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NCT ID: NCT05802199 Recruiting - Clinical trials for Non-alcoholic Fatty Liver Disease

Quantitative Detection Efficiency of UDFF for Nonalcoholic Fatty Liver Disease

UDFF
Start date: January 1, 2023
Phase:
Study type: Observational [Patient Registry]

Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease worldwide, affecting more than 25 % of the population globally. Approximately 20 % - 25 % of NAFLD patients can develop nonalcoholic steatohepatitis (NASH), which leads to more rapid progression from fibrosis to cirrhosis, and even liver failure or hepatocellular carcinoma (HCC). Early detection and treatment may halt or reverse NAFLD progression. Although liver biopsy has been the well-accepted clinical reference standard for both diagnosis and staging of the different histological changes in NAFLD, this procedure is invasive with complications such as bleeding and infection, and is unreliable for quantifying steatosis due to sampling errors. Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) currently has been accepted as the preferred alternative to the histological assessment of hepatic steatosis in patients with NAFLD. Magnetic resonance elastography (MRE) provide additional information of inflammation and fibrotic components of NAFLD. However, important limitations hinder the widespread clinical application of MRI, including high cost, low availability, long scan times and exclusion of patients with metal implants. Ultrasound (US) has been recommended by several guidelines as the first-line screening tool for patients at risk of NAFLD. The developed ultrasound-derived fat fraction (UDFF) is designed to assess hepatic steatosis by estimating the frequency-dependent attenuation coefficient (AC) and backscatter coefficient (BSC) through processing acoustic radiofrequency (RF) signals returned from the liver tissue as fat vesicles in hepatocytes have a different characteristic impedance compared to normal liver tissue. UDFF is available on the Acuson Sequoia ultrasound system (Simens Healthineers, Mountain View, CA, USA), with reference to integrated phantom data to correct for system impact, and produces a UDFF value presented as a fat fraction (%), which is potentially related to MRI-PDFF and can be directly compared with MRI-PDFF. In addition, automatic point shear wave elastography (auto-pSWE) is available on the Acuson Sequoia ultrasound system to obtain liver stiffness measurement (LSM) for assessing hepatic fibrosis, simultaneously with UDFF measurement. The prospective, multicenter study aims to evaluate the efficiency of UDFF as a quantitative non-invasive alternative for NAFLD.

NCT ID: NCT05800704 Recruiting - Clinical trials for C. Difficile Enteritis

Support of Colonization Resistance of the Gut Microbiota With the Synbiotic Food Supplement Nagasin®

Start date: March 10, 2023
Phase: N/A
Study type: Interventional

The aim of this randomized, controlled, double-blind, parallel, multicentric trial is to investigate wether the synbiotic food supplement Nagasin® can support the colonization resistance of the gut microbiota after disturbance by antimicrobial treatment. The main question is whether Nagasin® can prevent any increase in abundance of C.difficile within the first four weeks after antimicrobial treatment for a C. difficile infection. Participants will receive Nagasin® or the comparator as a food supplement during the first four weeks after antimicrobial treatment for a C. difficile episode.

NCT ID: NCT05799417 Recruiting - Anesthesia Clinical Trials

Brain Oscillatory Signatures of Auditory Stimuli Across Different Vigilance and Sedation States

Start date: February 28, 2023
Phase: N/A
Study type: Interventional

The investigators want to explore how presenting acoustic stimuli influences brain oscillatory signatures and heart rhythm- dynamics across different vigilance and sedation states. The investigators will administer acoustic stimuli during sedation and anaesthesia while brain activity and heart activity are being recorded by electroencephalogram and electrocardiogram. On the day following anaesthesia an optional nap/sleep period's EEG and ECG will be recorded. During this short sleep, patients will again be exposed to acoustic stimuli. The recorded EEG and ECG will be compared intra-and inter-individually to recordings from sedation and anaesthesia.

NCT ID: NCT05798520 Recruiting - Clinical trials for Relapsing Forms of Multiple Sclerosis

A Study to Evaluate Safety and Efficacy of BIIB091 in Participants With Relapsing Forms of Multiple Sclerosis

FUSION
Start date: July 25, 2023
Phase: Phase 2
Study type: Interventional

The primary objectives are to investigate the safety and tolerability of BIIB091 monotherapy in participants with relapsing multiple sclerosis (RMS) (Part 1), and to evaluate the effects of BIIB091 combination therapy with Diroximel Fumarate (DRF) compared with the DRF monotherapy arm, on the key Magnetic Resonance Imaging (MRI) measure of active Central Nervous System (CNS) inflammation (Part 2). The secondary objectives are to evaluate the effects of BIIB091 monotherapy on the MRI measures of active CNS inflammation, to evaluate the effects of BIIB091 combination therapy with DRF compared with the DRF monotherapy arm on additional MRI measures of active CNS inflammation, to investigate the safety and tolerability of BIIB091 combination therapy with DRF in participants with RMS.

NCT ID: NCT05798117 Recruiting - Clinical trials for Systemic Lupus Erythematosus

An Open-label, Study to Assess Safety, Efficacy and Cellular Kinetics of YTB323 in Severe, Refractory Systemic Lupus Erythematosus

Start date: February 28, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The study is intended to assess safety, efficacy and cellular kinetics of YTB323 treatment in participants with severe refractory systemic lupus erythematosus.

NCT ID: NCT05791656 Recruiting - Clinical trials for Anterior Cruciate Ligament Injuries

Interference Screw Mectascrew-C Postmarket Study

Start date: March 22, 2023
Phase:
Study type: Observational

An observational prospective study with the aim to analyze the presence at 6 months of a specific composite IS (Medacta Mectascrew C) in the reconstructive treatment of ruptured ACL or PCL by means of an autograft or allograft.

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: 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: NCT05790161 Recruiting - Caffeine Clinical Trials

Consequences of Caffeine Intake in Sleep Restricted Teenagers

Start date: March 31, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to systematically investigate two prominent factors in teenagers' daily life: Caffeine and sleep restriction (SR) and their combined influence on sleep, cognition, and behavior in healthy adolescents. The main questions it aims to answer are: The effects of caffeine under conditions of SR and SE: - on sleep pressure and sleep continuity. - on BOLD activity differences in reward related areas during a reward task (monetary incentive delay task) and on reaction times (behavioral aspect) in the same task. - on BOLD activity differences during a risk taking task (wheel of fortune task) and on risky decision-making (behavioral aspect) in the same task. Participants will be either in the SR or SE condition (between-subject). The protocol consists of 2x of approximately one week in which a participant will receive caffeine or placebo (within-subject) at the last two evenings. The experiment consists of an ambulatory and a laboratory phase: - The ambulatory phase consists of 5 nights, including 3 stabilization nights (8h sleep opportunity) prior to 2 nights consisting of either SR with 6h sleep opportunity or SE with 9.5h sleep opportunity. Participants will wear an actiwatch and fill out sleep diaries during this period. - The laboratory phase will be the 6th evening, night and morning of the protocol and will be spent in our lab. Participants will do the following: - treatment (caffeine vs. placebo) intake - saliva sampling - drug screening - cognitive tests, including risk-taking and reward task - filling in questionnaires (sleep diary, sleep quality, sleepiness, mood, expectancy) - waking and sleep with EEG The next day, participants will undergo an fMRI scan, including the following: - resting-state scan - structural scan - arterial spin labeling scan - reward task scan - risk-taking task scan Around the scan, participants will fill out/undergo: - saliva sampling - questionnaires (reward task, mood, sleepiness, expectancy)

NCT ID: NCT05789082 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation

Krascendo 170
Start date: June 20, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of divarasib combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).