Treatment Trials

63 Clinical Trials for Various Conditions

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COMPLETED
Temporally-Oriented Subjective Well-being Across Transitions-Resources & Outcomes
Description

As individuals age, they undergo transitions in many aspects of their lives. These transitions include social, economic and health transitions. People review their lives, and reflect on past choices. Future time is limited by the increasing proximity to end of life. This may lead to regrets and, in people with the ability to use compensatory mechanisms, a redoubling of efforts to achieve valued goals or a reprioritization of valued goals. In the context of aging, individuals' past, present, and future-oriented subjective well-being (SWB) may change. There is an incomplete understanding of the relationship of SWB, intra- and inter-personal resources, and outcomes, (particularly health and healthcare-cost outcomes). These issues have complicated the use of SWB measures and the investigators are left with traditional metrics such as life expectancy, infant mortality, wealth, and poverty to assess healthy aging, resulting in an incomplete picture of healthy aging. This project will examine the relationships among SWB, intra- and inter-personal resources, and health and healthcare-cost outcomes. It will advance the understanding of SWB and its role in healthy aging in order to assist policy makers in valuing the potential benefits of improving SWB on health and healthcare costs. The investigators will accomplish this through the following specific aim: Aim 1: To determine how SWB (past, present, and future-oriented): (1) is affected by life transitions, and (2) affects outcomes after life transitions.

Conditions
RECRUITING
Fulfillment Center Study on Work, Health, and Wellbeing
Description

This study seeks to evaluate how work conditions affect workers' health and well-being, job attitudes and decisions on the job, and key organizational outcomes. This study is being carried out in partnership with a national retailer's e-commerce division. The study centers on a cluster randomized trial evaluation of changes in workplace policies and practices in order to understand their impact on workers, families, and the firm but also utilize multi-method data to gain a better understanding of the stressors and sources of resilience for this growing, but understudied population of low-wage workers.

COMPLETED
Enduring Happiness and Continued Self-Enhancement
Description

Over the past several decades, a new science of subjective well-being has produced insights into the factors that make people happy-from cultivating strong relationships to pursuing the right goals. Drawing on these empirical findings, the investigators created a comprehensive 12-week intervention program, ENHANCE: Enduring Happiness and Continued Self-Enhancement. The investigators multimodal program is designed to teach people essential skills in order to produce sustainable changes in behavior and, as a result, long-lasting increases in happiness. To test the effectiveness of ENHANCE, the investigators designed a six-month randomized clinical trial. Participants will be assigned to an active treatment group or a waiting group control. They will complete baseline assessments, and follow-up assessment at three and six months after the start of the intervention. These assessments will contain measures of subjective well-being and objective measures of health, as well as a variety of psychological mediators (e.g., psychological needs) and moderators (e.g. personality). The investigators will thus be able to explore not only whether ENHANCE works to improve well-being, but also why and how ENHANCE works.

Conditions
NOT_YET_RECRUITING
Florida Community-Engaged Research Alliance (FL-CEAL) in Communities Disproportionately Affected by Health Inequities
Description

The purpose of the study is learn more about ways to help people with non-medical issues that can affect participant health. The study team will examine if Community Health Workers, members of a community who provide basic health and medical care within communities, are more helpful to people with non-medical issues than simple reading materials on how participants can do it.

RECRUITING
Evaluation of the CHIME Intervention for Improving Early Head Start/Head Start Educator Well-being
Description

This study will test how well a mindfulness-based intervention called CHIME improves the emotional well-being of educators in Early Head Start and Head Start (EHS/HS) settings. The study also will examine if there are any benefits to young children's social emotional health as a result of the CHIME program. Researchers will compare educators who participate in CHIME to educators who are asked to participate at a later time to see if there are benefits to their emotional health and teaching practices.

COMPLETED
Efficacy and Safety of Hemp-derived, Full Spectrum Cannabigerol (CBG) in Adults
Description

The goal of this observational study is to provide exploratory research into the in vivo physiological and psychological effects, if any, of cannabigerol (CBG) in healthy human adults age 21 or over. The main questions it aims to answer are: * What effect, if any, does daily oral consumption of 50mg of full spectrum CBG have on the mental, physical, and emotional wellbeing of healthy individuals, as measured by self-report Medical Symptom Questionnaire and 36-Item Short Form Health Survey scores? * Is CBG effective at reducing inflammation in the body, as measured by HSCRP, ESR, and PSA inflammatory markers? * Do age, gender, weight, or state of body inflammation have an effect on the perceived efficacy of CBG? * What adverse effects, if any, are associated with CBG use? Over the course of the 12-week study, participants will: * Take baseline MSQ and SF-36 surveys, as well as a clinical visit with blood draws for HSCRP, ESR, and PSA testing * Consume one (1) 50mg capsule of full spectrum CBG daily by mouth with food for 8 weeks, followed by a 4-week washout period * Complete biweekly SF-36 surveys as well as MSQ surveys every 4 weeks * Attend a clinical visit every 4 weeks for clinical observation and blood draws for HSCRP, ESR, and PSA (male subjects)

COMPLETED
Personal Lifestyle Engine (PLX) - Personal Lifestyle Medicine Center (PLMC)
Description

It has been suggested that the best medicine should include four principles (4P) - Medicine should be personalized, predictive, preventative and participatory. Technology has provided the tools to collect data in ways not previously possible. Individuals can now collect information on their genome (including their genetic predisposition to tolerate medications and to respond to healthy lifestyle programs) that will modify their lifestyle and therapeutic choices. Beyond spot checks of vital signs and weight, individuals can now collect information on body composition, continuous monitoring of heart rate, blood pressure, and even blood sugar. Data on food consumption at a caloric, macronutrient and even micronutrient level can be collected. Standard medical histories and detailed physical examination findings and laboratory biomarkers can be correlated with this data. Collections of individual patient data will need to be managed through computer programs and smart phone applications that provide direct feedback about the influence of lifestyle on health, wellness and biomarkers. To this end, Metagenics is designing and is launching a smart phone application, Personal Lifestyle Engine (PLX), for individual use by patients and their healthcare providers. The statistical analysis of these data is the primary objective of this study.

COMPLETED
Personalized Lifestyle Intervention for Improving Functional Health Outcomes Using N-of-1 Tent-Umbrella-Bucket Design
Description

The LIFE-HOUSE research project is designed to evaluate the impact of a personalized lifestyle intervention program on functional capacity as an approach to quantitating health, and its relationship to well understood disease risk determinants. LIFE-HOUSE will utilize an innovative Tent-Umbrella-Bucket design. Participants will gather under the Tent of an all-inclusive 'N of 1' Case Series providing a shelter of Functional Medicine interventions against the storm of chronic disease. Under this Tent are a collection of Umbrellas where participants with similar clinical challenges are evaluated as clinically defined groups with loose guidelines for the planned interventions. Finally, participants standing under these Umbrellas may step into specific Buckets that gather individuals with nearly identical clinical presentations into more formally described prescriptive randomized arms for intervention. Individuals will be offered the opportunity to participate in all Umbrellas and Buckets for which they qualify. They may accept or reject participation in any Umbrella or Bucket and yet remain eligible for participation in the overall Tent.

COMPLETED
The Effects of a Multi-vitamin Supplement in Adult Females
Description

The investigators are examining how the daily consumption of a multi-vitamin/mineral supplement affects the following variables in 21-40 year old women: 1. blood levels of various micronutrients (assessed from blood draws using mass spectrometry-based assays) 2. blood cell gene expression patterns (assessed from blood draws and real-time PCR assays) 3. mood (assessed via questionnaires) Blood and questionnaires will be collected prior to supplementation, and 12 weeks into supplementation.

COMPLETED
CT-P13 (Infliximab) Subcutaneous Administration by Pre-filled Syringe and Auto-injector in Healthy Subjects
Description

This study compares two administration methods of CT-P13. Half of participants will receive CT-P13 by pre-filled syringe while the other half will receive CT-P13 by auto-injector.

ACTIVE_NOT_RECRUITING
The IGNITE for Kids Study on Concentrated Investment in Black Neighborhoods and Child Health and Well-Being
Description

Black children and adults in the United States fare worse across nearly every health indicator compared to White individuals. In Philadelphia, the location of this study, these health disparities result in a stark longevity gap, with average life expectancies in poor, predominantly Black neighborhoods being 20 years lower than in nearby affluent, predominantly White neighborhoods. The investigators will conduct a cluster randomized controlled trial (RCT) of a suite of place- based and financial-wellbeing interventions at the community, organization, and individual/household levels that address the social determinants of racial health disparities. At the community level, the investigators address underinvestment in Black neighborhoods by implementing vacant lot greening, abandoned house remediation, tree planting, and trash cleanup. At the organization level, the investigators partner with community-based financial empowerment providers to develop cross-organizational infrastructure to increase reach and maximize efficiency. At the individual/household levels, the investigators increase access to public benefits, financial counseling and tax preparation services, and emergency cash assistance. The investigators will test this "big push" intervention in 60 Black neighborhood micro-clusters, with a total of 480 children. The investigators hypothesize that this "big push" intervention will have significant impact on children's health and wellbeing.

COMPLETED
Evaluation of Mindfulness and Yoga in Basic Combat Training
Description

The present study is a group randomized trial assessing the impact of mindfulness and yoga training on the health, performance, and well-being of soldiers in Basic Combat Training (BCT). Randomization occurred at the platoon level, and platoons received either a combined mindfulness and yoga regimen or training as usual.

ACTIVE_NOT_RECRUITING
The IGNITE Study on Concentrated Investment in Black Neighborhoods
Description

Black Americans in the US fare worse across nearly every health indicator compared to White individuals. In Philadelphia, the location of this study, these health disparities culminate in a stark longevity gap, with average life expectancies in poor, predominantly Black neighborhoods being 20 years lower than in nearby affluent, predominantly White neighborhoods. The investigators will conduct a cluster randomized controlled trial (RCT) of a suite of place-based and financial-wellbeing interventions at the community, organization, and individual/household levels that address the social determinants of racial health disparities. At the community level, the investigators address underinvestment in Black neighborhoods by implementing vacant lot greening, abandoned house remediation, tree planting, and trash cleanup. At the organization level, the investigators partner with community-based financial empowerment providers to develop cross-organizational infrastructure to increase reach and maximize efficiency. At the individual/household levels, the investigators increase access to public benefits, financial counseling and tax preparation services, and emergency cash assistance. The investigators will test this "big push" intervention in 60 Black neighborhood microclusters, with a total of 720 adults. The investigators hypothesize that this "big push" intervention will have significant impact on overall health and wellbeing.

COMPLETED
Nature and Well-Being Project
Description

The investigators pilot test two intervention strategies to increase green space use- place-based and person-based, as well as evaluate the dose-response relationship between green space use and health.

COMPLETED
Practical Alternative to Hospitalization
Description

The investigators test the PATH program to evaluate whether the program allows patients to spend more days at home in comparison to patients who receive regular care. The program will involve patients from Penn Presbyterian Medical Center with a set of diagnoses and will provide patients with enhanced services upon discharge from the emergency department.

RECRUITING
Developing a Down Syndrome Health Instrument
Description

Although over 200,000 individuals with DS live in the United States, studies to date have focused on outcomes apart from health. The foundation for this proposal is based on the need to accurately measure health of all individuals - specifically, with DS - and the dearth of available tools for this population. Creating such an instrument will provide a barometer of the current state of health for DS and hold use in future research. In this project, I propose to create an instrument that directly assesses health in DS - the Down syndrome Health Instrument (DHI). More specifically, the aims of this proposal are: 1. To conduct focus groups among caregivers, individuals with DS, panels of experts on DS and primary care physicians, and cognitive interviews to refine a conceptual model of health for DS and create an item pool, 2. To administer the DHI and establish internal validity, reliability, and external validity of the DHI for use in clinical research, and 3. To test the usability of the DHI in two pilot settings: research and clinical. This instrument will measure patient-reported health in DS for the first time and allow measurement of health as an outcome which is not currently possible in this population. This can identify gaps in care, then direct and optimize interventions that will improve care.

COMPLETED
The Effects of a Nutrition Supplement on Health Related Quality of Life
Description

The purpose of this study is to evaluate the health related benefits of a superfoods nutrition supplement on health related quality of life.

UNKNOWN
HDL Function Dietary Supplement Safety and QOL
Description

Nutritional supplements are routinely purchased by consumers with suboptimal HDL to support their health, lifestyle and overall quality of life. Many such products receive minimal evaluation prior to marketing. This study aims to evaluate a specific nutritional supplement for its safety, tolerance and acceptability as well as the potential for positive impact on quality of life.

COMPLETED
Resistant Starch Blend Gastrointestinal Impact
Description

This study aims to test the hypothesis that a unique blend of resistant starches and fiber will promote gastrointestinal health, as measured by an increase in short-chain fatty acids and improvement in quality of life measures in conjunction with microbial community changes. This study specifically evaluates the impact on short-chain fatty acids and gut microbiota and the impact on quality of life from a resistant starch blend in healthy adult humans with occasional gastrointestinal distress.

TERMINATED
PLAY LONG: The Effect of Sports and Recreation Participation for Young chiLdren With physicAl disabilitY
Description

Ten year longitudinal survey following children with disabilities who have participated in Sports and Recreation from a young age (5 to 10), and the parents of children who have participated in Sports and Recreation at a young age (5 to 10). These children will be followed for 10 years with surveys every 6 months, whether they are currently participating in sports and recreation activities or not. The purpose of this longitudinal study is to examine the effects of early participation in organized sports and recreation activities (S\&R) on self-reported health and health-related quality of life of children and youth (C\&Y) with disabilities and their parent-reported social participation. This project will examine child and parent reported differences between: 1. C\&Y with disabilities who participate in S\&R and those who have discontinued participation in S\&R programs 2. C\&Y with disabilities who participate in sports vs. those who participate in recreation, and 3. C\&Y with disabilities who participate in S\&R and normative data on C\&Y with disabilities and those without disabilities.

COMPLETED
Family Automated Voice Reorientation Study
Description

This randomized clinical trial tests a cognitive reorientation intervention to prevent delirium in the intensive care unit using scripted audio messages, recorded by the patient's family and played at hourly intervals during daytime hours, to provide information about the ICU environment to the patient (the Family Automated Voice Reorientation intervention, FAVoR). The investigators hypothesize that providing ongoing orientation to the ICU environment through recorded audio messages in a voice familiar to the patient will enable the patient to more accurately interpret the environment and reduce risk of delirium. Increasing awareness of daytime by cuing patients during waking hours may also improve day/night orientation, nighttime sleep/rest, and further reduce risk of delirium.

COMPLETED
Feasibility and Efficacy of A Remote Tai Chi Program in Older Adults
Description

This project is designed to explore the feasibility and preliminary efficacy of a remote Tai Chi program on older adults' 24-hour movement behaviors (i.e., physical activity, sedentary behavior and sleep patterns).

Conditions
ENROLLING_BY_INVITATION
Examining the Differential Effects of Traditional Float-REST and Dry Float on Subjective and Objective Health Outcomes
Description

The objective of this research study is to assess how the implementation of various modern strategies for augmented recovery affect sleep quality, subjective wellness and other indices of general well-being.

Conditions
COMPLETED
The Effect of Hot Cereal on Digestive Health in Children
Description

The objective of this study is to examine the effects of 2 servings of hot cereal per day over 2 weeks on digestive health in children that typically eat low fiber diets.

ACTIVE_NOT_RECRUITING
Brain Health Program for Older Adults with Subjective Cognitive Decline
Description

The investigators will compare two brain health programs in older adults with subjective cognitive decline and lifestyle risk factors for dementia. The primary aim of the study is to determine the credibility, expectancy, feasibility, acceptability, appropriateness, fidelity, and satisfaction of the programs.

COMPLETED
Brain Health Together: Development and Pilot Test
Description

The objectives of this study were to develop and pilot-test Brain Health Together (BHT), a 12-week, virtual-group program that combines our evidence-based, mind-body, group movement program with brain health education and coaching to reduce dementia risk through targeting modifiable risk factors among older adults with cognitive impairment.

COMPLETED
Wellness Intervention for Nurses Post Traumatic Growth and Selfcare
Description

Nurses working in home and hospice care settings find their roles emotionally challenging and are at high risk for trauma, strain and fatigue. Such sufferings were high among nurses during the Covid-19 pandemic. Our study tested the effectiveness of a self-reflexive wellness intervention to promote resilience, posttraumatic growth and subjective wellbeing among nurses. Participants were divided in three different groups. One group did not intervention whereas the other two were assigned writing 2 blogs each week and attending a wellness workshop. Findings showed that writing weekly blogs helped nurses to be self reflexive about their feelings, generated self-awareness and improved their wellbeing.

RECRUITING
Digital Accessible Remote Olfactory Mediated Health Assessments for Preclinical AD
Description

The goal of this study is to objectively test one's sense of smell, called olfaction, in participants with Subjective Cognitive Concerns (SCC), Mild Cognitive Impairment, Mild Behavioral Impairment (MBI), and age-matched controls. The main question it aims to answer is whether the AROMHA Brain Health Test could serve as a predictive biomarker of neurodegenerative disorders. This understanding will aid in the development of a noninvasive, cost-effective diagnostic tool that reliably and specifically distinguishes disease and normal aging populations. Participants will take the approximately 45-minute AROMHA Brain Health Smell Test where they will peel and sniff labels on the physical smell cards and answer questions on the web-based app relating to what they smelled. Participants will undergo tests for odor intensity, odor identification, odor discrimination, and episodic olfactory memory, but will not be provided the results of these tests.

UNKNOWN
Health and Health Care Utilization Effects of Medical Debt Forgiveness
Description

The goal of this study is to estimate the direct, causal impact of medical debt on health care utilization, mental health, and wellbeing of patients. The investigators will conduct a survey to measure the impact of the debt forgiveness on health care use, mental health, and wellbeing. The survey will be administered to approximately 17,000 subjects of a recent medical financial intervention. In that prior intervention, a non-profit charity, RIP Medical Debt, purchased and abolished medical debt for a randomly selected about 6,000 (out of the 17,000) individuals. In this current protocol, the investigators will administer the survey, and will compare surveyed outcomes of subjects who received and did not receive the intervention.

UNKNOWN
ACAR Brain Health Intervention Study
Description

The main objective of this study is to assess the effectiveness of four Total Brain Health educational programs, TBH Brain Workout (1.0 and 2.0) and TBH Memory (1.0 and 2.0), in older adults residing in independent living facilities through the Acts Center for Applied Research (ACAR). Each TBH program trains for lifestyle intervention skills across the wellness spectrum shown by research to promote cognitive performance and reduce dementia risk, using social-based training methods, and experiential learning activities. Each TBH program also has two levels of difficulty (1.0 and 2.0), which will be assessed in independent groups. Each independent living community will administer one TBH program at a time such that participants will be randomly assigned to one of three categories: 1) one of the four educational programs, 2) an active book club that will read and discuss on tips to improve one's brain health, and 3) a wait-list control group. All groups other than the wait-list control group will have 8 sessions across 2 months. The older adults who agree to be a part of the research will be asked to fill out a survey at pre-intervention, post-intervention 1 (immediate), and post-intervention 2 (2 months). We predict that the participants in the TBH Brain Workout and TBH Memory programs (all difficulty levels) will have a greater knowledge about brain health, improved subjective appraisals of their memory, improved social outcomes, lower depression, and reduced dementia risk compared with the two control groups. The investigators predict that the active book club control will differ on brain health knowledge than the wait-list control group. Due to the more cognitively challenging nature of the harder TBH programs, the investigators also predicted that the harder versions would have greater improvement in brain health knowledge and improved subjective appraisals of their memory than the easier versions.

Conditions