Oncology Clinical Trials

Change in Perceived Stress [ Time Frame: 24 weeks ]
Change in psychosocial stress (perceived stress) will be examined using changes in the perceived stress scale via linear mixed models with subject level random effects to account for longitudinal measures on each subject, with treatment by time interactions testing differences in changes over time across study arms. Model fitting strategy will check model specification and fit by examining concordance with distributional assumptions.

Change in Life’s Essential 8 Blood Pressure [ Time Frame: 24 weeks ]
Change in Life’s Essential 8 Blood Pressure (range 0-100, higher is better) will be measured via an automated sphygmomanometer and examined using linear mixed models with subject level random effects will account for longitudinal measures on each subject, with treatment by time interactions testing differences in changes over time across study arms. Model fitting strategy will check model specification and fit by examining concordance with distributional assumptions.

Change in Life’s Essential 8 Blood Lipids [ Time Frame: 24 weeks ]
Change in Life’s Essential 8 Blood Lipids via Non-HDL Cholesterol (range 0-100, higher is better) will be measured via a blood sample and examined using linear mixed models with subject level random effects will account for longitudinal measures on each subject, with treatment by time interactions testing differences in changes over time across study arms. Model fitting strategy will check model specification and fit by examining concordance with distributional assumptions.

Change in Life’s Essential 8 Blood Glucose [ Time Frame: 24 weeks ]
Change in Life’s Essential 8 Blood Glucose via hemoglobin A1c (range 0-100, higher is better) will be measured via a blood sample and examined using linear mixed models with subject level random effects will account for longitudinal measures on each subject, with treatment by time interactions testing differences in changes over time across study arms. Model fitting strategy will check model specification and fit by examining concordance with distributional assumptions.

Change in Life’s Essential 8 Body Mass Index [ Time Frame: 24 weeks ]
Change in Life’s Essential 8 Body Mass Index via body mass index measurement from height (meters) and weight (kilograms), calculated as kilograms per meter squared (range 0-100, higher is better) and examined using linear mixed models with subject level random effects will account for longitudinal measures on each subject, with treatment by time interactions testing differences in changes over time across study arms. Model fitting strategy will check model specification and fit by examining concordance with distributional assumptions.

Change in Life’s Essential 8 Diet (subjective) [ Time Frame: 24 weeks ]
Change in Life’s Essential 8 Diet (subjective) measured via the 16-item Mediterranean Eating Pattern for Americans (range 0-100, higher is better) and examined using linear mixed models with subject level random effects will account for longitudinal measures on each subject, with treatment by time interactions testing differences in changes over time across study arms. Model fitting strategy will check model specification and fit by examining concordance with distributional assumptions.

Change in Life’s Essential 8 Diet (objective) [ Time Frame: 24 weeks ]
Change in Life’s Essential 8 Diet (objective) measured via dermal carotenoids using the Veggiemeter (range 0-100, higher is better) and examined using linear mixed models with subject level random effects will account for longitudinal measures on each subject, with treatment by time interactions testing differences in changes over time across study arms. Model fitting strategy will check model specification and fit by examining concordance with distributional assumptions.

Change in Life’s Essential 8 Physical Activity (subjective) [ Time Frame: 24 weeks ]
Change in Life’s Essential 8 Physical activity (subjective) measured via self-reported minutes of moderate or vigorous PA per week (range 0-100, higher is better) and examined using linear mixed models with subject level random effects will account for longitudinal measures on each subject, with treatment by time interactions testing differences in changes over time across study arms. Model fitting strategy will check model specification and fit by examining concordance with distributional assumptions.

Change in Life’s Essential 8 Physical Activity (objective) [ Time Frame: 24 weeks ]
Change in Life’s Essential 8 Physical activity (objective) measured via 1 week of accelerometry using an actigraph watch (range 0-100, higher is better) and examined using linear mixed models with subject level random effects will account for longitudinal measures on each subject, with treatment by time interactions testing differences in changes over time across study arms. Model fitting strategy will check model specification and fit by examining concordance with distributional assumptions.

Change in Life’s Essential 8 Nicotine Exposure [ Time Frame: 24 weeks ]
Change in Life’s Essential 8 nicotine exposure measured via self-reported use of cigarettes or inhaled nicotine delivery system (range 0-100, higher is better) and examined using linear mixed models with subject level random effects will account for longitudinal measures on each subject, with treatment by time interactions testing differences in changes over time across study arms. Model fitting strategy will check model specification and fit by examining concordance with distributional assumptions.

Change in Life’s Essential 8 Sleep Health [ Time Frame: 24 weeks ]
Change in Life’s Essential 8 sleep health measured via self-reported average hours of sleep per night (range 0-100, higher is better) and examined using linear mixed models with subject level random effects will account for longitudinal measures on each subject, with treatment by time interactions testing differences in changes over time across study arms. Model fitting strategy will check model specification and fit by examining concordance with distributional assumptions.

Change in Central Aortic Pressure [ Time Frame: 24 weeks ]
Change in central aortic pressure (mmHg) measured via the Sphygmocor XCEL device will be examined using linear mixed models with subject level random effects will account for longitudinal measures on each subject, with treatment by time interactions testing differences in changes over time across study arms. Model fitting strategy will check model specification and fit by examining concordance with distributional assumptions.

Change in carotid-femoral pulse wave velocity [ Time Frame: 24 weeks ]
Change in carotid-femoral pulse wave velocity (meters/second) measured via the Sphygmocor XCEL device will be examined using linear mixed models with subject level random effects will account for longitudinal measures on each subject, with treatment by time interactions testing differences in changes over time across study arms. Model fitting strategy will check model specification and fit by examining concordance with distributional assumptions.

Change in patient activation [ Time Frame: 24 weeks ]
Convergent parallel mixed methods will be used to integrate the quantitative and qualitative data on patient activation measured via the Patient Activation Measure at 12 and 24 weeks using the analytic framework described in the primary outcome. Qualitative analysis will involve in-depth immersion in the transcripts and audio and the iterative creation and synthesis of analytical memos and codes to organize data toward thematic insights. The investigators will use a deductive-dominant approach wherein a subset of central codes are determined a priori to focus the analysis, with inductive emergence of additional codes during analysis. The investigators will use Nvivo to facilitate coding and analysis. Mechanistic understanding of observed cardiovascular health will ultimately be enhanced via narrative based integration of qualitative and quantitative data.

Change in Social Needs [ Time Frame: 24 weeks ]
Convergent parallel mixed methods will be used to integrate the quantitative and qualitative data to capture the effect of the intervention on social needs. The quantitative analysis will use the data from the Centers for Medicare and Medicaid Services Accountable Health Communities Health-Related Social Needs Screening Tool at 12 and 24 weeks using the analytic framework described in the primary outcome. Qualitative analysis will involve in-depth immersion in the transcripts and audio and the iterative creation and synthesis of analytical memos and codes to organize data toward thematic insights. The investigators will use a deductive-dominant approach wherein a subset of central codes are determined a priori to focus the analysis, with inductive emergence of additional codes during analysis. The investigators will use Nvivo to facilitate coding and analysis.

Change in Social Functioning [ Time Frame: 24 weeks ]
Convergent parallel mixed methods will be used to integrate the quantitative and qualitative data to capture the effect of the intervention on social functioning. The quantitative analysis will use the data from the Patient-Reported Outcomes Measurement Information System Social Function scales at 12 and 24 weeks using the analytic framework described in the primary outcome. Qualitative analysis will involve in-depth immersion in the transcripts and audio and the iterative creation and synthesis of analytical memos and codes to organize data toward thematic insights. The investigators will use a deductive-dominant approach wherein a subset of central codes are determined a priori to focus the analysis, with inductive emergence of additional codes during analysis. The investigators will use Nvivo to facilitate coding and analysis.

Change in Social Relationships [ Time Frame: 24 weeks ]
Convergent parallel mixed methods will be used to integrate the quantitative and qualitative data to capture the effect of the intervention on social relationships. The quantitative analysis will use the data from the Patient-Reported Outcomes Measurement Information System Social Relationships scales at 12 and 24 weeks using the analytic framework described in the primary outcome. Qualitative analysis will involve in-depth immersion in the transcripts and audio and the iterative creation and synthesis of analytical memos and codes to organize data toward thematic insights. The investigators will use a deductive-dominant approach wherein a subset of central codes are determined a priori to focus the analysis, with inductive emergence of additional codes during analysis. The investigators will use Nvivo to facilitate coding and analysis.

Change in Hair Cortisol [ Time Frame: 24 weeks ]
Evaluation of hair cortisol measured via collection of hair from the vertex of the scalp at baseline, 12, and 24 weeks. Changes in hair cortisol over time. which will be calculated using between-subject differences rather than within-subject differences, using a linear mixed-effects to evaluate changes from baseline in hair cortisol. Study wave will be a covariate in the models. The model will contain data from baseline (0 weeks), during-intervention (12 weeks), and post-intervention (24-weeks). These models will assess differences between waitlist control and intervention participants using an interaction between time and treatment indicator. Residual plots will examine model assumptions and model fit, with transformation of the outcomes (e.g. log, square-root, Box-Cox) used as needed to satisfy modelling assumptions (e.g. normality, constant variance) and achieve appropriate model fit.

Change in Conserved Transcriptional Response to Adversity [ Time Frame: 24 weeks ]
Evaluation of change in conserved transcriptional response to adversity (CTRA) will be measured via collection of blood and measuring leukocyte gene expression to determine the CTRA at baseline, 12 and 24 weeks. For the CTRA score, background subtraction and normalization of raw data, and operationalize inflammatory and antiviral gene activity will be performed. CTRA change will be calculated using between-subject differences using a linear mixed-effects to evaluate changes from baseline. Study wave will be a covariate in the models. The model will contain data from baseline (0 weeks), during-intervention (12 weeks), and post-intervention (24-weeks). These models will assess differences between waitlist control and intervention participants using an interaction between time and treatment indicator. Residual plots will examine model assumptions and model fit, with transformation of the outcomes used as needed to satisfy modelling assumptions and achieve appropriate model fit.

Change in Gut Microbiome Health [ Time Frame: 24 weeks ]
Gut microbiome health will be assessed at baseline, 12 and 24 weeks. Participants will collect stool into a collection tube. Full-length 16S Sequencing using PacBio SMRT-Cell platform will be used for microbiome community structure and alpha diversity analysis. The Shoreline Biome Complete StrainID Kit will be used for full length 16S library prep and sequencing will be performed at the Nationwide Children’s Hospital Institute for Genomic Medicine Research. Sequences will be classified into Amplicon Sequence Variants (ASVs) using DADA2 and all statistical analysis will be performed using QIIME2, Songbird, and Qurro. Metagenomic sequencing will be performed by the OSUCCC Genomics Shared Resource using the Illumina NovaSeq SP Flow Cell from libraries produced with the KAPA Library System. Sequence filtering and scaffold assembly will be performed as (Co-I Proj 2 Gur) published, using MEGAHIT specifically. Differentially abundant genes will be identified with DESeq2, an R package.

Identify the organizational context and resources necessary to align, coordinate, and sustain academic-community-government partnerships focused on advancing cardiovascular health equity. [ Time Frame: 156 weeks ]
To determine the context and resources necessary to align, coordinate and sustain partnerships to advance health equity we will perform interviews with partners in the Black Impact intervention, take notes on partner meetings and review organizational documents. Through qualitative thematic analysis and structured content analysis of notes taken during on-site contextual inquiry and excerpts from key organizational documents we will develop themes. The themes, within and across data sources, will be summarized visually and narratively for presentation to organizational stakeholders during a series of co-creation sessions during which stakeholders will leverage insights from qualitative analyses to discuss and detail actions that can lead to greater alignment and coordination for current and future delivery of Black Impact and similar programs aimed at advancing cardiovascular health equity through academic-community-government partnerships.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

This study will be an unblinded, two-arm randomized controlled trial that enrolls up to 100 adult surrogates of living cardiac arrest patients hospitalized in the New York Presbyterian hospital system. Participants must be English- or Spanish-speaking and have a device with internet access. Participants will be randomized 2:1 to receive the informational intervention program or usual care (control).
Intervention arm participants will receive the informational intervention in three discrete packages upon study enrollment, movement to the general medical floor, and at one month post-discharge. All participants will be assessed at study enrollment, hospital discharge, and 3 months post-discharge for their illness uncertainty, psychological distress, and caregiver burden. All participants will also wear a GENEActiv sleep monitor to track their sleep for one week following hospital discharge.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Incidence, severity and relationship of adverse events(AEs) [ Time Frame: Baseline to Week 26 ]
Incidence, severity and relationship of adverse events as assessed by CTCAE v5.0

Number of abnormalities and change from baseline in Vital signs [ Time Frame: Baseline to Week 26 ]
Supine blood pressure and pulse rate, tympanic temperature, and respiratory rate

Number of abnormalities in 12-lead electrocardiogram (ECG) [ Time Frame: Baseline to Week 26 ]
PR interval, QRS interval, RR interval, QT interval and QT interval using Friderica’s correction (QTcF)

Number of abnormalities in clinical laboratory parameter [ Time Frame: Baseline to Week 26 ]
Hematology, clinical chemistry, and urinalysis parameters

Frequency and proportion of clinically significant finding of physical examination [ Time Frame: Baseline to Week 26 ]
Assessments of the following body categories : skin, HEENT (head, eye, ears, nose, and throat), cardiovascular, respiratory, gastrointestinal, endocrine/metabolic, genitourinary, psychiatric, hematologic/lymphatics, musculoskeletal, neurologic, hepatic, and allergic/immunologic

Proportion of patients who achieved the Investigator’s Global Assessment (IGA) score of 0 or 1 [ Time Frame: Baseline to Week 8 ]
The IGA is an assessment instrument used in clinical studies to rate the severity of Atopic dermatitis globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).

Change and percent change in Body Surface Area (BSA) [ Time Frame: Baseline to Week 8 ]
The BSA affected by atopic dermatitis will be assessed for each major section of the body (head, trunk, arms, and legs). Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).

Change and percent change in Eczema Area and Severity Index (EASI) [ Time Frame: Baseline to Week 8 ]
The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition.

Change and percent change in Scoring Atopic Dermatitis (SCORAD) [ Time Frame: Baseline to Week 8 ]
The SCORAD is a clinical tool for assessing the severity of Atopic Dermatitis. Total score ranged from 0 (absent disease) to 103 (severe disease).

Change and percent change in Pruritus Numerical Rating Scale (NRS) [ Time Frame: Baseline to Week 8 ]
The Pruritus NRS is a simple assessment tool used to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being ‘no itch’ and 10 being the’ worst itch imaginable’

Change and percent change in Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline to Week 8 ]
The DLQI is a validated questionnaire designed to measure the impact of skin disease on the Quality of Life. The higher the score, the greater the impact is on the quality of life

Change and percent change in Patient-Oriented Eczema Measure (POEM) [ Time Frame: Baseline to Week 8 ]
The POEM is a validated 7-item questionnaire used to assess disease symptoms with a scoring system of 1 to 28. The higher score, the higher morbidity

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Spatial Neglect (SN) is defined as pathological asymmetric spatial behavior causing functional disability and occurs in greater than 50% of individuals with right hemisphere stroke. SN post-stroke is associated with increased fall risk, increased hospital length of stay, poorer rehabilitation outcomes, and severe long-term disability. Prism adaptation therapy (PAT) is an evidence-based treatment for SN after stroke, however, the effects of SN on gait are not well known. Neuromuscular electrical stimulation delivered via surface electrodes is a common therapeutic adjunct in stroke rehabilitation, including for SN and gait training. However, the additive therapeutic effects of combining electrical stimulation and PAT, as well as the effects of motor training on gait deficits associated with SN are poorly understood. Furthermore, although there is limited literature examining the effects of electrical stimulation on corticospinal tract output (CST), there is an inadequate understanding of the neural mechanisms of PAT and the combinatorial effects of PAT with electrical stimulation. To parse out the neural mechanisms of PAT and electrical stimulation on the visuospatial system, researchers will first examine the effects of PAT with or without electrical stimulation in neurologically unimpaired adults, researchers will then compare results to individuals with stroke with spatial neglect.
The primary objective is to study the effects of PAT on visuospatial behavior and motor cortical excitability in able-bodied individuals (young and older), and on spatial neglect, motor cortical neurophysiology, and walking function in individuals post-stroke.
The long-term goal of this project is to develop novel, effective, and personalized rehabilitation protocols targeting SN deficits and gait dysfunction to reduce disability in stroke survivors. The rationale of this project is to explore and generate data regarding future novel combinatorial motor-spatial retraining approaches that will enhance the rehabilitation approach of SN and gait performance in individuals post-stroke.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.