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 goal of this clinical study is to determine the impact of starting the use of the FreeStyle Libre 2 glucose monitoring system, over a three month period, on HbA1c in adults with type 2 diabetes treated with a basal insulin regimen.
The goal of this study is to assess the safety, tolerability, anti-tumor activity (efficacy), pharmacokinetics (PK), and pharmacodynamics (PD) of the agent RVU120 when administered to adult patients with relapsed or refractory acute myeloid leukemia (AML) or relapsed or progressing high-risk myelodysplastic syndrome (HR-MDS) and who have no alternative therapies available. The study consists of two parts. Part 1 will assess the safety and tolerability of the dosages given and the level of anti-tumor activity or clinical response. Based on the results from part 1 the study will continue to enrol patient into Part 2 which will continue to evaluate safety and tolerability and anti-tumor activity in a larger number of patients.
Uncomplicated urinary tract infections (UTI) are one of the most common bacterial infections globally, causing a significant proportion of medical consultations in primary and outpatient settings. Recurrent UTI (rUTI) have a detrimental impact on the patient's quality of life, causing a negative effect on women's social relationships, self-esteem, as well as irritability and tiredness. Moreover, several real-life studies have shown that reproductive-aged women with rUTI more frequently experience sexual dysfunction as compared to controls without infections. The glycosaminoglycan layer of the bladder urothelium, mainly composed by chondroitin sulfate (CS) and hyaluronic acid (HA), provides a protective barrier against the penetration of bacteria. A deficiency of this layer facilitates bacterial adherence, leading to recurrent infection. Treatment to restore this layer with intravesical instillation of HA has been proven to reduce the incidence of rUTI episodes. Furthermore, intravesical instillation with HA has been associates with sexual function improvement in women with rUTI and painful bladder . Therefore, in conditions where the glycosaminoglycan layer of the bladder is impaired, such as rUTIs, treatment with HA to restore it appears to have a beneficial effect on urinary and sexual symptoms. Recently, a randomized control trial has demonstrated that an oral formulation of HA, CS, quercetin and curcumin was effective in improving urinary symptoms in women undergoing intravesical chemotherapy for bladder cancer. However, there are no studies investigating the impact of the oral administration of HA and CS on the sexual and urinary symptoms of women with rUTI. Since rUTI are highly prevalent in sexually active women and exert a detrimental impact on women's quality of life, sexual and urinary symptoms, the identification of oral treatments that could alleviate these bothersome consequences is of primary clinical importance. Therefore we will conduct this randomized, cross-over trial to evaluate the efficacy of an oral preparation of HA, CS, N-Acetylglucosamine and vitamin C in improving sexual and urinary symptoms in a cohort of reproductive-aged women with rUTI. Methods: Pre-menopausal, sexually active women referred to our center for symptomatic rUTIs. At the time of enrollment, participants were randomized with a 1:1 allocation ratio by means of a computer-generated random list in two groups: intervention (I) and control (C) (Figure 1). Inclusion and exclusion criteria We included sexually active, reproductive-aged women with symptomatic rUTIs. Exclusion criteria: younger than 18, if they had used combined hormonal contraception during the previous 6 months; pregnant, breastfeeding or trying to conceive, if they had symptoms of upper UTI, a history of urinary tract anomalies/vesicoureteral reflux, stress urinary incontinence, interstitial cystitis, diabetes, urinary tract stones, neurologic conditions, clinical depression or depressive symptoms. All women will be assessed with a thorough medical and sexual history. To psychometrically quantify sexual function impairment all participants completed The Female Sexual Function Index (FSFI) questionnaire at baseline and at each follow up assessment. Treatment Protocol Group I: an oral preparation (capsule) of HA 100 mg, CS 400 mg, N-Acetylglucosamine 200 mg and vitamin C 80 mg once a day in the morning plus an oral preparation of cranberry, D-mannose, propolis extract, tumeric and Boswellia twice a day for three months. Group C: an oral preparation of cranberry, D-mannose, propolis extract, tumeric and Boswellia twice a day for three months. After three months of treatment (follow up 1) all women were evaluated with medical and sexual history. Participants also completed the FSFI and IPSS questionnaires. At this point the treatment was reversed (crossover scheme) for additional three months. At 6 months follow up (follow up 2) participants were again investigated with medical and sexual history and the IPSS and FSFI were completed. Figure 2 report the complete study design. Monthly phone calls were performed to check for adherence to treatment. Statistics: The sample size consisted of 25 participants in each group, calculated by using the two-sample t-test analysis. Baseline clinical and psychometric scores will be compared between I and C groups. Second, potential differences in FSFI values at 3-6 months follow-up assessment will be evaluated between and within groups. Potential predictors of FSFI improvement will be evaluated.
Desmoid fibromatoses are rare (1-2 cases/million per year) and locally aggressive mesenchymal tumors. For asymptomatic disease, current guidelines suggest an initial period of active surveillance. The current scientific evidence regarding the efficacy and safety of the treatment of desmoid fibromatosis by arterial embolization is constituted by several retrospective and prospective studies. Embolization of desmoid tumors alone, without chemotherapy, on the contrary, has been shown to be inefficient. Using Doxorubicin in desmoid fibromatosis is effective but associated with systemic toxicity. Consequently, this drug is reserved for symptomatic, nonresponsive, rapidly growing or life-threatening tumors. The intrinsic hypervascularity of desmoid tissue can be exploited as a conduit to achieve local distribution of Doxorubicin by navigation of a catheter endovascular.
The goal of the study is to determine the benefit of using an ECochG-based corrective action guide during cochlear implant surgery compared to the traditional surgical approach without ECochG surveillance and guidance.
Endoscopy with endoscopic ultrasound (EUS) is a primary technique for diagnosing and treating severe pancreatic disorders. However, the procedure can cause fear and anxiety in patients, especially when a biopsy is involved. Graphic medicine, a form of visual storytelling that explores narratives of healthcare, is being used to alleviate this anxiety. This is a prospective single-center interventional pilot study with the aim to evaluate the impact of a novel graphic on the stress and behaviors of patients with pancreatic lesions undergoing EUS-FNB. The study will run for six months with the aim to enroll patients to llok for differences in the anxiety and stress levels. Enrolled patients will be randomly allocated to the test or control group, with the test group receiving a graphic novel to read while waiting for the procedure. Post-procedure, patients will complete the Beck Anxiety Inventory (BAI) and a modified version of the Depression Anxiety Stress Scales-21 (mDASS-21), now named mASS-14 (modified Anxiety Stress Scales-14), to assess anxiety and stress levels. This study is conducted according to the principles of the Declaration of Helsinki regarding experimentation involving human subjects, and written informed consent will be obtained from all participants before enrollment.
To study whether highly effective therapies can halt disease progression in people with multiple sclerosis by modulating the peripheral myeloid landscape.
The main goal of this multi-center interventional study is to improve the meal experience of children and adolescents with autism spectrum disorder trough the development of menus for collective catering targeted to their nutritional and sensory needs and the drafting of nutritional indications that can be a reference for collective catering nationwide. After an initial assessment of participants' consumption of meals in the collective service, menus adapted to their nutritional and sensory needs will be administered, and consumption between the initial and adapted menus will be compared. A population subgroup will also be selected whose caregivers will be invited to participate in a nutrition education course with the aim of providing parents of subjects with ASD, with knowledge tools to learn how to identify, manage and reduce their children's attitudes of food selectivity.
A minimally invasive procedure to directly assess portal pressure gradient under endoscopic ultrasound guidance (EUS-PPG) has become available and initial data have proved the technique to be safe. Aims of our proposal are: (i) to assess performance of EUS-PPG as compared to HVPG in evaluating hemodynamic response to non selective betablockers (NSBBs) in a large cohort of patients with CSPH;(ii) identification of markers of hemodynamic response(iii) identification of factors potentially affecting the accuracy of PPG measurement.
Extracellular vesicles, due to their ease of extraction and ability to represent the cells from which they originate, have high potential in the field of personalized medicine, especially in the identification of new early bio-markers of cancer, including hepatocellular carcinoma. Nevertheless, the development of high-throughput diagnostic methods in this area is still in its infancy, and the design of new integrated technological solutions is of great interest and topicality. The main hypothesis of this study is that the development of a novel technology integrating resonant gold nanostructures in the mid-infrared can significantly contribute to the development of new approaches for the diagnosis of hepatocellular carcinoma.