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: Cesarean delivery is one of the most common obstetric procedures experienced among women who are pregnant.1 Women with Cesarean deliveries have a higher rate of peripartum opioid prescriptions and persistent opioid use compared to those with vaginal deliveries.2 Since 2002, prescription opioid use and misuse has significantly increased among women, including those who are pregnant, showing over 31% increase in past-month heroin use among women of childbearing age.3 This indicates the importance of focusing on maternal population for prescribed opioid medication management during the immediate postpartum period to prevent long-term persistent opioid misuse. Few evidence-based approaches are available to remotely manage prescription opioid use post-discharge.4 Recent advances in mobile technology have made it possible to monitor behavior and maintain communication in near real-time, long after patients are discharged from their surgical procedures.5-7 Using a virtual platform via use of mobile technology offers potential for sustainable implementation of a behavioral intervention and patient-provider communication even during the COVID-19 pandemic.8 Continuous Precision Medicine (CPM™; Research Triangle Park, NC) has developed a mobile app to overcome these barriers for tracking pain and pain medication use among post-surgery patients and tested the logistical and technological feasibility in postpartum patients at Temple OB/GYN. Collectively, our team brings expertise and collaborations between Temple University Hospital, RTI International, and CPM for the following Specific Aims: Aim 1: To examine the preliminary impact of the CPM mobile app to reduce the use of opioids among women post-Cesarean surgery Hypothesis 1: Patients using the CPM application will use fewer Morphine Milligram Equivalents (MME) compared to the blister package group. Aim 2: To establish correlates of pain medication use among women post-Cesarean surgery to estimate the appropriate recommendable dosages per model. Hypothesis 2: Structural and intermediary social determinants such as younger age, lower socioeconomic status, violence and trauma exposure, substance use disorder, and mental and physical health issues will be associated with more opioid medication use.
This is a randomized, open-label, parallel-dosing, multi-center study to evaluate the safety and efficacy of rencofilstat as evidenced by assessing changes in the HepQuant Shunt Disease Severity Index Score (DSI), safety labs, and clinical events in adult NASH subjects with compensated Fibrosis stage F 2/3. Antifibrotic biomarker activity will be evaluated on an exploratory basis.
Phantom limb pain (PLP) is defined as pain or discomfort in a missing limb following amputation, whereas residual limb pain (RLP) is often experienced as pain at the site of amputation. Unfortunately, PLP can affect as many as 80% of upper- or lower-extremity amputees, with 40-60% also experiencing RLP. There are many theories regarding the mechanisms underlying these types of pain, but effective treatments remain elusive .Amputation of a limb is often accompanied by a traumatic event that can be emotionally devastating. Consequently, studies have reported high levels of depression in this population, up to 80%. Other studies have reported elevated levels of depression (70%), suicidality (30%) and posttraumatic stress disorder (PTSD, 20%) with PTSD being highly correlated with PLP. Thus, it is critical that effective treatments be employed that address, not only the chronic pain, but the comorbid conditions as well. Diet interventions have been utilized as a non-pharmacological method to reduce pain and/or inflammation. We have shown that a low-carbohydrate diet (LCD) reduced pain independent of weight loss. Importantly, we observed a reduction in depressive symptomology and improved quality of life (QOL) following the LCD. Thus, it is reasonable to expect that the LCD may have beneficial effects of pain experience and also on measures of QOL. Phase 1: To characterize the dietary habits, pain severity and psychological well-being of the local amputee population. Hypotheses: We expect that the local population will show high prevalence of phantom limb pain (PLP) and/or residual limb pain (RLP). Self-report of depressive symptomology, poor-quality diet, will coincide with low QOL reports. Phase 2: To assess the feasibility and efficacy of a low-carbohydrate diet (LCD) to reduce pain and increase QOL in amputees. Hypotheses: All participants will complete the 6-week LCD. Compared to baseline, a 6-week LCD will reduce self-reports of pain and depressive symptoms. Overall QOL will improve over 6 weeks with concomitant improved mood and sleep.
Western omnivore diets tend to use beef as a good source of protein. Studies have shown cattle who are fed different diets results in varying nutritional meat profiles in terms of amino acids, types and relative amounts of fat, and other nutrients. While overlap between organic and conventionally raised beef is expected, dietary impacts on human health are potentially meaningful as small changes in diet may have large downstream effects on human metabolism. To date, no studies have been conducted in humans that evaluate the health effects of organic grass-fed beef consumption to conventionally-fed beef consumption. To fill this gap in research, the investigators propose to identify metabolic differences in response to consumption of organic grass-fed compared to conventional-fed beef on a wide array of blood borne nutrients including amino acids, lipids, bile acids, and hundreds of other metabolites. This comprehensive analysis is expected to differentiate nutritional and metabolic impacts relevant to human health and provide a foundation for future research. The purpose of this study is to determine how a beef steak meal may affect bile acids in the gut, inflammation, and the metabolic health of healthy individuals. This research will investigate the following questions: 1. How do specific foods affect bile acids in the blood? 2. How do specific foods changes inflammation, metabolism, and other health measures? If researchers learn how food affects different health related markers in the blood and how that may influence health, then this information can be used to do more research to improve the health of people in a future study.
The purpose of this study is to examine the effectiveness of the Stress Management and Resilience Training (SMART) in increasing resilience in Air Force (AF) healthcare personnel. SMART includes practices that focus on six factors that promote individual-level resilience. A pretest-posttest, randomized control trial will be used to examine the effectiveness of SMART and is guided by the Defense Centers of Excellence Resilience Continuum. After institutional review board approval, the principal investigator (PI) will recruit a sample of AF healthcare personnel assigned to the 88th Medical Group or USAF School of Aerospace Medicine at Wright Patterson AF Base. SMART will be provided via either a two-hour, video teleconference (VTC) or in-person training or a self-paced, on-line version completed over four to eight weeks. VTC or on-line versions will be utilized to prevent transmission of severe acute respiratory syndrome coronavirus-2. If in-person training is feasible and safe at a future point in time, in-person training will replace VTC training. A baseline survey will include questions regarding age, gender, marital status, race, ethnicity, previous deployment, military rank, and military job duty. The Connor Davidson 10-Item Resilience Scale has demonstrated reliability and validity, and has been used in studies to measure service member resilience. Additional measures include the Perceived Stress Scale, Generalized Anxiety Disorder Scale, and a Quality of Life measure. The CD-10, PSS, GAD-7, and QoL measure will be readministered 12, 18, and 24-weeks after SMART completion. Initial analysis will include descriptive statistics to characterize demographics, military grade, duty location, and previous deployment status. Cronbach's α will be calculated for each scale. Analyses will be reported as point estimates with 95% confidence intervals and estimates of effect size. Both VTC and on-line groups will be analyzed separately and scores will be pooled to test for overall intervention effects. The investigators will conduct regression models on the pre-post intervention difference while controlling for demographic characteristics and previous deployment. The investigators will consider clustering effects among participants from the same organizational unit using random effects. Changes in resilience, stress, anxiety, and QoL over time will be assessed by analyzing changes from baseline to weeks 12, 18, and 24. The investigators will consider a joint analysis of resilience, stress, anxiety, or QOL.
The goal of this project is to develop a scalable physical activity intervention tailored to rural men. We will recruit participants nationwide from ResearchMatch data base, emails, and social media posts. Participants will have access to health education materials hosted on Healthie, a health coaching software platform, and provided an activity monitor (e.g., Fitbit) to support behavior change. The health education materials provide participants with education, motivation, and support for making health behavior change (e.g., increasing physical activity levels). We will measure physical activity behaviors, psychosocial, and several health outcomes
This is a Phase 2, multicenter, open-label extension (OLE) study to evaluate the long-term safety, tolerability, and effectiveness of CIN-107 for up to 52 weeks in patients with HTN who have completed Part 1 or Part 2 of Study CIN-107-124. The study will be conducted at clinical sites that have participated in the double-blind, Phase 2 Study CIN-107-124.
The aim of this study is to investigate the stain removal efficacy of 2 experimental anti-dentin hypersensitivity (DH) dentifrices with four and eight weeks twice daily use. A daily use, regular fluoride dentifrice will be included as a reference dentifrice.
This project will utilize a quasi-experimental, multiple baseline pretest-posttest design where participants will complete postural stability assessments, physical performance assessments, and questionnaires to evaluate perceptions toward injury prevention before and after completing a 6-week neuromuscular-cognitive prevention program.
We will conduct a prospective clinical study involving up to 40 non-Small Cell Lung Cancer (nSCLC) patients to determine dose thresholds for central and peripheral BSS elements. All imaging will be performed under motion control (e.g., with or without abdominal compression) defined as breathing with a resultant motion ≤5mm by fluoroscopy. In this study, a high-resolution breath-hold CT scan (BHCT) will be acquired from each patient immediately before or after the 4DCT scan. A follow-up high resolution BHCT (also under motion control) will be acquired from each patient 8-12 months post-SabR, and BSS elements will be segmented in LungPointRT. A radiation oncologist will compare the pre- and post-SabR contours to determine segmental collapse.