Clinical trial: Improving Diagnostic Standards in Dysphagia (NCT04773184)

Eligibility criteria:
Healthy Cohort:

        132 individuals with no history of swallowing impairment or any health conditions known to
        impact swallowing function will be included in this study to serve as a comparative control
        group or reference standard group here and in future studies.

        Inclusion criteria:

          1. Adults aged 18-90.

          2. No history of stroke, head and neck cancer or other disorder that might contribute to
             a swallowing impairment.

          3. No COVID-19 symptoms within the past 14 days, nor has been around someone testing
             positive for COVID-19 in the past 14 days.

          4. Not pregnant.

          5. No allergies to barium.

        Exclusion criteria:

          1. Individuals under the age of 18 or over the age of 90.

          2. History of stroke, head and neck cancer or other disorder that might contribute to a
             swallowing impairment.

          3. Within the past 14 days, individuals with COVID-19 symptoms or a positive COVID-19
             test, or who have been exposed to someone with confirmed COVID-19.

          4. Pregnant women.

          5. Individuals with allergies to barium.

        Disordered Cohort:

        132 individuals with an underlying condition documented to lead to dysphagia will be
        enrolled in this study.

        Inclusion criteria:

          1. Adult participants aged between 18 and 90 years.

          2. Confirmed medical diagnosis associated with an increased risk of dysphagia including
             but are not limited to: head and neck cancer, neurologic (e.g., stroke, traumatic
             brain impairment), neurodegenerative (e.g., Parkinson's disease, amyotrophic lateral
             sclerosis), neuromuscular disorders (e.g., myotonic dystrophy, Pompe disease,
             inclusion body myositis) rheumatologic diseases (e.g., dermatomyositis, inclusion body
             myositis, scleroderma), chronic respiratory illnesses (e.g., chronic obstructive
             pulmonary disease), structural (e.g., mass or trauma to the upper aerodigestive tract)
             and iatrogenic conditions (e.g., post-surgical such as anterior cervical
             discectomy/fusion or cardiac, post-radiation treatment to the upper aerodigestive
             tract).

          3. No COVID-19 symptoms within the past 14 days, nor has been around someone testing
             positive for COVID-19 in the past 14 days.

          4. Not Pregnant.

          5. No allergies to barium.

        Exclusion criteria:

          1. Individuals under the age of 18 or over the age of 90

          2. Within the past 14 days, individuals with COVID-19 symptoms or a positive COVID-19
             test, or who have been exposed to someone with confirmed COVID-19.

          3. Pregnant women.

          4. Individuals with allergies to barium.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 90 Years

Patient description (medical language): A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough.  Her other medical problems include hypertension, dyslipidemia, and osteoarthritis.  She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg.  The patient's breath smells bad. Other physical examinations are normal.  A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus.

Patient description (patient's own words): I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus.

Does the patient match the trial criteria? Entailment