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 purpose of this study is to compare two different dosing strategies of a drug named protamine.
Neurodevelopmental disorders of inattention and disruptive behavior, such as Attention-Deficit/ Hyperactivity Disorder (ADHD) and Oppositional Defiant Disorder (ODD), are among the most common youth mental health conditions across cultures. An efficacious and feasible solution to improving affected youth's ADHD/ODD is training existing school clinicians to deliver evidence-based intervention with fidelity. Despite initial promising results of training school clinicians to treat ADHD/ODD in settings suffering from high unmet need, such as Mexico, scalability is limited by a lack of researchers with capacity to train, monitor, and evaluate school clinicians in such efforts on a large scale. Thus, there is a need to develop more feasible interventions and training programs for school clinicians, as well as create a system with capacity for scalable training and evaluation, to combat the widespread impact ofADHD/ODD worldwide. Converting interventions and school clinician professional development programs for fully-remote delivery allows for more flexibility, accessibility, affordability, scalability, and promise for ongoing consultation than in-person options. Supporting scalable training for school clinicians could address a significant public health concern in Mexico, as only 14% of Mexican youth with mental health disorders receive treatment and less than half of those treated receive more than minimally adequate care. The study team is uniquely suited for this effort, given that they developed the only known school-homeADHD/ODD evidence-based intervention in Latin America-and-have developed a web-based training for U.S. school clinicians with promising preliminary results. The study team's prior studies and high levels of unmet need make Mexico an ideal location for this proposal; however, lessons learned could be used to expand scalable school clinician training for evidence-based intervention in other settings and/or for other disorders. Thus, this study focuses on conducting an open-trial of the fully-remote program and make iterative changes. It is predicted that: H1) school clinicians trained remotely will be satisfied and show improved evidence-based practice skills; H2)families and teachers participating remotely will be satisfied and youth will show improved ADHD/ODD; H3) observation/feedback from a 3-school open-trial will guide iterative changes to the remote program.
This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine ([Prevnar 20™ / APEXXNAR™]) in pneumococcal vaccine-naïve adults. It is hypothesized that V116 is noninferior to PCV20 for the common serotypes and superior to PCV20 for the unique serotypes as assessed by serotype specific opsonophagocytic activity (OPA) 30 days postvaccination. It is also hypothesized that V116 in participants 18 to 49 years of age immunobridges to V116 in participants 50 to 64 years of age as assessed by serotype specific OPA geometric mean titers (GMTs) 30 days postvaccination for all 21 serotypes in V116. Participants ≥50 years of age will be enrolled in Cohort 1, and participants 18 to 49 years of age will be enrolled in Cohort 2.
The goal of this clinical trial was to compare transdermal glomerular filtration rate (tGFR) to plasma-derived indexed (to body surface area; BSA) GFR (nGFR) using MB-102 (relmapirazin) as the fluorescent compound. Adults with kidney function ranging from normal to Stage 4 chronic kidney disease (CKD) and participants spanning the entire range of human skin colors as defined by the Fitzpatrick Skin Scale (FSS) were included in the study. The main questions that the study aimed to answer were: - To establish that the MB-102 transdermal fluorescence measured GFR using the MediBeacon Transdermal GFR Measurement System is comparable to the measured MB-102 plasma GFR - To evaluate the safety and tolerability of a single dose of MB-102 in study participants - To evaluate the safety and effectiveness of the MediBeacon Transdermal GFR Measurement System (TGFR) for the non-invasive transdermal fluorescence detection of MB-102 in participants Participants had a transdermal sensor placed on their upper chest, and the TGFR collected background fluorescence. Participants then received a single dose of MB-102. Blood samples were collected and fluorescent measurements were taken over a 12- to 24-hour period. Following completion of the treatment period, participants returned to the study center approximately 1 week later for a safety follow-up visit. Researchers compared the results to see if the transdermal GFR measurements were comparable to the measured plasma GFR in those with and without normal kidney function and different skin coloration.
The investigators administer a functional neuroimaging task to investigate the effect of cue expectancy on participants' self-reported ratings across a variety of affective and cognitive domains. The experiment incorporates three tasks in which participants experience and rate 1) somatic pain, 2) vicarious pain, and 3) cognitive effort. In the somatic pain task, participants receive a brief thermal stimulus administered to a site on their arm; in the vicarious pain task, participants watch a short video clip of a patient with back/shoulder pain; in the cognitive effort task, participants perform a cognitively demanding "mental rotation" task that requires them to indicate whether two 3D objects are the same or different when rotated along the y-axis. Each trial follows a sequence that begins with a fixation, followed by a social influence cue, then an expectation rating, followed by a condition-specific stimulus, and then, an actual rating of the outcome experience. There are four events of interest: 1) cue perception, 2) expectation rating, 3) stimulus experience, and 4) outcome rating. First, participants are presented with a cue that depicts how other participants responded to the upcoming stimulus ("cue perception"). Although the participant is told these are real ratings, they are in fact, fabricated data points that vary in intensity (low, high). Then, based on the provided cues, participants are prompted to report their expectation of the upcoming stimulus intensity ("expectation rating") After providing an expectation rating, participants are presented with a condition-specific stimulus (somatic pain, vicarious pain, or cognitive effort) that also varies in three levels of low, medium, high stimulus intensity ("stimulus experience"). Once the stimulus presentation has concluded, participants are prompted to provide an actual rating of their experience ("outcome rating"). For the somatic pain condition, participants rate their expectations and actual experience of how painful the stimulus was; for the vicarious pain condition, they rate their expectations and actual perception of how much pain the patient was in; and for the cognitive condition, the participant provides expectation and actual ratings of task difficulty.
Single-center, open label, single-session study to evaluate methadone pharmacokinetics and pharmacodynamic in adults.
Exercise-induced gastrointestinal dysfunction is common amongst endurance athletes and is characterized by gastrointestinal permeability, also known as "leaky gut." Probiotics have been shown to improve gut permeability through the secretion of mucin, immunoglobulin A and improvement in stability of tight junctions between epithelial cells. This study will determine the efficacy of a probiotic containing the bacterial strains P. acidilatici, CECT 7483, L. plantarum CECT 7484, L. plantarum CECT7485) in altering markers of gut inflammation and dysfunction, and symptoms of gastrointestinal distress.
The proposed study will investigate the utility of a single-session emotion regulation training to reduce CVD risk among young adults diagnosed with MDD living in Southern MS. Using an single-arm, non-randomized design, young adults aged 18-29 will undergo a single-session emotion regulation skills training. Before and immediately after the skills training session, participants will supply several biological metrics tied to CVD risk: resting HRV, inflammation (measured via c-reactive protein [CRP]), and blood pressure. Participants will provide the same biological metrics at a one-week follow-up visit to assess short-term sustained gains following the single-session intervention and complete a 7-day ecological momentary assessment (EMA) of their daily emotion regulation skills use and depressive symptoms between these two visits.
Chiropractic adjustment has been shown to gap certain joints in the spine, thereby improving mobility in individuals with decreased movement capabilities. During normal motion, joints in the spine produce sounds and vibrations called crepitus. The purpose of this study is to assess how this crepitus may be used as an indicator for joint degeneration in healthy human subjects and those with low back pain, and if chiropractic adjusting causes change in this crepitus. We hypothesis that change in crepitus after adjustment may be a useful indication of changes in joint mobility and joint stiffness.
Explore barriers, facilitators, acceptability, feasibility, and fidelity of the telemedicine management of hypertension intervention