Treatment Trials

164 Clinical Trials for Various Conditions

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COMPLETED
DryShield vs Cotton Roll Isolation During Sealants Placement: Efficiency and Patient Preference
Description

The goals of this study are to determine if 1) placement times of pit and fissure sealants using the DryShield system differ from those when using the cotton roll isolation technique; and 2) there is a significant difference in patient preference between Dryshield and the cotton roll technique.

COMPLETED
A Clinical Trial Comparing Isolite® vs. Cotton Roll Isolation in the Placement of Dental Sealants
Description

The purpose of this split-mouth, randomized, controlled trial is to evaluate the retention rates of sealants placed under Isolite vs. cotton roll isolation. This study will also compare the patient and operator acceptability and satisfaction of the two isolation techniques as well as the time consumed for sealant application during the two isolation techniques.

COMPLETED
Comparison of Bacterial Contamination Rates Between Isolation and Non-isolation Rooms
Description

This study is to determine if medication cabinets located outside of isolation rooms in hospitals and their contents, particularly medications and the delivery folders are at a higher risk of having harmful bacteria on them.

NOT_YET_RECRUITING
Precision Ablation for Pulmonary Vein Isolation: Targeting Pulmonary Vein Myocardial Sleeves (PVMS) with Omnipolar Mapping Technology
Description

The purpose of this study is to compare procedural times and Radiofrequency (RF)applications required for Pulmonary vein myocardial sleeves targeted pulmonary vein ablation (PVS-PVI) , to compare the efficacy of PVS-PVI , to compare the safety of PVS-PVI and to assess other clinical outcomes of PVS-PVI in individuals with symptomatic paroxysmal Atrial fibrillation (AF) using Omnipolar Technology with conventional Wide area circumferential ablation (WACA).

ACTIVE_NOT_RECRUITING
Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF
Description

The primary objective of this clinical investigation is to demonstrate the safety and 12-month effectiveness of pulmonary vein isolation (PVI) and posterior LA wall isolation in the treatment of subjects with symptomatic paroxysmal and persistent atrial fibrillation using the pulsed field ablation with the VARIPULSE™ catheter and the TRUPULSE™ generator.

RECRUITING
LEAPTogether: An Intergenerational Intervention to Address Loneliness and Social Isolation
Description

Older adult participants will engage in exercise videos twice a week for 8 weeks either while paired with a peer (same age group) or paired with a younger adult with the ability to simultaneously video chat while exercising.

COMPLETED
Reducing Isolation and Feeling of Loneliness During Critical Illness
Description

The trial is a pilot-randomized trial testing feasibility and limited-efficacy of delivering social engagement using technologic strategies to reduce periods of social isolation.

COMPLETED
Evaluating Patient Comfort and Environmental Conditions in the Carecube Negative Pressure Isolation Chamber.1
Description

This is a human non-significant risk (NSR) clinical study designed to objectively and participatively verify that the Carecube Negative Pressure Isolation Chamber is a safe and non-hostile environment for the patients that will be contained within the chamber during normal operations.

TERMINATED
Efficacy Rate of Unipolar Polarity Switch for Lesion Assessment in Pulmonary Vein Isolation
Description

The technique of intraprocedural electrogram morphology as a measure of lesion effectiveness in an attempt to achieve durable PVI, clearly led to shortened procedural time, radiation exposure, and superiority in outcomes, with the implementation of a reproducible, readily available intraprocedural tool that can be applied universally.

ACTIVE_NOT_RECRUITING
Virtual Yoga for Social Isolation and Loneliness in Rural Veterans
Description

The overarching goal of this project is to decrease social isolation and loneliness through increased awareness and uptake of virtual yoga group classes among rural Veterans.

COMPLETED
Combatting Social Isolation in Older Adults
Description

Increasing evidence suggests that perceived social isolation and loneliness are major risk factors for physical and mental illness in later life. The prevalence of loneliness in US older adults warrants concern, with an estimated 30% of American adults aged 70 years and older reporting heightened loneliness. A wide variety of interventions have been developed to address social isolation and loneliness ranging from social facilitation to animal therapies. While many intervention studies have attempted to address loneliness, social isolation and related constructs in older adults, this literature is underdeveloped and there is not an established or widely accepted set of treatments. Moreover, existing treatments tend to be lengthy, burdensome, and result in high dropout rates. Brief, mechanism focused interventions are an alternative to more traditional forms of treatment. Because they are structured and brief, these treatments can be readily placed on the internet, making them extremely efficient, destigmatizing, and highly scalable. The investigators have developed and tested a web-based intervention called "Combating Social Isolation" (CSI) that the investigators believe offers an alternative to existing interventions for loneliness and social isolation in older adults. CSI evolved out of Interpersonal Theories of mood psychopathology (Joiner, 2005) and targets two risk factors central to social disconnection: perceived burdensomeness and thwarted belongingness (PB/TB). The investigators have one randomized clinical trial using CSI and are nearing completion of two other RCTs using this intervention. Evidence shows that CSI has very high levels of acceptability, and despite the brevity of the protocol (approximately 1 hour) can markedly impact loneliness. Moreover, reductions in these risk factors mediate later improvements in mental health outcomes and social disruption. The purpose of the current proposal is to adapt our existing protocol for older adults reporting loneliness and then obtain preliminary acceptability and efficacy data from a Phase II randomized clinical trial.

COMPLETED
Caring Connections: a Program to Alleviate Social Isolation and Loneliness in Individuals Living with Spinal Cord Injury
Description

This study will use a randomized controlled design with an active attention control group to evaluate an intervention intended to reduce social isolation and loneliness in persons with SCI/D. The intervention, Caring Connections, is a peer-based intervention which is important because peers with SCI/D play an important role in improving quality of life, mental health, and social health in persons with SCI/D.

COMPLETED
Implementation of CareCube Negative Pressure Isolation Units
Description

Pilot study to provide a descriptive analysis of the real-world feasibility of using a CareCube for COVID-19 patients in a high-volume tertiary care hospital.

COMPLETED
Peer Support Intervention to Mitigate Social Isolation and Stigma of Adolescent Motherhood in Zimbabwe
Description

A community-based peer support intervention for adolescent mothers aged 14-18 years in Harare, Zimbabwe was developed and tested in partnership with adolescent mothers, community health workers, and key community stakeholders. The intervention leveraged peer support, technology via WhatsApp Messenger, community health workers, peer educators and involvement of key community stakeholders to reduce prevalence of loneliness, depressive symptoms and common mental disorders, improve perceived social support, and develop coping, parenting, and communication skills to mitigate potential stressors and stigma of adolescent motherhood.

COMPLETED
Isolation and Characterization of Multiple Microbial Species From Diverse Healthy Adults
Description

Isolation and characterization of fecal/oral/skin/nasal/throat microbial species from a diverse cohort of healthy adults.

COMPLETED
Pilot Study Evaluating the Safety and Efficacy of a Patient-Specific Enteroatmospheric Fistula Isolation and Management Device Independent of Negative Pressure Wound Therapy
Description

This study aims to assess the efficacy of a custom fitted device designed to isolate enteroatmospheric fistulas effluent independent of negative pressure wound therapy and to evaluate the effects on the device related to dressing changes, time required for dressing changes, management costs, and the ease of use.

COMPLETED
Stay Connected: Testing an Intervention to Combat Coronavirus-related Social Isolation Among Older Adults
Description

This study will use the University of Washington's ALACRITY Center's (UWAC) Discover, Design, Build, \& Test (DDBT) method to develop and test an intervention to address the mental health health needs of older adults in senior housing ("clients") who are forced to not only shelter-in-place but cannot have family or other visitors during this time. Older people (those over 60 years in age) are especially vulnerable and are more likely to have severe - even deadly - coronavirus infection than other age groups. These facts led to the need to have older adults socially isolate in order to protect their health; visits with family and friends are limited, and in senior housing (independent, supported and assisted care residences) have limited such visits by family to one person a day. This necessary practice of social distancing, while addressing an important public health crisis, unintentionally creates social isolation and loneliness, another deadly epidemic amongst the older population. Even before COVID-19, social isolation and loneliness was a prominent mental health and social problem in the aged, one that is associated with increases in other chronic conditions, dementia and suicide. Effective interventions for social isolation exist but are difficult to access and may not address all the concerns older adults have about this particular period of social isolation. The purpose of this proposed study is to deploy an adaptation of Behavioral Activation Therapy called Stay Connected to treat depression in older adults. The adaptation will allow activity directors and staff ("clinicians") in these settings and senior centers to deliver the therapeutic elements of the intervention (behavioral activation) in the context of social distancing/shelter-in-place policies. Social workers in these settings will oversee the activity director and staff delivery of the intervention. The investigators are working with a variety of senior housing types (HUD certified and private systems) and senior centers in Skagit county (rural) and King county (urban) in Washington (WA) so that the resulting intervention is not tied to economic levels or access to digital technology.

RECRUITING
Neurobehavioral Mechanisms of Social Isolation and Loneliness in Serious Mental Illness
Description

The proposed research will test the hypothesis that objective social isolation and loneliness are linked to neurobehavioral mechanisms involved in social perception and motivation in individuals with and without serious mental illness. Moreover, it will investigate the specific dynamic interactions among these experiences in daily life and how they, and their neurobehavioral predictors, are linked to day-to-day functioning. The findings of this project could provide novel targets for therapeutics aimed at improving functioning and overall quality of life in individuals with serious mental illnesses, as well as quantitative phenotypes for use in early detection efforts.

COMPLETED
Management of Depression and Social Isolation in Older Adults With Dementia With Home-based Telehealth Delivered Behavioral Activation + Caregiver Facilitation.
Description

The purpose of this study is to evaluate the feasibility of using behavioral activation therapy with caregiver support delivered via telemedicine to older adults with depression and probable mild dementia.

Conditions
WITHDRAWN
Isolation of Cells From Biopsy Tissue to Aid in Kidney Repair
Description

Endothelial progenitor cells that reside in renal vasculature may be stimulated to initiate differentiation programs during episodes of injury. It is hypothesized that endothelial progenitor cells resident in the kidney can transition to a post-injury phenotype that promotes endothelial repair.

COMPLETED
An Isolation Device to Contain Aerosol During Aerosol Generating Procedures in the Operating Room
Description

The purpose of this study is to test the safety and efficacy of a new isolation device to contain aerosol during aerosol-generating procedures in the operating room.

ACTIVE_NOT_RECRUITING
Left Atrial Posterior Wall and PV Isolation Using Cryoballoon for Treatment of Persistent AF
Description

The purpose of this study it to learn whether pulmonary vein isolation (PVI) along with isolation of the posterior left atrial wall (PWI) in the region of the pulmonary venous component will reduce the likelihood of atrial fibrillation (AF) recurrence in patients with persistent atrial fibrillation at 12 months, after a single ablation procedure, in comparison to PVI alone. The investigator hypothesizes that the combination of PVI + PWI will result in a significant reduction in recurrence of atrial fibrillation at 12 months after ablation.

ACTIVE_NOT_RECRUITING
Optimizing Platelet Isolation (The Cell Study)
Description

The research study is about blood cells (platelets) and their power houses (mitochondria). The investigators want to learn about their behavior in order to ensure that our laboratory procedures are generating optimal results.

Conditions
COMPLETED
Effects of Arts Engagement on Physical Performance, Cognition, Social Isolation, and Self-Perception in Older Adults
Description

The purpose of this community-engaged project is to examine how taking part in different arts (dance \& music), compared to control (no arts) affects older adults' Health-Related Quality of Life (HRQoL using the Short Form-20(SF) form), physical performance (Short Physical Performance Battery-SPPB), cognition (using the Montreal Cognitive Assessment-MoCA), social engagement (National Social Life, Health, \& Aging Project-NSHAP survey), and perceptions of self (focus interviews).

ACTIVE_NOT_RECRUITING
Tertulias Social Isolation Women's Groups Study
Description

This study will use a multi-level, community-engaged approach to implement "TERTULIAS" ("conversational gatherings" in Spanish). The intervention uses an innovative, culturally and contextually situated peer support group design that was developed by the investigators to improve health outcomes and reduce health disparities for FMI participants in Albuquerque, New Mexico. The study will use a rigorous, transdisciplinary, QUAL⇒QUANT, mixed-method research design. The investigators will document results of the intervention on the primary hypotheses of a decrease in depression, and increases in resilience and social support, as well as on the secondary hypotheses of decreased stress (including the use of innovative testing of hair cortisol as a biomarker for chronic stress), and an increase in social connectedness and positive assessment of knowledge and empowerment gained through the TERTULIAS intervention.

TERMINATED
Posterior Wall And Left Atrial Appendage Empiric Electrical Isolation for Non-Paroxysmal Atrial Fibrillation
Description

The purpose of this study is to evaluate the safety and effectiveness of empirical posterior wall isolation (PWI), left atrial appendage electrical isolation (LAAEI) and coronary sinus isolation (CSI) when compared to pulmonary vein isolation (PVI) alone: * PVI alone, * PVI + PWI, * PVI + PWI + LAAEI, * PVI + PWI + LAAEI + CSI.

RECRUITING
Comparing Pulmonary Vein Isolation to Pulmonary Vein Isolation + OPTIMA Ablation in Patients Undergoing Ablation for Atrial Fibrillation
Description

Catheter ablation is an established cornerstone of therapy for patients with symptomatic atrial fibrillation (AF) who wish to avoid anti-arrhythmic drug therapy or for whom anti-arrhythmics have proven ineffective. Pulmonary vein isolation (PVI), in which circumferential ablation is performed around the ostia of the pulmonary vein - left atrial junctions, is the standard ablation approach internationally. Single-procedure success rates (1y, freedom from AF, off anti-arrhythmics) for patients with paroxysmal AF is roughly 70%, and even worse (roughly 50%) for patients with persistent AF. A number of strategies have been developed to improve outcomes in patients undergoing AF ablation, particularly in patients with persistent AF. Unfortunately, large prospective randomized trials (including STAR-AF II, published in NEJM in 2015) have demonstrated a failure of ancillary ablation techniques to improve AF ablation outcomes relative to PVI alone. In a collaborative effort between the Cardiology electrophysiology group and the Trayanova laboratory (Biomechanical Engineering), investigators have developed a strategy of patient-specific modeling to identify pro-arrhythmic sites in AF patients that may be amenable to ablation. In this approach, patients undergo a pre-ablation cardiac MRI with late gadolinium enhancement, to delineate regions of healthy atrial tissue and regions of scar (this scan is clinically indicated, and performed currently in patients undergoing PVI for AF). A novel in silico modeling to determine regions supporting electrical reentry in the atrium, driving ongoing AF, has been developed by the Trayanova lab. In preliminary studies, investigators have demonstrated the ability to identify and target these regions with catheter ablation in patients undergoing PVI. Investigators would like to conduct a prospective, randomized clinical trial in patients undergoing ablation for symptomatic persistent AF. All patients enrolled would undergo standard pre-procedure imaging (LGE-MRI) prior to the day of procedure. Investigators have developed methodology termed OPTIMA (OPtimal Target Identification via Modeling of Arrhythmogenesis) to determine, based on non-invasive patient-specific anatomic and tissue data from late gadolinium enhancement cardiac MRI (LGE-CMR) and simulation of cardiac electrical function, personalized ablation targets for persistent AF in patients with fibrotic remodeling.. Patients would be randomized to receiving PVI only versus PVI + OPTIMA ablation at the time of ablation. Patients would then be followed in standard clinical fashion at 3m, 6m, and 12m to assess for ablation efficacy and for procedural complications. Investigators postulate a 20% improvement in freedom from AF with PVI + OPTIMA ablation form 50% to 70% (compared to PVI alone), investigators anticipate that in 1:1 randomization, a sample size of 80 patients in each arm will yield a power calculation of 80% with an alpha of 0.05. Investigators anticipate that enrollment and 1y clinical follow-up for 160 patients (total) undergoing AF ablation will require a 4y timeline.

COMPLETED
Effects of a Proactive Social Robot for Older Adults in Reducing Loneliness and Social Isolation
Description

This project will to evaluate whether a proactive social robot (ElliQ) has an impact on reducing social isolation and loneliness in older adults who are living alone, while also promoting independence and aging in place. To achieve this, the following research questions will be investigated: 1. How does the use of ElliQ impact the following outcomes in older adults: * Loneliness and social isolation; * Accessibility to and use of technology; * Quality of life, mood, and overall well-being; and * Caregiver experience? 2. Do particular characteristics of the older adult population influence these impacts?

UNKNOWN
Effectiveness of Rubber Dam Isolation Versus Cotton Roll Isolation on Bonded Fissure Sealant Retention
Description

The purpose of this study is to evaluate and compare the clinical retention of bonded fissure sealants placed under rubber dam isolation and cotton roll isolation.

COMPLETED
Reduction of Radiation Dose and Contrast Use During Cryoballoon Pulmonary Vein Isolation
Description

This is a multi-site, randomized, investigator-initiated pilot study to evaluate the efficacy of investigational techniques to reduce fluoroscopy time or radiation dose and the amount of radio opaque contrast used during a cryoballoon pulmonary vein isolation procedure for atrial fibrillation. One group of subjects will have the procedure performed with intracardiac echo maneuvers to assess cryoballoon occlusion of the pulmonary vein and will be compared to a group of subjects who will receive the standard medical treatment with fluoroscopy and angiography.