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.
Background. Depression is a highly frequent condition in the elderly, with a huge impact on quality of life, life expectancy, and medical outcomes. SSRIs are commonly prescribed in elderly depressed patients and, although generally safe, they may be associated with tolerability issues. Based on available studies, vortioxetine is likely to have a promising tolerability profile in the elderly, as it does not adversely affect psychomotor or cognitive performance, wakefulness, body weight, and electrocardiogram parameters. Objectives. Assessing the comparative tolerability, safety and efficacy of vortioxetine compared with the SSRIs as a group (including sertraline, citalopram, escitalopram, paroxetine, fluoxetine, fluvoxamine) in elderly patients affected by major depression. The primary outcome will be the withdrawal rate due to adverse events. Methods. This is a pragmatic, multicenter, open-label, parallel-group, superiority, randomized trial. Twelve Italian Community Psychiatric Services will consecutively enrol elderly patients suffering from an episode of major depression who get in contact over a period of 12 months. By employing the web-based application RedCap, doctors will be able to randomize patients to vortioxetine or one of the SSRIs, chosen on the basis of clinical judgment, and to collect basic socio-demographic and clinical data. Trained and blinded assessors will administer five validated rating scales: Montgomery-Åsberg Depression Rating Scale (MADRS), Antidepressant Side-Effect Checklist (ASEC), EuroQual 5 Dimensions (EQ-5D), Charlson Age-Comorbidity Index (CACI), and Short Blessed Test (SBT). Patients will be assessed after 1, 3 and 6 months. Expected results. On the basis of current literature, the investigators hypothesize vortioxetine to be superior to SSRIs as a group in terms of tolerability. As vortioxetine is expected to reduce the withdrawal rates due to adverse events of about 12% compared to SSRIs, and assuming that about 23% of the participants could be lost within 6 months, the investigators aim to enrol 358 patients (179 in each group).
The use of music is widely supported in various areas of medicine: first of all in the psychiatric field as in the treatment of autism in children, obtaining surprising results even on Alzheimer's patients, or the unparalleled effect of music on those suffering from depression. To strengthen the thesis of the usefulness of music in medicine there is what is called PNEI, or the psychoneuroendocrinoimmunology. This discipline consists in the study of mutual interactions between mental activity, behavior, nervous system, endocrine system and immune reactivity. The PNEI itself no longer pays attention to the mind with respect to the body, but using the principles of the empirical epistemology of the scientific method strives to clarify those connections that make the nervous system, mind, immunity and hormonal regulation a unique and complex homeostatic control system of the individual, whose synergism would be able to modify certain biological behaviors, such as the transition from a distress to an eustress. This passage would seem to be of particular obstetric interest going to significantly change the course of labor in terms of pain, anxiety and well-being of women. In fact, many women prefer not to resort to partoanalgesia and famaci for pain control during labor. A recent Cochrane Review analyzed the effectiveness of music in the control of pain in labor, confirming its role in this sense. However, he concluded that the quality of available evidence varied from low to very low, thus highlighting the need for further studies in this area. Thus, the present study arises with the rational to satisfy this need for further investigation into the positive effects of music on pain in women in labor.
Cardiovascular disease (CVD) occurs less frequently in women than in juvenile men.Frequently the estrogen deficiency associated with the menopausal state affects cardiovascular outcomes. In fact, in the post-menopausal state, even younger women may experience an increase in the rate of ischemic heart disease (IHD). On the other hand, CVD may also occur in premenopausal young women, due to not well known and/or not clearly investigated mechanisms. In addition, pre-menopausal women with IHD show atypical symptoms and more frequently myocardial infarction vs. angina pectoris. In detail, in these patients IHD is frequently due to mono-vessel coronary heart disease, and to the presence of cardiovascular risk factors such as hypertension, hyperlipidemia and type 2 diabetes. So, it is clear that all these pro-atherogenic risk factors which lead to IHD in women, are significantly lower in the pre-menopausal vs. post-menopausal patients. However, the causes leading to IHD and acute coronary events in pre-menopausal women remain poorly understood and poorly investigated, and these factors might be different from the traditional coronary risk factors evident in the general population. In this context, recently some authors have shown that subcutaneous abdominal fat affects cardiovascular performance at 1 year of follow-up in patients with normoglycemia vs. pre-diabetic. Therefore, here authors can hypothesize that in a population of female subjects, the fat tissue present in the mammary gland and the different degrees of mammary adipocyte infiltration can somehow invalidate the number of cardiovascular events in women of childbearing age. In detail, the different distribution of adipose tissue in the mammary gland can influence the density of the breast, as studied by mammographic examination, which is used to divide breast density into 4 different categories: - Category A: the breast is represented by 80% of adipose tissue and less than 20% by fibro-glandular tissue. - Category B: the breast is represented by adipose tissue in the range of 50-75% and for the rest by fibro-glandular tissue. - Category C: the breast is represented by fatty tissuein the range 25-50% and the rest is from fibro-glandular tissue - Category D: the breast is represented by almost entirely fibro-glandular tissue. Therefore, in the present study authors correlated the 4 different breast categories with CVD and 10-year follow-up IHD in women of child-bearing age. In fact, according to authors' opinion, a breast with higher fat density (category A) might influence the number of adverse cardiovascular events at 10-year follow-up in asymptomatic women. Thus, pre-menopausal women with breast tissue in category A ("fatty breast") as compared to women with prevalence of fibro-glandular tissue ("non-fatty breast") may have a higher frequency of adverse cardiac ischemic events at 10 years of follow-up. On the other hand, the molecular pathways implied in worse CVD in these cohorts of women are not fully investigated. Furthermore, the authors aimed to investigate the expression of inflammatory cytokines and sodium glucose transporter 2 (SGLT2) protein expression, as markers of over-inflammation, at level of breast gland in these cohorts of women. Thus, these markers were analyzed in the breast fat tissue excissed from the fatty vs. non-fatty breast women.
Alzheimer's disease is a global health challenge. Efforts aim at developing an effective treatment able to meet the needs of patients and their families. Thus, the primary aim of this project is to investigate the efficacy of a non-invasive brain stimulation, namely repetitive transcranial magnetic stimulation (rTMS), on cognition in patients with mild Alzheimer's disease. rTMS is considered a safe, well tolerated and relatively cheap treatment. The appealing idea of the intervention is to improve memory by directly modulating the activity of precuneus, key area linked to memory impairment. Patients will be treated with rTMS in two phases: an intensive phase and a maintenance phase for a total of six months. This project aims to provide a valid treatment to slow the worsening of symptoms and improve quality of life for those with Alzheimer's and their caregivers.
This Phase 3 multicenter, randomized, placebo-controlled, double-blind study is designed to evaluate the efficacy and safety of apremilast in subjects with moderate to severe genital psoriasis (modified sPGA-G ≥3, moderate or severe). Approximately 286 subjects with moderate to severe genital psoriasis will be randomized 1:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks.
single institution cases series review of histological, radiological and clinical data
In literature there is a huge amount of works demonstrating the direct correlation between volemic overload or fluid deficit and hypoperfusion and the increase in the rate of major postoperative complications in patients with high cardiovascular risk and chronic renal failure candidate to kidney transplantation from cadaver. It is also widely demonstrated that in certain populations with high surgical and post-operative complications risk, the adoption of targeted haemodynamic and clinical-therapeutic management protocols is indicated. The current trend is therefore to guarantee greater precision in the intraoperative management of patients undergoing kidney transplantation from cadaver by using a specific protocol that can be framed in the recent and innovative concept of Perioperative Gold Directed Therapy (PGDT), resulting from the adoption of an advanced minimally invasive hemodynamic monitoring technology with a special sensor called FloTrac (Edwards Lifesciences), already extensively tested in an extensive case series of high perioperative risk patients underwent to major abdominal surgery, major vascular surgery, major orthopedic surgery and cardio-thoracic surgery. In the present study there will be enrolled all patients who are candidates for kidney transplant from cadaver at the University Hospital "G. Rodolico" of Catania that meet the inclusion criteria of the study and will give their informed consent to participation. The enrolled patients will be monitored for a maximum period of 7 days from transplantation. As control group there will be considered an historical cohort of patients who underwent kidney transplantation from cadaver in 2015, in which a PGDT protocol was not used, but a common hemodynamic monitoring, based on parameters such as central venous pressure and / or invasive arterial pressure, was performed according to the international guidelines.
A short ketogenic diet (KD) treatment can prevent migraine attacks and correct excessive cortical response. Here, investigators aim to prove if the KD-related changes of cortical excitability are primarily due to cerebral cortex activity or are modulated by the brainstem. Through the stimulation of the right supraorbital division of the trigeminal nerve, there will be concurrently interictally recorded the nociceptive blink reflex (nBR) and the pain-related evoked potentials (PREP) in 18 migraineurs patients without aura before and after 1-month on KD, while in metabolic ketosis. nBR and PREP reflect distinct brain structures activation: the brainstem and the cerebral cortex respectively. It will be estimated nBR R2 component area-under-the-curve as well as PREP amplitude habituation as the slope of the linear regression between the 1st and the 2nd block of 5 averaged responses.
The primary objective of the study is to assess the impact of treatment with apremilast 30 mg twice daily for 16 weeks, compared to placebo, on health-related quality of life (QOL) in adults with manifestations of plaque psoriasis and impaired quality of life.
The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with JIA from 2 years to less than 18 years old.