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:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2025-12-24 @ 1:29 PM
NCT ID:
NCT01476995
Eligibility Criteria:
Inclusion Criteria:
Five Diagnosis Group:
1. Sex: Male or Female
2. Age range: 18 to 85
3. Qualifying medical diagnoses (5 diagnosis groups)
\- For potential subjects presenting with one of the five qualifying diagnoses, the patient presents with confirmed active medical diagnoses affecting the following systems or organs:
* Cardiovascular system: coronary artery disease, left sided congestive heart failure with EF \<50%, valvular heart disease, atrial fibrillation, and hypertension
* Kidney: pyelonephritis, acute renal failure, or chronic renal failure stages II-V
* Liver: viral hepatitis, alcoholic hepatitis, steatohepatitis, or cirrhosis
* Pulmonary system: asthma, COPD, bronchitis, emphysema, or pneumonia
* Gastrointestinal/Endocrine: inflammatory bowel disease (including Crohn's disease, ulcerative colitis, or diverticulitis), peptic ulcer disease, IBS, cholecystitis, pancreatitis, or malabsorption disorders (including Celiac Sprue); diabetes (Type 1 and Type 2)
4. The patient or legal representative is able to understand and provide signed consent for the procedure.
5. Every effort will be given to balance subjects by gender, age, and race. At least 60 subjects from each of the 5 diagnostic groups and the 1 control group will be recruited.
Control Group:
1. Sex: Male or Female
2. Age range: 18 to 85
3. Freedom from qualifying medical diagnoses (control group)
\- For potential subjects for the control group, the subject is free from active medical diagnoses affecting the following systems or organs:
* Cardiovascular system: coronary artery disease, left sided congestive heart failure with EF \<50%, valvular heart disease, atrial fibrillation, and hypertension
* Kidney: pyelonephritis, acute renal failure, or chronic renal failure stages II-V
* Liver: viral hepatitis, alcoholic hepatitis, steatohepatitis, or cirrhosis
* Pulmonary system: asthma, COPD, bronchitis, emphysema, or pneumonia
* Gastrointestinal/Endocrine: inflammatory bowel disease (including Crohn's disease, ulcerative colitis, or diverticulitis), peptic ulcer disease, IBS, cholecystitis, pancreatitis, or malabsorption disorders (including Celiac Sprue); diabetes (type 1 and type 2)
4. The patient or legal representative is able to understand and provide signed consent for the procedure.
5. Every effort will be given to balance subjects by gender, age, and race. At least 60 subjects from each of the 5 diagnostic groups and the 1 control group will be recruited.
Exclusion Criteria:
* Patients \< 18 years in age or \> 85 years in age.
* Inability or unwillingness to provide informed consent.
* Patients with pacemakers or another electrical device implanted somewhere in their body.
* Pregnant women.
* Patients currently undergoing therapy for cancer of any kind.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01476995
Study Brief:
Protocol Section:
NCT01476995