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NCT ID: NCT04755153 Not yet recruiting - Hypertension Clinical Trials

Community Intervention to Reduce CardiovascuLar Disease in Chicago

CIRCL-Chicago
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Hypertension affects 1 in every 3 adults in the US and contributes to 410,000 deaths annually. Hypertension and its associated complications disproportionately affect minority populations living in urban areas. In Chicago, health status indicators show worsening disparities between black and white residents, with the highest rates of hypertension, heart disease, and stroke clustering in the predominantly black South and West Sides. Kaiser Permanente demonstrated that a bundle of evidence-based interventions implemented within a large, integrated health system in Northern California significantly increased blood pressure control rates. However, it is unclear whether a health system centered intervention can be adapted to other settings, particularly under-resourced urban communities. Therefore, the overall goal is to support a community-centered design and adaptation of the Kaiser bundle. The investigative team will adapt the delivery model of the Kaiser bundle to be centered within churches within the South Side of Chicago, one of the most medically underserved communities in the United States. The proposed interventions are the same as in the Kaiser bundle (e.g., registry/audit and feedback, simplified treatment regimens, accurate Blood Pressure measurement) but implementation of the components of the bundle will be adapted for delivery in the community. The intervention will be carried out by local community health workers and ministry facilitators, with health clinics and hospitals in the community as support, all connected through a common data platform. Thus, the proposed project will identify the best strategies to support adoption, implementation with fidelity, and sustainability of the Kaiser bundle in the community setting. The proposed study will follow the Exploration, Preparation, Implementation and Sustainment (EPIS) process model and implementation is rigorously evaluated using a multimethod approach to the Reach, Effectiveness, Adoption, Implementation, and Maintenance (REAIM) evaluation framework. The specific aims are: Aim 1: Convene community stakeholders in order to adapt implementation strategies using the Dynamic Adaptation Process model. Aim 2: Design, implement, and evaluate pilot projects in order to optimize implementation strategies within the target community. Aim 3: Implement, test and evaluate an adapted implementation strategy to control hypertension through faith-based organizations in the South Side of Chicago. The study uses a hybrid Type 2 effectiveness-implementation design based within one primary community area (South Side Chicago) and in two settings (church and clinic). The overall study outcome is the Public Health Impact metric (reach * effect size of the intervention). Aim 4: Disseminate findings internally to community stakeholders and externally through creation of community implementation toolkits.

NCT ID: NCT04752319 Not yet recruiting - Motor Recovery Clinical Trials

BreEStim for Motor Recovery in Chronic Stroke With Moderate Impairment After a Long-term Use (Pilot).

Start date: September 1, 2024
Phase: N/A
Study type: Interventional

The overall goal is to investigate the effectiveness of a novel intervention - Breathing-controlled electrical stimulation (BreEStim) on finger flexor spasticity reduction and hand function improvement in chronic stroke with moderate impairment after a long-term use.

NCT ID: NCT04750564 Not yet recruiting - Motor Recovery Clinical Trials

BreEStim for Motor Recovery in Chronic Stroke With Severe Impairment (Pilot)

Start date: September 1, 2024
Phase: N/A
Study type: Interventional

The overall goal is to investigate the effectiveness of a novel intervention - Breathing-controlled electrical stimulation (BreEStim) on finger flexor spasticity reduction and hand function improvement in chronic stroke with severe impairment.

NCT ID: NCT04750551 Not yet recruiting - Motor Recovery Clinical Trials

BreEStim for Motor Recovery in Chronic Stroke With Moderate Impairment (Pilot).

Start date: September 1, 2024
Phase: N/A
Study type: Interventional

The overall goal is to investigate the effectiveness of a novel intervention - Breathing-controlled electrical stimulation (BreEStim) on finger flexor spasticity reduction and hand function improvement in chronic stroke with moderate impairment.

NCT ID: NCT04750252 Not yet recruiting - Clinical trials for Osteo Arthritis Knee

Safety and Tolerability of StroMelâ„¢ in Subjects With Moderate to Severe Osteoarthritis of the Knee Joint

Start date: August 22, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this trial is to evaluate the safety and tolerability of autologous StroMelâ„¢ for the treatment of moderate to severe OA of the knee joint.

NCT ID: NCT04742894 Not yet recruiting - Aphasia Clinical Trials

Neural Bases of Vocal Sensorimotor Impairment in Aphasia

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Aphasia is the most common type of post-stroke communication disorder characterized by deficits in speech comprehension, production and control. While recovery can be promoted with speech therapy, improvement remains modest and typically requires a large number of sessions contributing to rising health care costs. Traditional aphasia therapy focus on enhancing speech motor output; however, recent evidence suggests that the auditory feedback also plays a critical role in fluent speech. Therefore, a key step toward refining treatment strategies is to develop objective biomarkers that can probe the integrity of sensorimotor mechanisms of speech auditory feedback and identify their impaired function in patients with post-stroke aphasia. This study aims to examine the behavioral, neurophysiological (EEG), and neuroimaging (fMRI) biomarkers of speech impairment following stroke with focus on understanding the role of auditory feedback for speech production and control. We plan to test individuals with post-stroke aphasia and a matched neuroptypical control group during different speech production tasks under the altered auditory feedback paradigm. In addition, we aim to examine the effect of audio-visual feedback training on enhancing communication ability during speech. These biomarkers will be combined with existing lesion-symptom-mapping data in the aphasic group in order to identify the patterns of brain damage and diminished structural connectivity within the auditory-motor areas of the left hemisphere that predict impaired sensorimotor processing of speech in aphasia. The long-term goal of this research is to develop a model for identifying the source of sensorimotor deficit and improve diagnosis and targeted treatment of speech disorders in aphasia.

NCT ID: NCT04741256 Not yet recruiting - Clinical trials for Head and Neck Cancer

Implementation of a Standardized Tracheostomy Education Discharge Protocol

Start date: October 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to identify and establish a safe and effective tracheostomy teaching protocol for caregivers. Results of this study will help in the development of a discharge protocol that allows for caregiver confidence and activation in tracheostomy care for patients.

NCT ID: NCT04734106 Not yet recruiting - Clinical trials for Interstitial Cystitis

Safety and Efficacy of Aloe Vera in the Management of the Symptoms of Interstitial Cystitis

Start date: July 2024
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of super-concentrated, freeze-dried aloe vera capsules for treatment of interstitial cystitis.

NCT ID: NCT04733781 Not yet recruiting - Clinical trials for Musculoskeletal Pain

Subcutaneous Injection of Large Volumes of Tumescent Lidocaine and Epinephrine by Laypersons

TLE-RCT
Start date: February 22, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This research is intended to show that it is safe and not difficult for nearly anyone to inject at least 125ml of a dilute solution of tumescent lidocaine and epinephrine (TLE), where a TLE solution consists of lidocaine (1gm/L) and epinephrine (1mg/L) in normal saline.

NCT ID: NCT04730180 Not yet recruiting - Depression Clinical Trials

Comparison of Targeting Methods for Transcranial Magnetic Stimulation Treatment of Depression

XRnav
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

We aim to learn whether use of a mixed reality device for transcranial magnetic stimulation (TMS) targeting can improve treatment outcomes compared to targeting through scalp measurements or a commercial neuronavigation system. Prior studies indicate that neuronavigation can lead to improved treatment outcomes compared to scalp measurements, but neuronavigation adaption has been lacking due to the increased burden of the neuronavigation setup on the TMS operator. We will assess whether use of a mixed reality device can decrease that burden and speed up the neuronavigation process and is feasible to be used in a clinical setting.