Clinical trial: Woodsmoke Particulate + Hypertonic Saline (NCT03851406)

Eligibility criteria:
Inclusion Criteria:

          -  Age 18-45 years, inclusive, of both genders

          -  Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy

          -  No history of episodic wheezing, chest tightness, or shortness of breath consistent
             with asthma, or physician-diagnosed asthma.

          -  forced expiratory volume at one second (FEV1) of at least 80% of predicted and
             FEV1/forced vital capacity (FVC) ratio of >0.70.

          -  Oxygen saturation of >93%

          -  Ability to provide an induced sputum sample.

          -  Subject must demonstrate a >10% increase in sputum %PMNs 6 hours following inhaled WSP
             exposure, when compared to baseline sputum (to be completed in a separate protocol
             IRB# 15-1775).

        Exclusion Criteria:

          -  Clinical contraindications:

          -  Any chronic medical condition considered by the PI as a contraindication to the
             exposure study including significant cardiovascular disease, diabetes, chronic renal
             disease, chronic thyroid disease, history of chronic infections/immunodeficiency.

          -  Viral upper respiratory tract infection within 4 weeks of challenge.

          -  Any acute infection requiring antibiotics within 4 weeks of exposure or fever of
             unknown origin within 4 weeks of challenge.

          -  Abnormal physical findings at the baseline visit, including but not limited to
             abnormalities on auscultation, temperature of 37.8° C, Systolic BP > 150mm Hg or < 85
             mm Hg; or Diastolic BP > 90 mm Hg or < 50 mm Hg, or pulse oximetry saturation reading
             less than 93%.

          -  Physician diagnosis of asthma

          -  If there is a history of allergic rhinitis, subjects must be asymptomatic of allergic
             rhinitis at the time of study enrollment.

          -  Mental illness or history of drug or alcohol abuse that, in the opinion of the
             investigator, would interfere with the participant's ability to comply with study
             requirements.

          -  Medications which may impact the results of the WSP exposure, interfere with any other
             medications potentially used in the study (to include steroids, beta antagonists,
             non-steroidal anti-inflammatory agents)

          -  Cigarette smoking > 1 pack per month

          -  Unwillingness to use reliable contraception if sexually active (IUD, birth control
             pills/patch, condoms).

          -  Use of immunosuppressive or anticoagulant medications including routine use of NSAIDS.
             Oral contraceptives are acceptable, as are antidepressants and other medications may
             be permitted if, in the opinion of the investigator, the medication will not interfere
             with the study procedures or compromise safety and if the dosage has been stable for 1
             month.

          -  Orthopedic injuries or impediments that would preclude bicycle or treadmill exercise.

          -  Inability to avoid NSAIDS, Multivitamins, Vitamin C or E or herbal supplements.

          -  Allergy/sensitivity to study drugs or their formulations

          -  Pregnant/lactating women and children (< 18 years as this is age of majority in North
             Carolina) will also be excluded since the risks associated with WSP exposure to the
             fetus or child, respectively, are unknown and cannot be justified for this
             non-therapeutic protocol. Individuals over 45 years of age will not be included due to
             the increased possibility of co-morbidities and need for prohibited medications.

          -  Inability or unwillingness of a participant to give written informed consent
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 45 Years

Patient description (medical language): A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago.  It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol.  Family history is significant for similar problems in his mother.  Vital signs are normal and the patient has no other medical conditions.  Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed.

Patient description (patient's own words): I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor.

Does the patient match the trial criteria? Entailment