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NCT ID: NCT05355480 Recruiting - Parkinson Disease Clinical Trials

Handwriting Analysis in Movement Disorders

HANDWRML
Start date: December 1, 2022
Phase:
Study type: Observational

Handwriting is a complex cognitive prowess that deteriorates in patients affected by neurodegenerative diseases, including movement disorders. More in detail, patients with Parkinson's disease (PD) may manifest prominent handwriting abnormalities which have been collectively identified as parkinsonian micrographia. MIcrographia may manifest at the onset of the disease and then worsens progressively with time. Previous techniques released to investigate micrographia in PD relied on perceptual analysis of simple tasks or were based on expensive technological tools, including tablets. However, handwriting can be promptly collected in an ecological scenario, through safe, cheap, and largely available tools. Also, the objective handwriting analysis through artificial intelligence would represent an innovative strategy even superior to previous techniques, since it allows for the analysis of large amounts of data. In this experimental project, the investigators apply a specific machine learning algorithm to analyze handwriting samples recorded in healthy controls and PD patients. The study aims to verify whether the technique proposed by the investigators would be able to detect parkinsonian micrographia objectively, monitor the evolution of handwriting abnormalities and assess the symptomatic improvement of handwriting following L-Dopa administration in PD patients.

NCT ID: NCT05354037 Recruiting - Clinical trials for Intrabony Periodontal Defect

Flapless Approach for the Treatment of Intrabony Defects

Start date: May 13, 2021
Phase: N/A
Study type: Interventional

The use of Enamel Matrix Derivative (EMD) associated to microsurgical flaps was demonstrated to be effective for the treatment of intrabony defects, in particular in presence of a self-contained anatomy. The main aim of this study will be to evaluate the difference in Clinical Attachment Level (CAL) between baseline and 1-year follow-up, comparing flapless periodontal regeneration using EMD versus the use of EMD after microsurgical flap elevation (Modified-Minimally Invasive Surgical Technique (M-MIST) / Single-flap approach).

NCT ID: NCT05353517 Recruiting - Parkinson Disease Clinical Trials

Non-invasive Assessment of Synaptic Plasticity

NEUROPLAST
Start date: December 1, 2022
Phase:
Study type: Observational

The pathophysiological mechanisms underlying Movement Disorders, including Parkinson's disease, have been related to altered synaptic plasticity affecting several structures of the central nervous system. Although several previous neurophysiologic investigations have shown abnormal long-term potentiation and depression-like plasticity in M1, other regions crucially involved in motor planning and execution, including the spinal cord, have been studied less. Parkinson's disease arises from the progressive loss of dendritic spines followed by atrophy of specific cortical (i.e. M1) and subcortical structures (i.e. putamen). These structural changes are responsible for the main clinical features of PD such as bradykinesia and rigidity. The present research project aims to probe non-invasively the main pathophysiologic mechanisms underlying altered synaptic plasticity in M1 and spinal cord and their relationship in a cohort of patients with movement disorders, including Parkinson's disease. More in detail, the investigators will use specific methodologies able to induce plasticity, including the repetitive transcranial magnetic stimulation (TMS), concerning the M1 and the focal muscle vibration, regarding the spinal cord. The neuromodulation protocol will imply 2 separate sessions, randomly scheduled to take into account the effect of the symptomatic pharmacologic treatment. Furthermore, patients will be randomly assigned to sham or real non-invasive stimulation groups. Before and after the stimulation protocol, the investigators will collect specific clinical as well as neurophysiologic measures (i.e., thresholds) according to standardized procedures. In conclusion, the goal of the study is to investigate the abnormal plasticity in the M1 and spinal cord in patients affected by specific movement disorders, through non-invasive techniques.

NCT ID: NCT05352672 Recruiting - Melanoma Clinical Trials

Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

Start date: July 14, 2022
Phase: Phase 3
Study type: Interventional

This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called REGN2810, also known as cemiplimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on patients with a type of skin cancer known as melanoma. The aims of the study are to see how effective the combination of fianlimab and cemiplimab are in treating the melanoma skin cancer, in comparison with a medication, pembrolizumab, approved for the treatment of melanoma skin cancer in adults, and to observe any similarities, or differences, in how the study drugs work in adolescent participants compared with adult participants. The study is looking at several other research questions, including: - What side effects may happen from receiving the study drugs - How much study drug is in the blood at different times - Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections. - How administering the study drugs might improve quality of life

NCT ID: NCT05352295 Recruiting - Clinical trials for Bone Remodeling Bone Fragility Resulting From Covid19

Evaluation of the Effects of Covid 19 Infection on Bone Remodeling and Bone Fragility

CovidBone
Start date: February 18, 2021
Phase:
Study type: Observational

Although SARS-CoV-2 infection and subsequent COVID-19 disease is regarded as a disease that primarily affects the lungs, it can also damage many other organs. This organ damage may increase the risk of long-term health problems, but much remains to be elucidated as to how COVID-19 infection will affect those who have contracted the infection over time. Since SARS-CoV-2 infection mainly affects elderly people, one of the aspects to be evaluated in the near future is its interaction with bone metabolism, which progressively worsens with advancing age. So far, data on bone metabolism in SARS-COV-2 infection are very scarce. Furthermore, it is not clear whether the incidence of osteoporosis and the risk of fracture may increase in patients after recovery from the infection, due to the interaction of their risk factors (old age, smoking, long-term bed rest). term, hypovitaminosis D and steroid treatment) with the COVID-19 inflammatory process. In patients after recovery from severe acute respiratory syndrome (SARS), osteonecrosis and bone abnormalities with reduced bone density were observed, which were partly but not entirely explained by short-term use of steroids. Infections, trauma and injuries induce the production of endogenous signaling mediators of the inflammatory response. Significantly higher serum concentrations of pro and anti-inflammatory cytokines, including IL-6, TNF-α, and IL-10, characterized by severe versus moderate cases, suggest that disease severity may be associated with a "cytokine storm. "[14]. The interaction between inflammatory molecules, such as cytokines, and the bone system is defined as "osteoimmunology" and osteoimmunological mediators, such as RANKL, OPG, RAGE, play a fundamental role in osteoclastogenesis in physiological and pathological conditions. Although the long-term effects of COVID-19 are still unknown, the alleged consequences of the disease would likely be similar to those of coronavirus-related diseases, including SARS (Severe acute respiratory syndrome). In the case of SARS, viral infection-mediated effects have been described that stimulate osteoclatogenesis. Similarly, the current SARS-Cov-2 could have a dual effect, both direct and indirect, on osteoclastogenesis and, consequently, on bone resorption: indirectly by inducing the cytokine storm that promotes bone resorption, direct by stimulating differentiation and osteoclastic activation through the activation of osteoimmunological mediators.

NCT ID: NCT05351736 Recruiting - Schizophrenia Clinical Trials

Impact of Structural and Myelin Abnormalities on Cognitive Impairments in Recent-onset Schizophrenia - Before and After Lurasidone Treatment (MARYLU)

MARYLU
Start date: January 26, 2022
Phase: Phase 4
Study type: Interventional

The present longitudinal study aims to investigate the impact of lurasidone treatment in recent-onset psychosis patients. The effects of lurasidone will be studied primarily in terms of structural and myelin modifications, in relation to clinical outcomes, before and after treatment and in healthy controls. Furthermore, neuropsychological tests will be used to evaluate changes in cognitive performance.

NCT ID: NCT05351385 Recruiting - COVID-19 Clinical Trials

S Protein and COVID-19: a Monocentric Prospective Study

PROS-Covid
Start date: September 23, 2021
Phase:
Study type: Observational [Patient Registry]

The aim of this study is to compare plasma S Protein levels to SARS-CoV-2 viral load in COVID positive patients.

NCT ID: NCT05349539 Recruiting - Parkinson Disease Clinical Trials

Instrumental Assessment of Motor Symptoms by Means of Wearable Sensors in Patients With Parkinson's Disease

Start date: June 1, 2022
Phase:
Study type: Observational

The clinical management of Parkinson's disease (PD) is frequently challenged by the occurrence of motor disorders and complications, such as freezing of gait, fluctuations and the ON-OFF phenomenon, primarily manifesting at home. Therapeutic decisions are usually based on periodic neurological examinations and patients' anamnestic experience collected in an outpatient setting, thus limited by several issues, including "recall bias" and subjective, semi-quantitative and operator-dependent evaluations in non-ecological settings. In the last two decades, new wearable technologies, consisting of "wireless" sensors (e.g., inertial, electromyography), have been widely applied to quantitatively assess movements in physiological and pathological conditions, even for prolonged periods in free-living settings (i.e., long-term monitoring). The aim of this study is to evaluate motor symptoms in patients with PD, such as bradykinesia, tremor, gait disturbances and balance disorders, objectively and quantitatively through the application of wearable sensors in intra- and extra hospital settings, also during common activities of daily living, in order to obtain ecological data possibly useful in the therapeutic management of the disease.

NCT ID: NCT05349214 Recruiting - Sjogren Syndrome Clinical Trials

Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome

NEPTUNUS-2
Start date: August 4, 2022
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-2)

NCT ID: NCT05348967 Recruiting - Clinical trials for Polycystic Ovary Syndrome

Combination of D-chiro-inositol With Ketogenic Diet

Start date: October 14, 2022
Phase: N/A
Study type: Interventional

The study aims to evaluate whether the combination of a product based on D-chiro-inositol and the ketogenic diet can improve the metabolic/endocrine picture of overweight/obese women with PCOS, with insulin resistance, in a shorter time than the ketogenic diet alone