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.
Different reciprocal positions of mother and newborn during breastfeeding may be adopted. Other than the one derived from UNICEF guidelines, or standard position, an approach called biological nurturing has been recently proposed. It aims to promote the activation of neonatal primitive reflexes, breast problems reduction (e.g. cracked or sore nipple) and, overall, spontaneity and naturalness of mother-newborn dyad behaviour during feeding. The study of newborn cortical activation by functional near-infrared spectroscopy (fNIRS), a safe and minimally invasive functional neuroimaging technique based on haemoglobin absorption of near-infrared light, showed that baby's cortex exhibit a wide activation associated with breastfeeding. Moreover, preliminary and not yet published data, collected by fNIRS hyperscanning (e.g. the simultaneous detection of brain functional activation from two individuals living the same experience) in the Nursery of our Institute, evidenced that mother-newborn dyads adopting a biological nurturing approach to breastfeeding show a neural synchronization between their frontal cortex during such experience. Basing on this new evidence, it is now worth to understand if a biological nurturing approach to breastfeeding may promote such neural synchronization, even when postpartum depressive symptoms are present. Accordingly, biological nurturing may result to be protective for the neural basis of mother-newborn relationship, also in case of a postnatal affective suffering and helping to prevent its potential long term consequences on maternal wellbeing and infant neurodevelopment as well. Moreover, since oxytocin is a neuropeptide with widespread influence on parental function, including lactation and nurturing maternal behaviour physiology, if a biological nurturing approach to breastfeeding may promote the oxytocin level in the mother and/or in the newborn is worth to understand as well, taking into account again possible relations with postpartum depression symptoms. the aim of this study is to evaluate, by fNIRS hyperscanning, if the frontal cerebral cortex functional synchronization of mother-newborn dyads, who adopt a reciprocal positioning according to the biological nurturing approach during breastfeeding, differs from that of mother-newborn dyads adopting the standard position, taking into account the intensity of mother's postpartum depressive symptoms.
This is a proof-of-concept, Open label, randomized, multicentric, superiority phase-2 study.
Gastroesophageal reflux (GER), defined as the backflow of gastric material into the esophagus, it is a condition with a high prevalence during the first year of life. The disease from Gastroesophageal reflux (GERD), a rarer condition, is defined as the presence of symptoms and complications caused by gastroesophageal reflux. For the diagnosis of GERD in infants it is necessary to perform instrumental diagnostic tests invasive. Several efforts have already been made to identify diagnostic strategies non-invasive but, at the state of the art, no non-invasive biomarker has yet been found of GERD in infants. Therefore, the aim of this pilot study is to identify possible biomarkers salivary gastroesophageal reflux in a population of infants with GER or GERD. Infants from 2 months to the first year of life, with age, will be prospectively enrolled postmenstrual > 40 weeks, hospitalized, with symptoms of GER or GERD and undergoing 24-hour esophageal MII-pH. Saliva samples will be collected during the execution of the MII-pH of the esophagus 24 hours, at defined time points, at least 2 hours after the last meal, so as to study the circadian variations of their composition. A control group made up of healthy infants will also be enrolled and will be sampled a single saliva sample during a health assessment. The salivary pH, the buffer capacity, the electrolytes (Na, K, Cl, HCO3) and the saliva pepsin/pepsinogen concentrations of enrolled infants. The expected results include the description of the salivary biochemical profile of GER infants vs. GERD, so that the investigators can develop non-invasive diagnostic strategies and detect personalized therapeutic treatments.
Depression after an acute coronary syndrome (ACS) but also at any time after CAD diagnosis, is highly associated with death, and it predicts mortality more than any other risk factor, comorbidity or follow-up events, suggesting that the standard medical therapy may not be sufficient to prevent the poor prognosis in these patients. This study aims to assess whether depression might affect the response to dual antiplatelet therapy (DAPT) as recommended in coronary artery disease (CAD) patients. Specific aims: - to evaluate whether depression affects the antithrombotic response during Aspirin (ASA) plus clopidogrel (CLP) therapy in CAD patients. - to assess the antithrombotic effects of ASA plus ticagrelor or prasugrel (TCG/PSG) therapy in CAD patients with depression by evaluating pro-thrombotic phenotype in CAD patients with and without depression during ASA+TCG/PSG. - to assess whether there is or not the reactivation of pro-thrombotic profile after cessation of dual antiplatelet therapy in CAD patients with or without depression in single antiplatelet therapy after TCG/PSG cessation.
This study is open to adults with moderate to severe hidradenitis suppurativa (HS). The purpose of this study is to find out whether a medicine called spesolimab helps people with HS. People who have previously taken specific medicines such as immunosuppressive biologics other than Tumor necrosis factor (TNF) inhibitors cannot take part. This study has 2 parts. In Part 1, participants are divided into 4 groups of almost equal size. 3 groups get different doses of spesolimab, 1 group gets placebo. All participants get injections into a vein or under the skin. Placebo injections look like spesolimab injections, but do not contain any medicine. Every participant has an equal chance of being in each group. In the beginning, participants get the study medicine every week and later every 2 weeks. After 4 months, participants in the placebo group switch to spesolimab treatment. In Part 2, participants are divided into 2 groups. One group gets a suitable dose of spesolimab that was found in Part 1 of the study. The other group gets placebo. After 4 months, participants in the placebo group switch to spesolimab treatment. Participants join only one of the two parts. They are in the study for about 1 year. During this time, they visit the study site in the beginning every week and later every 2 weeks. Some of the visits can be done at the participant's home instead of the study site. The doctors regularly check participants' HS symptoms. The results are compared between the groups to see whether spesolimab works. The doctors also regularly check participants' general health and take note of any unwanted effects.
The purpose of this randomized, double-blind, placebo-controlled study is to assess the efficacy of BIA 28-6156 over placebo in delaying clinical meaningful motor progression over 78 weeks in subjects with Parkinson's disease who have a pathogenic variant in the glucocerebrosidase 1 (GBA1) gene (GBA-PD).
Study RAD-GRIN-101 is a phase 1B trial to assess safety, tolerability, PK, and potential efficacy of radiprodil for the treatment of GRIN-related disorder in children with a Gain-of-Function (GoF) genetic variant. The study is open-label, so all participants will be treated with radiprodil. Subjects' participation in the study is expected to last up to six months in Part A. After the end of part A, all participants who are still eligible can choose to continue to receive radiprodil as part of an open-label long-term treatment period (Part B).
The goal of this multicenter randomized clinical trial is to test the superiority in terms of efficacy of the Angiography-derived fractional flow reserve (AIR) over that based on conventional angiography (ANGIO) strategy in the management of non-culprit lesions in STEMI patients with multivessel disease. The main questions it aims to answer are: - is an Angiography-derived fractional flow reserve strategy superior to a conventional angiography strategy in reducing the occurrence of the composite efficacy endpoint of all-cause death, myocardial infarction, cerebrovascular accident, or ischemia-driven revascularization. - is an Angiography-derived fractional flow reserve strategy superior to a conventional angiography strategy in reducing the occurrence of the composite safety endpoint of of contrast-associated acute kidney injury and Bleeding Academic Research Consortium (BARC) type 3-5. Participants will be randomized after the successful treatment of the culprit lesion to one of the two strategies and prospectively followed-up.
To describe the effectiveness, treatment patterns, quality of life, and safety of participants with moderately or severely active UC treated with filgotinib in a real-world setting.
This phase II open label trial randomized patients who completed the induction with nivolumab plus ipilimumab without complete response or progressive disease will be randomized 1:1 to receive axitinib in addition to nivolumab (Arm A) or continue with nivolumab alone (Arm B).Treatment will be continued until progression of disease, unacceptable toxicity, patient's refusal, or physician decision whichever occurred first.