Clinical trials: sponsored by Federico II University
Friedreich's Ataxia
Efficacy of Epoetin Alfa in Patients With Friedreich's Ataxia
Friedreich's ataxia is a rare genetic disorder characterized by severe neurological disability and cardiomyopathy. Friedreich's ataxia is the consequence of frataxin deficiency.
- Trial name
- NCT00631202
- Testing
- Epoetin alfa
- Where
- Italy
- Volunteers
- 10 people
- Sponsor
- Federico II University
Amyotrophic Lateral Sclerosis
Growth Hormone in Amyotrophic Lateral Sclerosis
Several drugs have been proposed for ALS. These drugs included: Topiramate, Lamotrigine, creatine, Vit. E, Pentoxifylline, etc. Although most of the trials showed a positive trend, none of them reached a statistically significant…
- Trial name
- NCT00635960
- Testing
- Growth Hormone (Somatropin)
- Where
- 2 sites in Italy
- Volunteers
- 40 people
- Sponsor
- Federico II University
Oral Mucositis
Hexetidine and Chlorobutanol for Lesions Due to Prostheses
Objectives: The study aimed at assessing the efficacy of a new mouthwash in treating oral lesions due to removable prostheses. Methods: The present prospective randomized clinical trial was performed on 44 patients.
- Trial name
- NCT01115049
- Testing
- chlorobutanol, hexetidine, Chlorhexidine
- Where
- Italy
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Federico II University
Acute Myocardial Infarction
Effects of Cardiac Rehabilitation on High Mobility Group Box-1 Levels After Acute Myocardial Infarction
This purpose of this study is to examine the relationship between HMGB-1 and postinfarction predictors of outcome such as cardiopulmonary and echocardiographic parameters before and after a 6-month exercise-based cardiac…
- Trial name
- NCT00755131
- Testing
- Exercise-based Cardiac Rehabilitation program
- Where
- Italy
- Volunteers
- 75 people
- Sponsor
- Federico II University
Diarrhea
Oral Rehydration Solution With Zinc and Prebiotics in Acute Diarrhea
Hypotonic oral rehydration solutions (ORS) containing zinc and/or prebiotics have been proposed for the treatment of pediatric acute diarrhea but conclusive clinical data about their effect are scanty, especially for children…
- Trial name
- NCT01025583
- Testing
- hypotonic oral rehydration solution, Hypotonic oral rehydration solution with Zn and prebiotics
- Where
- Italy
- Volunteers
- 130 people
- Sponsor
- Federico II University
Postprandial Lipemia, Type 2 Diabetes
Ezetimibe and Statins on Postprandial Lipemia in Type 2 Diabetes
The purpose of this study is to determine whether ezetimibe in association with statins is more effective than statins alone on postprandial lipemia in type 2 diabetic patients.
- Trial name
- EZE (NCT00699023)
- Testing
- ezetimibe tablets, simvastatin tablets
- Where
- Italy
- Volunteers
- 13 people
- Sponsor
- Federico II University
Polycystic Ovarian Syndrome, Insulin Sensitivity
PED/PEA-15 Protein, PCOS, Obesity, Insulin Sensitivity Indexes, Metformin, Oral Contraceptives
Insulin-resistance plays an important role in polycystic ovary syndrome (PCOS) physiopathology. The phosphoprotein enriched in the diabetes (PED/PEA-15), a 15 kDa protein related to insulin sensitivity, is over-expressed in type…
- Trial name
- NCT00948402
- Testing
- Metformin, oral contraceptive
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Federico II University
Obesity
Growth Factor/Insulin-like Growth Factor (GH/IGF)-1 Axis in Obese Subjects in Treatment With Orlistat
The beneficial effects on plasma lipids of Orlistat, a selective gastrointestinal lipase inhibitor, are largely independent of weight loss, and might include differential effects plasma non-esterified fatty acid (NEFA).
- Trial name
- NCT00991926
- Testing
- Orlistat, normo-caloric diet
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Federico II University
Respiratory Tract Neoplasms, Thymic Neoplasms
High Dose Somatostatin Analogues in Neuroendocrine Tumors
Octreotide (OCT) is a somatostatin analogue (SSA) available in a long-acting formulation, conventionally administered every 28 days at the maximum dose of 30 mg.
- Conditions
- Respiratory Tract Neoplasms, Thymic Neoplasms, Pancreatic Neoplasms, Gastrointestinal Neoplasms
- Trial name
- HIDONET (NCT00990535)
- Testing
- Octreotide-LAR
- Where
- Italy
- Volunteers
- 28 people
- Sponsor
- Federico II University
Systemic Mastocytosis
Evaluation of Response of Dasatinib to Treat Mastocytosis
This is a multicenter, open-label, single arm phase II non-randomized study of dasatinib in which subjects with systemic mastocytosis (SM) will be treated with a continuous regimen of dasatinib.
- Trial name
- NCT00979160
- Testing
- Dasatinib
- Where
- 12 sites in Italy
- Volunteers
- 30 people
- Sponsor
- Federico II University
Advanced Hepatocellular Carcinoma
GH, IGF-I and Somatostatin Analogues in Hepatocellular Carcinoma
The hepatocellular carcinoma (HCC) represents more than 5% of all human malignancies, with more than 500,000 deaths per year (1).
- Trial name
- SS-HCC (NCT00495846)
- Testing
- Octreotide-LAR, Lanreotide Autogel, Locoregional treatments
- Where
- Italy
- Volunteers
- 25 people
- Sponsor
- Federico II University
Hypertension, Ventricular Remodeling
Efficacy and Safety of Valsartan Plus Hydrochlorothiazide in Patients With Slight Hypertension and Target Organ Damage
Patients with slight increase in blood pressure levels have an increased cardiovascular risk. In particular this has been demonstrated also in subjects with high-normal blood pressure in whom an exaggerated blood pressure…
- Conditions
- Hypertension, Ventricular Remodeling, Erectile Dysfunctions
- Trial name
- NCT00687206
- Testing
- Valsartan 160mg plus HCT 25mg
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Federico II University
Chronic Heart Failure
Effects of Growth Hormone on Exercise Capacity
The purpose of this study was to assess whether Growth Hormone(GH)improves exercise capacity and cardiopulmonary performance in patients with chronic heart failure.
- Trial name
- NCT00501514
- Testing
- Growth hormone
- Where
- Italy
- Volunteers
- 22 people
- Sponsor
- Federico II University
Overweight, Hyperlipidemia
Cross-Over Multicentre Study in Adolescents
The main objective of this study is to evaluate the effects of two diets with different glycemic index and fibre content on glucose metabolism and plasma lipid profile of 80 adolescents in 4 European centres.
- Trial name
- HELENA-COMS (NCT00635544)
- Testing
- dietary treatment
- Where
- 4 sites in Greece, Hungary and 2 more
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Federico II University
Postprandial Lipemia, Type 2 Diabetes
Mediterranean Diet and Postprandial Lipemia
The aim of this intervention study was to evaluate in type 2 diabetic patients the effects on postprandial lipemia and other metabolic parameters (in both everyday life conditions and after a standard test meal) of two diets, one…
- Trial name
- NCT00789295
- Testing
- Mediterranean diet and Low-Carbohydrates diet
- Where
- Italy
- Sponsor
- Federico II University
Acromegaly
Impact of Somatostatin Analogs vs. Surgery on Glucose Metabolism in Acromegaly
To investigate the 60 month impact of surgery and somatostatin analogues (SSA) on glucose metabolism in acromegaly we will analyzed data from 100 patients with acromegaly according with different treatments (group A=with SSA…
- Trial name
- GLUSSA (NCT00703079)
- Testing
- Octreotide-LAR or lanreotide, Transsphenoidal adenomectomy
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Federico II University
Hyperlipidemia, Endothelial Dysfunction
Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function
Some nutraceuticals are often advised for their lipid lowering effects. Although many clinical trials have been conducted to assess their efficacy many doubts remain whether they could be considered an effective alternative to…
- Trial name
- NCT00654459
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Federico II University
Prolactinomas
Cardiac Valve Complications in Prolactinomas Treated With Cabergoline
Dopamine agonists are first-line agents for the treatment of prolactinomas (1) and Parkinson's disease (2). There is evidence supporting a causal relationship between the occurrence of drug-induced "restrictive" valvular heart…
- Trial name
- ValveCab (NCT00460616)
- Testing
- Cabergoline
- Where
- Italy
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Federico II University
Obesity, GHD
Replacement GH Therapy After Bariatric Surgery in Patients With Very Severe Obesity
Obesity and obesity-related diseases have reached epidemic proportions in Western countries (1-3). Laparoscopic-adjustable silicone gastric banding (LASGB) is a purely restrictive operation that determine effective weight loss…
- Trial name
- GH&LASGB (NCT00553852)
- Testing
- Recombinant GH Saizen (Merck-Serono)
- Where
- Italy
- Volunteers
- 24 people
- Sponsor
- Federico II University
Acromegaly
Lanreotide Autogel-120 mg as First-Line Treatment of Acromegaly
Recently, a new formulation of lanreotide, lanreotide Autogel (ATG) 60 mg, 90 mg and 120 mg was developed in order to further extend the duration of the release of the active ingredient.
- Trial name
- ATG1line (NCT00627796)
- Testing
- Lanreotide-Autogel 120 mg
- Where
- Italy
- Volunteers
- 27 people
- Sponsor
- Federico II University