Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol and L-Carnitine Compared to Standard PD Solutions in Continuous Ambulatory Peritoneal Dialysis (CAPD)
Brief Summary: Prospective, randomized, controlled clinical trial. The aim is to compare the effects of the peritoneal dialysis solution IPX15, containing glucose (0.5%), xylitol (1.5%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 2.5% glucose PD solution), for the nocturnal exchange with the PD solution IPX07, containing glucose (0.5%), xylitol (0.7%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 1.5% glucose PD solution), for the diurnal (short dwell) exchanges. Planned total recruitment is 40 patients with stable end-stage renal disease (ESRD) treated by continuous ambulatory peritoneal dialysis (CAPD). Treatment duration will be 4 weeks plus a 4 weeks safety follow up with no treatment.


Options:
A: Inclusion Criteria:

* Diagnosis of ESRD treated for at least three months with CAPD, as stated by the medical staff of the center;
* Stable clinical condition within four weeks before the screening period, certified by medical/surgical history, physical examination and laboratory exploration;
* Hemoglobin level ≥ 9g/dL;
* Absence of acute peritonitis and/or peritoneal catheter infection (either exit site or subcutaneous tunnel) episodes within three months before selection;
* To understand and sign an informed consent form.

Exclusion Criteria:

* History of alcohol or drug abuse in the last six months before selection for the study;
* Androgen therapy in the last six months before selection;
* Active infections;
* History of congestive heart failure stage III and IV New York Heart Association (NYHA);
* History of major cardiovascular events like stroke, acute myocardial infarction, coronary or other arterial revascularization procedures in the last three months before selection;
* Clinically relevant cardiac arrhythmia;
* Clinically relevant abnormalities of functional hepatic tests;
* Therapy with L-carnitine or its derivatives in the last three months before selection;
* Pregnancy, lactating women or female subjects of childbearing potential who do not use an effective method of contraception;
* Presence of relevant chronic medical conditions that could suggest exclusion of patient from the study or could interfere with the assessment of study parameters, especially if the life expectancy is less then one year;
* Participation in another clinical study within the past month;
* Known allergic reactions to L-carnitine or xylitol.
B: Inclusion Criteria:

* Adult subjects (\>18 y/o) undergoing hemodialysis more than 6 months previous at inclusion.
* At least one of these caloric malnutrition criteria: a) involuntary weight loss \>5% in 3 months or \>10% in 6 months; b) serum albumin \< 3.5 g/dl or prealbumin \<28 mg/dl; c) body mass index (BMI) \< 23 kg/m2; d) muscular mass loss \>5% in 3 months or \>10% in 6 months.
* Standard hemodialysis therapy (3 days/week, 240 min, high permeability dialyzer, blood flow \>250 ml/min and dialysate flow 500 ml/min) or on-line hemodialysis therapy that was not modified in the last 3 months previous to the inclusion.
* Written informed consent obtained.

Exclusion Criteria:

* Type 1 diabetes mellitus or type 2 diabetes mellitus with HbA1c\>9%.
* Unstable dry weight.
* Limb amputation.
* Significant edema.
* Active malignancy.
* Hospital admissions in the last 3 months.
* Acute gastrointestinal disease in the 2 weeks before the inclusion.
* Gastrectomy, gastroparesis or abnormal gastric emptying.
* Acute heart failure grade IV.
* Severe hepatic insufficiency (men gamma glutamyl transferase -GGT- \>150 U/l, women \>120 U/l).
* Alcohol or other drugs abuse.
* Participants enrolled in other research study at inclusion.
* Pregnant women.
* No informed consent obtained.
* Patients who received any oral nutritional supplement (specific for hemodialysis patients or not) in the 4 weeks before the inclusion.
* Patients receiving enteral tube feeding.
* Galactosemia, fructosemia, or requirement of a no fiber diet.
* Allergy or hypersensitivity to any ingredient of the oral nutritional supplement.
* Ongoing treatment with glucocorticoids.
* Patients who received any oral fatty acids omega-3 supplement in the 4 weeks before the inclusion.
* Patients who received intradialytic parenteral nutrition in the 3 months before the inclusion.
* Patients who received any probiotics or prebiotics (not as part of the diet) in the 3 months before the inclusion.
* Anemia (Hemoglobin \< 10 g/dl) or Epoetin resistance.
C: Inclusion Criteria:

being in the age range of 18-75 having the history of at least 12 weeks of hemodialysis and at least three times a week and each session almost for four hours having serum triglyceride or total cholesterol concentration \>200 mg/dl or serum HDL concentration \>40 mg/dl in the beginning of the study.

Exclusion Criteria:

taking carnitine supplement or the drug that interact with carnation lowering the seizure threshold in the last month being affected by liver function abnormalities, hypothyroidism, chronic infectious diseases (such as hepatitis), inflammatory diseases, CNS mass having the history of seizure.
D: Inclusion Criteria:

* HD \>3 months
* Fluid overload ≥15% of extracellular volume (ECV) predialysis, as determined by BCM-measurement, after one of the 2 the midweek interdialytic intervals
* Informed consent of the patient

Exclusion Criteria:

* none, except those specified by the Declaration of Helsinki

Answer: A