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.
Background: Stroke is a leading cause of long-term disability in the US. Mild stroke comprises half of stroke hospital admissions, but most people with mild stroke receive no rehabilitation services. Mild stroke is often the manifestation of uncontrolled chronic conditions (e.g. hypertension, diabetes), and people with mild stroke also experience ongoing chronic symptoms (e.g. depression, fatigue) that may impact their daily activities. An inability to manage chronic conditions and symptoms may lead to decreased participation in pre-stroke roles and activities, which may increase the chance of sustaining a second stroke. An effective intervention to manage chronic conditions and support participation is self-management. A meta-review of 13 systematic reviews demonstrated that self-management interventions significantly improve stroke survivors' daily activities, independence, and mortality. National research agendas from the Department of Health and Human Services (HHS) and Institute of Medicine (IOM) include self-management as one key goal of a strategic framework, aligning with the AOTF Research Priorities, for promoting (1) health behaviors to prevent and manage chronic conditions. Our preliminary studies indicate that mobile health (mHealth), defined as the delivery of healthcare services via mobile devices, can be used to precisely monitor participation in daily activities and mood and is acceptable in stroke survivors. Our meta-analysis indicates that digital self-management interventions are more effective in improving depression, fatigue, anxiety, and self-efficacy in people with neurologic disorders in comparison to non-digital self-management interventions. These studies support the AOTF Research Priorities that include (2) use of technology to support home and community activities, and (3) emotional influences. Objectives: The investigators will harness mHealth technology for a self-management program. Our intervention is a mobile phone intervention called iOTA, which builds on extensive work by my mHealth mentor and colleagues in health behavior research. The investigators will use a formal implementation science framework to adapt and test the iOTA intervention. The investigators will cohere an adaptation framework by soliciting stakeholder input to adapt the iOTA from Improving Participation after Stroke Self-Management (IPASS), an evidence-based intervention that targets self-management of chronic conditions and increased community participation in stroke survivors. Methods: The investigators will use a two-step approach, including a rigorous treatment adaptation and a Phase I feasibility trial. Our first step is to adapt the intervention with input from all relevant stakeholder levels. Our second step is to use a pre-post, non-randomized study design to test the adapted iOTA. Ten community-dwelling people with mild stroke will participate in the iOTA for 3 months. The iOTA incorporates daily short message service (SMS) text messages to supplement monthly in-person health coaching and weekly videoconference sessions. The investigators will include an occupational therapist (OT) as a health coach to teach individuals to incorporate self-management strategies into their daily routines to support participation in meaningful activities. Expected Outcome: This mHealth treatment development study will increase the reach and access of IPASS-a patient-centered, participation-focused self-management program for stroke survivors. The iOTA created will not only maximize our potential for the future randomized controlled trial (RCT) but also lay the groundwork for future funding mechanisms.
This is a Phase Ib/II, multicenter, open-label study to evaluate the safety and preliminary efficacy of TT-00420 tablet, as monotherapy or in combination regimens, in patients with advanced solid tumors.
Will use a subset of the main study cohort of transgender or non-binary individuals to evaluate the relationships between self-reported exogenous hormone use, endogenous hormone values, renal biomarkers, drug levels and directly measured renal function.
This pilot study will expand knowledge and application needling using the Epistamp device for the improvement of a new vitalized epidermal layer with new vibrant active cells, supported by more robust collagen and elastin fine lines, deep wrinkles, and collagen production.
The goals of this study are 1) to validate the use of a wearable diagnostic capability and software as a medical device (SaMD) algorithm for the pre or early-symptomatic detection of COVID-19 infection, 2) assess the wearable device on the subjects, and 3) ensure data are collected, securely stored, and easily read and interpreted by non-laboratory personnel.
The primary purpose of this study is to evaluate the safety and tolerability of single ascending intravenous doses of ASP1128 in healthy adult male and female subjects and multiple ascending intravenous doses of ASP1128 in healthy adult male and female subjects and healthy elderly male and female subjects. This study will also evaluate the pharmacokinetics and the effect on the QT interval using Fridericia's correction formula (QTcF) in these subjects.
Following painful surgical procedures of the breast, postoperative analgesia is often provided with a nerve block called a "paravertebral" block. For intense, but shorter-duration acute pain, a single-injection of numbing medicine is used which lasts about 12 hours. Recently, a new type of block has been reported: the "Pecs-2" block. The theoretical benefits include ease of administration since it is closer to the skin (less deep) compared with the paravertebral block and therefore easier to identify and target with ultrasound (therefore increasing success rate); and, a lower risk of complications. Lastly, it might be easier to insert a tiny tube which would allow additional numbing medicine to be injected. There are, therefore, multiple theoretical reasons to prefer the Pecs-2 over the paravertebral nerve block. Unfortunately, it remains unknown if the pain control provided by this new type of block is comparable to that provided with the older block. The investigators therefore propose to compare these two blocks with a clinical study.
Reduction of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop medications has been shown to be effective in delaying or preventing the progression of glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field loss. This study is being conducted to determine how well DE-126 ophthalmic solution works (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate the safety and efficacy of DE-126, ophthalmic solution in subjects with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT). The IOP will be measured at 3 different times throughout the day, over 4 total visits during a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop taking current eye drops to lower IOP). Safety assessments will be done throughout the study, including ocular signs and symptoms, and vital signs. While the most important time-point to measure IOP in this study and evaluate efficacy will be at the final study visit (month 3), IOP values will also be evaluated at other visits throughout the 3-month treatment period.
Study is to assess the effects of food on the Pharmacokinetics(PK) of single-dose administration of K-877 in healthy adult volunteers.
This will be a prospective, randomized, single-blinded controlled trial in which the investigators evaluate post-operative serum glucose control using conventional point-of-care glucose monitoring in the morning and before meals (standard of care) versus continuous glucose monitoring using the Medtronic Guardian™ Sensor 3 continuous glucose monitor. The investigators will compare the average daily glucose level in the post-operative period (through post-operative day five) between the two arms in patients with diabetic nephropathy immediately post-renal transplant. This will serve as a pilot study to in order to power a main study.