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 purpose of this global Phase 2 study is to determine the efficacy, safety, and tolerability of 3 dose levels of OG-6219 in pre-menopausal women between 18 and 49 years of age (inclusive), who have moderate to severe endometriosis-related pain.
This study is open to adults aged 18 and older or above legal age who have systemic sclerosis. People can participate if they have a specific subtype called diffuse cutaneous systemic sclerosis. People with another subtype called limited cutaneous systemic sclerosis can also participate if they are anti Scl-70 antibody positive. Systemic sclerosis is also called scleroderma. The purpose of this study is to find out whether a medicine called Avenciguat (BI 685509) helps people with scleroderma who have symptoms due to lung fibrosis or vascular problems. Participants are put into 2 groups by chance. One group takes Avenciguat (BI 685509) tablets 3 times a day and the other group takes placebo tablets 3 times a day. Placebo tablets look like BI 685509 tablets but do not contain any medicine. Participants take the tablets for at least 11 months. Afterwards, participants can continue to take the tablets until the last participant has completed the 11-months treatment period. This means that the time in the study and duration of treatment is different for each participant, depending on when they start the study. At the beginning of the study, participants visit the study site every 2 weeks. The time between the visits to the study site gets longer over the course of the study. After the 11-months treatment period, participants visit the study site every 3 months. During the study, participants regularly do lung function tests. The results are compared between the 2 groups to see whether the treatment works. The participants also regularly fill in questionnaires about their scleroderma symptoms. The doctors regularly check participants' skin condition and general health and take note of any unwanted effects.
Given the current increase in the incidence of dyslipidemia and obesity in the general population, there is a strong interest in identifying dietary factors capable of preventing the onset of metabolic diseases or at least capable of reducing metabolic risk. Several experimental evidences have shown that improving the carbohydrate and lipid profile in subjects at risk can reduce mortality linked to cardiovascular, neurodegenerative diseases and cancer. The diet is, therefore, an effective prevention tool in combating diseases related to metabolism, such as MAFLD (Metabolic Associated Fatty Liver Disease). In particular, fruit with its high content of polyphenols has been shown to exert a high anti-inflammatory, antithrombotic and antiproliferative action. Polyphenols extracted from oranges of the "Tacle" variety have demonstrated in vitro an inhibitory action of cholesterol synthesis. In addition, the consumption of orange juice has been shown to improve the serum lipid profile of obese subjects, as well as "hesperedine", a flavonoid mainly present in oranges is able to reduce the proliferative activity of MCF-7 (human breast cancer cell line with estrogen, progesterone and glucocorticoid receptors) cells.
This is a prospective, open, randomized phase II trial.
Instrumental delivery is performed in 3-15% of all births (1). Successful instrumental delivery avoids need for cesarean section with associated maternal surgical morbidity, risk from neonatal disimpaction and future pregnancy implications. However, instrumental birth carries risk of maternal perineal and anal sphincter injury, postpartum haemorrhage, shoulder dystocia and fetal trauma (2,3). Additionally, failure of instrumental birth requires delivery by cesarean section with a more deeply impacted fetal head, resulting in compounding of fetal and maternal risks (3,4). Therefore, appropriately identifying women that are at risk of failed instrumental birth is important to reduce maternal and neonatal morbidity. Fetal head position and station are key determinants in success of instrumental birth, traditionally assessed with digital vaginal examination (1,5). There is now high quality evidence showing that intrapartum ultrasound is a more reliable tool in determining fetal head position and station compared to digital vaginal examination (6,7). Additionally, intrapartum ultrasound has been shown to predict outcome of instrumental birth and improve accuracy of instrument placement (8-11). However, no randomised studies to date have demonstrated a benefit in maternal and neonatal morbidity from using intrapartum ultrasound, possibly due to being underpowered. Low recruitment of studies has been suggested to occur due to practitioners electing to use ultrasound rather than randomise participants, despite the absence of evidence supporting clinical benefit (13). This study aims to evaluate whether the assessment of the fetal occiput position by intrapartum sonography before instrumental delivery improves labour outcomes by using an observational design with propensity score matching analysis. This international multicentre prospective observational study will compare outcomes of two parallel groups: - Group 1: patients submitted to instrumental delivery preceded by the use of ultrasound for the assessment of the occiput position by clinicians who routinely perform intrapartum sonography as an adjunct to clinical examination prior to vacuum delivery - Group 2: patients having submitted to instrumental delivery without the adjunct of by clinicians not performing intrapartum sonography prior to vacuum delivery The investigators will perform a propensity score (PS) matching analysis to assess the effect of US as an adjunct to clinical examination prior to instrumental delivery on the occurrence of failed instrumental delivery, adjusting for important differences in baseline characteristics between groups to reduce confounding bias. The investigators will assess two primary outcomes of vaginal delivery and composite adverse perinatal outcome in additional to maternal morbidity and instrumental failure rates.
This is an observational study on GBM surgical samples to investigate if increasing doses of radiation therapy could improve the radiation response; and in particular the investigators will assess if there is a correlation between the number of the phosphorylated H2AX nuclear foci and the different dose level of radiation therapy.
Cardiomyopathy refers to a diverse group of myocardial diseases with multiple causes. In 1995, the World Health Organization classified cardiomyopathies into hypertrophic, dilated, restrictive, and mixed type. This classification is based on the pathophysiology of the disease. However, with rapid evolution of molecular genetics in cardiology, the American Heart Association in 2006 has classified cardiomyopathies into two major groups based on predominant organ involvement and etiology; Primary cardiomyopathies are those solely or predominantly confined to heart muscle and are relatively few in number. Secondary cardiomyopathies show pathologic myocardial involvement as part of a large number and variety of generalized systemic (multiorgan) disorders.Current evidence supports the use of genetic testing in clinical practice to improve risk stratification for clinically affected patients and their at-risk relatives for cardiomyopathies.
The purpose of this study is to evaluate the safety and efficacy of ALXN1720 for the treatment of generalized MG (gMG) in adults with autoantibodies against acetylcholine receptor (AChR).
Psoriasis, is an inflammatory chronic skin disease which has a heavy physical and psychosocial impact on participant's life. This is a study to finalize and validate a questionnaire to assess the long-term effect of long-term psoriasis in adult participants. Approximately 550 adult participants with moderate to severe plaque psoriasis will be enrolled in approximately 15 dermatology centers in Italy. Participants will receive standard of care while participating in this study. No drug will be administered as a part of this study. The duration of this study is up to 22 months. There is no additional burden for participants in this study. Participants will attend regular visits during the course of the study at a hospital or clinic.
This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab in combination with pemetrexed and platinum chemotherapy in participants with no prior therapy for advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).