Clinical Research Directory

REVIVE Prospective Registry Cohort Study

The main purpose of this registry is to collect observational, long-term safety and effectiveness data in participants who have received iltamiocel as part of the blinded portion of the REVIVE clinical study.

Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event

This observational study will examine the effects of thickened feeds on clinical outcomes and healthcare utilization in infants with brief resolved unexplained event (BRUE).

WeCareToFeedDysphagia to Reduce Care-partner Burden Full-scale RCT

The goal of this clinical trial is to learn if a newly-created website tool, called WeCareToFeedDysphagia, helps to reduce feelings of burden in care partners of patients with Alzheimer's disease and related dementias (AD/ADRD) who were diagnosed with trouble swallowing (oropharyngeal dysphagia). The main questions this study aims to answer are: * How effective is the WeCareToFeedDysphagia tool in reducing feelings of burden in care partners? * Does the WeCareToFeed Dysphagia tool help improve patient outcomes? * Does care partner age, gender, and patient dysphagia severity impact the strength of the effect of the WeCareToFeedDysphagia tool? * Is the strength of the effect of the WeCareToFeedDysphagia tool impacted by care partner's beliefs in being able to manage behavior and stress (self-efficacy)? Researchers will compare a group of care partners who have access to the WeCareToFeedDysphagia tool (intervention) to a group of care partners who do not have access to the tool. Both groups will receive contact information for help from a speech language pathologist expert (enhanced usual care). Participants will: * be given access to the web tool and receive 3 text message reminders over 3 weeks to use the tool (intervention group only). * be asked to complete a remote, web-based survey three times: when enrolled in the study, at 1 month following patient leaving the hospital, and at 3 months following patient leaving the hospital.

Biological Determinants and Neural Compensation of Dysphagia in Parkinson's Disease

Parkinson's disease (PD) is the second most common neurodegenerative disorder and frequently leads to oropharyngeal dysphagia, a swallowing disorder that strongly affects patient health and quality of life. Dysphagia in PD is associated with aspiration pneumonia, malnutrition, and impaired medication intake, which together represent one of the leading causes of morbidity and premature mortality in these patients. Despite its clinical relevance, the underlying biological mechanisms of dysphagia in PD are not fully understood, and current treatment strategies are limited. The purpose of this study is to investigate the clinical, biological, and neural determinants of oropharyngeal dysphagia in patients with PD, and to explore compensatory mechanisms of the brain that may counteract swallowing difficulties. We hypothesize that dysphagia in PD is linked not only to disease severity and progression but also to specific biological markers and neural plasticity in the swallowing network. This is a prospective, cross-sectional observational study including 100 patients with PD. Swallowing function will be systematically assessed using flexible endoscopic evaluation of swallowing (FEES), a gold standard method for detecting penetration and aspiration. Additional clinical data will be collected, including motor and non-motor symptoms, disease severity, and quality of life measures. Biological assessments will include blood-based biomarkers related to inflammation and neurodegeneration. Furthermore, functional magnetic resonance imaging (fMRI) will be used to examine cortical and subcortical activity patterns associated with swallowing and to identify potential compensatory activation in dysphagic and non-dysphagic patients. By integrating clinical, biological, and imaging approaches, this study aims to provide a comprehensive characterization of dysphagia in PD. The findings are expected to improve the understanding of disease mechanisms and to identify predictors of dysphagia onset and severity. Ultimately, this knowledge may help to guide the development of targeted therapeutic strategies, reduce the risk of severe complications, and improve quality of life for patients with Parkinson's disease.

Autologous Muscle Derived Cells for Treatment of Tongue Dysphagia

The primary objective of this double-blind, randomized, placebo-controlled, multicenter clinical trial is to evaluate the safety of AMDC-GIR during the 24 months following 2 consecutive treatments of tongue dysphagia in male and female patients who have undergone surgery and/or chemo- and/or radiotherapy for squamous cell cancer of the oropharynx.

Oral and Swallowing Function in Older Adults

The purpose of this study is to learn about oral and swallowing function in older adults presenting to the emergency department. The hypothesis is that older adults often have problems with oral and swallowing function and these problems relate to other conditions. Study activities are done during the emergency department visit and include providing saliva samples, completing a bedside water swallow test, completing oral function assessments, completing respiratory function tests, and answering survey questions.

Training Swallowing Initiation During Expiration

Head and neck cancers have escalated to epidemic levels in the United States, and survivors are suffering from life-long, devastating swallowing disorders with limited therapeutic options. This clinical trial investigates a novel swallowing treatment that trains initiation of swallowing during the expiratory phase of respiration to improve swallowing safety and efficiency.

The Effect of Swallowing Exercise and Maneuver Program For Older Adults With Dysphagia in Nursing Home

This clinical trial aimed to evaluate the effectiveness of a structured swallowing exercise and maneuver program for older adults with dysphagia living in a nursing home. Dysphagia, or difficulty in swallowing, is common in elderly populations and may lead to malnutrition, dehydration, and aspiration pneumonia. In this study, 72 participants aged 60 years and older were randomly assigned to either an intervention group or a control group. The intervention group received a combined swallowing exercise and maneuver program-including Masako Maneuver, Chin Tuck Against Resistance, Supraglottic Swallow, and Super-Supraglottic Swallow-performed three times daily before meals over a six-week period. The control group received standard care, including upright sitting posture during meals. Swallowing ability was measured using the EAT-10 questionnaire. The intervention group showed significant improvement in swallowing scores, while no meaningful changes were observed in the control group. This study suggests that nurse-led swallowing exercises can be a safe, simple, and effective strategy to improve swallowing function and quality of life in older adults living in long-term care settings.

Investigation of a Free Water Protocol

Hypothesis: Use of a Free Water Protocol (FWP) will improve patient satisfaction scores (Dysphagia Handicap Index), will not increase the risk of aspiration pneumonia/pneumonitis, and will result in improved oral hygiene (as assessed by the Oral Assessment Guide). Aim: To demonstrate that improvement in patient satisfaction and quality of life scores outweighs the potential risks of aspiration of plain water in an acute care setting; to qualitatively assess the implementation of a Free Water Protocol from the viewpoints of the patient and family/caregivers; to quantify changes in oral hygiene practices for individuals on the Free Water Protocol.

Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) for Tongue Dysphagia

The primary objective of this study is to evaluate the safety of Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) during the 12 months following treatment of tongue dysphagia in male and female patients who have undergone surgery and/or chemo- and/or radiotherapy for squamous cell cancer of the oropharynx.

Nursing Care Bundle on Oral Intake Among Critically Ill Children With Post-Extubation Dysphagia

the aim of this study is to evaluate the effect of Nursing care Bundle on Oral Intake among Critically Ill Children with Post-Extubation Dysphagia