Clinical trial: Prospective Surveillance of Lung Development During Childhood, Adolescence and Adulthood in Healthy and Patients With Cystic Fibrosis (NCT04395820)

Eligibility criteria:
Inclusion Criteria:

        Individuals with CF:

          -  Diagnosis of CF

          -  Signed written informed consent

          -  ≥3 - 18 years of age, depending on the cooperation and if lung function measurements
             are possible

        Healthy volunteers:

          -  Signed written informed consent

          -  Informed consent of participant and if under 18 years, legal representative
             respectively

          -  Children and adults with no history of chronic lung disease or acute respiratory
             infection in the four weeks prior to the study visit

          -  ≥3 - 18 years of age, depending on the cooperation and if lung function measurements
             are possible

        Exclusion Criteria:

        The presence of any one of the following exclusion criteria will lead to exclusion of the
        participant, for example:

          -  Women who are pregnant or breast feeding.

          -  Intention to become pregnant during the course of the study

          -  Lack of safe contraception, defined as: Female participants of childbearing potential,
             not using and not willing to continue using a medically reliable method of
             contraception for the entire study duration, such as oral, injectable, or implantable
             contraceptives, or intrauterine contraceptive devices, or who are not using any other
             method considered sufficiently reliable by the investigator in individual cases.

          -  Please note that female participants who are surgically sterilised/hysterectomised or
             post-menopausal for longer than 2 years are not considered as being of child bearing
             potential.

          -  Other clinically significant concomitant disease states (e.g. renal failure, hepatic
             dysfunction, cardiovascular disease, etc.)

          -  Known or suspected non-compliance, drug or alcohol abuse

          -  Continuous glucose monitor

          -  Inability to follow the procedures of the study, e.g. due to language problems,
             psychological disorders, etc. of the participant

          -  Metal in body, e.g. pacemaker

          -  Participation in another study with investigational drug within the 30 days preceding
             and during the present study

          -  Subjects which are respiratory insufficient to attend on the lung function
             measurements (oxygen demand)

          -  Subjects who are unable to perform the MRI without sedation

          -  Participants which were born preterm (<36. week of pregnancy)

          -  Current smokers

        In addition for individuals with CF:

          -  Known diseases other than related to CF

        In addition for healthy individuals:

          -  Current upper respiratory infection (cough, cold, fever) will lead to postponement of
             the visit to 4 weeks after the end of symptoms
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 3 Years old.
Subject must be at most 18 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? Contradiction