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NCT ID: NCT06294158 Not yet recruiting - Critical Illness Clinical Trials

Light and Noise: Objectively Assessing Environmental Risk Factors for Delirium in the ICU

LANYARD-ICU
Start date: April 2024
Phase:
Study type: Observational

Recognition of delirium as a medical entity with relevance to both morbidity and mortality, especially in critically ill patients, is a relatively recent development. However, research into delirium prevention and treatment is now in focus of scientific efforts internationally. Knowledge of intensive care unit (ICU) environment as a potential modifiable risk factor for delirium is insufficient to this date. This study thus seeks to evaluate, whether potentially modifiable environmental factors, such as noise or dazzling, are associated with development of delirium. Knowledge derived from this investigation could change both the process of care provision in intensive care units as well as the design of ICUs in general in the future. This project is planned to be carried out as an observational pilot study at three perioperative ICUs at the University Medical Centre Graz. Adult patients shall be screened for inclusion, if not deeply sedated. Suitable patients shall be included into the study after written informed consent or deferred consent if they can be expected to remain in the ICU for at least another two days, if they are not already in delirium, if the ICU environment is not actively modified for therapeutic reasons and if no treatment limitations are in place. Over a study duration of one year, 250 to 300 patients are expected to be enrolled into the study. Of those, 60 to 120 patients are likely to develop delirium. Baseline data known to be of relevance for outcome prediction in critically ill patients and factors known to predispose for development of delirium during ICU and hospital stay will be collected. Study equipment will be deployed to measure noise levels and illumination repeatedly over the day. Daily assessments for delirium using the Confusion Assessment Method in Intensive Care Units (CAM-ICU) will be performed. Vital status, physiologic parameters and parameters of ongoing treatment will concomitantly be documented on a daily basis. Data on light and noise levels are then to be unified with parameters of physiology and treatment, vital status, and results of daily assessments for delirium. Statistical analysis using methods of descriptive and comparative statistics as well as both unadjusted and adjusted logistic regression analysis will be performed to identify factors significantly associated with the development of delirium (i.e., risk factors).

NCT ID: NCT06292988 Not yet recruiting - Clinical trials for Medullary Thyroid Cancer

Predictive Factors for Medullary Thyroid Cancer Aggressiveness

MYELO
Start date: March 1, 2024
Phase:
Study type: Observational

This study is a retrospective study trying to find the predictive factors for medullary thyroid aggressiveness in terms of tumor metastasis and patients' survival.

NCT ID: NCT06292013 Recruiting - Clinical trials for Atherosclerotic Cardiovascular Disease (ASCVD)

A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a)

Start date: March 5, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. The study drug will be administered subcutaneously (SC) (under the skin).

NCT ID: NCT06291675 Recruiting - Gender Dysphoria Clinical Trials

Gender-Affirming Hormone Therapy and Its Impact on Myocardial Mass and Cardiac Function, Heart, Liver and Pancreatic Fat Content

Start date: March 3, 2023
Phase:
Study type: Observational

Background: Gender affirming hormone therapy (GAHT) leads to profound changes in sex hormone levels, carrying a wide range of implications for major physiological processes in the body. GAHT has been shown to be associated with changes in cardiovascular parameters, the insulin system, body composition, and the psychological state. However, despite the fact that GAHT is usually a long-term intervention, the majority of the research concerns itself with an overall short duration of the therapy and the data on the mid- to long-term effects of GAHT is scarce. Objectives: The study aims to investigate the effects of gender affirming hormone therapy on the cardiovascular risk profile, insulin system, body composition, various metabolic parameters, and the psychological state after 2, 5, and 10 years of the treatment. Study design: The study is designed as an observational longitudinal monocentric study, which includes transgender men and transgender women who have been taking gender affirming hormone therapy during the past 2 years and took part in our pilot study. Our probands will undergo a magnetic resonance scan, extensive bloodwork, an oral glucose tolerance test, and a psychological self-assessment after 2, 5, and 10 years of the treatment. Materials and methods: The magnetic resonance imaging and spectroscopy will be performed with a 3-Tesla magnetic resonance device. We will also perform an extensive blood analysis and an 75g- 2h oral glucose tolerance test. Additionally, the psychological state of the probands will be assessed with 3 questionnaires. Study population: 30 transgender men 30 transgender women who participated in our pilot study and have been taking the gender affirming hormone therapy for the past 2 years. Relevance and implications of the study: The majority of previous research has focused on the short-term effects of gender affirming hormone therapy. Contrastingly, our study aims to focus on the effects of hormone therapy at 2, 5 and 10 years after the beginning of the treatment. Moreover, our study group utilizes measurements of myocardial, hepatic, and pancreatic fat content as well as an MR-assisted measurement of cardiac function, which is a topic that has not been present in research into the effects of gender affirming hormone therapy outside of our pilot study.

NCT ID: NCT06291376 Recruiting - Clinical trials for Immunoglobulin A Nephropathy

Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

ICAN
Start date: March 29, 2024
Phase: Phase 3
Study type: Interventional

The primary objective of this study to evaluate the efficacy of ravulizumab compared with placebo to reduce proteinuria and slow the rate of eGFR decline in adult participants with IgAN who are at risk of disease progression.

NCT ID: NCT06288412 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

A Study to Test How a New Long-acting Insulin Works in the Body of Patients With Type 2 Diabetes During Exercise and Prolonged Fasting

Start date: February 26, 2024
Phase: Phase 1
Study type: Interventional

The study will investigate the safety of once weekly insulin icodec subcutaenously (s.c.) during and after exercise and prolonged fasting in patients with type 2 diabetes (T2D). Participants will first receive insulin decludec (Tresiba®, a long-acting insulin taken once daily) for atleast one week. Afterwards participants will receive insulin icodec that will be administered once weekly at the study site (for a minimum of 7 weeks and maximum of 14 weeks). Insulin icodec is a novel long-acting insulin analogue for once-weekly administration for the treatment of type 2 diabetes. The study will last for about 16-30 weeks. Participant must not participate if participant have suspected hypersensitivity reactions to the study products or cardiovascular diseases within the last 180 days. Female participant cannot take part if she is pregnant, breast-feeding or planning to become pregnant during the study period.

NCT ID: NCT06286657 Recruiting - Infection Viral Clinical Trials

Xanthohumol and Viral Infections (XL)

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

The aim of the present study is to determine if a regular oral supplementation of xanthohumol attenuate the severity of symptoms and duration of´viral infections.

NCT ID: NCT06286644 Recruiting - Clinical trials for Inflammatory Response

Hop Compounds on the Immune System (VH)

Start date: May 30, 2022
Phase: N/A
Study type: Interventional

The aim of the present study is to determine the effect of Iso-alpha-Acids and Xanthohumol from hops on the immune response of healthy participants over a timeframe of 6 hours.

NCT ID: NCT06284512 Recruiting - Uveal Melanoma Clinical Trials

Uveal Melanoma - Comparative Study

Start date: October 15, 2023
Phase:
Study type: Observational

The progress of uveal melanoma is typically monitored with sonography by experienced onco-ophthalmologists. However, there is evidence that twodimensional measurements in color fundus photography match precisely with sonography measurements. This study aims to compare sonography and color fundus photography measurements in order to evaluate the feasibility of monitoring of uveal melanoma with color fundus photography.

NCT ID: NCT06283966 Recruiting - Clinical trials for COPD (Chronic Obstructive Pulmonary Disease)

A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease

THARROS
Start date: February 21, 2024
Phase: Phase 3
Study type: Interventional

This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.