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 trial is to characterize PCOS in terms of neuropeptide expression and to make the comparison between women with and without PCOS by going to analyze venous blood samples taken during the three phases of the ovarian cycle and follicular fluid, taken during the ovulatory phase as part of the oocyte pick-up. Specifically, the expression of neuropeptides such as CGRP, SP, VIP and enkephalins in the three phases of the ovarian cycle (follicular phase, ovulatory phase and luteal phase) will be evluated in three groups of women afferent to the medically assisted reproduction centre. In particular, Group 1 (control) will include women with regular ovarian cycle; Group 2 will include non-PCOS women undergoing ovarian stimulation and ICSI treatment; finally Group 3 will include women with PCOS undergoing ovarian stimulation and ICSI treatment. The main question[s] it aims to answer are: - Is there a fluctuation in blood neuropeptides concentrations of women with normal ovarian cycles during the three phases of the ovarian cycle? - Do PCOS women has altered levels of blood and follicolar fluid concentration of neuropepides with respect to non-PCOS individuals? - Is blood and follicolar fluid concentration of neuropeptide modulated by protocols of ovarian stimulation? Participants of Group 1 will follow the ovarian monitoring protocol, during which blood samples will be taken at the three phases of the ovarian cycle. Participants of Group 2 and 3 will undergo ovarian stimulation and ICSI treatment, followed by blood and follicular fluid sampling at the specified cycle phases. Researchers will compare the control Group 1 with Group 2 and 3 to see if there is a significative difference in the concentration of blood neuropeptides between the three groups at the same phase of the ovarian cycle. Moreover, they will evaluate if there is there significant different concentration of neuropeptides in follicolar fluid between group 2 and 3 during the ovulatory phase.
Schizophrenia (SZ) affects approximately 4.5 million people across the European Union (EU) and is associated with annual healthcare and societal costs of 29 billion Euros. The impact on the daily life of patients is huge, ranging from frequent relapses and hospitalisations, the inability to maintain a job or continue scholing, to a low quality of life, impaired cognitive functioning, suicidal ideation and an increase morbidity rate, next to the large burden for carers 1. When diagnosed with schizophrenia or related disorder, patients are commonly prescribed antipsychotics. One-third of the schizophrenia patients are regarded treatment-resistant (TR), meaning that at least two antipsychotic trials have failed. Typically, clozapine is prescribed for TR patients, which is effective for approximately 40% of patients. Clozapine is among the most effective treatments, with the lowest all-cause mortality. Although it is among the most effective antipsychotics, it is generally not used earlier in the illness course due to a small risk of severe neutropenia/agranulocytosis, which is why patients treated with clozapine are intensely monitored. However, this small risk outweighs the burden of not receiving an effective treatment. Since clozapine is among the most effective treatments, this leads to the research question whether earlier initiation of third-line treatment ('early intensified' pharmacological treatment; EIPT) would be more beneficial than the current second-line treatments (treatment as usual; TAU). If this is indeed the case, this could lead to the prevention of unnecessary trials of ineffective treatments, hospitalisations, and recommendations for adaptations of worldwide guidelines as well as a reduction of healthcare and societal costs The INTENSIFY-Schizophrenia trial is part of the larger Horizon 2021 project Psych-STRATA, with the central goal of paving the way for a shift towards a treatment decision-making process tailored for the individual at risk for treatment resistance. To that end, the inestigators aim to establish evidence-based criteria to make decisions of early intense treatment in individuals at risk for treatment resistance across the major psychiatric disorders of schizophrenia, bipolar disorder and major depression. The current protocol focuses on the sample of schizophrenia patients.
Serological positivity for anti Ro-SSA antibodies is frequently found in pathologies such as Sjogren's Syndrome and SLE. Worldwide, approximately 0.5-1% of women of reproductive age are positive for Ro-SSA antibodies, and in 1-2% of these women, pregnancy will be complicated by cardiac abnormalities of the fetus, particularly varying degrees of atrioventricular block. It is essential to promptly identify patients with fetal heart rhythm abnormalities to prevent both intrauterine deaths and the birth of newborns with third-degree atrioventricular block, requiring lifelong cardiac pacing. At the moment, the only means to identify these alterations is represented by fetal cardiac ultrasound. Fetal atrioventricular block can develop within a few hours in these patients and fetal ultrasound, normally performed no more frequently than once every two weeks, does not allow for the timely identification of these conditions and therefore for pharmacological intervention. Using home fetal heart rate monitoring, carried out directly by patients three times a day with the aid of a special device that allows easy identification of the fetal heart rhythm, would allow rapid recognition of rhythm alterations and early access to confirmation tests and possible therapies. Fetal heart rhythm surveillance could detect a medically reversible disease that, if untreated, would progress to lifelong cardiac pacing, with its many associated comorbidities. Applying such protocol in pregnant women anti-Ro/SSA positive could become standard practice. The main objectives of this study are: - Estimation of the incidence of the development of fetal AV conduction abnormalities in patients with positivity for Ro/SSA autoantibodies; - Estimation of the reliability of home monitoring of fetal heart rate with fetal Doppler device in detecting fetal atrioventricular conduction disturbances; - Evaluation of the results of the therapy administered early, immediately after the diagnosis of fetal atrioventricular conduction disorders.
Neonatal infections are still one of the leading causes of mortality among newborns worldwide. For example, omphalitis is particularly common and can lead to the development of neonatal sepsis. This pathology more frequently affects developing countries, where hygienic conditions are often precarious, but the incidence of this disease should not be underestimated even in developed countries. Therefore, it is essential to properly care for the umbilical stump during the first days of life to prevent infections, both in the hospital and at home. The complications related to poor hygiene of the umbilical stump can be more or less serious. Mild complications include wet stumps, purulent secretions, granulomas, or periumbilical erythema. The most serious complications involve infections of the umbilical cord stump which can manifest locally or systemically, causing respectively omphalitis or neonatal sepsis. Despite the numerous benefits that derive from proper umbilical cord care, the most suitable approach remains controversial and several modalities of care have been described. The World Health Organization suggests two techniques depending on the neonatal mortality rate. In developed countries the use of dry cord care is recommended while in countries with a high neonatal mortality rate (>30 deaths/1000 live births) the topical application of antiseptics, such as chlorhexidine, is recommended. Recent studies have focused on the possible advantages of using natural products of plant origin, whose natural anti-inflammatory and dermal protective action is known. Among them, the anti-inflammatory, antibacterial and immunomodulatory properties of arnica montana have been studied and it has been shown that the use of a powder containing this plant extract reduces parental stress and drop time of the umbilical cord stump. However, there is little evidence demonstrating the lower rate of mild to moderate complications resulting from umbilical cord stump care with this product.
The goal of this observational study is to verify the role of adipose tissue in determining the vitamin D serum level after monthly oral administration in subjects with vitamin D deficiency. The main questions it aims to answer are: - Adipose tissue represents a storage environment for vitamin D or it's an environment where vitamin D is sequestered and no longer released - On the other hands, it's possible to verify whether the adipose tissue carries out a bi-modal activity towards vitamin D - If adipose tissue exerts a bi-modal effect, it is possible to identify a specific threshold between the two effects Participants will undergo anthropometric measurements (height, weight, waist/hip ratio waist circumference) at baseline and after 6 months of intake of cholecalciferol 50,000 IU/month
The purpose of this study is to better understand the natural history of Inherited Retinal Disease (IRD) and help inform patient management.
Ruptured thoracoabdominal aortic aneurysm (TAAA) represents an emergency medical challenge that needs to be treated promptly. Over the past years different endovascular techniques have emerged such as fenestrated or branched endovascular aortic repair (FB-EVAR). However, FB-EVAR is a technique that uses a custom-made device which needs to be manufactured and this process take months, therefore, it could not be used in urgent settings. Off-the-shelf graft stents are pre-made graft stents, which can be used in urgent cases. A retrospective, multicenter cohort study was planned to include patients who underwent endovascular procedures between January 2015 and January 2022 (85 months) to evaluate the technical and survival outcomes of the use of off-the-shelf stent graft, physician-modified endograft and parallel graft technique in endovascular aortic repair of free and contained ruptured TAAA. Data will be collected anonymously and retrospectively, including patient demographics, risk factors, diagnosis and anatomical details, procedure details and post-operative outcomes.
The aim of the project is to investigate the effectiveness of a home training managed through audio-guides in comparison to a classic supervised training on the physical and psychological parameters of patients with severe low vision. In this study the feasibility and effectiveness of a self-managed physical activity protocol with audio guides on physical performance (strength, mobility and aerobic capacity) will be assessed and compared to the same protocol supervised in a fitness environment. Secondary aims are the effects of the two types of administration of the protocol on quality of life, autonomy and psychological impact on the caregiver.
Hydra-IT is a multicenter observational study aim to collect clinical, procedural and follow-up data and evaluate the short, medium and long term results of Hydra TAVI System in patient with severe aortic stenosis.
Mutations in the CAPN3 gene cause muscular dystrophies with dysfunction in calpain-3. Calpainopathies are usually inherited in an autosomal recessive manner but in some families they can occur in a dominant inheritance. The significance of heterozygous variants is difficult to interpret in the absence of family history. In this study, the investigators will review the clinical and laboratory information in a cohort of patients identified in the participating centers, with the aim of improving the diagnostic strategy of dominant calpainopathies.