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.
It has been reported that a consistent percentage of the general population consider themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though they do not have celiac disease or wheat allergy. This clinical condition has been named Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat causes the symptoms in NCGS patients, and the investigators also showed that these patients had a high frequency of coexistent multiple food hypersensitivity. To our knowledge, there are very few studies which assessed the prevalence of self-reported gluten-related symptoms in the community and analyze diagnostic outcomes in those referred to secondary gastrointestinal care. In one of these, performed in UK, the authors showed that gluten-related symptoms are self-reported by 13% of the population, with 3.7% consuming a gluten-free diet, despite only 0.8% being aware that they have a formal diagnosis of celiac disease. Of those patients presenting to the gastroenterology department, the majority do not have CD but NCWS. No data are available for boys and girls. Therefore, the aims of this study were 1) to determine the prevalence of self-perceived gluten-sensitivity in a population of high-school students, and 2) to evaluate the demographic and clinical differences between students self-reporting gluten sensitivity and students not reporting food hypersensitivity.
RATIONALE AND OBJECTIVE OF THE STUDY Patients with low functional capacity (frail patients) with cardiovascular disease, in particular those undergoing invasive procedures or suffering from coronary artery disease, have a much higher adverse events, death and re-hospitalizations. and complications, suggesting the need for a more accurate functional stratification and a more careful evaluation of the risk/benefit ratio of some invasive procedures. An early and ad hoc physical activity intervention could be improve functional autonomy of these patients early after discharge with benefit on long-term outcome. The present study is performed to assess the impact, evaluated by Short Physical Performance Battery (SPPB), of a program of physical activity early after discharge in elderly patients aged 75 years and older with low physical performance. This is an interventional, multicenter, prospective, randomized, phase III study. The present study is expected to enroll elderly patients admitted to hospital for acute coronary syndrome undergoing percutaneous coronary angioplasty and stratified with SPPB score predischarge. At the moment of discharge there will be a screening: patients with SPPB score 0-2 o 10-12 will be exclusively followed up by clinical visit every year. Patients with SPPB score 3-9 will be evaluated during the inclusion visit when SPPB will be repeated. If SPPB score will be 0-3 or 10-12, patients will be considered screening failure and will be followed up by clinical visit; patients with SPPB score between 4 to 9 will be randomized to standard of care (see below) or to an ad hoc physical activity program (see below). The aim of the study is to demonstrate 6 months later an improvement in the SPPB score (at least 1 point) in patients randomized to physical activity intervention versus patients randomized to standard of care. All patients will be evaluated until 3 years after randomization.
Recently it has been reported that a consistent percentage of the general population consider themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though they do not have celiac disease or wheat allergy. This clinical condition has been named Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat causes the symptoms in NCGS patients, and the investigators also showed that these patients had a high frequency of coexistent multiple food hypersensitivity. It is also believed that this condition is worldwide increasing, due to the evolution of wheat breeding (i.e. consumption of wheats with high gluten content), and that "ancient" wheat flour varieties are better tolerated by NCWS patients than the "modern" ones. This effect could be related to a lower immunogenic stimulation of the ancient wheat than the modern ones. The aim of the study is to evaluate the effect of a diet based on ancient grains in a "closed" community (i.e. nuns from enclosed religious order) as regard to 1) main haematochemical parameters and vitamins, 2) intestinal microbiota (bacterial flora), and 3) cytokines production from peripheral blood mononuclear cells (PBMC), before and after the diet period (30 days) with ancient grains.
The purpose of the study is to investigate whether corifollitropin alfa (MK-8962), administered alone for 12 weeks and then in combination with human chorionic gonadotropin (hCG) for 52 weeks, increases the testicular volume in adolescent males aged 14 to <18. In addition, the study will evaluate participants for safety, tolerability and for the development of corifollitropin alfa antibodies. No formal hypothesis will be tested for this estimation study
Menopause is usually associated with an increase in body weight, a change in body composition and fat distribution and a large number of cardio-metabolic changes, such as hypertension, reduction of insulin-sensitivity and dyslipidaemia. The first-line strategy for these complications is the modification of dietary habits and lifestyle in terms of physical activity. Besides, there is also a growing interest in complementary therapies (i.e. nutraceuticals) that can be used alone or in combination to achieve more consistent results. In this context, preliminary evidence supports the potential role of some compounds of vegetal origin such as berberine, chlorogenic acid and tocotrienols. However, in support of their use, the evidence from good quality trials is limited.
Recently it has been reported that a consistent percentage of the general population consider themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though they do not have CD or wheat allergy. This clinical condition has been named Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat causes the symptoms in NCGS patients, and the investigators also showed that these patients had a high frequency of coexistent multiple food hypersensitivity. The clinical picture of NCWS is characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis) and extra-intestinal and/or systemic manifestations (headache, depression, anxiety, 'foggy mind,' tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm numbness, and anemia). Nowadays no data are available on the abdominal ultrasonographic features of NCWS patients. Therefore, the aim of the present study is to evaluate the abdominal ultrasonographic features of NCWS patients in comparison with patients affected with celiac disease.
A Study to Evaluate Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of HNO Donor in Hospitalized Patients with Heart Failure and Impaired Systolic Function
This Phase III, multicenter, randomized, open-label study will evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) in combination with enzalutamide compared with enzalutamide alone in participants with mCRPC after failure of an androgen synthesis inhibitor (e.g., abiraterone) and failure of, ineligibility for, or refusal of a taxane regimen. Participants will be randomized to one of the two treatment arms (atezolizumab in combination with enzalutamide, and enzalutamide alone) in a 1:1 ratio (experimental to control arm) in global randomized phase. Participants will receive treatment until investigator-assessed confirmed radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3) criteria or unacceptable toxicity.
The objective of this study is to evaluate the safety and performance of the Trifecta™ GT (Glide Technology) valve through 5 year follow-up in a prospective, multi-center, real-world setting. This study is intended to satisfy post-market clinical follow-up requirements of CE Mark in Europe.
The study evaluate the anesthetic efficacy of Pecs II block II and parasternal block during quadrantectomy with or without axillary dissection, in breast cancer surgery