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.
Lyndra is developing an oral, extended release (ER) formulation of risperidone (LYN-005) presented in a capsule dosage form with the intent of reducing the frequency of dosing orally-administered medications to once weekly or less and thereby improving the management of schizophrenia. Study LYN-005-C-004 will evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple dose administration of the ER formulation at two dose levels of LYN-005 relative to IR risperidone.
To evaluate the efficacy of bilateral continuous erector spinae blocks (BESB) for postoperative analgesia in children and adolescents undergoing cardiac surgical procedures via sternotomy in the Early Recovery After Surgery (ERAS) program in a single arm, open label, interventional study.
This is a prospective randomized control trial design to evaluate the effectiveness of a hospital based violence intervention program. Participants will be randomized into a "treatment as usual" group who will receive written referrals for services and an "enhanced services" group who will receive intensive case management over a one year period. Primary outcome will be rate of violent reinjury after enrollment. Follow-up will be for one year.
Our objective is to determine the effectiveness of varied outreach methods (e.g. automated reminder calls/text messages with or without personalized calls/texts) to children age 12-14 months or 4 years old who are due for a WCC visit and don't have one scheduled in the next 45 days on the outcomes of appointment scheduling, appointment completion, and receipt of the MMR vaccination.
The objectives of this trial are to assess the efficacy, safety, and tolerability of NOV03 ophthalmic solution in comparison to a saline control for the treatment of the signs and symptoms of Dry Eye Disease (DED) associated with Meibomian Gland Dysfunction (MGD).
Nearly 20 million Americans report use of cannabis in the past month, and heavy cannabis use has increased by nearly 60% in the U.S. since 2007. Heavy cannabis use is associated with lower educational attainment, reduced physical activity, increased rates of addiction and unemployment, and neuropsychological deficits. Studies suggest that cannabis use is also associated with increased mental health symptoms, drugged driving, and traffic accidents. While there is evidence that sustained abstinence can lead to improvements in the functional outcomes of former users, the degree to which reductions alone (i.e., not sustained abstinence) in cannabis use might be associated with positive changes in functional outcomes is unknown. This is a critical gap in the literature, as many interventions for cannabis and other drugs are associated with decreases in frequency and quantity of use, but fail to achieve an effect on overall abstinence rates. The objective of the present research is to use ecological momentary assessment (EMA), a real-time, naturalistic data collection method, to prospectively study the impact of reduced cannabis use on functional outcomes in heavy cannabis users. Contingency management (CM) will be used to promote reductions in frequency and quantity of cannabis use. CM is an intensive behavioral therapy that is highly effective at producing short-term reductions in illicit drug use. We have recently developed a novel approach that leverages mobile technology and recent developments in cannabis testing. We have pilot-tested this approach with heavy cannabis users and found that it is an acceptable and feasible method. The present research will use this technology in conjunction with EMA methods to study the impact of reduced cannabis use on key functional outcomes. Our central hypothesis is that reductions in frequency and quantity of cannabis use will lead to positive changes in cannabis users' mental health, self-efficacy, physical activity, working memory, health-related quality of life, and driving behavior. The rationale for this research is that it will provide the first and only real-time data concerning the potential impact of reductions in cannabis use on functional outcomes. As such, the findings from the present research will directly inform ongoing efforts to include reductions in illicit drug use as a valid, clinically-meaningful outcome measure in clinical trials of pharmacotherapies for the treatment of substance use disorders.
This is a 6-visit, subject-masked, multi-site, 2×3 crossover dispensing trial that will last approximately 2 - 4 months.
Purpose: To better understand the impact of different front-of-package labels (FOPLs) on consumer purchasing intentions and ability to identify unhealthy foods. Participants: ~8,000 Colombians, recruited from Offerwise, that are 18 years or older. Procedures (methods): Participants will be randomly assigned to view images of food and drink products with either a nutrient warning label, Guideline Daily Amount label, Nutriscore label, or no-label control. They will be asked a series of questions about the products and the labels (excluding control group) on them. Questions will also include standard demographic and health related variables.
The Centers for Disease Control and Prevention has identified insufficient sleep as a public health epidemic, with more than 70 million US adults experiencing insomnia each year. However, access to current evidence-based interventions for sleep disturbance (e.g., Cognitive Behavior Therapy for Insomnia [CBT-I]) is limited due to the need for specialized providers as well as monetary and logistical barriers that prevent many individuals from attending in-person treatment sessions (e.g., scheduling, transportation, childcare). Novel modes of delivery are needed to extend the benefits of these treatments to a wider range of individuals in need. The purpose of this study is to evaluate Calm Sleep Coaching in adults with sleep disturbance (score of greater than or equal to 8 on the Insomnia Severity Index) by 1) determining the feasibility (i.e., acceptability, demand) of Calm Sleep Coaching and 2) determining the preliminary effects of Calm Sleep Coaching on primary (sleep quality) and secondary outcomes (i.e., symptoms of insomnia, mental health, well-being, resilience, and productivity). Investigators also aim to explore coaches' experiences with implementation of Calm Sleep Coaching using an investigator developed survey and assess the participants stage of change (transtheoretical model) throughout the program. Investigators hypothesize that 1) Calm Sleep Coaching will be feasible among individuals with sleep disturbance and 2) participating in the Calm Sleep Coaching program is associated with improvements in primary and secondary outcomes compared to the control group (with greater improvements observed among those participating in higher touch coaching interventions). Investigators aim to recruit N=200 participants. Participants will be randomized into one of four groups: 1) High-touch intervention (N=50; real-time video and chat messaging, coach response via live videos), 2) medium-touch intervention (N=50; real-time video and pre-recorded video and chat messaging with response from coach), 3) low-touch intervention (N=50; chat messaging with response from coach), or 4) Sleep education control (N=50; no coaching).
The purpose of the study is to determine whether biweekly (every 2 weeks) administration of Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) produces a steady-state area under the concentration versus time curve (AUC) of total Immunoglobulin G (IgG) that is non-inferior to that produced by weekly administration of IGSC 20% in treatment-experienced participants with primary immunodeficiency (PI).