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NCT ID: NCT05696626 Recruiting - Clinical trials for Metastatic Breast Cancer

Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

ELAINEIII
Start date: October 31, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation. The main question the study aims to answer is: • To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day.

NCT ID: NCT05695950 Recruiting - Dermatomyositis Clinical Trials

A Study Evaluating the Effects of GLPG3667 Given as Oral Treatment for up to 24 Weeks in Adults With Dermatomyositis

GALARISSO
Start date: February 27, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered GLPG3667 once daily for 24 weeks in adult participants with dermatomyositis (DM).

NCT ID: NCT05694325 Recruiting - Clinical trials for Immune Thrombocytopenia

Biologic Characterization of Patients With ITP

Start date: November 27, 2023
Phase: N/A
Study type: Interventional

This is a no-profit, multicenter, biological, non-pharmacologic study aimed to characterize from a biological point of view previously untreated primary ITP patients. To this end, peripheral blood, fecal and bone marrow samples will be collected at baseline and at 30 days and 180 days after treatment initiation - for each line of therapy - and the results of the biological analysis performed at each time point will then be compared.

NCT ID: NCT05694312 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Ibrutinib for the Treatment of AIHA in Patients With CLL/SLL or CLL-like MBL

Start date: November 24, 2023
Phase: Phase 2
Study type: Interventional

This is a multicenter, single arm, phase II study aimed at evaluating ibrutinib therapy for the treatment of AIHA in patients with CLL/SLL or CLL-like MBL.

NCT ID: NCT05693753 Recruiting - Clinical trials for Gingival Recession, Generalized

Xenogenic Collagen Matrix for the Treatment of Multiple Gingival Recessions

Start date: February 2, 2023
Phase: N/A
Study type: Interventional

The primary aim of this study is to evaluate whether the use of a xenogenic collagen matrix (XCM) for the treatment of multiple adjacent gingival recessions (MAGRs) with a multiple coronally advanced flap technique (mCAF) achieves better results than the use of an autologous connective tissue graft (CTG) in terms of recession reduction (primary outcome) and other secondary root coverage outcomes (e.g. complete root coverage, mean root coverage). Moreover, this study aims to compare secondary clinical variables (e.g. keratinized tissue width (KTW) changes, probing pocket depth (PPD) changes, volumetric gain (VG), etc.), also with a digital approach, the patient-reported outcome measures (PROMs e.g. pain, swelling, bleeding). The hypothesis of this study is that at 6 months and 1 year follow-up the mCAF with XCM is not inferior to CTG in terms of recessions reduction and secondary clinical variables, and superior regarding to PROMs.

NCT ID: NCT05693116 Recruiting - Clinical trials for Squamous Cell Carcinoma

Survival and Prognostic Factors of Squamous Cell Carcinoma of the Nasal Vestibule

NV-SCC
Start date: December 1, 2022
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to learn about survival and prognostic factors in patients who underwent surgical treatment for primary squamous cell carcinoma of the nasal vestibule. The main questions it aims to answer are: - what is the prognosis of patients affected by squamous cell carcinoma of the nasal vestibule? - are there any specific factors that could influence prognosis? - is it possible to elaborate a new staging system, able to overcome the limitations of the currently used ones? Data about patients, tumour and type of surgery performed will be collected. Participants will be followed-up for a minimum 6 months period after surgery.

NCT ID: NCT05693038 Recruiting - Clinical trials for Brachial Plexus Injury

Brachial Plexus Injury After Prone Positioning

BPX
Start date: April 6, 2022
Phase:
Study type: Observational

The goal of this prospective observational study is to estimate the prevalence of brachial plexus injury after prone positioning in patients with ARDS and to evaluate the safety of swimmer position. The main questions it aims to answer are: - Could arm positioning during pronation play a role in the development of any nerve injury at the brachial plexus level? - Is swimmer position safe when adopted during prone positioning? Participants will be studied at selective time points using EMG assessment.

NCT ID: NCT05692180 Recruiting - Asthma Clinical Trials

A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma (DOMINICA)

DOMINICA
Start date: April 5, 2023
Phase: Phase 3
Study type: Interventional

A study to evaluate the efficacy and safety of benralizumab administered subcutaneously in patients ≥ 6 to < 18 years of age with severe eosinophilic asthma, including a well-documented history of asthma exacerbations and uncontrolled asthma receiving high-dose inhaled corticosteroid (ICS) plus at least one additional controller medication.

NCT ID: NCT05692063 Recruiting - Clinical trials for Anomalous Aortic Origin of the Coronary Artery (AAOCA)

Anomalous Aortic Origin of Coronary Artery

AAOCA
Start date: June 27, 2019
Phase:
Study type: Observational [Patient Registry]

This project has several objectives ranging from clinical data analysis to computational simulations as listed below: A) Clinical objectives: 1. Retrospective review of all patients with AAOCA treated surgically and followed medically at the IRCCS Policlinico San Donato aiming to identify risk factors for ischemia or sudden cardiac deaths. 2. Prospective follow-up of all enrolled patients, treated and followed, in adjunct to all the new patients referred aiming to follow across the years any potential rare adverse event (ischemia, angina event, sudden cardiac death). B) Experimental objectives: 1. Retrieve morphological measurements from CT or MRI (de-identified) of the aortic root and the coronary vessels following the previous work of our group. 2. Construct a parametric model of the aortic root defined by population-based morphologic parameters to describe both healthy/diseased population. 3. Run solid mechanics simulation mimicking the movement of the aortic root in order to test configurations at more risk. 4. Reconstruct 3D surfaces representing the coronary vasculature from imaging for automatically perform the parameter estimation and run computational fluid dynamics simulations.

NCT ID: NCT05691595 Recruiting - Clinical trials for Nutrition Disorders in Old Age

Attitudes, Knowledge, Self-efficacy, and Behaviors of Nurses in Nutritional Care for Older People

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

Even if awareness among nurses regarding the importance of nutritional care for older people has increased in recent years, nurses continue to underestimate the necessary approach to prevent malnutrition. Therefore, some authors have argued the critical importance of understanding which factors can influence nurses' caring behaviors during real situations and affect the prevention and management of malnutrition under actual working conditions. Specifically, the relationship between nurses' attitudes, knowledge, and self-efficacy in nutritional care for older people has not been described yet. Understanding these relationships can provide a framework to enhance adequate caring behaviors, mitigating the negative attitudes. Considering that self-efficacy has been previously theorized in several populations as the mediator of the relationship from knowledge and attitudes to specific behaviors, the investigators hypothesized that knowledge and attitudes in the specific area of nursing nutritional care have moderately positive effects on nursing caring behaviors in nutritional care only through the mediation of nursing self-efficacy. The study design is a multi-phase, descriptive observational cross-sectional, multicentric study, collecting data using a web-survey.