Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT03648658
Eligibility Criteria:
Inclusion Criteria:
* \- Patients: Men, women and children diagnosed with/biochemically verified SMA and CP
* Patients admitted to the ICU: Men, women, children diagnosed with/biochemically verified SMA and CP
* Healthy controls: Need to be healthy, evaluated by the investigator.
* Age:
* Children: 6-18 years
* Adult patients: 18-45 years
* Healthy controls: 18-45 years
* ICU-admitted patients: 6-45 years
* Signed informed consent to participation in the trial
Exclusion Criteria:
* \- Inability to understand the purpose of the trial or cooperate in the conduction of the experiments.
o For the children this will concern of course the parents or the guardians of the child.
* Competing conditions at risk for compromising the results of the study.
* Participation in other trials that may interfere with the results.
* Intake of medications that may interfere with the results, evaluated by investigator.
* Pregnancy and breastfeeding.
* BMI \>30\*
* In morbidly obese patients, the median area under the plasma concentration-time curve from 0 to 8 h. (AUC0-8h) of paracetamol is significantly smaller (p = 0.009), while the AUC0-8h ratios of the glucuronide, sulphate and cysteine metabolites to paracetamol are significantly higher (p = 0.043, 0.004 and 0.010, respectively). In this model, paracetamol CYP2E1-mediated clearance (cysteine and mercapturate) increased with lean body weight.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
45 Years
Study:
NCT03648658
Study Brief:
Protocol Section:
NCT03648658