Clinical trial: Real-life Study of Changes of Gastroesophageal Reflux Disease Manifestations Due to Behavioural and Diet Adherence (NCT04255693)

Eligibility criteria:
Inclusion Criteria:

          -  willingness to participate (based on the signed informed consent form);

          -  presence of gastroesophageal reflux disease, based on the following: a) typical
             symptoms, like heartburn and/or regurgitation (for primary selection, symptoms should
             be present at least weekly, be actual for at least 3 months prior to the enrolment,
             and the patient should report the history of symptoms which lasts for at least 6
             months); b) previous response to the intake of proton pump inhibitors; c) data of
             24-hours oesophageal pH-impedance monitoring with detected pathological
             gastroesophageal reflux according to the Lyon consensus definitions;

        Exclusion Criteria:

          -  pregnant or breast-feeding females;

          -  abdominal or chest surgery (except appendectomy or cholecystectomy in case they are
             not followed by adhesive disease of the abdominal organs);

          -  constant use of non-steroidal anti-inflammatory agents (NSAIDs), sporadic use of
             NSAIDs will be allowed in case the course of treatment was discontinued at least 2
             weeks prior to the enrolment, in case that constant use of NSAIDs happen to be
             necessary after the enrolment, the patients may continue in the study but doses,
             frequency and duration of treatment should be carefully documented;

          -  history or current evidence of cancer of any aetiology and location besides skin
             cancer in situ successfully treated before the enrolment;

          -  severe patient's conditions which may lead to misinterpretation of data, or in case of
             patient's enrolment may put him at risk of exacerbation of co-morbid conditions, or in
             cases when on discretion of the investigator patient's condition would not allow him
             to complete the course of the observation. These conditions include, but not limited
             to: heart failure (class III-IV by NYHA), uncontrolled hypertension, severe
             neurological disorders, decompensated liver cirrhosis (Child-Pugh B or C), severe
             depression or other psychological disorders;

          -  the patient may stop his participation in the study at any time by informing the site
             personal about his/her decision to withdraw the consent.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 48-year-old man comes to the office complaining of heartburn and acid reflux.  He has taken over-the-counter antacids but sees no relief.  Other medical history is unremarkable.  The patient does not use tobacco, alcohol, or illicit drugs.  Vital signs are within normal limits.  BMI is 31 kg/m2.  Physical examination is  positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart.  A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus.

Patient description (patient's own words): I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm!

Does the patient match the trial criteria? Contradiction