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 new recreational marijuana markets are contributing to polysubstance-impaired driving and other harms, especially when marijuana is used in combination with alcohol, by selling marijuana to obviously-intoxicated customers. In this study, the effectiveness of an intervention to reduce the risk of marijuana sales to obviously-intoxicated customers will be tested in the state-licensed recreational marijuana market in Oregon, one of the first states to ban such sales. The intervention will combine efforts by state regulators to increase deterrence of the state law prohibiting marijuana sales to obviously-intoxicated customers with training of store personnel to recognize signs of intoxication and refuse sales. It will also include testing the rate at which visibly intoxicated customers are refused alcohol at nearby establishments that sell alcohol either on-site or off-site
This study aims to compare the use of Dextenza, an FDA-approved intracanilular drug-eluting insert that is designed to deliver a tapered dose of dexamethasone to the ocular surface for 30 days, to the standard of care, or the use of a month-long topical prednisolone acetate 1% (PredForte) eye drops starting from four times daily. Following treatment, Dextenza resorbs and exits the nasolacrimal system without the need for removal. Three prior phase 3 clinical trials have demonstrated that Dextenza is equally efficacious to a month-long topical Pred Forte taper in the treatment of postoperative inflammation following cataract surgery. This proposed study strives to demonstrate the non-inferiority of using Dextenza to treat postoperative inflammation following corneal collagen crosslinking compared to standard of care eye drops in a randomized trial. By demonstrating Dextenza's non-inferiority to treatment postoperative inflammation, the investigators hope to provide an alternative modality of treatment to patients who are unable to cooperate with or tolerate postoperative topical eye drop regimens, allowing for improved adherence to necessary therapy and thus improved postoperative outcomes.
This study aims to assess the feasibility, acceptability, and safety of using ReCognitionVR virtual reality-based software in older surgical patients. Results from this study will be used to inform the design of a future study in critically ill hospitalized patients at risk for delirium.
The goal of this study is to examine the impact of a 12-week sports sampling and physical literacy program on rural girls' physical activity.
The goal of this prospective, digital randomized controlled trial is to evaluate the effectiveness of a predictive ILI detection algorithm and associated alerts during influenza season for adults living in the contigent United States. The main study objectives are to assess the effectiveness of predictive ILI detection algorithm and associated alerts on protective behaviors related to ILI and assess the accuracy of a predictive ILI detection algorithm using participant self-reported ILI symptoms and diagnosis.
Chronic pain impacts about 20% of US Adults. Though non-pharmacologic, integrative pain management therapies are now considered first-line treatment by clinical guidelines, these therapies are still rarely covered by health insurance and therefore inaccessible to lower-income individuals. The Integrative Medical Group Visit (IMGV) program was developed to offer low-income, diverse patients with chronic pain an introduction to integrative pain management approaches, through a model that is covered by health insurance under existing billing codes. An initial pragmatic randomized control trial found that IMGV led to significant improvement in mental health related quality of life and lower use of high-cost care. However, there has been little research investigating the implementation of IMGV, and none in Federally-Qualified Health Centers (FQHCs), where the program was initially designed to be implemented. In this study, the investigators test strategies to implement IMGV in FQHCs, including training and coaching clinic staff, and measure the effectiveness of the IMGV on health outcomes for patients with chronic pain.
Youth involved in the juvenile justice system evidence disproportionately high rates of suicidal thoughts and behavior (STB) and non-suicidal self-injury (NSSI) compared to adolescents in the general population. It is estimated that upwards of 50% of justice-involved youth (JIY) in secure facilities report NSSI and suicide attempts.1-3 Suicide attempts are estimated to be between two and four times more frequent in incarcerated JIY than adolescents in the community,4 and the rates of STB in JIY are higher than non-JIY in the community. The overwhelming majority of JIY are not placed in secure facilities and almost all incarcerated youth are eventually released to the community.5 Consequently, STB is a major concern of JIY residing in the community and it is critical that this population has access to evidence-based treatment for STB and NSSI. Contributing to the problem, racial and ethnic minority youth are disproportionately represented among JIY6 and JIY are more likely to reside in neighborhoods with limited resources,7 including restricted access to community mental health treatment.8,9 Further, most community mental health providers who treat JIY have not been trained in evidence-based interventions that are specifically designed to treat NSSI and STB; this often leads to JIY experiencing prolonged periods of NSSI and/or STB.10 Training community mental health providers who serve JIY in the detection and treatment of NSSI and STB has promise to decrease the overall suicide risk for JIY. The primary goal of this application is to train community providers in established, core strategies for adolescent STB and NSSI.11 The training program has been used in two clinical trials, refined for inpatient psychiatric and Emergency Department providers, and modified for use in community practice. Our Primary Aim is to implement a systems-level intervention focused on increasing access to evidence-based treatment strategies specifically designed to treat STB and NSSI behaviors for the JIY referred to outpatient care by the RIFC. First, the investigators will conduct a stepped wedge cluster randomized trial with 9 Rhode Island CMHAs who serve JIY. After all sites complete a Usual Care phase, three CMHAs per year will be randomized to the Preparation Phase to receive training in evidence-based strategies for NSSI and STB, using a training program called COPES,11 developed by the MPI for inpatient psychiatry units and Emergency Departments, transported to CMHAs by Consultant and consistent with recommendations in SAMHSA's Youth Suicide Treatment Guide.13 Agencies then move into Implementation Phase for consultation and support followed by a Sustainment phase. Second, guided by the Reach Effectiveness-Adoption Implementation Maintenance (RE-AIM) framework, the investigators will conduct qualitative interviews and administer agency and provider demographic questionnaires and organizational readiness measures with CMHA providers and administrators to identify system-, agency-, and provider-level factors that promote or hinder the uptake and sustainment of evidence-based treatment for STB and NSSI at CMHAs serving JIY. At the provider level, the investigators hypothesize that training in the use of evidence-based treatment strategies for STB and NSSI will: a) significantly increase the use of these strategies and b) the quality of their delivery will be in the "acceptable" range during the Sustainment Phase. At the client/patient level, the investigators hypothesize that the intervention will keep families engaged more than Usual Care phase, increase sessions attended, and reduce rates of adolescent STB and NSSI that require emergency psychiatric care. At the systems level, the investigators hypothesize that the training program will be sustained for at least one year, and up to 3 years, by CMHA administrators. The investigators will also examine factors that may affect the effectiveness of uptake and sustainment of the training program, i.e., organizational readiness, climate, and leadership at each CMHA.
Study 22403 is a Phase 1 / Proof of Concept exploratory investigation to assess the non-inferiority of low dose gadobutrol and SubtleGAD™, a software medical device using an Artificial Intelligence (AI) deep learning-based method to enhance the contrast signal from images acquired with low dose administration of gadobutrol (GAD) contrast. The primary objective is to demonstrate noninferiority of synthesized Central Nervous System (CNS) magnetic resonance (MR) images for 1 or 2 different gadobutrol-enhanced low-dose groups (0.01mmol/kg, and0.025 mmol/kg) compared to gadobutrol-enhanced CNS MR images at a standard dose of 0.1 mmol/kg. This investigation is a prospective, randomized, open label, multi-center study with blinded reads in participants with known or highly suspected CNS pathology. There will be at least 60 participants enrolled (30 per study arm). SubtleGAD will be used as a post-processing tool, prior to blinded read assessment of MR images acquired in either arm of the study.
This pilot comparative effectiveness trial will compare two active smoking cessation treatments in terms of effectiveness, equity across patient subpopulations, and efficiency among adult patients diagnosed with cancer within the past 3 years. An enhanced treatment comprising 12 weeks of varenicline treatment and 7 smoking cessation coaching calls with a cancer focus will be compared against an active comparator modeled after standard quitline treatments (2 weeks of nicotine patch therapy with 3 phone coaching calls). Approximately 50 participants will be recruited to generate estimates of the effects, acceptability, costs, and equity of enhanced treatment (vs. standard treatment), with the primary outcome being abstinence from smoking 26 weeks after trying to quit.
Life-threatening low blood pressure due to a serious infection is called "septic shock." Septic shock is treated with vasopressors, medications that raise blood pressure. Sometimes first-line vasopressors are inadequate, prompting addition of a second-line vasopressor called vasopressin. However, the threshold at which to start vasopressin remains unclear. This pragmatic, cluster-randomized, cluster-crossover trial will evaluate two different strategies for septic shock treatment commonly used in current practice, comparing a lower versus a higher threshold for adding vasopressin to first-line vasopressors.