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.
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.
Sleeve gastrectomy, the most commonly performed bariatric surgery procedure, carries limitations both short-term including postoperative complications such as hemorrhage and gastric fistula and long-term such as weight regain and gastro-esophageal reflux. A new procedure has been proposed to overcome many of these limitations: laparoscopic vertical clip gastroplasty (LVCG) with Bariclip. Primary outcome were major postoperative complications. Secondary outcomes included weight loss, incidence of de-novo GERD and comorbidity resolution.
This study will investigate the effect of tirzepatide on the reduction of morbidity and mortality in adults living with obesity and provide additional evidence for the potential clinical benefits of tirzepatide in this population.
The PARABONE study aims to investigate the interaction between bone and parathyroid glands in patients with primary hyperparathyroidism (HPT). The study consists of a clinical part aimed at evaluating a series of circulating molecules of bone derivation (osteocalcin, molecules of the WNT pathway, RANKL, osteoprotegerin, Scelrostin, FGF23) in patients with HPT. In particular, the study has as its primary objective to identify the correlation between circulating levels of PTH and levels of GlaOC and GluOC in patients with HPT.
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 characterize the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of MYK-224 in participants with obstructive Hypertrophic Cardiomyopathy (oHCM)
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).