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.
Up to 28% of undergraduate college students report a suspected history of traumatic brain injury. Following traumatic brain injury, college students fail and repeat more courses and have lower grade point averages. Further complicating this problem may be the fact that college students lack knowledge of traumatic brain injury definition, its associated symptoms, and individuals involved in post-injury management. In this project, the investigators propose to compare the use of an established treatment model (i.e., the Dynamic Coaching Model) to a novel protocol (i.e., the Apprenticeship Approach) that includes explicit instruction about traumatic brain injury in college students with this population. The investigators will use a group comparison design to examine the efficacy of this instructional component. This work incorporates findings from educational psychology and speech-language pathology (e.g., the included instructional materials adhere to the principles of adult learning). As such, this work will advance the field's basic understanding of currently recommended treatment components and will systematically examine the effects of incorporating explicit instruction into an existing treatment model.
The investigators aim to validate if a digital tool for increased self-management of chronic pain can improve the quality of life for patients with chronic pain. The validation is based on the change in pain interference (Quality of life), pain intensity, physical functioning, depression, and anxiety based on self-reported information from baseline to study end.
The PYCC is a system for parents of young children (2-5 years old) with Disruptive Behavior Problems (DBPs). The program is designed with the intentions of being used a pediatric primary care visit. Parents that report elevated child behavior problems go through a three part program. First, they go through a brief intervention on a tablet (i.e., the initial check-up) to receive feedback and learn about the PYCC; the aim is to build motivation to make parenting changes and engage in the parenting young children check-up. Next, parents receive text messages to connect them to further parent training content. Finally, parent training content is delivered via a web-based resource (i.e., the PYCC website), which includes videos to teach parenting skills. In this pilot RCT, the investigators will focus on examining the impact of the brief intervention (i.e., the initial check-up). Secondarily, the investigators will examine overall impact of the whole PYCC program and use of the parenting training website. Parents will learn about the research opportunity through select community-based organizations in Detroit, Michigan, local posting, and a local participant registry. Through a phone call, parents will complete a demographics questionnaire and the DBP screener. The investigators aim to screen 200 parents in order to enroll 40 parents in the clinical trial. If parents report elevated DBPs and do not meet any exclusion criteria, then they will be eligible to further participate. Parents that are eligible will complete a consent form (i.e., an online information sheet) and then be randomly assigned to intervention (n = 20) or control (n = 20). Both groups will complete a brief baseline. Both groups will also learn about the Parenting Young Children Check-up (PYCC). However, the way in which they learn about the program will differ. The control group will see a brief description about the program (i.e., an online flier) and will receive a brochure for the program through the mail. The intervention group will go through the full PYCC initial check-up and also receive a brochure through the mail. Both groups will receive text messages prompting them to engage in the PYCC. After initial participation, parents will be free to use, or not use, the Parenting Young Children Check-up web-based resource as much as they want. Parents will enter their phone number and first name when accessing the web-based content in order for use to track their engagement. All use of the web-based resource will start with "Session 1. In this, they will choose what parenting skills they want to learn. If parents go through session 1, they will be further connected to PYCC content through tailored text messages. Texts contain links to all PYCC web-based content. Parents will be able to learn content related to "Special Time," "Labeled Praise," "Family Rules," "Effective Commands," "Offering Choices," "Routines," "Removing Attention," "Logical Consequences," and "Time out." All content of the PYCC is based on evidence-based parent training program content. The purpose of this project is evaluate the Parenting Young Children Check-up. In particular, the investigators are interested in if the initial check-up leads parents to engage in the PYCC (i.e., completing session 1 and using the parent training content on the PYCC website). Hypotheses include: Primary Hypothesis: The intervention group (i.e. those randomized to complete the full initial check-up) will visit the parent training website more than the control group. The investigators hypothesize that, compared to the control group, more parents in the control group with complete "session 1," and use the PYCC web-based content to learn parenting skills (i.e., more parents will use any of this content and parents will use it more frequently). Secondary Hypothesis (a): Participants assigned to the intervention group, as compared to those in the control group, will have higher scores for all domains consistent with the Theory of Planned Behavior at follow-up. Secondary Hypothesis (b). Participants in the intervention group will report high levels of satisfaction (i.e., >=4 on a 5-point scale). The investigators will also explore the impact of the PYCC on reported parenting and child behavior problems. Furthermore, the investigators will explore the impact of the initial check-up on intentions to use the parent training website.
This study proposes a safe dosing regimen IFN-γ that is sufficient to stimulate IFN-γ receptors on malignant blasts in patients who developed relapsed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after alloSCT with no active or history of III-IV acute graft-versus-host disease (GVHD). It is hypothesized that IFN-γ will promote graft-vs-leukemia (GVL) in patients with AML/MDS that has relapsed after alloSCT.
Prospective, Single Center, Open Label Clinical Study. The purpose of the study is to collect safety data associated with the use of the OsteoProbe System. Study Duration is expected to take approximately 3 months from first subject enrolled to the last follow-up visit.
Black adolescents who are pregnant represent a high-risk and understudied perinatal population in health research. Adolescent pregnancy (<20 years) is disproportionately prevalent among Blacks compared with Whites and is a prominent risk factor for obesity. Fortunately, metabolic consequences of increasing physical activity coupled with minimal sedentary time can mitigate biological imperils and behavioral interventions targeting perinatal populations have demonstrated efficacy for this approach. Intervention studies to promote physical activity and reduce sedentarism among Black, perinatal adolescents in disadvantaged, rural settings may be a promising strategy to prevent obesity and reduce disparities. In the proposed study, investigators will assess the feasibility and acceptability of #BabyLetsMove, a mobile health intervention targeting three behavioral goals: (1) limit TV time to less than 2 hours a day (sedentary behavior); (2) take 10,000 steps or more per day (physical activity); and (3) do 20 minutes or more of structured activity like prenatal yoga or dance videos per day (exercise). In the #BabyLetsMove feasibility trial investigators aim to conduct a single-arm, 4-week pilot with 20 Black adolescents (15- to 19-years) enrolled in Mississippi's Supplemental Nutritional Program for Women, Infants and Children (WIC) to test the intervention's feasibility and acceptability. Participants will receive one text message per day for 4-weeks targeting behavior change strategies and two health coaching sessions via mobile phone; an introduction session in week one and a problem-solving session in week three. Investigators will also use qualitative interviewing with additional adolescents (n=20) to solicit user feedback regarding the acceptability of intervention content and materials. Finally, in preparation for a pilot study using an effectiveness-implementation hybrid study design, investigators will conduct a pre-implementation evaluation using quantitative surveying (n=6 surveys) with WIC providers (n=60) to better under the culture and climate of WIC. Investigators hypothesize the #BabyLetsMove intervention will be acceptable to adolescents and a future pilot randomized controlled trial will be feasible. Investigators also anticipate identifying modifiable barriers and facilitators to implementing the intervention through WIC, which will help to design an implementation strategy with a high likelihood for uptake by WIC.
Knee osteoarthritis (OA) is the most common lower extremity joint pain condition, and it is estimated that 15 million people in the US are living with symptomatic knee OA and that more than half (8 million) are under 65 years of age. To that end, the Centers for Disease Control and Prevention strongly recommends non-pharmacological treatments for chronic pain including physical therapy and weight loss; however, these interventions have significant barriers that can prevent their success. An intervention that targets pain specifically is transcutaneous electrical nerve stimulation (TENS), which is a low-cost intervention with evidence to support pain reduction. As used in the majority of research to date, the intervention called "TENS" refers to the application of electricity across the skin that produces a tingling sensation that is strong but comfortable. However, electricity is applied at a noxious level is thought to result in strong activation of the endogenous pain modulation system, thus producing longer-lasting pain inhibition. However, noxious electrical stimulation (NxES) has rarely been investigated as a treatment intervention. Recent studies, including our own, demonstrate that NxES produces immediate and potentially greater pain relief. Despite some promising research, the clinical use of NxES is sparse and more research is necessary to demonstrate its effects on resting pain, movement-related pain, physical function, and quality of life. The investigators hypothesize that the application of NxES will activate pain modulation mechanisms and change the pain modulation profile toward an anti-nociceptive state in adults with chronic knee osteoarthritis (OA) pain, and thereby decrease pain (at rest and with movement), improve physical function, and improve quality of life. The investigators expect individual differences; therefore, participants will be classified at baseline and their response to the intervention tracked using psychophysical tests and clinical response. The hypothesis will be tested through 2 Specific Aims. Aim 1: The investigators will test the magnitude and duration of pain relief and functional improvement of a single treatment with NxES in adults with chronic knee OA pain. Aim 2: The investigators will determine if repeated NxES treatments show greater pain relief and/or functional improvements and if so, whether the gains plateau after a certain number of treatments. The knowledge gained by this study will be important to physical therapists and other health care practitioners who treat people with chronic knee osteoarthritic pain. If noxious electrical stimulation is found to be an effective strategy to decrease pain at rest and with movement, it may lead to improved patient care, improved function, and decreased chronic pain in people with knee osteoarthritis.
It is known that vitamin D has been found to decrease incidence of viral respiratory infections, as well as have effects on multiple cytokines involved in immunomodulation and the bradykinin/renin-angiotensin system. Recently, data was released showing a correlation between baseline vitamin D deficiency status and increased risk of contracting COVID-19. Separate analysis shows that many of the deleterious effects of COVID-19 may be due to the bradykinin/RAS system, and that vitamin D is one plausible treatment option to modulate these effects. Studies are currently ongoing to determine if vitamin D supplementation of those hospitalized with COVID-19 has a beneficial effect on patient outcomes. Healthcare resources have been strained during the pandemic in areas of heavy caseload. It is possible that those with concurrent vitamin D deficiency and COVID positivity have an increased need for escalation of care. A small study has been conducted in this area, but was limited by small number of subjects.
This is a Phase 1, open-label study to evaluate the safety profile of CORVax +/- pIL-12, (electroporated SARS-CoV-2 spike (S) protein plasmid DNA vaccine with or without the combination of electroporated IL-12p70 plasmid.
The current study is the second clinical administration with PF-07304814, the phosphate prodrug of the active moiety PF-00835231, and the first in healthy adult participants. It is to evaluate safety, tolerability and PK of single escalating doses of PF 07304814 given as a 24-h IV infusion.