Treatment Trials

15 Clinical Trials for Various Conditions

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RECRUITING
Family Caregiver Online Survey (Dementia and Swallowing Difficulties)
Description

The Family Caregiver Survey is a one-time, 30-minute, online survey for people living with and caring for a family member with dementia. The goal of this research is to explore the needs of family caregivers, specifically when it comes to managing swallowing difficulties (dysphagia).

ENROLLING_BY_INVITATION
Review of Infant Oral Feeding and Skills
Description

This study evaluates the infant's feeding skill level at discharge from the neonatal intensive care unit. The goal is to determine whether the ability to "full feed by volume" implies "full skill development" for infant oral feeding.

COMPLETED
Acetaminophen's Efficacy For Post-operative Pain
Description

The purpose of this study is to compare IV acetaminophen to oral acetaminophen for pain control in children undergoing tonsillectomy with or without adenoidectomy.

COMPLETED
Efficacy of Voice Treatment for Parkinson's Disease
Description

The purpose of the research study is to determine the effects of two different kinds of speech treatment on certain behaviors in individuals with parkinson's disease. These behaviors include speech, voice, related communication behaviors, swallowing and body movement.

COMPLETED
Early Detection of Barrett's Esophagus
Description

Background: The incidence rate for esophageal adenocarcinoma (EAC) has risen 10% per year over the past two decades and is the most rapidly increasing cancer in the U.S. Barrett's esophagus (BE), a metaplastic change from the normal squamous esophageal epithelium to a specialized intestinal-type columnar mucosa, increases the risk of EAC by 30-125, and is considered a precursor lesion for EAC. Individuals diagnosed with BE are currently entered into endoscopic surveillance programs to look for dysplasia or EAC. However, only 5% of subjects diagnosed with EAC have a previous diagnosis of BE or have been part of a surveillance program, so alternative screening methods are needed. Objectives: The primary goal of this project is to identify a practical blood-based biomarker(s) that can be used as a screening test to determine who has BE and who does not. Secondary goals of the project are to characterize germ-line and tissue biomarkers associated with BE, and to compare biomarkers in non-BE patients with and without GERD. Tertiary goals are to explore associations between biomarkers in blood or tissue and progression from BE to dysplasia or EAC, and to assess the stability of proteomic patterns over time. Eligibility: This study will be conducted among patients in the Barrett's Esophagus Registry (currently with 206 registrants) established at the National Naval Medical Center (NNMC) in Bethesda beginning in 1992, as well as a comparison group of approximately 600 matched non-BE patients endoscoped in the GI clinic at NNMC for other conditions. Design: Blood and tissue samples will be collected as well as questionnaire data on risk factors and medications as well as GERD. Data analyses will be based primarily on laboratory testing of newly collected esophageal biopsies, brush samples, and blood samples, but secondarily will also include use of archival tissue biopsy samples. Follow up of BE Registry patients will include standard periodic surveillance endoscopies, additional blood samples, and ascertainment of disease status (i.e., progression). To distinguish BE versus non BE-patients in this case-control study, we will: assess predictability of BE status from serum proteomic patterns; characterize esophageal biopsies and brush samples for selected DNA alterations, RNA expression, and proteomic profiles; genotype patients for selected polymorphisms potentially associated with BE; compare blood and tissue biomarkers in non-BE patients with and without GERD; explore the association of biomarkers with progression from BE to dysplasia or EAC; assess proteomic pattern stability over time in BE patients.

WITHDRAWN
Whether Proton Pump Inhibitors, Administered Prior to or After Surgery, Can Reduce the Incidence and/or Severity of Difficulty Swallowing Foods and/or Liquids,Following Anterior Cervical Surgery
Description

The researchers wish to investigate whether proton pump inhibitors, administered prior to or after surgery, can reduce the incidence and/or severity of difficulty swallowing foods and/or liquids,following anterior cervical surgery.

COMPLETED
Screening for Barrett's Esophagus in Otolaryngology Patients
Description

The purpose of this project is to develop an accurate method to identify patients that suffer from acid reflux, but may not present with classic reflux symptoms (such as heart burn). Additionally, it is the purpose of this project to utilize the Unsedated Small-caliber Endoscopy (USE) to assess the prevalence of Barrett's esophagus in a population of patients with laryngopharyngeal reflux (LPR) symptoms and to define normal patterns of LPR. Laryngopharyngeal reflux (LPR) is when a small amount of stomach contents and acid are pushed up through the esophagus and may affect the vocal cords and upper respiratory tract. It is suspected that patients with LPR symptoms may have a prevalence of Barrett's esophagus similar to that found in a population with typical reflux symptoms. We propose to systematically test this hypothesis using the USE. This project is designed to improve the methods of identifying patients with a form of acid reflux that is often undetected, and thus untreated. If this project is successful then more patients with Barrett's esophagus will be identified; furthermore, screening and treatment for this pre-cancerous condition will be improved.

RECRUITING
Effect of Dupilumab on the Muscle Function of the Esophagus (food Pipe) in Participants with Eosinophilic Esophagitis (EoE)
Description

The goal of this study is to research Dupilumab, an FDA approved medication in treating patients diagnosed with Eosinophilic esophagitis (EoE). The drug works by controlling allergic inflammation of the esophagus. The esophagus is a food pipe that transfers food from the mouth into the stomach. Participants with EoE have dysfunction of the muscle of the esophagus (impaired peristalsis) that is not favorable for the transport function. Main question this study aims to answer is: Whether Dupilumab helps improve muscle activity of the esophagus in participants with EOE? Participants will: Take Dupilumab every week for 12 weeks. Visit the clinic before and after starting the medication. Keep a diary of symptoms.

RECRUITING
Non-standardized vs. Standardized Screening for Dysphagia
Description

The purpose of this study is to compare two different screening tests for detecting dysphagia (difficulty swallowing) as well as the risk for aspiration (silent swallowing of liquids/solids into the lungs) in patients after an ischemic stroke (when a blood clot blocks or narrows an artery leading to the brain).

Conditions
COMPLETED
Randomized Controlled Trial of Endoscopic Dilation: Triamcinolone Injection
Description

The purpose of this pilot study is to find out if adding triamcinolone (steroid) injection at the participant's initial esophagogastroduodenoscopy (EGD) procedure will improve the opening of their esophagus and decrease the need for repeat dilations.

Conditions
COMPLETED
Per-Oral Endoscopic Myotomy
Description

This is a prospective chart review/data collection study of the per oral endoscopic myotomy (POEM) procedure, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a POEM procedure. Data will be collected and reviewed through 12 months post-op.

Conditions
TERMINATED
Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis
Description

This study determined the efficacy, safety, tolerability and the PK profile of BAF312, a novel immunomodulator, in polymyositis and dermatomyositis patients who were not responsive to traditional immunosuppressive and/or corticosteroid therapy. The study consisted of a 12 week, randomized, placebo controlled period, followed by another 12 weeks where all subjects received BAF312 treatment.

COMPLETED
A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis
Description

The purposes of this study is to demonstrate the analgesic efficacy of flurbiprofen 8.75 mg lozenge compared to its vehicle lozenge and to demonstrate the safety of the flurbiprofen lozenge throughout the course of treating sore throat due to acute pharyngitis.

Conditions
TERMINATED
Use of Xtampza ER to Overcome Difficulties in Swallowing Opioid Pills
Description

This study will examine how the use of Xtampza ER, an opioid analgesic packaged in openable microsphere-containing capsules, affects swallowing satisfaction, pain, and physical and mental health outcomes in chronic pain patients.

COMPLETED
Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties
Description

Swallowing dysfunction and delay of oral feeding skills in premature infants significantly delay discharge from the hospital. Thickening oral formula or breast milk feeds with commercial thickeners and rice cereal has been used in some nurseries with the goal of promoting development of adequate feeding skills. The objective of this pilot study is to examine the effect of thickened feeds on premature infants with oral feeding difficulties due to dysfunction secondary to immature swallowing. Hypotheses: * Thickened feeds will lead to a reduction in symptoms secondary to immature swallowing in 32-40 weeks gestational age infants when compared to non-thickened feeds * Thickened feeds will promote transition to hospital discharge.