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NCT ID: NCT05761483 Recruiting - Biliary Stricture Clinical Trials

Endoscopic Management of Non-anastomotic Biliary Strictures Following Liver Transplantation.

STEBINANSIED
Start date: March 12, 2020
Phase:
Study type: Observational [Patient Registry]

The study will evaluate the results of endoscopic treatment of NON-anastomotic biliary strictures following liver transplantation

NCT ID: NCT05761314 Recruiting - Noonan Syndrome Clinical Trials

Solid Tumors in RASopathies

4218
Start date: October 12, 2021
Phase: N/A
Study type: Interventional

RASopathies are a group of syndromes, caused by variants of genes involved in the regulation of the Ras/MAP/ERK pathway. This intracellular transduction pathway profoundly affects embryogenic development, organogenesis, synaptic plasticity and neuronal growth. RASopathies are characterized by multi-organ involvement, growth delay, premature aging and haemato-oncological manifestations. Based on evidences provided by literature, cancer screening protocols are applied in some individuals affected by RASopathies, even though detailed information about prevalence and molecular pathogenesis of such tumors is still not clearly elucidate.

NCT ID: NCT05761262 Recruiting - Clinical trials for Spinal Muscular Atrophy

SMN Circular RNAs as Potential Biomarkers for the Therapeutic Response to Nusinersen in Spinal Muscular Atrophy Patients

Start date: December 13, 2019
Phase:
Study type: Observational

The first cure for Spinal Muscular Atrophy (SMA; Nusinersen) has been approved by FDA in 2017. Although it improves the clinical picture of most SMA patients, not all exhibit the same response to treatment. In this project the aim will be: i. identifying cell-free SMN circular RNAs (circRNAs) in body fluids of SMA patients as potential biomarkers before and after Nusinersen; ii. evaluating their prognostic power as predictors of the clinical response of SMA patients to Nusinersen; iii. identifying human intronic polymorphisms that affect SMN circRNAs biogenesis and impact on the efficacy of Nusinersen. The results obtainable with this project will evaluate if different concentration of cell free SMN circRNAs in SMA patients could underlie the genotype-phenotype mismatch, usually observed, and the reduced response of a subset of SMA patients to therapy. Our research could highlight the need for these of combinatorial 'SMN-plus' and "personalized" therapies that account for individual differences.

NCT ID: NCT05761210 Recruiting - Obesity Clinical Trials

Characterization of Serum Proteome in Young Obese Subjects (POSING)

POSING
Start date: April 19, 2022
Phase:
Study type: Observational

With the project proposal we aim to identify serum markers for the characterization of steatosis in subjects affected by essential obesity at a young age. In this case the markers could be useful not only for the development of new diagnostic scores, or for combining them with diagnostic imaging technologies, but also for understanding the metabolic alterations according to the patient's gender, extremely important data in this disease to which only recently has biomedical research started.

NCT ID: NCT05761054 Recruiting - Soft Tissue Sarcoma Clinical Trials

Sarcoma Preoperative Radiation With Simultaneous INTegrated Boost (SPRINT)

SPRINT
Start date: July 19, 2022
Phase: N/A
Study type: Interventional

Intervention prospective monocentric one arm study on the use of neoadjuvant radiotherapy with simultaneous integrated boost (Simultaneous Integrated Boost, SIB) in patients with STS with indication for preoperative radiotherapy. The treatment will be administered in 25 daily fractions (Monday-Friday) at the disease site to include the region of suspected micrometastatic spread (Clinical Target Volume 1, CTV1) at a dose of 50 Gy (2Gy / fraction) with SIB intensification on volume reduced corresponding to the interface sites between the tumor and the vascular / nerve axes (Clinical Target Volume 2, CTV2) at a dose of 60 Gy (2.4 Gy / fraction). The association with neoadjuvant chemotherapy based on anthracyclines is allowed.

NCT ID: NCT05760495 Recruiting - HIV Infections Clinical Trials

Analysis of Oxidative Stress Biomarkers and Their Determinants in ART-experienced PLWH

4477
Start date: September 2, 2022
Phase:
Study type: Observational

The project aims to assess the level of oxidative stress biomarkers in HIV patients on effective antiretroviral treatment in correlation with other therapeutic, clinical, and viro- immunological parameters. The analysis aims to better characterize the patient on treatment through an innovative approach based on two specific tests for complementary assessment of total oxidant and anti-oxidant plasma capacity.

NCT ID: NCT05760404 Recruiting - Colorectal Cancer Clinical Trials

Modulatory Effects of Active Drugs on the Endocannabinoid System on Spontaneous and Induced Contractility of the Colon

CB1 - CONTRACT
Start date: December 19, 2022
Phase:
Study type: Observational

The endocannabinoid system plays important roles in the modulation of gastrointestinal motility and secretions. These effects are mainly mediated by the activation by the endocannabinoids anandamide (AEA) and 2-arachidonylglycerol (2-AG) of CB1 receptors expressed on cholinergic neurons. Cannabis sativa extracts also perform these activities, through the detection of CB1 receptors by the phytocannabinoids they contain, in particular delta9-tetrahydrocannabinol. CB1 receptors are abundantly expressed at the synaptic terminals of excitatory motor neurons and cholinergic secretomotor neurons and their activation induces prejunctional inhibition of acetylcholine release. It is thought that the endocannabinoids AEA and 2-AG, by activating these receptors, may exert a physiological control on gastrointestinal contractility and secretions. This research hypothesizes that drugs capable of inhibiting the biosynthetic and catabolic enzymes of endocannabinoids, of inhibiting the transmembrane transport of endocannabinoids or of allosterically modulating CB1 receptors induce important regulating effects of basal contractility and excitatory motor responses, induced by activation of neurons intramural cholinergics, of colonic circular smooth muscle. The effects of drugs acting on CB receptors, endocannabinoid biosynthetic and catabolic enzymes and endocannabinoid membrane transporters on basal contractility or induced by neuronal activation of colonic preparations in vitro will be evaluated. The study will enroll patients affected by colorectal cancer to undergo elective resective surgery at any stage, undergoing upfront surgery or after neo-adjuvant therapy with a therapeutic interval greater than 6 weeks. In the selected patients (see inclusion/exclusion criteria), a fresh sample of about 2.5 cm of healthy colon (healthy resection margin) will be taken, which will be taken in the operating room and sent to the laboratory for in vitro study. Expected results: The study is expected to provide new evidence regarding the induction of pharmacological effects by allosteric receptor modulators of CB1 receptors, inhibitors of endocannabinoid biosynthetic and catabolic enzymes, and inhibitors of cannabinoid transporters in the human colon, which may open interesting perspectives regarding the development of new therapeutic strategies for the treatment of constipation, diarrhea and irritable bowel syndrome.

NCT ID: NCT05760326 Recruiting - Atrial Fibrillation Clinical Trials

Diagnostic and Prognostic Role of Clot Analysis in Stroke Patients

DICAS
Start date: September 2, 2022
Phase:
Study type: Observational

BACKGROUND AND RATIONALE OF THE STUDY The analysis of the composition of the clot constitutes a promising tool for investigating the possible pathogenetic mechanisms underlying ischemic stroke. This analysis was made possible thanks to the numerous mechanical thrombectomy operations which have now become routine. Several studies have attempted to explore the possible relationship between the primary site of thrombus formation and clot composition, reporting that cardioembolic stroke may have a higher percentage of platelet-rich areas than noncardioembolic thrombosis. However, the data are conflicting and do not seem to support an association between clot histology and etiology. Furthermore, thrombus composition appears to influence thrombolysis and the efficacy of thrombectomy. For example, fibrin-rich thrombi appear to reduce the effectiveness of thrombolytic treatment and require more steps with mechanical thrombectomy treatment. Primary ENDPOINT: Evaluate how clot composition relates to stroke etiology according to the TOAST classification. Secondary ENDPOINT: - relationship between different clot components and the degree of thrombectomy recanalization as defined by treatment modified cerebral ischemia score (mTICI). - relationship between the different components of the clot and the number of steps required to achieve recanalization. - relationship between the different clot components and outcome indicators (NIHSS score and mRS score). TARGET POPULATION Patients with ischemic stroke with occlusion of large intracranial vessels will be included in the study if deemed suitable for mechanical thrombectomy therapy in accordance with national and international guidelines. INCLUSION CRITERIA - age > 18 years; - Patients diagnosed with large vessel occlusion stroke in the emergency room CT Angio-study, undergoing mechanical thrombectomy procedure. - Recovered thrombus available for analysis EXCLUSION CRITERIA ● Lack of written informed consent. MATERIALS AND METHODS The clot will be portioned. Part of the sample will be fixed in a 10% formalin solution (3.7% formaldehyde), part will be frozen in liquid nitrogen. Within 24-48 hours of fixation, formalin-fixed thrombi will be dehydrated by increasing the concentration of ethanol (70%, -80%, -95%, 100%) and paraffin-embedded allowing good preservation of tissue morphology and easy long-term storage. The included samples will be sectioned along the major axis of the thrombus, in slices with a thickness between 4 and 5 µm. Base staining will be used to visualize RBC, PLT and fibrin. - Hematoxylin and Eosin (H&E) will allow visualization of general thrombus structures and identification of aggregates of fibrin/platelets (colored pink), red blood cells (red), and nucleated cells (dark blue). - Martius Scarlet Blue (MSB), selectively stains fibrin (dark pink/red), red blood cells (yellow) and collagen (blue - Mallory-Azan for collagen and phosphotungstic acid hematoxylin for fibrin. - immunohistochemistry to detect the presence of - Platelets (CD42-Gp-Ib+, CD41a-Gp-IIb/IIIa+, CD61-GpIIIa), - white blood cells (CD45+, common leukocyte antigen), or monocytes/macrophages (CD14+, CD1a+, CD68+), - T lymphocytes (CD3+, CD8/CD4+), or natural killers (CD16+, CD56+), or mobile premature endothelial cells and blood progenitors (CD34+), or neutrophils (CD45+, CD16+), or fibrinogen or von Willebrand factor.

NCT ID: NCT05760287 Recruiting - Cardiac Amyloidosis Clinical Trials

Echocardiographic Characterization of Cardiac Amyloidosis: an Observational Study

Echo-AMY
Start date: December 9, 2022
Phase:
Study type: Observational

This is a mono-center observational ambispective study in which patients with cardiac amyloidosis evaluated at our institution will be enrolled. The primary aim is to investigate echocardiographic findings, particularly using advanced echocardiographic techniques, such as two- and three-dimensional speckle-tracking analysis, that may be helpful in the differential diagnosis between cardiac amyloidosis and other cardiomyopathies with hypertrophic phenotype. Secondary aims are: 1) to evaluate the reversibility of myocardial damage, assessed by echocardiography, in response to a newly available specific treatment for patients with transthyretin-related cardiac amyloidosis (tafamidis ) and its correlation with the clinical response 2) to investigate potential novel echocardiographic predictors of adverse cardiovascular outcomes.

NCT ID: NCT05760274 Recruiting - Clinical trials for Gastro Esophageal Reflux

Esophageal pH-MII Duration: 12 or 24 Hours?

Start date: July 13, 2022
Phase:
Study type: Observational

To check whether the first 12 hours of MII-pH recording are sufficient to diagnose gastroesophageal reflux disease (GERD) among newborns/infants, with a diagnostic accuracy similar to 24 hours of recording as currently advised.