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.
HP-hMG, recombinant FSH (r-hFSH) and a combination of r-hFSH/r-hLH, are commonly used for ovarian stimulation in infertile women undergoing IVF/ICSI treatments. Several publications have compared the effectiveness of these compounds, in terms of clinical outcomes. The aim of our study is to investigate the effects of three different ovarian stimulation protocols (HP-hMG, r-hFSH and r-hFSH/r-hLH), in a pilot prospective observational study, evaluating the effects of recombinant LH and extractive hCG (with LH like activity) on the biological outcome as well as on the clinical outcome. We will use the apoptosis rate of the cumulus cell, usually discarded after oocyte collection, as molecular biomarker to assess the oocyte quality, as biological outcome. The clinical outcome was estimated measuring implantation and ongoing pregnancy rates within and between the three different ovarian stimulation protocols
This was a within group, randomised, repeated dose, placebo- and octreotide controlled study in a target population of 45 healthy male subjects. Subjects were required to attend the clinical for screening procedures between 3 and 28 days before dosing commenced. The study was conducted in 4 groups of subjects; Groups 1 to 3 were a double-blinded, randomised design, each consisting of 12 subjects. Group 4 was an open-label design and consisted of 9 subjects. There was a minimum interval of 96 h between dosing of Groups 1, 2 and 3 to allow for interim analyses of PK and safety/tolerability data for dose escalation purposes. Group 4 (the active control group) was still to proceed if the decision was taken to prematurely stop dosing with ITF2984 (somatostatin analogue) following review of the PK and safety data presented at the interim decision meeting; dosing of this group was conducted independently from Groups 1 to 3. On Days 1 to 6, subjects in Groups 1 to 3 were to receive 2 doses of investigational medicinal product (IMP) approximately 12 h apart; subjects in Group 4 were to receive 3 doses of IMP approximately 8 h apart. For all groups, subjects were scheduled to receive their final dose of IMP on the morning of Day 7. In addition, subjects were to receive exogenous test administrations(stimulation test) on Day -1, Day 1 and Day 7 at the same time on each day (ie for Day -1, 23.5 h before the first dose of IMP, and for Days 1 and 7, 0.5 h after the first dose of IMP on the respective day). Blood samples for PD and PK analyses were taken at specified time points after each dosing. Subjects remained on site for 10 days (ie 36 h after the final dose of IMP on Day 7) providing that discharge conditions had been met, and returned to the clinic between 5 and 10 days after the last IMP administration for a follow-up visit.
Some studies have recently shown that the concentration of erythropoietin in the vitreous humor of diabetic patients suffering from diabetic retinopathy is higher than non-diabetic patients. It was reported a higher concentration of erythropoietin in vitreous humor than blood, indicating a local production. In some cases it was also found a positive association between concentrations of Erythropoietin and Vascular Endothelial Growth Factor (VEGF). Both of these factors, erythropoietin and VEGF, show important angiogenic activity and may play a role in the development of diabetic retinopathy. This study enrolled type 2 diabetic patients with PDR who had to undergo vitrectomy during the period May 2011-January 2012 at the Unit of Ophthalmology, A.O. Civil Hospital and University of Brescia. Inclusion criteria were the following: type 2 diabetes, age greater than 18 years, and PDR; exclusion criteria were: age less than 18 years, type 1 diabetes, initial DR, PDR patients not requiring surgery, previous vitrectomy in the eye under examination or other ophthalmic surgery or laser therapy within the previous 3 months. Non-diabetic patients who underwent vitrectomy for macular hole or pucker represented the control group (CTRLs); their inclusion criteria were: age greater than 18 years and the presence of macular pucker or macular hole requiring vitrectomy. Exclusion criteria were: age less than 18 years, diagnosis of diabetes mellitus, and previous vitrectomy in the eye under examination or other ophthalmic surgery or laser therapy within the previous 3 months. All patients underwent a complete ophthalmologic examination (visual acuity, slit lamp, tonometry, fluorescein retinal angiography, and optical coherence tomography -OCT-). Informed consent was obtained from all patients after a detailed description of the aims and procedures of the study. The following data were recorded for each patient: 1. Population: age (years), sex (M/F); 2. Clinical: diabetes (Absent or Type 2); time since initial diagnosis of diabetes (years); type of therapy for DM: diet, oral hypoglycaemic agents, mixed (oral agents and insulin, insulin); hypertension (defined as systolic blood pressure > 140 and diastolic blood pressure > 90 mmHg or on antihypertensive drugs); current (Yes/No) antihypertensive therapy; use of angiotensin II receptor blockers (ARB) or angiotensin converting enzyme inhibitors (ACE-i); presence of hypercholesterolaemia, comorbidities, therapy with statins (Yes/No), anticoagulants (Yes/No), antiplatelet therapy (Yes/No); other therapies performed, smoking (non-smoker, active smoker); complications of diabetes mellitus present at the time of evaluation (heart disease, nephropathy, neuropathy); 3. Ocular: eye (OD/OS); visual acuity; presence and grade of diabetic retinopathy; presence of emovitreo; presence of diabetic macular oedema; presence of cataract or lens implant; intervention with phacoemulsification during vitrectomy; presence of retinal diseases, or any other concomitant eye diseases; performance of previous retinal laser therapy, intravitreal injection of Avastin before the vitrectomy; 4. Biochemical: Haemoglobin (g/dL); glucose (mg/dL); glycated haemoglobin (%); platelets (N/mmc); creatinine (mg/dL); albuminuria (mg/day), creatinine clearance (mL/min), calculated by the Modification of Diet in Renal Disease (MDRD) formula; total cholesterol (mg/dL); HDL and LDL; triglycerides (mg/dL). All patients underwent a 23- or 25-gauge pars plana vitrectomy. The primary outcome of the study was the measurement of EPO and VEGF concentrations in serum and vitreous and aqueous humor. Blood samples, taken before surgery, were centrifuged at 3000 rpm for 10 minutes to separate the serum fraction, which was stored at -80°C. Aqueous and vitreous humor were taken during the surgery and immediately frozen at -80°C. Both EPO and VEGF concentrations were measured in serum and vitreous humor; however, owing to the small amount of sample, only EPO concentrations were determined in aqueous humor. EPO was assayed by radioimmunoassay (Immulite EPO 200, Siemens), with the lowest detection limit of 1.0 mIU/mL. VEGF was assayed by ELISA (Human VEGF Immunoassay, R & D Systems Europe, Abingdon, UK) with a lower limit of detection of 10.0 pg/mL. VEGF concentrations below the lower limit of detection were set to 5 pg/mL to perform statistical analysis. VEGF values above 2000 pg/mL were set to 2500 pg/mL; statistical tests were also performed after deleting the data above 2000 pg/mL.
The aim of the project is to compare the nephro-protective effects of high-dose atorvastatin and high-dose rosuvastatin on the incidence of Contrast Induced-Acute Kidney Injury in patients with non-ST-elevation acute coronary syndromes scheduled for early invasive strategy.
The purpose of the study was to evaluate the efficacy, safety and tolerability of intravenous infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients.
A double-blind, placebo Randomized Controlled Trial, To evaluate the effects of L. reuteri in adult patients with functional constipation.
To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of stenosis or occlusion of native below-the-knee arteries.
The overarching objective is to develop new evidence-based treatment guidelines for invasive fungal diseases in children. To accomplish that, this protocol will focus on two specific aims: 1) Compare the effectiveness of echinocandin versus amphotericin B or triazole antifungal therapy for pediatric invasive candidiasis and for the subset of patients with invasive candidemia; 2) Characterize the incidence rate of inpatient pediatric invasive candidiasis per hospital admissions.
Despite adequate antimicrobial prophylaxis and perioperative correction of risk factors, surgical site infections (SSI) remain the most frequent complication of colorectal resection (range 10-17%). Several strategies may be implemented to prevent SSI. Among these, the use of local antimicrobial agents seems successful. The primary aim of the present trial was to evaluate the efficacy of a surgical suture, coated with Triclosan a synthetic soluble antimicrobial agent, in reducing the SSI rate after colorectal operations.
Aim was to investigate efficacy of current treatments - water, chewing gum, and olive oil, in resolving postoperative ileus.