16 Clinical Trials for Various Conditions
The goals of this project are aimed at the following: 1. Identifying psychiatric comorbidity in patients presenting to the HNSCS clinic 1F and Duke Otolaryngology of Raleigh clinic using the validated assessment tool Brief Symptom Inventory (BSI-18) and the patient control scale. The BSI-18 is an 18 question and patient control an 8 item tool that takes about four minutes to complete. 2. Gathering data regarding patient satisfaction in new patients to the HNSCS clinics via the CG-CAHPS visit survey. 3. Examining relationships between psychiatric comorbidity and patient satisfaction. 4. Examining relationships between psychiatric comorbidity and healthcare system use.
This study will assess the use of ultrasound-a test that uses sound waves to produce images-as a diagnostic tool for evaluating speech and swallowing. The following categories of individuals may be eligible for this study: 1) healthy volunteers between 20 and 85 years old with normal speech and hearing, 2) patients 6 to 85 years old with developmental neurological deficits in speech or swallowing, and 3) patients with tumors of the oral cavity, pharynx or larynx being treated at the Greater Baltimore Medical Center. Participants will undergo a 30-minute speech and oral motion evaluation, in which they imitate sounds, words and oral movements while a speech pathologist evaluates their lip, tongue and palate movements. They may also be asked to drink a small amount of water for examination of swallowing function. For the ultrasound examination, a 3/4-inch transducer (device for transmitting and receiving sound waves) is placed under the participant's chin. While the transducer is in place, the subject 1) repeats sounds and a series of syllables in several sequences, 2) swallows three times with and without a small amount of water, and 3) swallows 3 teaspoons of non-fat pudding. The ultrasound images are recorded on tape for later analysis.
This study has been designed to evaluate how effective the Bizact tonsillectomy device is in reducing operating time and complications that occur after surgery. This device operates in a different way than the standard device that is used for most tonsillectomies. In 2019, a study was conducted in 186 children and adults using this device in tonsillectomies. Results showed lower blood loss and shortened time in surgery. However, the rate for bleeding as a complication after surgery was the same as other procedures that are used in tonsillectomy
This is a prospective within-subjects repeated-measures study that will enroll 24 adult users implanted with a HiResolution Bionic Ear System (HiRes 90K or newer). Subjects will be assigned to one of two cohorts based on audiometric results at the Baseline visit
The purpose of this feasibility study is to evaluate the benefit of unilateral implantation in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).
The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing sensitivity can be preserved in newly implanted adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) using the HiResolution™ 90K™ Advantage cochlear implant with the HiFocus™ Mid-Scala electrode to support the development of electro-acoustic stimulation technology (EAS).
Purpose of this study is to determine the efficiency and safety of a Sensory Enrichment Multimodal Device (SEMD) when applied in conjunction with usual care vestibular-balance physical therapy for rehabilitation of patients who fall as a result of vestibular inducted disequilibrium. Study participants will receive regular physical therapy, and some will use the SEMD device while receiving usual care vestibular-balance physical therapy. The device is an elastic belt that holds eight small battery powered vibrating disks. When using the device, you will sit or stand on a force platform that measures body sway. That movement information is sent to a computer which then sends the information to you via the vibrating disks. The vibrating disks are similar to a vibrating cell phone: you can feel the vibration but it is not uncomfortable. You can also see your sway movement on the computer screen. Some tests and activities will be paced with a beeping sound. The aim of this study is six-fold: 1. Demonstrate the relative efficiency between SEMD and conventional vestibular-balance physical therapy as reported by treating physical therapists' by counting number of skills acquired in a treatment session, and the amount of time needed to acquire the skill; 2. Demonstrate greater improvement earlier on in balance test scores when using the SEMD as an adjunct to conventional vestibular-balance physical therapy; 3. Determine the difference in vestibular habituation between physical therapy plus SEMD and conventional vestibular-balance physical therapy; 4. Demonstrate a more immediate reduction in fall occurrence when using SEMD as an adjunct to conventional vestibular-balance physical therapy; 5. Determine the patient's perception of quality of life between physical therapy plus SEMD and conventional vestibular-balance physical therapy; 6. Determine difference in acquisition of large movement tasks of tandem walk, step quick-turn, and kneel-shoulder rifle-return to stand between subjects that have trained with SEMD and conventional vestibular-balance physical therapy . In addition to primary and secondary outcome measurements, efficiency of skill acquisition, devised for this study, will be evaluated by tracking the number of skills and length of time needed to acquire each skill for each physical therapy session using the Patient Skill Acquisition Chart (PSAC). Usefulness of Tandem Walk, Step Quick-turn, and Kneel- Shoulder Rifle-Return to Stand as intervention outcome, also devised for this study, will be evaluated with pre test to post tests Modified Functional Independence Measure - Motor (MFIM-Motor). These measurements were devised for this study, and will be evaluated for informational purposes only.
The primary purpose of this study is to assess the effect of verekitug (UPB-101) on the endoscopically determined size and extend of nasal polyps in participants with chronic rhinosinusitis with nasal polyps (CRSwNP) and to assess the safety and tolerability of verekitug (UPB-101) compared to placebo.
This is a trial studying patients with human papilloma virus (HPV) positive oropharyngeal cancer with tumors that can be removed via transoral surgery. Following surgery, patients will be classified as either low, intermediate, or high risk based on the characteristics of the tumors. Low risk patients (Arm S) will receive no further treatment after surgery. Intermediate risk patients (Arm RT) will be treated with Intensity Modulated Radiotherapy (IMRT) after surgery. High risk patients (Arm CRT) will receive a combination of IMRT and chemotherapy after surgery. Patients will be followed for up to five years after the completion of treatment.
This is a multicenter, open-label, single-arm Phase 1B/2 study to assess the safety and efficacy of tabelecleucel in combination with pembrolizumab for the treatment of subjects with platinum-pretreated, recurrent/metastatic Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC).
The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.
The population in rural Alaska, which is predominately Alaska Native, experiences a disproportionately high burden of hearing loss compared to the general US population. The impact of untreated hearing loss in early childhood is tremendous and has grave implications for school achievement. Preschool children with hearing loss experience speech and language delays and are less likely to be ready for kindergarten than their normal-hearing peers. Early identification and treatment can reverse these ill effects. Importantly, the majority of hearing loss in this age group in rural Alaska is infection-mediated, arising from acute and chronic otitis media that is treatable. In response, preschool hearing screening is federally mandated at all Head Start centers across the country. In accordance with this mandate, hearing screening is already performed by the three organizations that offer early childhood education in the Norton Sound region: Kawerak Inc, RurAL CAP, and Bering Strait School District. While the concept of screening in this age group is well established nationally, what is less well understood is the optimal screening protocol for preschool children. There is little evidence evaluating sensitivity and specificity of different screening protocols in this age group. Further, loss to follow up in the referral stage is a problem in preschool hearing screening just as it is in school hearing screening. Alaska has already developed innovative strategies to address hearing loss. A network of village health clinics staffed by community health aides provide local care, and telemedicine has been adopted in over 250 village clinics statewide. Despite being widely available, telemedicine has not yet been used to speed up the referral process for preventive services such as hearing screening. Norton Sound Health Corporation has partnered with Duke and Johns Hopkins Universities to evaluate hearing screening and referral processes in early childhood education in the Norton Sound region of northwest Alaska. Preschool children will receive screening from the preschool and a new mHealth screening protocol. These will be compared against a benchmark audiometric assessment to determine sensitivity and specificity. Communities will then be randomized to continue the current primary care referral process or to adopt telemedicine referral. The primary outcome will be time to ICD-10 ear/hearing diagnosis. Secondary outcomes will include sensitivity and specificity of screening protocols and prevalence of hearing loss. The goal of this study is to evaluate the optimal screening and referral strategy for preschool children in rural Alaska.
The aim of this present study is to investigate the use of benralizumab as treatment for severe nasal polyposis. The effect of benralizumab on nasal polyps will be assessed over a 56 weeks of treatment period in patients with severe bilateral nasal polyposis who are still symptomatic despite standard of care therapy, i.e current use of intranasal corticosteroids (INCS) and prior surgery and/or use of systemic corticosteroids. The first 200 patients that complete the 56-week treatment will have a 6 month follow-up (FU) period without dosing.
The primary objective of the trial is the confirmation of the efficacy of AM-111 in the recovery of severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL).
A prospective, nonrandomized trial to evaluate postoperative healthcare resource utilization after maxillary balloon antrostomy using FinESS Sinus Treatment in the physician's office.
This is a Phase I dose escalation study of PXD101 administered orally. Oral belinostat will be given once or twice daily at various dosing schedules to patients with solid tumors. Doses will be escalated until the maximum tolerated dose (MTD) is identified. In parallel, a cohort of lymphoma patients will be given oral belinostat on a discontinuous once daily dosing schedule.