There are about 21062 clinical studies being (or have been) conducted in Italy. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This study is being conducted to evaluate the impact of DR-102, a 28-day oral contraceptive compared to a standard 28-day oral contraceptive regimen on hemostatic parameters in healthy women.
The purpose of this study is compare two different surgical treatments of splenic artery aneurysms: open and laparoscopic approach.
This clinical trial is aimed at extending the chance of liver transplantation, through downstaging procedures, to patients with hepatocellular carcinoma (HCC) exceeding conventional Milan Criteria. Those patients that will achieve a sustained tumor response after downstaging will be randomized either to undergo liver transplantation or to proceed with conventional non-transplant treatments. The aim of the study is to demonstrate unequivocally that liver transplantation may provide a survival benefit, with an acceptable survival rate of at least 60% at 5 years, to patients that demonstrate a radiological and sustained tumor response after downstaging. Noteworthy is that response is chosen rather than stage migration as endpoint of downstaging.
Objectives This protocol is intended to provide information regarding the efficacy and safety of the nicotine partial agonist varenicline tartrate, at a dose of 1 mg twice daily, for smoking cessation in diabetic subjects who smoke. Given that a better understanding of predictors of smoking cessation can be useful in identifying potential quitters and likely relapsers and that little is known about these predictors in diabetics, the role of different predictors of abstinence at the end of the study will also be examined Study Population The study will enroll 150 type 2 diabetic patients (≤ 75 years) who are regular smokers (≥10 cigs/day) and motivated to stop smoking in each of 2 treatment arms (active drug and placebo) Study Design The study is a double-blind, placebo-controlled, randomized clinical trial designed to assess the efficacy and safety of varenicline 1 mg BID in comparison to placebo for smoking cessation. The duration of active treatment will be 12 weeks and subjects will be followed in the nontreatment phase for an additional 12 weeks. This clinical study has an optional research component to prolong the follow up in the nontreatment phase for a full year. Predictors of abstinence at the end of the study will also be examined Study Endpoints Primary Endpoint: Success rates at week 24 in the varenicline vs placebo group. Success rates will be defined as the Continuous Quit Rate since last visit. Subjects will be classified as responders if they are able to maintain abstinence from cigarette smoking during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm. This measure will be obtained through reports of cigarette use by means of the Nicotine Use Inventory confirmed by a measurement of an end-expiratory exhaled carbon monoxide concentration that is ≤ 10 ppm on the study visit at week 24 Co-primary endpoint: Success rates at week 12 in the varenicline vs placebo group. Success rates will be defined as Continuous Quit Rate for Weeks 8 to 12 of treatment. Subjects will be classified as responders if they are able to maintain complete abstinence from cigarette smoking in each of the last four study visits (week 9, week 10, week 11, and week 12) with end-expiratory exhaled CO measurements ≤ 10 ppm. This measure will be obtained through reports of cigarette use by means of the Nicotine Use Inventory during the last four study visits (week 9, week 10, week 11, and week 12) confirmed by a measurement of an end-expiratory exhaled carbon monoxide concentration that is ≤ 10 ppm on each study visit Secondary Endpoint: Success rates at week 52 in the varenicline vs placebo group. Success rates will be defined as the Continuous Quit Rate throughout the last three visits (week 24, week 36, and week 44). Subjects will be classified as responders if they are able to maintain abstinence from cigarette smoking during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm. This measure will be obtained through reports of cigarette use by means of the Nicotine Use Inventory during the last three study visits (week 24, week 36 and week 44) confirmed by a measurement of an end-expiratory exhaled carbon monoxide concentration that is ≤ 10 ppm on each study visit Additional Measures: Given that a better understanding of predictors of smoking cessation can be useful in identifying potential quitters and likely relapsers and that little is known about these predictors in diabetics, the role of different predictors of abstinence at week 24 and at week 52 will also be examined
The administration of Anamorelin in patients with Stage III-IV non-small cell lung cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.
Surgical resection in patients with multiple hepatocellular carcinomas (HCC) remains controversial. The aim of this study was to investigate the outcome of a consecutive cohort of patients resected for multiple HCC, without macrovascular invasion, in order to identify clinically reliable parameters to select patients for surgery.
Idiopathic nephrotic syndrome (INS) is the most frequent glomerular disease in childhood. Currently, all children with INS are treated at onset with steroids. The optimal duration and dosage of steroid therapy is debated. For each patient, the challenge is to minimise potential side effects of steroids, while achieving a good clinical response. The aim of our study is to assess the benefits and potential adverse effects of a prolonged initial corticosteroid regimen, for the treatment of the initial episode. The results will be compared with data obtained retrospectively. In addition genetic studies will be undertaken with the aim of evaluating pharmacodynamics of steroid treatment with the ultimate goal to individualise treatment in single patients. 1. Study group: children aged 6 months - 18 years, diagnosed with an initial episode of idiopathic nephrotic syndrome 2. Control group: data of children with a onset INS between January 2007 and December 2009 from the same area of the study group and treated with a short steroid regimen will be retrospectively analysed and compared
HGT-FIR-086 is a multicenter, open-label, non-randomized, single-arm study to evaluate the Pharmacokinetics, tolerability,safety, and efficacy on reproductive hormones, of a single subcutaneous (SC) administration of icatibant in approximately 30 pediatric subjects with Hereditary Angioedema (HAE) during an initial acute attack.
This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog beta pegol) during surgical procedures in patients with haemophilia B.
Study Hypothesis. combination chemotherapy with Clofarabine VP16 and Cyclophosphamide is able to induce remission in resistant/refractory acute leukemias in pediatric. Forty children with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML) entered the study and received the association of clofarabine (40 mg/m2/day) in combination with etoposide (100 mg/m2/day) and Cyclophosphamide (440 mg/m2/day) in 1 or 2 induction cycles End point were complete remission (CR)or CR without platelet recovery (CRp) and toxicity