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NCT ID: NCT06452654 Recruiting - Clinical trials for Diabetes Mellitus, Type 1

Anti-viral Action Against Type 1 Diabetes Autoimmunity

Start date: May 8, 2024
Phase: Phase 4
Study type: Interventional

The study GPPAD-05 AVAnT1A is a phase 4 clinical trial intending to enroll 2252 children, who will be randomly assigned to receive COVID-19 vaccination (Comirnaty® 3 μg Omicron XBB.1.5 or new variant Comirnaty vaccines ) or placebo from age 6 months. The study is an investigator initiated, randomized, controlled, multicentre, multinational, primary prevention trial for children at increased risk of type 1 diabetes. The primary objective is to determine whether vaccination of children with elevated genetic risk for type 1 diabetes against COVID-19 from 6 months of age reduces the cumulative incidence of islet autoantibodies or type 1 diabetes in childhood. Secondary objectives are: 1. to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of multiple islet autoantibodies in childhood. 2. to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of type 1 diabetes in childhood and 3. to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of celiac disease-associated transglutaminase autoantibodies in childhood. Further exploratory objectives are described in the study protocol. Study participants will be identified through an ongoing study screening for genetic risk of type 1 diabetes using a polygenic risk score (NCT03316261). Eligible participants will be enrolled at age 3.00 to 4.00 months (baseline visit). Randomization to vaccine or placebo will occur at age 6.00 to 7.00 months at visit 2. Consent will be obtained by the custodial parents prior to enrollment.

NCT ID: NCT06452277 Not yet recruiting - Clinical trials for Advanced Non-small Cell Lung Cancer

A Study to Learn More About How Well BAY 2927088 Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Human Epidermal Growth Factor Receptor 2 (HER2)

SOHO-02
Start date: June 24, 2024
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations. Advanced NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body or that are unlikely to be cured or controlled with currently available treatments. HER2 is a protein that helps cells to grow and divide. A damage (also called mutation) to the building plans (genes) for this protein in cancer cells leads to a production of abnormal HER2 and therefore abnormal cell growth and division. The study treatment, BAY 2927088, is expected to block the mutated HER2 protein which may stop the spread of NSCLC. The main purpose of this study is to learn how well BAY 2927088 works and how safe it is compared with standard treatment, in participants who have advanced NSCLC with specific genetic changes called HER2 mutations. The study participants will receive one of the study treatments: - BAY 2927088 twice every day as a tablet by mouth, or - Standard treatment in cycles of 21 days via infusion ("drip") into the vein. The treatment will continue for as long as participants benefit from it without any severe side effects or until they or their doctor decide to stop the treatment. During the study, the doctors and their study team will: - take imaging scans, including CT, PET, MRI, and X-rays, of different parts of the body to study the spread of cancer - check the overall health of the participants by performing tests such as blood and urine tests, and checking - heart health using an electrocardiogram (ECG) - perform pregnancy tests for women - ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.

NCT ID: NCT06450808 Active, not recruiting - Clinical trials for Pharmacokinetic Parameters

The Microalga Phaeodactylum Tricornutum a Potential Fish Substitute?- Pharmacokinetic Study

MikroFisch
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

In a cross-over design, pestos enriched with different levels of the microalgae Phaeodactylumtricornutum (2-3-4%) will be tested. The bioavailability of long-chain omega-3 fatty acids, in particular EPA and carotenoids, will be analysed in blood plasma postprandially within two days after a single dose. Pharmacokinetic parameters will be calculated from the measured data. The aim of the study is to gain insight into the bioavailability of selected microalgae constituents and the acceptance of microalgae pesto.

NCT ID: NCT06450197 Not yet recruiting - Clinical trials for Moderate to Severe Crohn's Disease

Phase IIa Study Evaluating AZD7798 in Crohn's Disease

AMALTHEA
Start date: June 17, 2024
Phase: Phase 2
Study type: Interventional

This is a randomised, double-blind, parallel group, placebo-controlled Phase IIa study designed to evaluate the efficacy and safety of AZD7798 in participants with moderate to severe Crohn's disease.

NCT ID: NCT06447506 Not yet recruiting - Dermatitis, Atopic Clinical Trials

Long-Term Study (AtDvance) to Evaluate GSK1070806 in Atopic Dermatitis.

AtDvance
Start date: June 4, 2024
Phase: Phase 2
Study type: Interventional

The study is designed to evaluate the long-term safety and efficacy of GSK1070806 in participants with moderate-to severe atopic dermatitis, who have completed phase 2b parent GSK atopic dermatitis (AtD) study (NCT05999799).

NCT ID: NCT06446856 Recruiting - Schizophrenia Clinical Trials

EVEN - Effects of VR on Empathy for Nature in Patients With Psychosis and Depressive Disorders

EVEN
Start date: May 27, 2024
Phase:
Study type: Observational

Study group: Experimental study to evaluate empathy, compassion, and nature connectedness before and after an immersive virtual reality experience in patients with depressive disorder, patients with psychotic disorder and healthy control subjects (subjects between 18 and 65 years of age). Primary hypothesis: The increase in nature connectedness explored by virtual body ownership of a tree in VR differs depending on the health condition (schizophrenia, depression, healthy controls).

NCT ID: NCT06445673 Enrolling by invitation - Clinical trials for Pulmonary Arterial Hypertension

A Prospective Non-interventional Observational Study to Observe Long-term Treatment and Outcomes in Pulmonary Arterial Hypertension (PAH) Patients

TripleTRE-NIS
Start date: June 2024
Phase:
Study type: Observational

The goal of this observational study is to learn about the long-term development and outcomes of different treatment patterns of patients who initially participated in the TripleTRE study. The primary objective of this non-interventional follow-up study is to assess the long-term real-world clinical outcomes, including disease progression and survival rates, in patients who initially participated in and completed the randomized TripleTRE trial. Planned observation duration per patient is a minimum of 3 years.

NCT ID: NCT06445153 Recruiting - Clinical trials for Postoperative Delirium

Digitalized Clinical Decision Support for the Prevention of Postoperative Delirium (POD)

Start date: June 3, 2024
Phase: N/A
Study type: Interventional

The project aims to improve patient safety, reduce barriers to the implementation of current guideline recommendations, reduce workload in clinics, increase efficiency in work processes and close gaps in care.

NCT ID: NCT06444789 Not yet recruiting - Parkinson Disease Clinical Trials

AI-PROGNOSIS - Digital Biomarkers Development Study (dBM-DEV)

dBM-DEV
Start date: July 15, 2024
Phase:
Study type: Observational

dBM-dev study is a multicentre low-intervention research study which concerns REM sleep behaviour disorder (RBD) who is the best predictor for neurodegenerative diseases including Parkinson's disease (PD). RBD can only be confirmed by polysomnography, which is a cumbersome procedure. The main objective of this study is to identify a novel, robust dBM for the detection of RBD using smartwatch-based recordings of passive data.The study is conducted step-wise on two subsequent cohorts referred to as the development cohort and the confirmation cohort.

NCT ID: NCT06442410 Completed - Pain, Chronic Clinical Trials

Comparison of DTM™ SCS Therapy Combined With Conventional Medical Management (CMM) to CMM Alone in the Treatment of Intractable Back Pain Subjects Without Previous History of Lumbar Spine Surgery

Start date: July 24, 2020
Phase: N/A
Study type: Interventional

The purpose of this investigational study is to document the safety, clinical effectiveness and health economic analytics of DTM™ SCS programming delivered through the Intellis™ neurostimulator in subjects with chronic, intractable pain of the trunk with or without lower limb pain, including unilateral or bilateral pain without prior history of spine surgery and refractory to conservative treatment and are not candidates for lumbar spinal surgery.