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NCT ID: NCT05687266 Recruiting - NSCLC Clinical Trials

Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations

AVANZAR
Start date: December 29, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, open-label, multicenter, global study to compare the efficacy and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin compared with pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment of adults with stage IIIB, IIIC, or IV NSCLC without actionable genomic alterations (including sensitizing EGFR mutations, and ALK and ROS1 rearrangements).

NCT ID: NCT05686785 Recruiting - Clinical trials for Chronic Viral Hepatitis

Agreement and Reliability of Transient Elastography

HEPSCAN
Start date: June 1, 2023
Phase:
Study type: Observational

The aim of this study is to assess agreement, smallest detectable change, and reliability of repeated measurements of liver stiffness of transient elastography in patients with chronic viral hepatitis, and to explore factors associated with disagreement.

NCT ID: NCT05686512 Active, not recruiting - Anxiety Disorder Clinical Trials

Initial Evaluation of a Stepped Care Model for Treating Mild to Moderate Childhood Anxiety in Primary Care

Start date: February 13, 2023
Phase: N/A
Study type: Interventional

Objectives: In the past ten years in Sweden, a new form of primary care units called first line mental health (FLMH) has been implemented to improve mental health services for children and adolescents. Using a structured and collaborative approach including experts, clinicians, and patients, the investigators have developed a transdiagnostic psychological intervention for anxiety based on cognitive behavioural therapy (CBT) that aims to fit the FLMH care context. The current study aims to test the CBT intervention "Step-by-Step" in a randomized pilot study (N=36) to explore the feasibility of the study design. Rationale for study: Childhood anxiety is common and associated with suffering and impairment in several life areas. CBT is an evidence-based treatment for anxiety disorders in children, but there is a need of increasing access to treatment. Offering CBT for childhood anxiety in primary care is a way to offer early and accessible treatment. However, there is a lack of CBT interventions developed for and evaluated in primary care. Prior to a properly powered randomized controlled study, evaluating efficacy of the Step-by-Step, the investigators need to conduct a pilot study to, primarily, establish the feasibility of the study design and trial procedures and secondarily, provide preliminary data on acceptability and clinical efficacy.

NCT ID: NCT05686070 Recruiting - Clinical trials for Acute Non-cardioembolic Ischemic Stroke

A Study to Test Asundexian for Preventing a Stroke Caused by a Clot in Participants After an Acute Ischemic Stroke or After a High-risk Transient Ischemic Attack, a So-called Mini Stroke

OCEANIC-STROKE
Start date: January 26, 2023
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to prevent an ischemic stroke which occurs when a blood clot travelled to the brain in people who within the last 72 hours had: - an acute stroke due to a blood clot that formed outside the heart (acute non-cardioembolic ischemic stroke), or - TIA/mini-stroke with a high risk of turning into a stroke (high-risk transient ischemic attack), and who are planned to receive standard of care therapy. Acute ischemic strokes or TIA/mini-stroke result from a blocked or reduced blood flow to a part of the brain. They are caused by blood clots that travel to the brain and block the vessels that supply it. If these blood clots form elsewhere than in the heart, the stroke is called non-cardioembolic. People who already had a non-cardioembolic stroke are more likely to have another stroke. This is why they are treated preventively with an antiplatelet therapy, the current standard of care. Antiplatelet medicines prevent platelets, components of blood clotting, from clumping together. Anticoagulants are another type of medicine that prevents blood clots from forming by interfering with a process known as coagulation (or blood clotting). The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. Asundexian aims to further improve the standard of care without increasing the risk of bleeding. The main purpose of this study is to learn whether asundexian works better than placebo at reducing ischemic strokes in participants who recently had a non-cardioembolic ischemic stroke or TIA/mini-stroke when given in addition to standard antiplatelet therapy. A placebo is a treatment that looks like a medicine but does not have any medicine in it. Another aim is to compare the occurrence of major bleeding events during the study between the asundexian and the placebo group. Major bleedings have a serious or even life-threatening impact on a person's health. Dependent on the treatment group, the participants will either take asundexian or placebo once a day for at least 3 months up to 31 months. Approximately every 3 months during the treatment period, either a phone call or a visit to the study site is scheduled on an alternating basis. In addition, one visit before and up to two visits after the treatment period are planned. During the study, the study team will: - Check vital signs such as blood pressure and heart rate - Examine the participants' heart health using an electrocardiogram (ECG) - Take blood samples - 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 that happen in studies, even if they do not think the adverse events might be related to the study treatments. In addition, the participants will be asked to complete a questionnaire on quality of life at certain time points during the study.

NCT ID: NCT05685953 Completed - Clinical trials for COVID-19 Respiratory Infection

A Randomized, Phase I Study of DNA Vaccine OC-007 as a Booster Dose of COVID-19 Vaccine

OpenCorona1
Start date: February 8, 2023
Phase: Phase 1
Study type: Interventional

This is a randomized, placebo-controlled, double-blinded phase I study, designed to evaluate the safety including reactogenicity and immunogenicity of this investigational DNA vaccine delivered intramuscularly by in vivo EP in human adults. The vaccine doses will be given to healthy adults aged 18 to 60 years, who have been previously vaccinated against COVID-19 with 3 doses of either Comirnaty® or Spikevax®, or both in any combination ≥3 months ago.

NCT ID: NCT05685745 Recruiting - Premature Birth Clinical Trials

Multisite Inventory of Neonatal-Perinatal Interventions (MINI) Minimum Dataset

Start date: January 1, 2019
Phase:
Study type: Observational [Patient Registry]

The goal of the Tiny Baby Collaborative Multicenter Inventory of Neonatal-Perinatal Interventions (MINI) minimum dataset is to serve as a registry detailing the outcomes and practices for all deliveries and infants admitted to intensive care at 22-23 weeks' gestation at participating hospitals.

NCT ID: NCT05685316 Recruiting - Clinical trials for Cartilage or Osteochondral Defects in the Knee

COPLA® Cartilage Implant Pilot Clinical Trial

Start date: December 23, 2022
Phase: N/A
Study type: Interventional

This is a first-in-human clinical, open label, non-randomized, prospective investigation to assess the initial safety and performance of the COPLA® cartilage implant. In the investigation, the patients will receive COPLA® device during normal clinical practice for cartilage repair surgery with bone marrow stimulation.

NCT ID: NCT05683990 Recruiting - Clinical trials for Diabetes Mellitus, Type 1

Study to Evaluate the Safety and Feasibility of Diamyd® in Individuals at Risk for Type 1 Diabetes

Start date: November 14, 2023
Phase: Phase 2
Study type: Interventional

A 2-arm randomized Phase II Open Label Study to evaluate the safety and feasibility of intralymphatic administration of Diamyd® (Diamyd) in individuals at risk of Type 1 diabetes carrying the HLA DR3-DQ2 haplotype.

NCT ID: NCT05681351 Recruiting - Clinical trials for Severe Hypertriglyceridemia

A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)

Start date: December 13, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG.

NCT ID: NCT05679401 Recruiting - Clinical trials for Anti-Glomerular Basement Membrane Antibody Disease

A Study With Imlifidase in Anti-GBM Disease

GOOD-IDES-02
Start date: December 22, 2022
Phase: Phase 3
Study type: Interventional

An open-label, controlled, randomised, multi-centre Phase 3 trial evaluating renal function in patients with severe anti-GBM disease comparing imlifidase and standard of care (SoC) with SoC alone. All patients will remain in the trial for 24 months.