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NCT ID: NCT02001883 Recruiting - Clinical trials for Coronary Artery Disease

Low-dose Statins and Nutraceuticals in High-intensity Statin-intolerant Patients

ADHERENCE
Start date: November 2013
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to compare the efficacy and tolerability of low-dose statin therapy vs. the association between a low-dose statin and a nutraceutical-based protocol in high-dose statin-intolerant patients with coronary artery disease deemed to be at high-risk.

NCT ID: NCT01997242 Recruiting - SURGERY Clinical Trials

The Surgery After Stenting (SAS) Registry

SAS registry
Start date: June 2013
Phase: N/A
Study type: Observational [Patient Registry]

The SAS registry will include any patient with previous coronary stenting undergoing any type of surgery or operative endoscopic/endovascular procedure at the participating Centers. The relevant clinical, procedural and outcome data (within index surgical admission and at 30 days) will be entered in a specifically designed electronic case record form (eCRF).

NCT ID: NCT01993563 Recruiting - Stroke Clinical Trials

Graded Motor Imagery for Patients Within a Year After Stroke.

GMI
Start date: September 2014
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate whether a graded rehabilitation approach including Implicit and explicit motor imagery training and mirror therapy is more effective than other treatments commonly provided in a neuro-rehabilitation department.

NCT ID: NCT01991665 Recruiting - Clinical trials for Persistent Occiput Posterior Position During Labor

R. I. S. POS. T. A

RISPOSTA
Start date: January 2014
Phase: N/A
Study type: Interventional

A failed operative vaginal delivery is associated with increased risk of maternal and perinatal complications. It is very important the determination of the fetal head position prior to instrumental delivery. Generally,diagnosis of the fetal head position is made on transvaginal digital examination by delineating the suture lines of the fetal skull and the fontanelles. There is a paucity of studies on the accuracy of digital examination but the general consensus is that reproducibility is low and diagnostic uncertainty remains high even for operators with much experience. As the traditional clinical evaluation has many limitations, a new tool capable of increasing diagnostic objectivity and accuracy would be of great interest. The aim of our study was to evaluate, in a prospective study, if the complementary use of ultrasound scan, to diagnose the fetal head position prior to instrumental delivery, may play a role in labor outcome.

NCT ID: NCT01990144 Recruiting - Clinical trials for Diffuse Large B-cell Lymphoma

Rituximab Plus Bendamustine as Front Line Treatment in Frail Elderly (>70 Years) Patients With DLBCL: a Phase II Multicenter Study of the FIL

Start date: November 2011
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate feasibility and efficacy of rituximab-bendamustine (R-B)combination in elderly patients affected by diffuse large B-cell lymphoma and defined as frail according to CGA.

NCT ID: NCT01980134 Recruiting - Adenoma Clinical Trials

The MORDIS Study Clinical Investigational Plan

MORDIS
Start date: December 2013
Phase: N/A
Study type: Observational

To demonstrate the use of WavSTAT4 system during colonoscopy in identifying diminutive colorectal lesions (e.g. hyperplastic polyps) that can be resected and discarded (or even left in-situ) without adverse clinical impact.

NCT ID: NCT01975155 Recruiting - Celiac Disease Clinical Trials

Dietary Assessment and Mycotoxin Exposure in Celiac Disease

Start date: June 2013
Phase: N/A
Study type: Observational

Celiac disease (CD) is the most common autoimmune enteropathy in Western Countries. Gluten free diet is the only available therapy but few is known about its nutrient content and mycotoxin exposure.

NCT ID: NCT01973322 Recruiting - Clinical trials for Malignant Melanoma of Skin Stage III

Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumor Lysate or Homogenate Combined With Immunomodulating Radiotherapy and/or Preleukapheresis IFN-alfa in Patients With Metastatic Melanoma: a Randomized "Proof-of-principle" Phase II Study

ABSIDE
Start date: October 8, 2013
Phase: Phase 2
Study type: Interventional

Title: Vaccination with autologous dendritic cells loaded with autologous tumor lysate or homogenate combined with immunomodulating radiotherapy and/or preleukapheresis IFN-alfa in patients with metastatic melanoma: a randomized "proof-of-principle" phase II study. Study Design: Randomized selection design, proof of principle study Study Duration: 36 months Number of Subjects: 24 evaluable patients Diagnosis and Main Inclusion Criteria: Patients with non resectable stage III or stage IV malignant melanoma carrying at least 2 measurable lesions, any line after 1st line Vemurafenib in patients carrying BRAF mutation-positive melanoma and/or ≥ 2nd line Ipilimumab. Study Product, Dose, Route, Regimen and duration of administration: Intradermal Autologous Dendritic Cell vaccine loaded with autologous tumor lysate or homogenate on weeks 1, 4 6 and 8 during induction phase, and every 4 weeks during maintenance phase up to a maximum of 14 vaccine doses (each dose followed by IL-2 3 MU day 2-6) COMBINED OR NOT WITH - IFN-alfa 3 MU daily for 7 days before leukapheresis AND/OR - Three daily doses of 8 Gy up to 12 Gy delivered to one metastatic field between vaccine doses 1 and 2 (optional to one additional field between doses 7 and 8) utilizing IMRT-IMAT techniques.

NCT ID: NCT01971788 Recruiting - Clinical trials for Acute Myocardial Infarction, Coronary Stent Thrombosis, Antithrombotic Therapy

The MATRIX OCT Substudy

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

Residual thrombosis of stent struts may occur after the end of primary angioplasty and determine distal embolization and further myocardial damage. Bivalirudin is considered the most appropriate antithrombotic drug in the setting of primary PCI, but an initial increase in stent thrombosis has been reported. In order to overcome this potential adverse event, a prolonged infusion of bivalirudin after the end of PCI has been proposed. This aim of this study is to test whether the use of long-term bivalirudin infusion, as compared to the intra-procedural only administration, reduces residual thrombosis of stent struts evaluated by optical coherence tomography (OCT) at the end of primary PCI and at 3-5 days follow-up. A subgroup of patients enrolled in the MATRIX (Minimizing Adverse haemmhorragic events by TRansradial access site and AngioX study) study will be selected showing the following inclusion criteria: - patients affected by STEMI undergoing primary PCI with stent implantation and randomised to bivalirudin treatment, - patients who, in addition to the infarct related lesion, show at least one critical stenosis of other coronary vessels suitable for staged-PCI, - patients whose anatomy is suitable for OCT evaluation.

NCT ID: NCT01969630 Recruiting - Clinical trials for Peripheral Artery Disease

Paclitaxel-eluting Balloon Angioplasty With Provisional Use of Nitinol Stent Versus Systematic Implantation of Paclitaxel-eluting Stent for the Treatment of Femoropopliteal de Novo Lesions

Start date: October 2013
Phase: Phase 4
Study type: Interventional

To determine in patients with symptomatic femoropopliteal lesions whether percutaneous revascularization with paclitaxel-eluting balloon angioplasty (PEB) and provisional nitinol stent is superior with respect to the 12-month incidence of restenosis compared to treatment with systematic paclitaxel-eluting stent (PES) angioplasty