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 aims to assess the rotational stability of the new collameric Nanoflex toric intraocular lens (T-IOL) by STAAR inserted in astigmatic patients after cataract surgery. The purpose of this study is also to determine whether the use of a toric intraocular lens (T-IOL) improves visual acuity.
This is an open-label, phase IV trial. Adult patients, with moderately to severe, steroid dependent, acute ulcerative colitis not previously exposed to anti-TNF, will receive subcutaneous golimumab treatment, according to EU marketing authorization from baseline through week 14. At week 16, patients achieving clinical and endoscopic remission will continue with Golimumab, 50 mg or 100 mg (depending on body weight) every 4 weeks, through week 52. Patients not achieving clinical and endoscopic remission will be treated with infliximab, according to marketing authorization, and followed through week 52. This is not considered as an interventional arm but, since infliximab in Italy is considered as the first-line treatment for UC patients, as the usual clinical practice.
The purpose of this study is to retrospectively evaluate treatments and outcomes of patients with low grade serous ovarian carcinomas in Italy.
This is a multi-center, randomized, open-label, parallel group study designed to evaluate efficacy and safety of fulvestrant followed, at progression, by examestane and everolimus versus examestane and everolimus followed, at progression, by fulvestrant in postmenopausal women with HR+ and HER2- LABC or MBC whose disease has progressed to NSAI in the adjuvant or metastatic setting.
Crohn's disease is an immunologically mediated inflammatory bowel disease with a reported incidence of 4.0-7.0, 7.1, and 1.34 per 100,000 persons in Europe, the U.S., and Korea, respectively. Uncontrolled chronic inflammation finally causes various complications in intestine such as bowel obstruction, fistulas, abscesses, and anal fissures. The incidence of perianal fistula was reported in 13%- 39% of patients with Crohn's disease. Medical treatment for Crohn's fistulae initially focused on surgical intervention accompanied by symptomatic treatment with antibiotics and immunosuppressants. The most serious problem after surgical intervention is the relatively high incidence of postoperative anal incontinence caused by sphincter injury during the procedure. Conversely, available pharmacological therapies for Crohn's fistulae based on biologic agents such as infliximab do not generally reach ideal goal of treatment (e.g., complete closure of the fistula). A high recurrence rate after treatment with infliximab has also been reported, even after long-term maintenance therapy, which suggests that infliximab monotherapy does not provide adequate healing. The ACCENT II study demonstraded a complete fistula healing in 25% of patients. To reach a better clinical outcome, combination treatment with infliximab and surgical intervention is highly recommended for management of Crohn's fistulae. Nonetheless, even this strategy does not result in a satisfactory healing for many patients. The ideal therapeutic goal of treatment is not only complete closure of the fistula without recurrence but also preservation of anal sphincter function. Unfortunately, currently available medical or surgical treatment is not likely to offer a cure for perianal fistulae and, as noted above, recurrence is frequently reported. Together with active research in the field of bone marrow-derived mesenchymal stem cells (BM-MSCs) and hematopoietic stem cells, autologous or allogenic adipose tissue-derived stem cells (ASCs) have been studied for management of Crohn's disease and other disorders. Of particular relevance to this study, ASCs could be considered to be safe and efficacious therapeutic tools for the treatment of Crohn's fistulae. Importantly, ASCs do not cause fecal incontinence after injection into the lesion site in Crohn's disease patients. A phase I dose-escalation clinical study with ASCs manufactured by Anterogen Co., Ltd. (Seoul, Korea) demonstrated the safety and therapeutic potential of these cells for the treatment of Crohn's fistulae. A phase II study demonstrated a good rate of cronh's related fistula closure using a ASCS injection. Actually the best accepted treatment of Crohn related perianal fistula, is the surgical procedure in association whit medical therapy.
The purpose of this study is to clarify the mechanisms involved in the formation and glomerular deposition of immune complexes in lupus nephritis. The determination of an antibody pattern specific for systemic lupus erythematosus and lupus nephritis may also have a role in predicting disease progression in patients with systemic lupus erythematosus without renal impairment. As for the patients enrolled in the study, the determination of their antibody patterns may contribute to a more targeted and personalized treatment, allowing a prediction of disease progression and the introduction of early targeted treatments, in order to block the onset and/or progression of renal damage.
It is a observational prospective study. The aim of this study is to compare neostigmine vs sugammadex in the resolution of neuro-muscular blockade in great obese patients.
Biomime stent is a novel sirolimus-eluting stent (SES) (Meril Life Sciences Pvt. Ltd., Gujarat, India) with an ultra-thin stent platform (65 μm) and a biodegradable polymer licensed for the treatment of de novo coronary lesions. However no data regarding the efficacy and safety of this stent in an "all-comers" patient population treated with percutaneus coronary interventions (PCI) have been published so far. In this registry the investigators aimed to collect clinical and angiographic information about an extensive "all-comers" employ of this novel stent.
Polycystic ovary syndrome (PCOS) is the most common endocrinopathy of reproductive-aged women that manifests itself with chronic anovulation, hyperandrogenism and insulin resistance. Available guidelines recommend lifestyle intervention although they do not suggest the best dietetic regimen for the treatment of PCOS. Thus, the purpose of this study is to compare the effectiveness of two nutritional protocols, namely Mediterranean Diet and Hypocaloric Diet in PCOS women.
Polycystic ovary syndrome (PCOS) is the most common endocrinopathy of reproductive-aged women characterized by chronic anovulation, hyperandrogenism and insulin resistance. Available guidelines recommend lifestyle intervention although they do not suggest the best dietetic regimen for the treatment of PCOS. Thus, the purpose of this study is to compare the effectiveness of two nutritional protocols, namely Mediterranean Diet and standardized normocaloric Diet in normal weight women with PCOS.