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NCT ID: NCT06097156 Recruiting - Breast Cancer Clinical Trials

Evaluation of See.d as an Automated Blood Sample Preparator for Multiple Liquid Biopsy Applications

Start date: November 6, 2023
Phase:
Study type: Observational

This study aims to evaluate the feasibility of using See.d instrument and SBS slides for preparation of plasma and cytological samples from whole blood. Forty-five participants will be enrolled (20 healthy volunteers and 25 metastatic breast cancer patients) and each participant will be asked to provide a blood sample.

NCT ID: NCT06096350 Recruiting - Stroke Clinical Trials

Nutritional Status in Subacute Stroke Patients Under Rehabilitation 2.0

Nutristroke2
Start date: May 29, 2024
Phase:
Study type: Observational

The Nutristroke study's findings revealed a malnutrition scenario in post-stroke patients undergoing rehabilitation. This has highlighted the significance of a correct nutritional status assessment upon admission to a rehabilitation unit. The aim of Nutristroke2, therefore, is the assessment of nutritional status, dietary intake, dysphagia, the presence of stroke-related sarcopenia, and systemic oxidative status in patients with subacute stroke outcomes before and after rehabilitation treatment. A secondary aim is to assess whether there is any correlation between nutritional status, dietary intake, dysphagia, sarcopenia, and systemic oxidative status with rehabilitation outcomes.

NCT ID: NCT06096337 Recruiting - Clinical trials for Persistent Atrial Fibrillation

Pulsed Field Ablation (PFA) Versus Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation

AVANT GUARD
Start date: December 28, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to establish the safety and effectiveness of pulsed field ablation as a first-line ablation treatment for subjects with persistent atrial fibrillation as compared to subjects who received an initial treatment with anti-arrhythmic drugs.

NCT ID: NCT06095583 Recruiting - Clinical trials for Limited-stage Small Cell Lung Cancer (LS-SCLC)

Phase 3 Study of Toripalimab Alone or in Combination With Tifcemalimab as Consolidation Therapy in Patients With Limited-stage Small Cell Lung Cancer (LS-SCLC)

Start date: November 15, 2023
Phase: Phase 3
Study type: Interventional

The Study is a Phase 3, randomized, three-arm, double-blind, placebo-controlled, multi-regional clinical research study to evaluate the safety and efficacy use of toripalimab alone or in combination with tifcemalimab as consolidation therapy in patients with limited-stage small cell lung cancer without disease progression following chemoradiotherapy. Tifcemalimab is a monoclonal antibody against B and T lymphocyte attenuator (BTLA). Toripalimab is a monoclonal antibody against programmed death protein-1 (PD-1). Neither drug is approved for treatment of This combination regimen is investigational in limited stage-small cell lung cancer in any country.

NCT ID: NCT06095375 Recruiting - Clinical trials for Glioblastoma, IDH-wildtype

Regorafenib With Temozolomide With or Without RT in MGMT-Methylated, IDH Wild-type GBM Patients

REGOMA-2
Start date: July 4, 2022
Phase: Phase 1
Study type: Interventional

This study will evaluate the addition of regorafenib to standard of care treatment with TMZ as adjuvant therapy, and in combination with TMZ+RT as concomitant therapy. The standard of care for newly diagnosed GBM (ndGBM) includes surgical resection to the extent that is safely feasible, followed by RT plus concomitant TMZ chemotherapy, and up to 6 months of adjuvant TMZ. The dose escalation will be explored following a "3+3" design, escalating oral doses of regorafenib in combination with adjuvant (maintenance) TMZ (cohort A) to estimate the MTD of regorafenib as adjuvant (maintenance) therapy. After finding the MTD in the Adjuvant Therapy dose escalation, the Concomitant Therapy (cohort B) dose escalation will start, exploring escalating oral doses of regorafenib in combination with concomitant TMZ+RT, to estimate the MTD of regorafenib as concomitant therapy.

NCT ID: NCT06094595 Recruiting - Dysphagia Clinical Trials

Mealtime Assessment Scale-p Adaptation and Validation

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

The study aims to adapt the Mealtime Assessment Scale (MAS) in a pediatric population in order to provide an observational tool compiled by swallowing professionals, in Italian, for the assessment of swallowing efficacy and safety during mealtime in an ecological setting, as mealtime administration occurs independently or by the caregiver.

NCT ID: NCT06094296 Recruiting - NSCLC Clinical Trials

A Study of BMS-986315 and Nivolumab in Combination With Chemotherapy in Participants With First-line Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

Start date: November 27, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of BMS-986315 plus nivolumab in combination with platinum-based doublet chemotherapy (PDCT) versus nivolumab in combination with PDCT in the first-line treatment of Stage IV or recurrent non-small cell lung cancer (NSCLC).

NCT ID: NCT06094036 Recruiting - Metabolic Syndrome Clinical Trials

Physical Exercise as a Sustainability Tool in Men With Dysmetabolic Hypogonadism

ExLOH
Start date: January 11, 2023
Phase: N/A
Study type: Interventional

Aim of this project is to delineate sustainable physical exercise programs and to assess the effects of such programs mainly on endocrine-metabolic and neurovegetative outcomes in a cohort of men with metabolic syndrome-related late-onset central hypogonadism. Participants will undergo a personalised exercise program. After 6 months they will be subdivided into two groups, according to the weekly physical activity volume actually performed (above or below 600 MET·minutes/week). Changes in endocrine-metabolic and neurovegetative outcomes will be compared between the two groups.

NCT ID: NCT06093880 Recruiting - Cataract Clinical Trials

Observational, Prospective Clinical Investigation on Mini 4 Ready Intraocular Lens

Start date: January 8, 2024
Phase:
Study type: Observational

Cataract surgery presents an extremely high success rate in improving vision and quality of life and it is currently the most commonly performed ophthalmic surgery, especially considering its growing utility in the aging population (e.g., more than 20 million worldwide underwent the procedure in 2015); it is possible to affirm that benefits clearly outweigh risks. However, although cataract surgery is highly effective and relatively safe, owing to the enormous numbers, even uncommon surgical complications could potentially harm the patients. For this reason, it is essential to continue to consider the possible risks and undesirable side-effects associated to cataract surgery, such as post-cataract endophthalmitis (POE), postcataract opacification (PCO), PCME, dysphotopsias, retinal detachment, and IOL dislocation.

NCT ID: NCT06093204 Recruiting - Clinical trials for Esophagitis, Eosinophilic

The Potential Role of Compounds Derived From Ultra-processed Foods in Pathogenesis of Eosinophilic Esophagitis

Start date: April 12, 2023
Phase:
Study type: Observational

Eosinophilic esophagitis (EoE) is a chronic antigen-mediated inflammatory disease of the esophagus that affects both children and adults. The incidence and prevalence of EoE is rapidly increasing in Western countries with an estimated incidence of 6.6 per 100,000 person-years (95% CI, 3-11.7) in children and 7.7 per 100,000 person-years (95% CI, 1.8-17.8) in adults. Clinically, it is characterized by various symptoms related to esophageal dysfunction, including vomiting, regurgitation, feeding difficulties, epigastric heartburn, dysphagia, or food bolus impaction, and may cause growth retardation. Diagnosis is made on the basis of clinical symptoms and histological evidence of eosinophilic infiltration of the esophagus (at least 15 eosinophils/high power microscope field (eos /hpf), excluding other etiologies of esophageal eosinophilia (gastroesophageal reflux disease, infectious esophagitis, achalasia, celiac disease and Crohn's disease, connective tissue disorders, gra ft versus host disease, drug hypersensitivity and hypereosinophilic syndromes). EoE is primarily characterized by a T helper 2 type inflammation, but the pathogenesis and the immunopathological mechanisms underlying the pathology are not yet fully understood. Recent evidence suggests that in genetically predisposed individuals, interaction with environmental factors (e.g., dietary lifestyle) may play a role in activating several inflammatory pathways and cause EoE. Ultra-processed foods (UPFs) are food and beverage products resulting from industrial formulations, ready for consumption, typically obtained with five or more ingredients from different manufacturing processes (cooking methods, addition of additives such as stabilizers or preservatives). During the last decade, the consumption of the latter has increased significantly among the pediatric population to represent 30% of the daily caloric intake of an average child in Europe and America. Recent evidences show that UPFs favor the onset of chronic non-communicable diseases through the activation of different inflammatory pathways. The components mostly represented in UPFs are the advanced glycation end products (AGEs), a heterogeneous group of highly oxidizing compounds that are formed through non-enzymatic reactions (Maillard reaction) between reduced sugars and free amino groups of proteins, lipids, or nucleic acids. Evidence demonstrates that dietary AGEs are absorbed and contribute significantly to the total concentration of AGEs in the body. AGEs induce oxidative stress and inflammation, leading to structural and functional protein alterations, cellular apoptosis and multi-tissue/organ damage. These mechanisms are mediated at least in part by interactions with their cell-surface receptor for advanced glycation end-products (RAGE). The AGEs-RAGE interaction modulates the immune response. AGEs are able to activate le mast cells, to stimulate the release of histamine and to induce a chronic inflammatory state that promotes a T helper 2 type response.