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.
Two arm, randomized, open-label study, to determine the best time to secondary resistance between responding patients who discontinue treatment and resumed Trabectedin at the time of progression versus patients who continued treatment until progression. T
Friedreich ataxia is the most frequent early-onset autosomal recessive hereditary ataxia. It is caused by a pathological expansion of a GAA repeat in the first intron of the frataxin gene (FXN) and results in decreased levels of FXN protein. FXN deficiency results in a relentlessly progressive neurodegenerative condition which frequently presents around puberty. Patients gradually lose coordination, become dysarthric and are frequently wheel-chair bound as adolescents. There is no disease modifying therapy and many patients die prematurely of cardiomyopathy. It was subsequently found that the FXN gene is silenced at the chromatin level by the formation of heterochromatin and that this heterochromatin formation can be antagonized by histone deacetylase inhibitors (HDACi) (Chan et al., 2013). A recent proof-of-concept clinical study on ten patients with Friedreich ataxia demonstrated that FXN levels can be restored to those seen in asymptomatic carriers using the class III HDACi nicotinamide at a dose that is well tolerated by patients (Libri et al., 2014). Since carriers are asymptomatic, this degree of restoration of FXN expression might be expected to halt disease progression. Nicotinamide readily crosses the blood brain barrier and has previously been given at high doses for long periods to normal individuals without serious adverse effects (Gale et al., 2004; Knip et al., 2000). This study will be the first to provide clinical evidence for the efficacy and safety of nicotinamide in patients with Friedreich´s ataxia.
The purpose of this study is to describe pharmacokinetics of maraviroc (MVC) 300 mg and atazanavir/ritonavir (ATV/r) 200/100 mg QD in HIV-infected stable patients.
The purpose of this study is to determine the effectiveness of relatlimab plus nivolumab, alone or in combination with various standard-of-care treatments in participants with gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma that has come back or spread to other places in the body after prior therapy.
Pancreatic cancer represents the 11th most commonly diagnosed cancer in men and 9th in women, being the third leading cause of cancer-related death in the Western countries. Pancreatic cancer has a very poor prognosis and median overall survival is less than 5 months in population-based studies. Approximately 80% of patients with pancreatic cancer present with unresectable disease, which is either due to locally advanced or metastatic disease. About 40% of patients have metastases at the time of diagnosis and in another 30 to 40 % of the patients tumour resection is not feasible because of vascular invasion, or poor general conditions. In resectable patients surgical resection with negative margins (R0) continues to be worldwide considered the only chance to cure, however, this standard treatment is usually reserved to a small number of patients. In patients with locally advanced tumour, neoadjuvant treatment has been proposed in various modalities as a way to decrease size and downstage the tumour leading to a resectable disease. Several phase I - II studies have shown the capability of chemotherapy alone or chemo radiotherapy based regimens to increase the resection rates of these patients and the related median overall survival. Systemic chemotherapy followed by chemoRT or stereotattic body radiation therapy (SBRT) is an option for selected patients with unresectable disease and good PS who have not developed metastatic disease. This sequence is especially recommended in cases in which it is highly unlikely that the patient will become resectable (ie, complete encasement of SMA/superior celiac artery). Due to the significant rate of toxicity of the radio therapy (RT) treatment alone or in adjunct to chemotherapy, other local treatments with the goal to downstage the primary tumour with less or no toxicity as compared to RT have been proposed. Radiofrequency (RF) has been used with success in solid cancers like the hepatocellular carcinoma while cryoablation has been used for breast and renal cancers. RFA has been applied in few clinical trials in human pancreatic cancer either without any imaging guidance or just under intra-operatory ultrasound control during palliative open surgery. The HybridTherm probe (HTP), (ERBE Elektromedizin GmbH, Tübingen, Germany) combines bipolar RF-ablation with cryogenic induced cooling. A bipolar radiofrequency system creates ablation with less collateral thermal damage than standard monopolar systems but with the trade-off to lose overall efficiency. In a recent in-vivo study the feasibility of the HTP in patients with unresectable locally advanced pancreatic adenocarcinoma has been shown. HTP has been applied under EUS-guidance to patients who have been already treated by chemotherapy (two lines) and in many cases with the adjunct of RT.
This is a randomized, controlled, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetic (PK), and adenovirus (AdV) antiviral activity of multiple ascending doses of IV brincidofovir (BCV). Approximately 30 eligible subjects will be sequentially enrolled into 1 of 3 planned cohorts. Within each cohort, subjects will be randomized in a 4:1 ratio to receive IV BCV dosed twice weekly (BIW) (on Days 1, 4, 8, and 11) or to receive investigator-assigned standard of care (SoC).
This study will assess the relative bioavailability of s.c. infused ND0612 versus jejunally infused CLES in patients with advanced PD.
This is a study of experimental medication BMS-986205 given with Nivolumab with or without chemotherapy compared to chemotherapy in participants with previously untreated stage IV or recurrent non-small cell lung cancer.
Osmotherapy consists in the therapeutic use of osmotically active substances with the aim of reducing the volume and therefore the intracranial pressure. It therefore represents an essential component in the clinical management of cerebral edema and intracranial hypertension, whether they are a consequence of head trauma, ischemic or hemorrhagic stroke, and neoplasm or neurosurgical procedures. The current study aims at evaluating in vivo the effects on haemostasis parameters of hypertonic saline solutions at different concentration, as compared to mannitol, in patients with neuroradiological signs (CT / MRI) of cerebral edema / non-traumatic intracranial hypertension.
Trauma is the leading cause of death in young people. Trauma-induced coagulopathy (TIC) encompasses several aspects of traumatic bleeding. Monitoring of coagulopathy comprises use of Point-of-Care (POC) methods, such as thromboelastography (TEG) or Thromboelastometry (ROTEM) and conventional laboratory assays (platelet count, fibrinogen level, and PT or INR). POC tests are thought to have a better performance on mortality and bleeding control than conventional tests. The aim of this study is to compare POC and conventional assays with plasma consumption as a primary outcome and 28 days mortality as a secondary one.