Clinical trial: Effects of Endotoxin in Normal Human Volunteers (NCT00001303)

Eligibility criteria:
-  INCLUSION CRITERIA:

               1. 18 to 45 years of age, either male or female

               2. Employees or non-employees are eligible

               3. Normal screening examination:

                    1. history and physical examination, nonsmoker, no concurrent medications
                       including aspirin or nonsteroidal anti-inflammatory drugs, no active medical
                       problems;

                    2. complete blood count with differential and platelet counts;

                    3. serum chemistries including creatinine, blood urea nitrogen, glucose, liver
                       enzymes and function tests, electrolytes, prothrombin time, partial
                       thromboplastin time;

                    4. urinalysis;

                    5. female subjects must have negative urine pregnancy test within one week of
                       participation;

                    6. electrocardiogram;

                    7. chest radiograph.

               4. If age is 40 to 45 years, normal submaximal stress test to screen for
                  asymptomatic coronary artery disease.

        EXCLUSION CRITERIA:

        Pregnancy.

        Lactation.

        History of recent clinically significant asthma.

        Subjects who have an allergy to both sulfa- and penicillin-based drugs will not be eligible
        for the endotoxin instillation portion of the study.
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 45 Years

Patient description (medical language): A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia.  The patient is sexually active with his wife and does not use any contraception methods.  They have been trying to conceive for the past year with no success.  The patient has a past medical history of recurrent pneumonia, shortness of breath, and  persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol.  The patient has no history of other medical conditions including allergies or any kind of surgery.  On physical examination, the digits show clubbing.  An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test.

Patient description (patient's own words): I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test.

Does the patient match the trial criteria? Entailment