization on non-culprit vessel in STEMI patients with multi-vessel lesions.
Pseudohypoparathyroidism is a genetic disorder with limited treatment options, characterized by early-onset obesity, short stature, hormone resistance and cognitive impairment. This phase 2 clinical trial will test the efficacy of theophylline, a phosphodiesterase inhibitor, in pseudohypoparathyroidism. We hypothesize that theophylline will cause weight loss, improve glucose tolerance and decrease hormone resistance in children and young adults.
The purpose of this open-label, multicenter study is to determine the long-term safety, pharmacokinetics and effects of ALK-001 (C20-D3-retinyl acetate) on the progression of Stargardt disease. This study is an extension of NCT02402660 and enrolls participants who are at least 8 years old. Enrollment is by invitation only. Funding Source - FDA OOPD
The purpose of this study is to switch from insulin to oral sulfonylurea in patients with apparent type 1 diabetes or maturity onset diabetes in the young that are insulin treated. The molecular cause will be DNA variants in the HNF1A, HNF4A, or HNF1B genes that are of unknown significance (VUS, class 3) or known to be pathogenic (class 4 and 5).
The purpose of this study is to develop a clinical understanding of early liver transplantation (ELT) for patients with severe alcoholic hepatitis (SAH) and identify the public's opinion regarding this practice.
There are evidences that some healthcare teams are not proposing new therapeutic and technology options that have the potential to reduce hypoglycemia for people with type 1 diabetes. In practice, people living with type 1 diabetes report receiving education related to insulin pumps usage mainly on key functions (how the device works) at initiation and not enough about proactive adjustments (how to optimally use the device) especially on the long-term. In brief, short-term education is technical and product-specific, rather than being based on patients' needs.There is a need to test the efficacy of different programs that may be more suited to patients' needs and desires while offering the opportunity to reduce costs (e.g. web based). Since there is a lack of expertise related to optimal use of new technologies and therapies for people living with type 1 diabetes, we propose to design and test a web-based training (e.g. courses including videos and quizzes) and support (e.g. discussion forum) platform. This will be tested through a registry-based trial. The overall purpose of this study is to evaluate, among a group of adults living with type 1 diabetes, the SUPPORT online education platform in terms of users' satisfaction, engagement and efficacy to change the fear and the frequency of hypoglycemia.
This study aims to evaluate the efficacies of an online mindfulness-based intervention for emerging adults with ADHD in Malaysia. The investigators hypothesized that online mindfulness-based intervention may improve ADHD symptoms and executive functions of emerging adults with ADHD.