Clinical trial: Evaluation of the Role of the Autonomic Nervous System in Sj(SqrRoot)(Delta)Gren s Syndrome (NCT00565526)

Eligibility criteria:
-  INCLUSION CRITERIA:

               1. Diagnosis of primary Sjogren s syndrome based on American-European Consensus
                  Group Sjogren s syndrome classification criteria or healthy volunteers.

               2. Both genders and all minorities.

               3. Age at entry at least 18 and less than 65 years.

        EXCLUSION CRITERIA:

          1. Current use of medications known to significantly influence the activity of the
             sympathetic or parasympathetic nervous system if they cannot be held safely at the
             time of ANS testing

          2. Known co-existing diagnosis of ANS dysfunction (for healthy volunteers)

          3. Medications-requiring diabetes mellitus

          4. Diabetic autonomic neuropathy

          5. Vitamin B12, folate deficiency, requiring replacement

          6. Hepatic failure (AST or ALT greater than 1.5 x upper limit of normal)

          7. Renal failure (GFR less than 30 ml/min, as estimated by the MDRD)

          8. Congestive heart failure (Class II-IV)

          9. Refractory ventricular arrhythmias

         10. Symptomatic coronary heart disease

         11. Previously established diagnosis of sinus node dysfunction

         12. Severe anemia (Hgb less than 8)

         13. Psychosis

         14. Pregnant or lactating women

         15. A candidate subject is excluded if, in the judgment of the Principal Investigator,
             protocol participation would place the subject at substantially increased acute
             medical risk.

         16. Not able to provide informed consent

        Medications: A candidate subject is excluded if clinical considerations require that the
        subject continue treatment with a drug likely to interfere with the scientific results i.e.
        a tricyclic antidepressant or fludrocortisone. Subjects with known or suspected allergy or
        hypersensitivity to any test drug are excluded from receiving that drug. Subjects who must
        take medications daily in the following categories are excluded: tricyclic antidepressants,
        beta blockers, barbiturates, if they cannot be safely held during testing. Subjects unable
        to discontinue nicotine or alcohol temporarily are excluded. Subjects are not to
        discontinue any medications before the subject or the subject s physician discusses this
        with the Principal Investigator, Dr. Nikolov, or the Associate Investigator, Dr. Goldstein.
        If it is decided that discontinuing medications would be unsafe, then the subject is
        excluded from the study. Subjects must discontinue use of alcohol and tobacco throughout
        the period of testing in the protocol.

        Herbal Medicines and Dietary Supplements: Certain herbal medicines or dietary supplements
        are known or suspected to interfere with the experimental results, and such herbal
        medicines or dietary supplements must be discontinued before enrollment in the study. For
        many herbal medicines or dietary supplements, the mechanisms of action and therefore the
        possible effects on the experimental results are unknown. In cases where the subjects wish
        to continue their herbal medicines or dietary supplements while on study, and search of the
        available medical literature fails to identify effects that are known or expected to
        interfere with the experimental results, then the subjects may participate.
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 65 Years

Patient description (medical language): A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn.  The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness.  She also reports occasional joint pain.  Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease.  She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h)

Patient description (patient's own words): I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR.

Does the patient match the trial criteria? Entailment