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 main aim of this study is to check if there are side effects from BAX 888 and to determine the dose of BAX 888 for treating severe hemophilia A in male adults. Participants will receive one infusion with BAX 888 at the hemophilia treatment center. During the study, participants will visit their study clinic multiple times.
Motor imagery is increasingly used as a plasticity-booster to complement conventional rehabilitation. Here the investigators test the hypothesis that the combination of mental training with conventional rehabilitation may speed up the recovery in patients with total knee arthroplasty. The investigators also characterize the brain correlates of such recovery with imagery tasks for virtual reality environments.
This is a study to compare the efficacy of bimekizumab versus placebo and an active comparator in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).
The purpose of the study is to evaluate the long-term safety and tolerability of Padsevonil administered at individualized doses as adjunctive treatment for subjects with drug-resistant epilepsy.
The ability to interact with conspecifics is crucial in life, yet there is no consensus on the underlying cognitive and neural mechanisms beyond those associated with imitative behaviors. This project aims to define a coherent model of non-imitative (complementary) motor interactions. The investigators hypothesize that these might be substantially based on the ability to integrate one's own and a partner's action within a unitary, dual- person (dyadic), motor plan that incorporates a shared goal. With a novel "minimally-joint" paradigm the investigators will test this hypothesis and measure with behavioral measures (i.e., reaction times) whether the supposedly automatic tendency to imitate others is modulated by the need to coordinate with a partner to achieve a shared goal. This paradigm will be also applied during a functional MRI experiment to describe the underlying neurophysiological patterns; using dynamic causal modeling the investigators will measure how the brain regions relevant for dyadic motor control are functionally linked. This converging experimental strategy will permit to compare competing psychological and neural models of motor interactions in healthy participants, opening new experimental avenues for studies in adult neuropsychological patients and in children with typical and atypical social development.
The main purpose of the study was to assess the health-related quality of life (HRQoL) through the Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) scale in highly-active relapsing multiple sclerosis (RMS) particpants treated with Mavenclad® for 2 years (24 months).
Background: Problems with handwriting are frustrating and debilitating and affect the majority of people with Parkinson's. Manifest as micrographia it is a distinctive feature of the condition characterised by small handwriting and/or a progressive reduction in size through a sentence[2] coupled with a reduction in writing speed and legibility. In Parkinson's impaired automaticity is thought to contribute to handwriting deficits and attention has been shown to improve both 'consistent' (small handwriting) and 'progressive' (progressive reduction in letter size through a sentence) aspects of the symptom. Moreover, recent interventional studies indicate handwriting may be improved through practice. This study is investigating a novel handwriting practice stimulus to improve symptoms of micrograpthia Question: Is a diverging line cued handwriting intervention potentially more effective at improving symptoms of mircograpthia than a parallel line cued handwriting intervention in people with Parkinson's? Specifically, an assessor blind randomised controlled exploratory trial will: 1. Estatimate the effect of the intervention on measures of: Handwriting amplitude (consistent and progressive reduction), hand writing performance and percieved handwriting difficulties. 2. Explore the appropriateness of these outcome measures 3. Explore the approriateness of eligibilty criteria 4. Explore intervention fidelity 5. Explore participants views of the intervention Design: A phase II exploratory randomised controlled trial of a handwriting intervention with an active comparator control group and blinded assessments Setting: The intervention will be carried out at home Sample size: This study is not designed to determine efficacy. The aim to recruit a total of 50 people (25 people per group) in order to estimate the effects on outcome measures and achieve the aims of this exploratory trial. Assessment: Participants will be asked to follow their usual Parkinson's medication regime and if they have ON and OFF periods, assessments will be carried out during ON state. Duration and follow-up: the assessment is schedule 0Weeks (baseline), 6weeks (end intervention) and 12weeks (follow up). Assessments will be carried out by a researcher blind to trial arm allocation using all outcome measures.
During abdominal surgery, the intra abdominal pressure may increase determining lung bibasal atelectasis. The investigators hypothesized that the application of Positive End Expiratory Pressure (PEEP) promptly after extubation through Continuous Positive Airway Pressure (CPAP) would improved gas exchange, especially in those patients with abdominal pressure values close to those applied by CPAP. The investigators have therefore designed this subset study enrolling patients randomized to receive CPAP in the "Prevention of Respiratory Insufficiency after Surgical Management (PRISM)" Trial in order to ascertain the abdominal pressure in post-surgical patients (abdominal open surgery procedures) enrolled in PRISM trial. In addition they would evaluate the effects of CPAP on abdominal pressure and consequently on arterial blood gas, and whether there is a correlation between PEEP values, abdominal pressure values and arterial blood gas. One hundred patients included in CPAP group of the PRISM trial will be enrolled in this subset study. The investigators will perform measurements of the abdominal pressure an urinary catheter connected with an intra-abdominal pressure device (Uno-Meter ® - Uno-medical) in all patients undergoing on open-surgical procedures after mechanical ventilation withdrawal and extubation, 30 minutes and 4 hours after the application of CPAP.
The aim of hip replacement surgery is to re-establish the physiological hip function and to obtain a stable fixation between the prosthetic components and the native bone. Commonly, the fixation is obtained by bone ingrowth between the prosthesis and the native bone. Thus, the quality of the patient's bone stock is essential to achieve this aim. However, several clinical conditions may impair the bone stock; therefore, in these cases bone grafts are necessary to improve the prosthetic fixation. The gold standard is represented by autologous bone grafts (from iliac crest or from acetabular bone chips) or allogeneic bone grafts from cadaveric femoral heads. Nevertheless, the osteogenic potential of multipotent cells derived from different anatomical regions has never been examined. Thus, the aim of this study is to isolate multipotent cells from acetabular or femoral bone chips and from bone marrow aspirate of the same patient and to compare their osteogenic potential. The results of this study may reveal differences, which may have a clinical relevance for hip replacement surgery.
Severe haemophilia B (HB) is a bleeding disorder where a protein made by the body to help make blood clot is either partly or completely missing. This protein is called a clotting factor; with severe haemophilia B, levels of clotting factor IX (FIX) (nine) are very low and affected individuals can suffer life threatening bleeding episodes. HB mainly affects boys and men (normally one in every 30,000 males). Current treatment for HB involves intravenous infusions of factor IX as regular treatment (Prophylaxis) or 'on demand'. On demand treatment is highly effective at stopping bleeding but cannot fully reverse long-term damage that follows after a bleed. Regular treatment can prevent bleeding, however can be invasive for patients and also expensive. This research study aims to test the safety and effectiveness of a gene therapy which produces Factor IX protein in the body. The gene will be given using an inactivated virus called "the vector" ( FLT180a), in a single infusion. The vector has been developed from a virus known as an adeno- associated virus, that has been changed so that it is unable to cause a viral infection in humans. This "inactivated" virus is further altered to carry the Factor IX gene and to make its way within liver cells where Factor IX protein is normally made. Up to three different doses cohorts of FLT180a will be tested, in up to 24 patients with severe haemophilia B. Patients will be recruited from haemophilia centres in the EU and US. Patients will be in the trial for approximately 40 weeks and will undergo procedures including physical examinations, bloods tests, ECGs and liver ultrasounds.