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 includes a registry-based, nationwide analysis to describe the clinical outcome of adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who underwent an allogeneic hematopoietic stem cell transplantation (HSCT) after a Tyrosine Kinase Inhibitors (TKI)-based treatment.
The haematological neoplasia relapse is the cause of higher mortality after allogeneic stem cell transplantation (HSCT). When transplantation fails the most common therapeutic strategy is to increase the antitumor activity of the donor's immune system through the infusion of donor Lymphocytes (DLI). The use of DLI may limit the relapse, but may induce transplantation disease against the host (GvHD), in 40-60% of patients. With advances in transplantation procedures, the use of non-compatible (HLA-mismatched) haploidentical (aplo) donor cells has become feasible and is increasing. However, strategies for immune control of relapse after HSCT from haploidentical donor are hampered by the absence of prospective data that can guide treatment and limit the induction of GvHD in the setting of the HLA difference between the donor and the recipient. Cytokine-induced Killer Cells (CIK) are T lymphocytes from haploidentical donor expressing CD56 (e.g., double positive cells at CD3 / CD56). CIK are a product of advanced cell therapy (Advanced Therapeutic Medicinal Product, ATMP) for somatic cell therapy and have a reduced histocompatibility (MHC) complex: are cytotoxic, anti-tumor cells, possess the characteristics of both T cells and Natural Killer (NK) and show in vivo a very strong cytolytic activity against leukemia, but a low reactivity against the host. Therefore, this study has as its primary objective to investigate the safety of CIK cells deriving from the donor, especially in terms of the onset of GvHD, used as a treatment for relapse after transplantation with haploidentical stem cells. The study will allow to evaluate the possibility of using CIK cells, at the indicated dose combination (5x10 * 6 cells / kg, 5x10 * 6 and 10x10 * 6 cells / kg) as an effective and safe therapy in the context of haploidentical transplantation.
Pulmonary tuberculosis (TB) is an important risk factor for chronic respiratory disease due to residual lung damage. A recent review of the literature on TB sequelae and rehabilitation has provided clear evidence that TB is definitively responsible for lung function impairment. Functional evaluation of TB patients after completion of pulmonary tuberculosis treatment or spontaneous healing should be considered as part of clinical care. Unfortunately, few studies are available in the literature investigating the physiopathology of lung damage, its impact on quality of life, the potential need for pulmonary rehabilitation (PR), and the effects of a PR program.Objectives of this prospective multicentre international study are: Primary Objective-to assess the exercise capacity 6-min walking test in patients with post-TB lung impairment after completion of pulmonary tuberculosis treatment or after spontaneous healing. Secondary Objectives-to assess the effects of the PR program on dyspnoea symptoms and muscle fatigue, quality of life.
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) as first-line treatment in adults with no prior systemic therapy for their advanced melanoma. The primary study hypotheses are that: 1) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), and 2) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Overall Survival (OS). For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous Disease
POLAR is a phase III clinical trial, which will test the safety and efficacy of an investigational combination of drugs to learn whether the combination of drugs works for a specific cancer. Palbociclib (Ibrance®) is the name of the investigational agent, which is assessed together with standard anti-hormone therapy in this study. Palbociclib is used to treat patients with hormone receptor-positive / HER2-negative breast cancer which has spread beyond the original tumor and/or to other organs. During this study, anti-hormone therapy will consist of either a selective estrogen receptor modulator (such as tamoxifen) or an aromatase inhibitor (anastrozole, letrozole, exemestane) or fulvestrant (Faslodex®). Premenopausal women and men may also receive a drug called an LHRH (luteinizing hormone-releasing hormone) agonist by injection. It is standard of care for people with hormone receptor positive breast cancer to take anti-hormone therapy. The study doctor will determine the type of standard anti-hormone therapy that will be given during this trial. The purpose of the POLAR study is to compare the effect of using 3 years of palbociclib in combination with standard anti-hormone therapy with standard anti-hormone therapy alone and to evaluate the time until the breast cancer returns, if it does return.
The main objective is to assess long term tolerability and safety of treatment with oral nintedanib in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who have complete (and did not prematurely discontinue trial medication in) the phase III parent trial, INBUILD® (trial 1199.247).
Surgical site infection (SSI) is a leading cause of preventable morbidity and mortality in North America and worldwide. This condition has consistently been reported to account for up to 25% of all healthcare-associated infections. In a cost analysis, SSIs post-pancreaticoduodenectomy (PD) dramatically increases the treatment costs. More importantly, postoperative wound infections delay postoperative adjuvant chemotherapy, which is indicated in the majority of patients undergoing PD for pancreatic cancer. Protective covers or 'wound protectors' are hypothesized to be an improvement over adhesive membrane barriers as they are believed to reduce intraoperative contamination while concomitantly preserving the temperature and humidity of the surgical wound. The aim of this study is to assess if the use of wound protector can reduce the wound infection rate in patients undergoing to PD.
The functional hemodynamic test (FHT) called passive leg raising (PLR) has been successfully used for assessing the fluid responsiveness in ICU patients since 2009 and its reliability has been confirmed by three large meta-analyses. However, the PLR is not usually practicable in the OR. A lot of different FHTs have been proposed, as alternative to the PLR, in ICU and, more recently, OR. These tests could be basically subdivided in two groups. A subgroup of FHTs is based on sudden and brief variations of the mechanical ventilation to induce a change in right ventricle preload and/or after load and, as consequence, of left ventricle SV. A second subgroup aims at testing the increase in SV after the rapid administration of a small aliquot of the predefined FC. Among the first group, the end-expiratory occlusion test (EEOT) and the lung recruitment maneuver (LRM) have been previously successfully tested in surgical patients. The EEOT consists of the interruption of the mechanical ventilation for 30 seconds, whereas the LRM consists in the increase in the peak inspiratory pressure up to 30 cmH20 for 30 seconds and in the assessment of the changes in the SV after the maneuvers. These tests are safe and can be easily applicable during the surgery to predict fluid responsiveness and optimize the fluid therapy. The primary aim of the present study is to compare the reliability of EEOT and LRM in predicting fluid responsiveness in patients undergoing general surgery.
The primary objective of this study is to evaluate the steady-state pharmacokinetics (PK) and confirm the age-appropriate dose of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) in pediatric participants with chronic hepatitis C virus (HCV) infection.