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.
The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (72 μg daily) in comparison with placebo in pediatric participants, 6 to 17 years of age, who fulfill modified Rome III Criteria for Child/Adolescent Functional Constipation (FC). The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (145 μg or 290 μg daily) in pediatric participants, 7 to 17 years of age, who fulfill the Rome III criteria for child/adolescent Irritable Bowel Syndrome (IBS) and modified Rome III criteria for child/adolescent Functional Constipation (FC).
The primary purpose of this study is to assess the feasibility of an arm cycle ergometer training in subjects with proximal femur fracture surgically treated. The secondary purpose of this randomized controlled clinical trial is to verify whether the addition of aerobic activity can increase motor performance compared to a conventional exercise program in which no aerobic activity is foreseen.
This study aims at evaluating if a specific protocol, that can be framed in the innovative concept of Perioperative Goal Directed Therapy (PGDT), based on the evaluation of the Stroke Volume Variation (SVV) - a parameter deriving from the adoption of a minimally invasive advanced hemodynamic monitoring technology with a special sensor called FloTrac® (Edwards) or of a non-invasive monitoring system with the Clearsight® sensor (Edwards) - is able to guarantee a greater precision in the intraoperative management of patients undergoing spinal surgery in prone position.
The primary objective of this study is to evaluate invasive fungal infections (IFI) according to clinicians' opinion vs the opinion of an independent board of experts. The primary output of this study is the evaluation of inter-raters agreement. Secondary objectives are: evaluation of IFI incidence; description of clinical and laboratory features; frequencies of different antifungal treatments; description of outcome; impact on the treatment of underlying hematological malignancy. This is a multicenter, non-interventional observational, prospective study. The duration of the study will be 18 months. The study will recruit all consecutive eligible patients in each participating center, during a period of 6 months until at least 600 patients with acute myeloid leukemia are registered, that represented the highest risk category. Other disease types that fulfill the eligibility criteria in the participating centers during the same period will also be recruited in the study. The clinical, microbiological, diagnostic and therapeutic procedures operated on these patients will be collected. An eCRF will be compiled for all patients: T0: at the start of antifungal treatment, information will be collected regarding hematological malignancy, status of the disease at onset of infection and phase of treatment, last chemotherapy regimen, comorbidities and risk factors; previous IFI, neutropenia, antifungal and antibiotic prophylaxis and the kind of IFI clinicians retain the patient suffer (possible/probable/proven) and the kind of antifungal treatment started (empiric/pre-emptive/target); diagnostic work-up done, positive microbiology and biomarkers, positive radiological findings; antifungal treatment. T1: at 30-40 days (or before if the patient unfortunately died) a second form must be completed with information regarding any changes in/additional diagnostic work-up done, positive microbiology and biomarkers, positive radiological findings; any changes in antifungal treatment; outcome. At that time, the local physician must state any revision of his diagnostic classification between the moment in which antifungal treatment was started and the moment of evaluation of the outcome in order to estimate the differences regarding the level of evidence of diagnosis and treatment of IFI during time. Each case will be examined blinded by 2 different experts, who will review all records based on the existing guidelines, their own experience and the information that was known at the two time points, which may confirm or not the decision of local physician. The sample size will be driven by the AML patients (approximately 60-70% of the patients). Sample will be described in its clinical and demographic features via descriptive statistics. Quantitative variables will be summarized with the following measures: minimum, maximum, range, mean and standard deviation. Qualitative variables will be represented by frequencies tables.
Primary Objective: To demonstrate that high-dose quadrivalent influenza vaccine (QIV-HD) induces an immune response that is superior to the responses induced by standard-dose quadrivalent influenza vaccine (QIV-SD) for all 4 virus strains 28 days post-vaccination in participants 60 to 64 years of age and in participants 65 years of age and older. Secondary Objective: - Immunogenicity: To further describe the immune response induced by QIV-HD and QIV-SD in all participants by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD). - Safety: To describe the safety profile of all participants by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD).
stress cMRI with Dobutamine stress agent (stress cMRI), represent the combination of two orders of exams routinely performed (cMRI and stress diagnostic series of exams) without additional risk for the patient, but with the advantage of non-invasiveness and lack of radiation, and less laborious for the participants
The aim of this study is to determine if virologically suppressed Human Immunodeficiency Virus (HIV) Type 1 infected adults on a current antiretroviral regimen (CAR) (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching to dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC). The main objective of the study is to demonstrate the non-inferior antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 48 weeks in virologically suppressed adults living with HIV-1. The study will also evaluate information regarding the safety and health related quality of life. The study will include Screening Phase (up to 28 days), a Randomization Phase (up to Week 52) and a Continuation Phase (post Week 52). The Continuation Phase is not applicable for participants in Sweden and Denmark. Approximately 490 participants will be randomized in 1:1 ratio to receive DTG/3TC FDC once daily for up to 52 weeks or continue their CAR for 52 weeks. Participants in the DTG/3TC FDC arm who successfully complete up to 52 weeks of treatment will have the opportunity to continue receiving DTG/3TC FDC once daily in Continuation Phase.
Administration of a multicomponent dietary supplement (myo-inositol, vitamin D3, folic acid and melatonin) to women undergoing IVF procedures. The aim of the study is to monitor the effects on the pregnancy, implantation and abortion rates.
Short-term interventions that use very low-calorie ketogenic diets and meal replacements may be prescribed for selected overweight or obese patients with type 2 diabetes or prediabetes. Few, inconsistent data are available on protein intake from various sources on body weight, the composition of gut microbiota and metabolic outcomes in these patients. The aim of the present study is to compare efficacy, safety and effect on microbiota composition of short-term isocaloric VLCKDs using whey proteins, vegetable proteins or animal proteins in obese patients with diabetes or prediabetes. 50 obese diabetic/prediabetic patients will be randomly assigned to three isocaloric VLCKD regimens (≤800 kcal/day) containing either whey, plant or animal proteins for 45 days. Outcome measures will be anthropometric parameters, vital signs, metabolic profile, body composition and microbiota assessment.
Multi-center study on the effectiveness of treatment with a blue light medical device (EmoLED) in the reduction of ulcer surface in 10 weeks. The aim of BLUR clinical trial is to verify if the proposed treatment represents a valid and significant remedy for Chronic Venous Insufficiency ulcers. The effectiveness will be measured through the evaluation of the reduction percentage of the lesion area during 10 weeks of treatment comparing the lesion (or portion of it) treated with EmoLED versus the control lesion (or portion of it) treated only according to current Standards of Care(SOC). In the 10 weeks following the recruitment, the patient continues to follow the usual topical therapy with a frequency of once a week visit. The patient will be monitored up to the first event occurring: Complete healing or ten weeks. During the study, reports and evaluations will be made by medical staff on the device safety and usability. 90 patients will be recruited corresponding to the following criteria: - Subjects suffering from venous, arterial and mixed skin ulcers and surgical dehiscence lesions; - Presence of similar multiple lesions or lesions larger than 5 cm ; - Men and women ≥ 18 years old; - The patient must be able to understand the aims of the clinical study and provide informed consent in writing; - Chronicity of the lesion: at least 8 weeks. The present clinical trial will be a multi-center prospective, controlled study with the aim of verifying the clinical efficacy of a portable battery-powered device based on blue LEDs. We expect to record at least 20% of the difference between treated lesion and untreated lesion on the same patient during observation time. The treatment, additional to the standard therapy for the patient, will be performed at each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion or on part of it. In case of multiple lesions, one will be treated with EmoLED and one will be selected as a control lesion. In case of a very extensive lesion, it will be divided into two and one half will be the control of the other. All lesions will be cleansed with saline solution and a surgical debridement will be performed with a scalpel if a slough/black base is present. Only then the treatment with EmoLED will begin. If the patient has more than one lesion at the recruitment time, and all lesions are less than 5 cm in diameter, the worst lesions will be treated entirely with the EmoLED device and the others will constitute the control lesions. The evolution of all lesions in the ten weeks of the study duration will be evaluated. If the patient has only one lesion greater than 5 cm in diameter at the recruitment time, the lesion will be divided into two parts along the major side and one half of the lesion area will be treated. The other half of the lesion will be masked with multi-layered sterile gauze during treatment. The point of division of the lesion into two parts will be indicated with an indelible marker and retouched at each visit. If, at the time of recruitment, the patient has more than one lesion with a diameter greater than 5 cm, all lesions will be divided into two along the major side and will be treated as in the previous case. After treatment with EmoLED, a hydrofiber dressing will be applied to the lesion. If clinical signs of infection occur, a hydrofiber dressing with silver will be applied. If necessary, compressive bandage of the limb will be carried out.