Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effect of Far Infrared (FIR) Therapy on Access Flow of Arteriovenous (AV) Fistula, Echocardiographic Parameters and Endothelial Function in Patients With End Stage Renal Disease
Brief Summary: Vascular access complications are the leading cause of morbidity in hemodialysis (HD) patients, and are responsible for a significant percentage of hospitalization, with annual costs approaching one billion dollars in the United States. Thrombosis is the most common cause of vascular access failure, and usually develops from stenotic lesions in the venous outflow tract. It has been reported that far infrared (FIR) therapy can improve access flow and unassisted patency of AV fistula, however, the effect of FIR on cardiac function is unknown.

The aims of this study are to evaluate (1) the change of access flow of AV fistula and the effect of AV fistula on echocardiographic parameters and (2) the effect of FIR on access flow of AVF and echocardiographic parameters and the serum levels of endothelial markers in patients with end stage renal disease (ESRD) during the first 6 months after the creation of AV fistula.


Options:
A: Inclusion Criteria:

* Primary arteriovenous fistulas

  * Brachiocephalic
  * Radiocephalic (both proximal and distal)
* \>18 yrs old
* Diabetics and smokers will be eligible for inclusion

Exclusion Criteria:

* All complex vascular access procedures

  * Re-do brachiocephalic and radiocephalic fistulas
  * Brachiobasilic fistulas
  * Prosthetic grafts
* Cardiovascular dysfunction

  * Hypotension (systolic \<90)
  * Obstructive Cardiomyopathy
  * Severe Aortic stenosis (gradient \>40mmhg)
  * Confirmed myocardial infarction within the last 6 months
* Marked anaemia (Hb\<8)
* Migraine
* Medications

  * Sildenafil
  * Pre-existing nitrate use
* Nitrate allergy
* Closed-angle glaucoma
* Chronically raised intra-cranial pressure
* History of hypothyroid disease
* \< 18 years old
B: Inclusion Criteria:

1. Age of at least 18 years.
2. Chronic kidney disease with anticipated start of hemodialysis within 3 months or current hemodialysis dependence.
3. Planned creation of a new upper extremity AVG or "jump" graft

Exclusion Criteria:

1. Patients for whom this is the only potential site for an upper extremity vascular access.
2. Creation of a new AVG or "jump" graft in an upper extremity previously treated with an investigational gene or cell based therapy, or locally with an investigational pharmacological agent.
3. On physical examination or by other means, suspected proximal vein stenosis, occlusion, lack of continuity with the subclavian vein, central venous stenosis or central venous occlusion.
4. History or presence of an arterial aneurysm.
5. Previous treatment with PRT-201.
C: Inclusion Criteria:

* (1) age between 18 and 80,
* (2) chronic kidney disease (CKD) stage 5 with clearance of creatinine (CCr) less than 15 ml/min,
* (3) not receiving dialysis or renal transplantation,
* (4) is going to receive creation of AV fistula with the standardized surgical procedures of venous end-to-arterial side anastomosis in the upper extremity.

Exclusion Criteria:

* (1) creation of AV graft or Perm catheter as the type of vascular access,
* (2) heart failure in NYHA Fc III or IV,
* (3) episode of unstable angina, myocardial infarction, cerebrovascular event or receiving percutaneous coronary intervention therapy (PCI; including angioplasty or placement of stent ) within 3 months prior to screening.
D: Inclusion Criteria:

1. Age of at least 18 years.
2. Life expectancy of at least 6 months.
3. Diagnosis of Chronic Kidney Disease (CKD).
4. Planned creation of a new radiocephalic arteriovenous fistula (AVF)-revision of an existing AVF is not eligible.
5. Ability to understand and comply with the requirements of the entire study and to communicate with the study team.
6. Written informed consent using a document that has been approved by the Institutional Review Board (IRB).
7. If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative serum pregnancy test at the screening visit (Visit 1) and be willing to use contraception from the time of the screening visit to 2 weeks following study drug administration. Acceptable methods of birth control include abstinence, barrier methods, hormones, or intra uterine device.

Exclusion Criteria:

1. Malignancy or treatment for malignancy within the previous 12 months with the exception of the following cancers if they have been resected: localized basal cell or squamous cell skin cancer, or any cancer in situ.
2. Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study.
3. Previous treatment with PRT 201.
4. Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within the previous 90 days prior to signing informed consent.

Answer: C