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NCT ID: NCT05791708 Recruiting - Clinical trials for Cold Agglutinin Disease (CAD)

Cold Agglutinin Disease Real World Evidence Registry

CADENCE
Start date: December 12, 2019
Phase:
Study type: Observational [Patient Registry]

This is a multinational, multi-center, observational, prospective, longitudinal disease registry designed to collect data on participants with cold agglutinin disease (CAD) or cold agglutinin syndrome (CAS). Among them, a minimum of 30 patients with CAD treated with sutimlimab are expected to take part in the sutimlimab cohort study. Patients with CAD who have been enrolled in previous sutimlimab clinical trials (e.g., BIVV009-01/LTS16214 [NCT02502903,CAD patients], BIVV009-03/EFC16215 [NCT03347396], and BIVV009-04/EFC16216 [NCT03347422]) and who either completed or discontinued the corresponding clinical trial are eligible to participate in the registry.

NCT ID: NCT05791487 Recruiting - Ulcerative Colitis Clinical Trials

Combination of Diet and Oral Budesonide for Ulcerative Colitis

ReDUCE
Start date: December 1, 2023
Phase: N/A
Study type: Interventional

The ReDUCE Trial is a multinational single-blinded randomized controlled trial in mild to moderate flare of Ulcerative colitis (UC) disease patients. The purpose of the study is to validate the clinical efficacy of the UCED (Ulcerative colitis Exclusion Diet) with partial enteral nutrition (PEN) using a novel formula. The investigators anticipate that adding a novel specifically designed dietary intervention in addition to drug will lead to superior remission and mucosal healing via changes in the microbiome.

NCT ID: NCT05791357 Recruiting - Clinical trials for Endocarditis Infective

The Role of Polymerase Chain Reaction in the Management of Patients With Infective Endocarditis

Start date: April 1, 2020
Phase: N/A
Study type: Interventional

The aim of this study is to prospectively investigate the additional diagnostic value of broad range PCR targeting the 16 ribosomal DNA in diagnosis and management of patients with infective endocarditis who are candidate for surgicaltherapy;

NCT ID: NCT05791214 Recruiting - Clinical trials for Assessment Tool of Nurses' Skills

Evalution of Nurse's Abilities in ICU Setting

Start date: November 11, 2022
Phase:
Study type: Observational

The assessment of nurses' skills is of fundamental importance in order to predict their performance, this is true in all areas of care but especially in the critical area. The aim of the single center prospective observational study is to provide the organization and specifically the nursing coordinator with an evaluation form that is as specific and complete as possible for evaluating the performance of nurses in ICU. The nursing coordinators of 4 UOCs of intensive care for adults in the IRCCS Gemelli Polyclinic Foundation in Rome will be involved in the use of an evaluation scale for nurses. In each UOC, 10 nurses will be randomly selected for which to carry out the evaluation, subject to informed consent and compliance with the inclusion criteria in the study. Results Certify the reliability of the Scale for evaluating the performance and attitudes of nurses working in intensive care. It is hypothesized that an objective assessment tool of nurses' skills allows for an adequate allocation of resources not only in quantitative terms but also and above all in qualitative terms.

NCT ID: NCT05791201 Recruiting - Type 1 Diabetes Clinical Trials

A Safety, Tolerability, and Efficacy Study of VX-264 in Participants With Type 1 Diabetes

Start date: May 16, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to evaluate the safety, tolerability, and efficacy of VX-264 in participants with type 1 diabetes (T1D).

NCT ID: NCT05791006 Recruiting - Stroke Clinical Trials

Neuropsychology of Financial Capacity

NEUROFIN
Start date: August 4, 2021
Phase:
Study type: Observational

The present project aims to investigate the financial capacity in patients diagnosed with Parkinson's Disease or parkinsonism, brain tumor (glioma or meningioma) and cerebrovascular lesion (stroke), in order to evaluate the presence and degree of impairment, and the role of some factors as potential predictors of financial incapacity. The term 'financial capacity' means both operations relating, for example, to asset management or investing money, and activities of daily life such as shopping or using small sums of money; these activities are mediated by different cognitive functions, from numerical and arithmetic skills to decision making. Financial capacity is, in fact, an instrumental activity of daily life (i.e. Instrumental Activity Of Daily Living, I-ADL) whose impairment negatively affects the functional autonomy of the individual, so as to be subject to legal protection. To assess financial capacity, the Numerical Activities of Daily Living - Financial (NADL-F; Arcara et al., 2017) will be administered, a battery of tests aimed at investigating both financial performance and financial competence according to the most recent neuropsychological models proposed in the literature.

NCT ID: NCT05790473 Recruiting - Fetal Anomaly Clinical Trials

Artificial Intelligence Algorithm for the Screening of Abnormal Fetal Brain Findings at First Trimester Ultrasound Scan

AIRFRAME
Start date: May 1, 2023
Phase:
Study type: Observational

Visualization of the posterior fossa brain spaces, their spatial relationship and measurements can be obtained in the midsagittal view of fetal head, the same used for NT measurement (9), and plays an important role in the early diagnosis of neural tube defects, such as open spinal dysraphism (5), and posterior fossa anomalies, such as DWM or BPC (7). However, assessment of the fetal posterior fossa in the first trimester is still challenging due to several limitations including involuntary movements of the fetus and small size of the brain structures, causing difficulties for examination and misdiagnosis. Moreover, it is also operator-dependent for the acquirement of high-quality ultrasound images, standard measurements, and precise diagnosis. The use of new technologies to improve the acquisition of images, to help automatically perform measurements, or aid in the diagnosis of fetal abnormalities, may be of great importance for the optimal assessment of the fetal brain, particularly in the first trimester (10). Artificial intelligence (AI) is described as the ability of a computer program to perform processes associated with human intelligence, such as learning, thinking and problem-solving. Deep Learning (DL), a subset of Machine Learning (ML), is a branch of AI, defined by the ability to learn features automatically from data without human intervention. In DL, the input and output are connected by multiple layers loosely modeled on the neural pathways of the human brain. In the image recognition field, one of the most promising type of DL networks is represented by convolutional neural networks (CNN). These are designed to extract highly representative image features in a fully automated way, which makes them applicable to diagnostic decision-making. According to these observations, we propose a research project aimed to develop an ultrasound-based AI-algorithm, which is capable to assess the fetal posterior fossa structures during the first trimester ultrasound scan and discriminate between normal and abnormal findings through a fully automatic data processing.

NCT ID: NCT05790135 Recruiting - Intestinal GVHD Clinical Trials

Multiparametric Ultrasound Study in Diagnosing GvHD

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

The study evaluate the role of the use of bed-side multiparametric ultrasound study in the diagnosis of gastrointestinal acute graft-versus host disease (aGvHD) in patients underwent allogenic stem cell transplantation

NCT ID: NCT05789680 Recruiting - Clinical trials for Parathyroid Carcinoma

European Multicentric Study on Parathyroid Carcinoma

EMS-PC
Start date: December 15, 2022
Phase:
Study type: Observational

The main aim of the study is to evaluate the incidence of post-operative diagnosis of PC and atypical parathyroid neoplasm in patients who underwent surgery for pHPT in different European centers using the EUROCRINE® database. Moreover, we aim to evaluate the peri-operative surgical characteristics, operation extent, postoperative morbidity, and outcomes in these patients category.

NCT ID: NCT05789667 Recruiting - Clinical trials for Differentiated Thyroid Cancer

Gender-based Impact on Safety and Efficacy of Lenvatinib in Patients With Differentiated Thyroid Cancer

Gisel
Start date: May 27, 2020
Phase:
Study type: Observational

Lenvatinib is approved for the treatment of radioiodine refractory differentiated thyroid cancer. Despite gender can play a crucial role un in safety and efficacy of oncological product, little is know on gender difference in lenvatinb effacacy and safety in the context of radioiodine refractory differentiated thyroid cancer. The primary objective of the study is to assess safety and toxicity profile in male and female patients in terms of dose reduction. The secondary objectives are to assess sex and gender difference in: the number and the incidence of adverse events; response rate according to RECIST criteria 1.1; progression free survival, overall survival and duration of response.