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Filter by:This is a study of normal brain physiology in healthy human volunteers. The study aims to understand the physiology of connectivity between brain regions. To reach this aim, it delivers single-pulse transcranial magnetic stimulation (spTMS) to one or two brain areas at a time while electroencephalography (EEG) is measured. When only one brain area is stimulated (uni-focal TMS), the goal is to record how many milliseconds it takes for the activity to spread from the stimulated area to other brain regions (conduction delay). When two brain areas are stimulated (bi-focal TMS), the TMS pulses are separated by a short millisecond-level time interval ("asynchrony") in a so-called paired associative stimulation (PAS) design. The central hypothesis is that PAS may increase or decrease connectivity between the stimulated areas depending on the asynchrony value. All techniques in the study are non-invasive and considered safe.
An adequate bowel preparation is essential for a high quality of colonscopy. Nowdays, polyethyleneglyco is considered the most safe drug for bowel preparation, and is widely used around the world. However, previous study illustrated that bowel preparation by polyethyleneglyco could lead to qualitative changes in the intestinal microbiota both in mice and human. This study is aimed to investigate wether the changes in the intestinal microbiota could lead to a higher rate of intestinal infection.
In oncology, the search for genetic alterations or infectious agents in tumour tissues has become a major medical challenge for diagnosis, prognosis, prediction of response to treatment and in particular to targeted therapies, or for the biological monitoring of the disease. Over the last ten years, the development of new molecular biology tools based on high-throughput technologies has enabled us to revisit our conceptions of the development and natural history of cancers. The use of these tools has also allowed the dismemberment of numerous cancerous pathologies according to their molecular etiologies and oncogenetic histories. These new molecular biology tools have thus contributed to the emergence of so-called personalised or precision medicine.
This is a prospective non interventional study including patients with Relapsing-Remitting Multiple Sclerosis (RRMS) or with Neuromyelitis Optica Spectrum Disorders (NMOSD) and healthy subjects, who are enrolled within the routinely programmed clinical examinations at the IRCCS Neuromed (Pozzilli, Italy), IRCCS Polyclinic Hospital San Martino (Genoa, Italy) and Sant'Andrea Hospital - University of Rome La Sapienza (Rome, Italy). Specifically, the study investigates how ozanimod may contrast neurodegenerative mechanisms triggered by both arms of the adaptive immune response (T and B cells) and by their suboptimal regulation in MS. Overall, the project aims at assessing by in vitro experiments (there will be no patients on treatment with ozanimod and the drug will be only used in vitro): AIM1: ozanimod ability to modulate the synaptotoxic effect of T-cells derived from patients with MS relapse in a MS-chimeric ex-vivo model and to identify possible mediators (IRCCS Neuromed-Pozzilli, in collaboration with Synaptic Immunopathology Laboratory Dep. Systems Medicine, Tor Vergata University of Rome); AIM2: ozanimod ability to reduce the cytokine-mediated breakdown of the BBB and the migration of the here studied immune cells through ex vivo models of BBB (IRCCS Polyclinic Hospital San Martino); AIM3: ozanimod ability to affect the migration properties of Epstein Barr virus (EBV) infected B cells in MS (Sant'Andrea Hospital); AIM4: ozanimod ability to modulate the number and/or function of regulatory T cells (Treg), a lymphocyte population playing a key role in the control of pathogenic adaptive immune responses (Treg Cell Laboratory, Università degli Studi di Napoli "Federico II", Naples, Italy, receiving blood samples from Neuromed Hospital and Sant'Andrea Hospital; not recruiting unit). The work of the four labs is conceptually and operationally integrated: the labs at IRCCS Neuromed-Pozzilli/Tor Vergata University (Aim1) and at Polyclinic Hospital San Martino (Aim2) will investigate the effects of ozanimod on well-known mechanisms of damage in MS, inflammatory synaptopathy and BBB damage and immune cell migration. The lab at Sant'Andrea Hospital (Aim3), will verify whether B cells infected by different EBV genotypes are involved in BBB migration, and how ozanimod may interfere with this mechanism. The Treg Cell Laboratory (Aim4) will investigate whether ozanimod can also act "upstream" of these mechanisms by regulating the adaptive immune response.
Study Design This is a phase 1, randomized, Vehicle-controlled, double-blinded study to assess the safety of Caregen Intranasal CG-SpikeDown in healthy subjects. All randomized subjects will receive an active drug or Vehicle. Subjects randomized to the DP(Drug product) active treatment will receive CG- SpikeDown intranasally once daily for one or seven days at either a low (25 mg) or planned (50 mg) dose. Subject recruitment will be conducted via study advertisement on social media, and subjects will be adequately compensated. The subjects will arrive each day at the clinic to receive the treatment and will be hospitalized for safety monitoring for the first 24 hours post-DP or vehicle administration.
An open label, single center, parallel, single and multiple oral dose study to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of DWP16001 in healthy Koreans, Caucasians, and Hispanics
The REFRESH study is designed to collect data related to a signal in the brain that MindRhythm has named the Headpulse. The Headpulse occurs as a natural movement of the brain in conjunction with the beating of the heart. 500 "normal" subjects who are considered healthy as they do not have any current known neurological injury will collect the brain signal data from the non-invasive headband style headset for a duration of 3 minutes either once or multiple times. Upon consenting to participate to the study by way of the accompanying MindRhythm app, participants will be sent a Harmony headset kit which will include ECG leads to collect cardiac data in conjunction with the brain signal. The participant will receive training materials and instructions on how to collect and transmit data to investigators by way of the MindRhythm app. The data collected by these "normal" patients will be used as a comparator to individuals who are suspected of neurological injury. This data will assist in training the data analysis algorithm to optimize its diagnostic abilities in detecting neurological injury or abnormalities including but not limited to stroke, stroke type, and concussion. The data set will also be analyzed to determine how the signal varies within an individual and amongst other "normals." An additional benefit of collecting this data will be to gain knowledge related to the ergonomic factors of the app and the headset and its "user friendliness."
Virtual reality systems or simulators are more and more frequently used in the field of learning but also in motor rehabilitation. One of the key points of the success of these systems is the experience of "presence" which is associated with the capacity of these technologies to develop in the observer, who is static, the sensation of moving in the virtual environment (vection). However, the simulation generates a sensory conflict (an optical flow specifying self-motion and vestibular stimuli specifying body immobility). This conflict influences the temporal characteristics of the vection and consequently modifies the way users act in their virtual environment. Thus, contrary to a real situation, vection does not occur instantaneously with the appearance of a visual movement. Moreover, the visual stimulus often generates alternating periods of perception of movement of the environment and of oneself (bistable perception) which can lead to "simulator sickness", a disabling situation for the user. Thus, as vection is an essential element to allow an "optimal transfer of learning" from the simulator to reality, it may be important to promote its emergence while limiting its bistability. The aim of this project is to study the inhibitory or facilitative modulation of the emergence of the vection phenomenon by the use of non-invasive cortical stimulation techniques (transcranial electrical stimulation (tES), transcranial alternative current stimulation (tACS), and repeated transcranial magnetic stimulation (rTMS)).
A randomized clinical trial on a cohort of healthy subjects of legal age, both sexes, recruited from the university community and who will be randomly distributed into two groups (experimental and control). The objective is to assess neurophysiological activation by measuring oxygenation in the supplementary motor and premotor areas of oxygenation in the supplementary motor and premotor areas, through near infrared spectroscopy (NIRS) in healthy subjects spectroscopy (NIRS) in healthy subjects during the application of Vojta Therapy.
Stability studies on the peripheral biomarkers (lncRNAs, sncRNAs, mRNAs, proteins, lipids/metabolites) measured by Firalis IVD test candidates and effect of gender, age, nutrition on their expression level