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NCT ID: NCT05334368 Recruiting - Clinical trials for Hypereosinophilic Syndrome

Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial

DESTINY
Start date: September 6, 2022
Phase: Phase 3
Study type: Interventional

This is a 52-week, randomized, placebo-controlled, double-blind, parallel group, multicenter study of depemokimab in adults with uncontrolled HES receiving standard of care (SoC) therapy. The study will recruit patients with a confirmed diagnosis of HES and who are on stable HES therapy for at least 4 weeks prior to randomization (Visit 2). Eligible participants must have uncontrolled HES with a history of repeated flare (≥2 flares in the previous 12 months) and blood eosinophil count of ≥1,000 cells/ microliter (μL) during Screening. Historical HES flares are defined as documented HES-related worsening of clinical symptoms or blood eosinophil counts requiring an escalation in therapy. Participants who meet the inclusion and exclusion criteria will be randomized in a 2:1 ratio to receive either depemokimab or placebo while continuing their SoC HES therapy.

NCT ID: NCT05334290 Recruiting - Clinical trials for Neuroendocrine Tumors

Financial Toxicity and Patient-Reported Outcomes in GEP-NEN During Treatment

FiReNEN
Start date: August 6, 2020
Phase:
Study type: Observational

The aim of this study is to evaluate the financial toxicity reported by Italian patients affected by GEP-NEN during the first year of treatment after diagnosis and its correlations with patient-reported outcomes (PROs) and quality of life (QoL).

NCT ID: NCT05333081 Recruiting - Glycemic Index Clinical Trials

Glycemic Index of Italian Rice Varieties

Start date: June 8, 2021
Phase: N/A
Study type: Interventional

The service commissioned by the National Rice Authority required the evaluation of the Glycemic Index of 25 varieties of rice. As a reference, both for the comparison and for the calculation of the Glycemic Index, glucose was used, which clearly has characteristics of greater uniformity than white bread and was preferred because it is better suited to be used as a standard of measurement. In accordance with the ISO 26642 standard, a panel of selected volunteers (consisting of 10 subjects), healthy, not suffering from diabetes or other pathologies of glucose metabolism, were included in the study. As per protocol, the changes in glycaemia of all the subjects involved were evaluated after the intake of glucose (50g), as a standard food, and of rice (50g of available carbohydrates), taking into account the carbohydrate content of each variety. to determine the amount of rice to be fed. The test of each food was carried out for a maximum time of 120 minutes, by carrying out repeated measurements of the glycaemia of all subjects at a distance of 0, 15, 30, 45, 60, 90 and 120 minutes from the administration of the sample in order to obtain a glycemic curve for each sample considered. From the analysis of the area underlying the glycemic curve of each variety, it was possible to determine the Glycemic Index.

NCT ID: NCT05332288 Recruiting - Clinical trials for Osteochondritis Dissecans Knee

Triphasic Osteochondral Scaffold for the Treatment of the OCD of the Knee: Observational Study

MAIOCD
Start date: April 1, 2022
Phase:
Study type: Observational

The objective of the present study is to evaluate the clinical results of reconstructive treatment of knee OCD defects treated with osteochondral scaffolds implanted with specific instrumentation.The evaluation will be performed through clinical, subjective and objective assessments.

NCT ID: NCT05330325 Recruiting - Clinical trials for SGA, Turner Syndrome, Noonan Syndrome, ISS

A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow

REAL 8
Start date: August 10, 2022
Phase: Phase 3
Study type: Interventional

The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature. The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®. Somapacitan is a new medicine, and Norditropin® is a medicine doctors can already prescribe in some countries. The study will last for about 3 years. The participants will either get somapacitan once a week for 3 years or Norditropin® once a day for 1 year followed by somapacitan once a week for 2 years. Which treatment the participants get is decided by chance.

NCT ID: NCT05329987 Recruiting - Parkinson Disease Clinical Trials

Analysis of Postural Transitions in Subjects Affected by Parkinson Disease

Start date: May 18, 2022
Phase:
Study type: Observational

This observational trial aims to evaluate the effect of Rehabilitation on Postural Transfers (PTs) in subjects affected by Parkinson Disease. The PTs are evaluated by an inertial sensor (a device composed by an accelerometer, a gyroscope and a magnetometer) attached to the subjects. The data obtained by the inertial sensor are kinematic (e.g. acceleration and angular speed) and spatiotemporal parameters (e.g. time to completion and velocity). Additional clinical evaluations are carried out at the beginning and end of the rehabilitative intervention.

NCT ID: NCT05329792 Recruiting - Clinical trials for Merkel Cell Carcinoma

L19IL2/L19TNF in Skin Cancer Patients

IntriNSiC
Start date: March 9, 2023
Phase: Phase 2
Study type: Interventional

Phase II, open label, multicentric, proof-of-principle basket trial in patients with malignant tumors of the skin amenable to intratumoral injection, and in a curative or neoadjuvant or palliative intention.

NCT ID: NCT05329649 Recruiting - Sickle Cell Disease Clinical Trials

Evaluation of Safety and Efficacy of CTX001 in Pediatric Participants With Severe Sickle Cell Disease (SCD)

Start date: May 2, 2022
Phase: Phase 3
Study type: Interventional

This is a single-dose, open-label study in pediatric participants with severe SCD and hydroxyurea (HU) failure or intolerance. The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (CTX001).

NCT ID: NCT05328089 Recruiting - Clinical trials for Glioblastoma Multiforme

Vacuolar ATPase and Drug Resistance of High Grade Gliomas

GLIODRUG-V
Start date: January 30, 2020
Phase:
Study type: Observational

GBMs are still considered tumors with few available treatment options that are able only to achieve a temporary local control of the disease. In case of a GBM, tumor recurrence is generally expected within 12 months and it is due to the presence of marginal tumoral cells with pro-oncogenic molecular phenotypes that are resistant to actual chemotherapies and to radiation therapy. Nowadays, surgery still represent the first treatment option in case of suspected GBM and it aims to remove the contrast enhancing lesion seen at the pre-operative brain MRI. In particular, the peripheral layer of the tumor is made of low replicating cellsglioblastoma-associated stromal cell (GASC) that can show different carcinogenic properties and that are probably responsible for tumor recurrence. Metabolism of GBMs is mainly anaerobialglicolisis that leads to the transformation of glucose in ATP and lactates. The production of high lactate levels determines a decrease of intracellular pH that is counterbalanced by V-ATPase activity through H+ ions extrusion from the intracellular to the extracellular environment. Increased V-ATPase activity affects different pro-tumoral activities and plays a crucial role in chemoresistance. In fact, a low extracellular pH can reduce the efficacy of antineoplastic agents since a low pH might affect the structural integrity of drugs and their ability to pass through the plasmatic membrane. Finally, V-ATPase can act as an active pump able to excrete antineoplastic agents. GBMs with high V-ATPAse expression are able to transmit malignant features and to activate proliferation of GASC in vitro through a network of microvescicles (MV) like exosomes and large oncosomes (LO) that transport cell to cell copy DNA (cDNA) and micro-RNAs (miRNA).In this view, our work is intended to study: 1) the effects of proton pump inhibitors (PPI) on CSC and GASCs cultures as in vitro add-on treatments; 2) the MVs load (in terms of miRNAs and cDNAs) during the neuro-oncological follow-up in order to understand how it changes after surgery and adjuvant treatments; 3) the possible roles of V-ATPase as a clinical marker to be used to check tumor response to adjuvant treatments.

NCT ID: NCT05328050 Recruiting - Achondroplasia Clinical Trials

Registry for Patients With Achondroplasia / Hypochondroplasia (OMPR-Ach/Hy)

OMPR-Ach/Hy
Start date: September 1, 2021
Phase:
Study type: Observational [Patient Registry]

This registry is a observational, single-center study designed to collect clinical data on patients with achondroplasia and hypochondroplasia.