There are about 173942 clinical studies being (or have been) conducted in United States. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The hypothesis of this multisite Phase 2a study is that IXT-m200 will be well-tolerated in patients with acute mild to moderate METH toxicity. A randomized, open label design will be used in which one dose of IXT-m200 will be compared to treatment-as-usual (TAU). Approximately 40 participants will be enrolled in 4 cohorts. A dose escalation approach will be used so that progressively higher IXT-m200 doses will be evaluated in each cohort. In conjunction with safety monitoring, this design assures the opportunity to observe early safety findings before any participants are exposed to the next higher dose. The randomization ratio for IXT-m200 versus TAU is defined as 4:1 for each cohort so that the number of participants receiving TAU equals the number receiving each dose of IXT-m200 at the end of the study. Agitation scales and vital signs will be recorded to track effect of the antibody treatment versus TAU over time on agitation associated with METH use. While in the emergency department (ED), detailed and pertinent medical and psychiatric histories, and physical exam will be obtained, along with laboratory assessments and ECGs. In the ED, participants will give blood samples for analysis of METH and IXT-m200 concentrations and followed for development of adverse events. Participants will be evaluated at 2 days and 4 weeks after discharge from the ED for adverse events and drug use history. Cohort escalation reviews will be performed by the Sponsor, Medical Monitor, and Data and Safety Monitoring Board (DSMB) between cohorts and the next group will not start until after completion of this review.
The purpose of this interventional study is to identify the root cause(s) of AxSpA (Axial Spondyloarthritis) relapses, which are likely due to the combination of nutrition, gut microbiome activities, leaky gut, and human genes (particularly from the immune system). This will be done by identifying molecular features of the microbiome that are associated with AxSpA flares, progression and relapses. The study will recruit participants with confirmed AxSpA diagnosis and who are HLA-B27 positive. During screening potential participants allow access to medical records to confirm eligibility requirements, such as diagnosis. Once enrolled, collection kits are sent to participants to collect samples using at-home collection kits and then provide a fasting blood sample at a local lab. Samples are then analyzed to identify features that likely cause AxSpA issues. Survey's are also answered to collect additional health data. Scientists will then use the data to identify the features that likely cause AxSpA flares and relapses.
This is a research study to understand the changes in the heart and the cardiovascular system that may occur in women who develop high blood pressure during pregnancy.
Up to one third of the 700,000 U.S. military veterans of the 1990-91 Gulf War have Gulf War Illness (GWI), a symptom complex characterized by a combination of chronic pain, cognitive impairment, debilitating fatigue, gastrointestinal complications, and other persistent symptoms. Epidemiologic studies of 1990-1991 Gulf War veterans have identified the short but intense combined exposure to insecticides (e.g., organophosphates, DEET, permethrin), pills with anti-nerve gas agent pyridostigmine bromide (PB), and low-level chemical nerve agents as likely candidates of GWI. Animal models have shown that these neurotoxicants could induce neuroinflammation which is marked by enhanced inflammatory cytokines, and activated microglia and astrocytes. Inflammation has been linked to GWI. Secondary effects of neuroinflammation and glia activation could be excessive glutamate-mediated neuronal activation. There is currently no treatment for symptoms of GWI. Ketamine is an N-methyl-D-aspartate receptor (NMDAR) antagonist. Besides blocking activation of NMDARs, a sub-anesthetic dose (0.5 mg/kg over 40 minutes) of ketamine could be an anti-inflammatory agent, and could protect microglia and astrocytes from being activated by inflammatory agents. This low dose of ketamine has also been shown to improve fatigue within 24 hours after a single infusion, and to improve inflammatory pain. This makes ketamine a feasible candidate for the treatment of inflammation-associated symptoms of GWI. This pilot study will examine if GWI is related to NMDAR functioning, testing effects of a single 40-minute intravenous infusion of 0.5 mg/kg of ketamine on GWI symptom severity in 21 veterans of the 1990-1991 Gulf War who meet Kansas case definition criteria of GWI.
This study will compare the effects of closed incision negative pressure dressing vs. standard of care silver dressing on lower limb swelling after bilateral primary total knee arthroplasty.
The investigators plan to enroll individuals with medical temporal lobe epilepsy who are undergoing surgical workup with clinically implanted intracranial electrodes. The study intends to administer computerized memory tasks and stimulation during the intracranial Electroencephalography (EEG) monitoring period.
The Investigators hypothesize that an early 2 week post-operative protocol will have no difference in the successful osseointegration and stability of the total ankle replacement as compared to a delayed 6 week post-operative protocol. The importance of the research is to allow patients who receive a total ankle replacement to bear weight 4 weeks earlier than the current protocol with no negative effect on the osseointegration and stability of the ankle replacement.
This is a prospective study to evaluate the clinical outcome of varying doses of Micropulse TransScleral CycloPhotocoagulation (MP-TSCPC) laser in patients with glaucoma. The study will assess documented complication rates, changes in visual acuity after the procedure, changes in intraocular pressures and medication drop usage, and need for subsequent treatments (including further laser or surgery).
This study is a prospective, multicenter, double-blind, 1:1 randomized clinical trial. The purpose of this study is to demonstrate that the use of Celliant Socks increases tissue oxygenation (via oxygen saturation, StO2) and incidence of wound closure in subjects with diabetic foot ulcers. This study will use hyperspectral imaging and wound assessment to measure these outcomes. The study will enroll 254 evaluable subjects total, 127 per arm to meet the Primary Endpoint. Enrollment may continue up to twenty-five hundred (2500) evaluable subjects total to meet the Key Secondary Endpoint of complete wound closure.
The purpose of this research is to remotely monitor individuals who have tested positive for COVID-19 to learn more about progression and recovery from the disease. Individuals who test positive for COVID-19 will wear the Current Health wearable device continuously and answer a brief series of questions on Current Health tablet daily for up to 30 days. The health data will be used to develop predictive models of hospitalization risk.