There are more than 493,991 clinical trials published worldwide with over 60,000 trials that are currently either recruiting or not yet recruiting. Use our filters on this page to find more information on current clinical trials or past clinical trials (free or paid) for study purposes and read about their results.
The purpose of this study is to allow patients to undergo surgery with the SR™ PIP (Proximal Interphalangeal) Implants for finger arthritis. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of device
The main objective of this EAP is to ensure that participants participating in Study E2007-G000-332, Study E2007-G000-311, E2007-G000-238, E2007-G000-338 or EAP E2007-G000-401 continue to have access to perampanel until such time that the appropriate formulation of perampanel becomes commercially available in the country in which they reside or until no participants remain in the EAP.
The purpose of this compassionate use study, for two patients with thrombotic microangiopathy, is to provide expanded access to patients who have participated in the clinical trial OMS721-TMA-001 and in whom improvement in their disease markers was observed while on treatment or to patients who could otherwise benefit from the treatment. This is a treatment protocol; not a research protocol.Therefore, only patients in study OMS721-TMA-001 deemed eligible by the investigator may participate.
Metreleptin was approved in the United States as adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy in February 2014. The approval was based on results obtained in 2 open-label, investigator-sponsored studies (Studies 991265 and 20010769) conducted at the National Institutes of Health (NIH) to evaluate the safety and efficacy of metreleptin treatment in patients with lipodystrophy and 1 treatment IND (FHA101/MB002-002/MB002-002) conducted by Bristol-Myers Squibb on behalf of AstraZeneca (BMS/AZ) in patients with diabetes mellitus and/or hypertriglyceridemia related to lipodystrophy. These studies enrolled patients with lipodystrophy including both generalized and partial lipodystrophy. Although the marketing authorization restricted the indication to patients with generalized lipodystrophy, meaningful clinical benefit was achieved in a subset of patients with partial lipodystrophy, and these patients from FHA101/MB002-002 form the basis of the request for ongoing treatment under expanded access.
While fish-oil lipid emulsions have shown a benefit to the treatment of parenteral nutrition (PN)-associated cholestasis, the dose is limited to 1 g/kg/day. Similarly, in early PN-associated cholestasis the dose of soy-based lipid is limited to 1 g/kg/day. Often the calories that are lost from this relative decreased dose of lipids can be provided by adjusting the dextrose content of the PN solution and providing a higher glucose infusion rate. In some cases, this is not tolerated or even with maximizing this strategy, growth is inadequate. Inadequate growth is a direct cause of poor outcomes including poorer neurological outcome, failure to be able to stop mechanical ventilation and poorer growth of their often already damaged intestine. These outcomes can lead to severe disability and death. Therefore, infants receiving only 1 g/kg/day of lipids who are not adequately growing must have a greater intake of lipids to meet their needs for weight, length, and head circumference growth. SMOFlipid (Fresenius Kabi, Bad Homburg, Germany) contains a mixture of 4 different lipid sources: soybean oil providing essential fatty acids, olive oil rich in monounsaturated fatty acids which are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides showing a faster metabolic clearance than long-chain triglycerides, and fish oil for the supply of omega-3 fatty acids. It is safe to give in what is the usual dose for lipid therapy in neonates of 3 g/kg/day, rather than being limited to 1 g/kg/day as we do with cholestatic infants receiving Omegaven or soy lipids. Because this product includes both omega-6 and omega-3 lipids, it provides the benefits of the omega-3s for the liver and provides more than enough omega-6s to meet essential fatty acid requirements. Its use in situations in which growth is inadequate in babies who must be restricted to 1 g/kg/day can be expected to improve their growth and likely markedly increase their chances of both a good neurological outcome and survival. Purpose: We want to find out if this new intravenous fat mixture (SMOFlipid) will help promote good growth while reducing the severity (or seriousness) of liver disease or help put an end to liver disease in infants.
Gastroparesis is a digestive disorder in which motility of the stomach is either slowed or absent. The gastroparesis prevents normal digestion from occurring. The purpose of this study is to provide oral Domperidone offered under the U.S. Food and Drug Administration (FDA) expanded access program, to patients that, based on the treating doctor's assessment, could benefit from , a prokinetic effect for the relief of refractory gastroesophageal reflux disease with upper gastrointestinal (GI) symptoms, gastroparesis, and chronic constipation.
Non-invasive measurement of blood pressure is an instrument governed nursing routine care. The use of an automated oscillometric cuff is a common technique and validated if this is done on the arm with a suitable cuff, positioned opposite the brachial artery and up to the right atrium (the brachial site) . If cons-indication to use the brachial site, measurements are frequently performed at the ankle, calf or thigh. Among the blood pressure values measured on the 3 sites of the lower limb (thigh, calf or ankle), it may be a specific property of which the observed values are closest to the reference values (brachial). The objective of this study is to measure the non-invasive blood pressure values at three sites of the lower limb, to compare the reference value to determine which alternative site should be preferred when the reference measurement is not feasible . We want to determine the alternative site to obtain values as close as the measured values of the reference site. The three study sites are the thigh, calf and ankle. The reference site recommended for monitoring non-invasive blood pressureis the arm. It is also assessing the impact of certain parameters on the primary endpoint: - Physiological parameters: gender, weight, height, age, systolic blood pressure reference, listed measures. - A parameter related to measurement: discomfort felt when the blood pressure outlet. - Exposure setting: smoking.
FDA currently allows patients 12 years of age and older with various gastrointestinal (GI) conditions to be treated with Domperidone through the Expanded Access to Investigational Drugs program. These conditions include gastroesophageal reflux disease with upper GI symptoms, gastroparesis, and chronic constipation. Patients must have failed standard therapies to be eligible to receive Domperidone. This program facilitates availability of investigational drugs, (such as Domperidone) to patients with serious diseases or conditions when there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the patient's disease or condition.
This study is for patients who have participated in a previous study and who continue to receive benefit to have continued access to study drug and/or treatment.
The purpose of this protocol is to provide treatment with HBOC-201 to patients with life-threatening anemia for whom allogeneic blood transfusion is not an option. HBOC 201 [hemoglobin glutamer - 250 (bovine)] has been previously studied as an alternative to blood transfusions in severely anemic patients needing a way to enhance tissue oxygenation. HBOC-201 is purified, cross-linked and polymerized acellular bovine hemoglobin in a modified lactated Ringer's solution, and does not require blood compatibility.