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NCT ID: NCT05659264 Recruiting - Clinical trials for Chronic Heart Failure

A Study to Evaluate the Safety of mRNA-0184 in Participants With Heart Failure

Start date: December 5, 2022
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of single and multiple doses at escalating dose levels of mRNA-0184.

NCT ID: NCT05659004 Completed - Clinical trials for Chronic Limb Threatening Ischemia

Referrals for CLTI: Qualitative Study

Start date: January 10, 2023
Phase:
Study type: Observational

The goal of this qualitative study is to explore the experiences of patients who have been diagnosed with chronic limb-threatening ischaemia (CLTI). The main questions it aims to answer are: - What are the perceptions and experiences of patients between first symptom of CLTI and vascular surgery assessment - What is important to patients during this process. Participants will be interviewed and their words analysed using reflexive thematic analysis.

NCT ID: NCT05657795 Recruiting - Clinical trials for Mechanical Ventilation Complication

Optimising Neonatal Ventilation With Closed-loop Oxygen Control

Start date: December 7, 2022
Phase: N/A
Study type: Interventional

Ventilated newborns frequently need supplemental oxygen but its use must be monitored carefully as both giving too much or too little oxygen can have harmful effects. Giving too little oxygen results to low oxygen levels (hypoxia) and increases the risk of complications and mortality. Excessive oxygen delivery (hyperoxia) increases the risk of diseases involving several organs such as the retinas and the lungs. Although infants born very preterm require support with their breathing more often, more mature neonates may also need to be ventilated at birth and to receive supplemental oxygen. Therefore, they may suffer from problems related to hypoxia and hyperoxia. For the above reasons, oxygen levels are continuously monitored and the amount of oxygen provided is manually adjusted by the nurses and doctors. Closed-loop automated oxygen control systems (CLAC) are a more recent approach that involves the use of a computer software added to the ventilator. This software allows for automatic adjustment of the amount of oxygen provided to the baby in order to maintain oxygen levels within a desired target range depending on the baby's age and clinical condition. Previous studies in preterm and very small infants showed that automated oxygen control systems provided the right amount of oxygen for most of the time and prevented hypoxia and hyperoxia with fewer manual adjustments required by clinical staff. Preliminary results from a study that included infants born at 34 weeks gestation and beyond showed that CLAC systems allowed to reduce the amount of supplementary oxygen more rapidly. With this study we aim to compare the time spent in hyperoxia and the overall duration of oxygen treatment between infants whose oxygen is adjusted either manually or automatically while they remain ventilated. This will help us understand if CLAC systems help reduce the complications related to oxygen treatment.

NCT ID: NCT05657691 Active, not recruiting - Clinical trials for Major Depressive Disorder

Xanamem® in Adults With Major Depressive Disorder and Impaired Cognition (XanaCIDD)

Start date: November 28, 2022
Phase: Phase 2
Study type: Interventional

Xanamem is being developed as a potential treatment for symptomatic, early stages of Alzheimer's Disease (AD) and Major Depressive Disorder (MDD). This XanaCIDD Phase II study in MDD is to investigate the safety and efficacy of Xanamemâ„¢ in treating patients with cognitive and depressive symptoms. Trial participants will be randomized to either receive 10mg of Xanamemâ„¢ once daily or a Placebo at a 1:1 ratio in a double-blinded fashion.

NCT ID: NCT05657080 Recruiting - Gastric Cancer Clinical Trials

Cytosponge for Gastric Intestinal Metaplasia

CyGIM
Start date: October 16, 2023
Phase:
Study type: Observational

Gastric cancer has a very poor prognosis. The disease is often diagnosed at a late stage, when curative treatment options are limited or ineffective. There is a condition that predisposes to gastric cancer, known in medical terms as Gastric intestinal metaplasia (GIM). This pre-cancerous condition can be diagnosed with an endoscopic camera test, but it often very subtle and can be missed at routine endoscopy. There is evidence that about 7% of gastric cancers are missed at previous endoscopy. The Cytosponge-trefoil factor 3 (TFF-3) is a pill on a string combined to a molecular biomarker which could help early diagnosis of gastric cancer and GIM. Cytosponge-TFF3 has been showed in previous research to be useful to diagnose Barrett's oesophagus, a condition of the food pipe similar to GIM. The aim of this study is to investigate the utility of the Cytosponge in combination with molecular biomakers to diagnose GIM

NCT ID: NCT05656911 Completed - Atopic Dermatitis Clinical Trials

A Study to Learn How Well the Study Treatment Zabedosertib (BAY1834845) Works and How Safe it is Compared to Placebo in Adult Participants With Moderate-to-severe Atopic Dermatitis

Damask
Start date: December 21, 2022
Phase: Phase 2
Study type: Interventional

Researchers are looking for a better way to treat atopic dermatitis (AD), an often long-lasting inflammation of the skin. Atopic dermatitis, also called eczema, is causing patches of skin to become swollen, red, cracked, and itchy. The immune system helps protect the body from diseases. But sometimes the immune system can be too sensitive and overreact. This may then lead to allergies but also to skin conditions like atopic dermatitis. The study treatment zabedosertib (BAY1834845) is currently under development for the treatment of atopic dermatitis and other inflammatory diseases. It works by reducing the activity of a protein called IRAK4. IRAK4 promotes the production and activation of a series of proteins that trigger inflammation reactions in the immune cells. By reducing the activity of IRAK4, the inflammation reactions are expected to be reduced. The main purpose of the study is to learn how well zabedosertib works compared to placebo. A placebo is a treatment that looks like a medicine but does not have any medicine in it. How well it works means to find out the efficacy of zabedosertib. To answer this, the researchers will compare how many participants had 75% EASI score reduction after 12 weeks treatment between participants treated with zabedosertib and those treated with placebo. EASI represents Eczema Area and Severity Index (EASI). It is a tool for measuring the amount and severity of atopic dermatitis that a patient has on his or her body. The score ranges from 0-72, with 0 meaning clear skin and 72 meaning severe atopic dermatitis. In addition, the itch of the study participants and other tools for measuring the severity of atopic dermatitis will be assessed. The secondary purpose of the study is to learn how safe it is compared to placebo. To know this, study team will compare how many participants having adverse events after taking study treatment between participants treated with zabedosertib and those treated with placebo. In the study, participants will be randomly (by chance) assigned to receive zabedosertib or placebo. The participants from both treatment groups will take zabedosertib or placebo for up to 12 weeks. The study consists of an up to 28-day screening period (Visits 1 and 2), a 12-week treatment period consisting of 5 visits (Visits 3 to 7), and a 4-week follow-up visits (Visits 8). Thus, the total study duration per participant will be 17 to 20 weeks (approximately 140 days). During the study, the study team will: - take blood and urine samples - take skin samples (not obligatory for all patients) - check the participants' disease area for assessment - provide participants device to record their disease status and to take pictures on their disease areas - have participants complete self-reported questionnaires - do physical examinations - examine heart health using ECG - check vital signs - ask the participants questions about how they are feeling and what events they are having. An adverse event is any problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. At 28 days after the participants take their last treatment, the study team will check if participants have any events that might be related to the study treatment. This will be the last visit for the study.

NCT ID: NCT05656469 Recruiting - Anxiety Disorders Clinical Trials

Clinical Study Evaluating Pharmacogenomics-informed Pharmacotherapy Versus Dosing as Usual in Psychiatric Disorders

PSY-PGx
Start date: February 23, 2023
Phase: N/A
Study type: Interventional

A 24-week, patient- and rater-blinded, two-arm, parallel-group controlled, and multi-centre randomized clinical trial (RCT) to establish the benefits of pharmacogenetics-informed pharmacotherapy versus dosing as usual (DAU) in psychiatric patients suffering from mood, anxiety, or psychotic disorders.

NCT ID: NCT05656417 Recruiting - Gingivitis Clinical Trials

Individual Variability of Experimental Gingivitis Response

Start date: January 19, 2023
Phase:
Study type: Observational

The study aims to investigate the genetic cause of the variability between individuals seen in the development of the gum disease, gingivitis. This will be carried out through a 3 week programme where all oral hygiene is ceased, allowing 'experimental gingivitis' to develop, followed by a period of recovery when tooth cleaning is restored. Clinical assessments and biological samples will be taken during the course of the study for further analysis.

NCT ID: NCT05655741 Completed - Genetic Disease Clinical Trials

Modified Delphi for Genomic Bereavement Care

Start date: October 28, 2022
Phase:
Study type: Observational

It is estimated that 1 in 4 pregnancies end in loss, be these early miscarriages, ectopic pregnancies, or later intrauterine losses for any reason. Genomics is a major part of pregnancy loss, and clinicians want to offer the best and most appropriate test available to women and their families, whilst ensuring that there is equity in the access to this testing, so that no family goes through a loss without the right support and information. Whilst there is limited information to inform professionals as to how to incorporate genomics into bereavement care there is a need to identify current expert consensus as to how this should be performed, in order to make recommendations for best practice.

NCT ID: NCT05655156 Recruiting - Clinical trials for Multiligament Knee Injuries

OrthoPureXT Multiligament PMCF Study

Start date: May 2024
Phase: N/A
Study type: Interventional

To monitor residual risks in the post-market phase and to ensure continued clinical evaluation of the device safety and performance to ensure that no new or unexpected risks arise when used during multi-ligament knee reconstructions.