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NCT ID: NCT02611024 Recruiting - Glioblastoma Clinical Trials

Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors

Start date: May 6, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

Prospective, open-label, dose-ranging, uncontrolled phase I/II study of Lurbinectedin in combination with irinotecan. The study will be divided into two stages: a Phase I dose escalation stage and a Phase II expansion stage.

NCT ID: NCT02609360 Recruiting - Clinical trials for Acute Respiratory Failure

Effects of Different Crystalloid Solutions for Extra-corporeal Membrane Oxygenator (ECMO) Priming

Start date: May 2013
Phase: N/A
Study type: Interventional

Crystalloid solutions modify acid-base equilibrium according to their electrolyte composition. Moreover, it has been suggested that these alterations are generated by the difference between the solution strong ion difference (SID) and the plasma bicarbonate level. An increased risk of acute kidney injury and renal replacement therapy has been associated to the infusion of chloride rich crystalloids. This study aims to compare, in patients with acute respiratory failure undergoing ECMO support, the effects on acid-base status and renal function of crystalloids commonly employed for circuit priming to a balanced solution created with a SID equal to patients' bicarbonate level.

NCT ID: NCT02608437 Recruiting - Metastatic Melanoma Clinical Trials

A Study Investigating SGI-110 in Combination With Ipilimumab in Unresectable or Metastatic Melanoma Patients

NIBIT-M4
Start date: October 2015
Phase: Phase 1
Study type: Interventional

Thi pahse I, dose-escalation trial will determine the MTD, safety and the additional benefit achieved from adding SGI-110 to ipilimumab therapy in metastatic melanoma patients. Preclinical evidence generated with SGI-110 in vivo demonstrated that besides having a direct activity on tumor growth as a single agent, SGI-110 was able to "sensitize" neoplastic cells to the anti-tumor activity of CTLA-4 blockade, providing a sound scientific rationale to develop new immunotherapeutic approaches combining SGI-110 with therapeutic mAb to immune check-points.

NCT ID: NCT02606955 Recruiting - Uremia Clinical Trials

Probing the Dry Weight by Bioimpedance: The Resistance Stabilization Test

Start date: February 2015
Phase: N/A
Study type: Interventional

Clinical methods are fundamental in probing the DW. They must be supported by strict BIA protocols. REST appears to be a (the) brilliant solution in solving the old problem of DW in HD patients

NCT ID: NCT02591875 Recruiting - Atrial Flutter Clinical Trials

Atrial Flutter Ablation in a Real World Population

Start date: October 2015
Phase: N/A
Study type: Observational

The "LEONARDO" study is a non-randomized, multicenter, prospective study in which consecutive patients indicated for Atrial Flutter isthmus-dependent (AFL) ablation will be enrolled. Patients can be treated with any market released catheter for ablation. The decision to perform the ablation of AFL will be made based on clinical evaluation of the investigators according to their clinical practice. The study does not require specific surgical techniques. Patient time commitment for the study is approximately 12 months.The study has been designed to describe the italian clinical practice in relation to the approach of AFL ablation. In particular, the investigators will describe the methods for the validation of ablation success, the techniques adopted, and the patient management approaches in the participating centers.

NCT ID: NCT02589535 Recruiting - Sepsis Clinical Trials

Circulating Stem Cells, SDF-1, HIF-1 and Sepsis's Indices in Emergency Abdominal Surgical Patients

Start date: December 2015
Phase: N/A
Study type: Observational [Patient Registry]

Septic shock is a systemic inflammatory response syndrome with acute circulatory failure secondary to a documented infection. It is the most feared complication in ICU patients, with a 50% mortality rate. The study of stem cells and their experimental use in sepsis treatment is particularly relevant in the international scientific research, where Italy plays an important role. In the vast and complex field of stem cell research, the primary aim of the current proposal is to evaluate the time course level of circulating endothelial progenitor stem cells CD34 + / CD133 + (EPCs), and some factors EPCs-related, such as hypoxia- inducible factor (HIF- 1) and stromal derived factor-1 (SDF-1) in septic patients undergoing major abdominal surgery. Secondary objective 2: to investigate the relationship between CD133/CD34, HIF-1, SDF-1a and outcome of septic/septic shock patients treated with standard conventional therapy alone (CT) or with extracorporeal hemoperfusion therapy (HCT).

NCT ID: NCT02588131 Recruiting - Clinical trials for Pleural Mesothelioma

A Study of Tremelimumab Combined With the Anti-PD-L1 MEDI4736 Antibody in Malignant Mesothelioma (NIBIT-MESO-1)

Start date: October 2015
Phase: Phase 2
Study type: Interventional

This phase 2, open-label, single arm study aims to evaluate the efficacy of tremelimumab in combination with the anti-PD-L1 MEDI4736 in patients with unresectable malignant mesothelioma subjects

NCT ID: NCT02585583 Recruiting - Tremor, Limb Clinical Trials

Deep Brain Frameless Radiosurgery for Drug Resistant Invalidating Tremor. Dose Escalation Pilot Study

PRDBRS2
Start date: May 2015
Phase: N/A
Study type: Interventional

The gamma knife radiosurgical thalamotomy to treat many movement disorders is recently becoming a new and well defined treatment paradigm. The CyberKnife if compared to the frame-based radiosurgery, is a pain free procedure which offers the advantage of a better patient's compliance by avoiding local anaesthesia and the discomfort due to wearing the frame for the period of time needed for the whole procedure. Unfortunately the subtle but substantial differences about the 3D dose distribution and the dose fall-off features between GK and CK made mandatory investigations about the effectiveness and the safety when the cyberknife is used. Particularly the minimum effective and safety dose have to be defined yet A previous study (NCT02095600) failed in demonstrating the efficacy of 75 Gy, 80 Gy, 90 Gy. The aim of the present study is to investigate about the effectiveness of 100 Gy, 120 Gy, 130 Gy and 140 Gy. The safety and the targeting methodology will be also in investigated.

NCT ID: NCT02582138 Recruiting - Sarcopenia Clinical Trials

Multicomponent Intervention for Physical Frailty and Sarcopenia

SPRINTT
Start date: January 2016
Phase: N/A
Study type: Interventional

The SPRINTT study will evaluate the efficacy of a multicomponent intervention programme (physical activity, nutritional counselling/dietary intervention, and information and communications technology intervention) compared with a healthy aging lifestyle education programme on mobility disability, in non-disabled older people with physical frailty and sarcopenia.

NCT ID: NCT02578329 Recruiting - Clinical trials for Coronary Artery Disease

An Intervention Study to Assess the Effect of the Mediterranean Diet on the Plasma Fatty Acid Profile

RISMED
Start date: July 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a Mediterranean Diet, personalized in terms of total calories, total lipids and balanced in terms of saturated, mono- and poly-unsaturated lipids, corrects the adverse fatty acid profile of patients with CHD and reduces markers of oxidative stress and inflammation more effectively than a low-fat dietary advice.