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NCT ID: NCT06028438 Active, not recruiting - Clinical trials for Arthritis, Rheumatoid

A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis

DAISY
Start date: August 15, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of combination therapy with nipocalimab and certolizumab compared to certolizumab monotherapy.

NCT ID: NCT06015282 Active, not recruiting - Influenza, Human Clinical Trials

The Celljuvant Study: A Phase 3 Immunogenicity and Safety Study of aQIVc Vaccine in Adults Aged 50 Years and Older

Start date: November 3, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, parallel-group, comparator-controlled, observer-blind, multicenter study of immunogenicity and safety in approximately 7700 male and female adults aged 50 years and older (approximately equally split between two age groups: 50-64 years; 65 years and older), who are healthy or have stable comorbidities that increase their risk of complications from influenza infection. Three lots of aQIVc will be evaluated for consistency and pooled for the comparison with the 2 control vaccines. Subjects will be randomly assigned to receive 1 of 3 lots of aQIVc, QIV1, or QIV2 in a 1:1:1:2:2 ratio (for a 3:2:2 ratio for aQIVc, QIV1, and QIV2). The study will have a treatment period (Day 1 to Day 29) and a follow-up period (Day 30 up to Day 181); a subset of 770 subjects will be followed up up to Day 365.

NCT ID: NCT05999968 Active, not recruiting - Prostatic Neoplasms Clinical Trials

Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment

Start date: January 12, 2024
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to learn more about the safety and tolerability of abemaciclib when given in combination with darolutamide to participants with prostate cancer that has spread after initial treatment. Participation may last up to 32 months.

NCT ID: NCT05998161 Active, not recruiting - Stress Clinical Trials

Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout

LAVENDER
Start date: September 4, 2023
Phase: N/A
Study type: Interventional

In this single-blinded randomized controlled clinical trial 290 patients with stress or burnout will be investigated regarding the effectiveness of a digital therapeutic for improvement of stress level, the unguided online intervention reviga. Inclusion criteria are: age 18 or older, above average stress level (PSS score >21), living in Germany, working a minimum of 20h per week, having a stable treatment for at least 30 days at the time of inclusion, and consent to participation. Exclusion criterion is having plans to change the treatment in the upcoming three months at the time of inclusion. Patients will be randomized and allocated to either an intervention group, receiving reviga in addition to treatment as usual (TAU), or a control group, receiving only TAU. The control group will be granted access to the program at the end of the study. Primary endpoint will be the perceived stress measured by the PSS score, with three months post-allocation being the primary time point for assessment of effectiveness. Six months post allocation will be used as a timepoint for follow-up assessment of endpoints. Secondary endpoints will be anxiety symptoms, level of functioning, burnout symptoms, health-related quality of life, and sick days.

NCT ID: NCT05991765 Active, not recruiting - Clinical trials for Split Skin Donor Site

Evaluation of Digit Tip and Split Skin Donor Site Transcriptome

Start date: June 1, 2021
Phase:
Study type: Observational

Regrowth of amputated fingertips presents a unique regenerative healing process in mammals, with subcutaneous volume regrowth, restoration of the dactylogram, and suppression of scar formation. In addition, wound healing from split-thickness donor sites shows almost scar-free healing. Transcriptome analysis is necessary to better understand the specific healing mechanisms of these two wound entities. Since no data are available to date, this study aims to fill the gap.

NCT ID: NCT05990907 Active, not recruiting - Hemodynamics Clinical Trials

Influence of RIC on the Orthostatic Competence of the Microcirculation

Start date: July 30, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial (pilot study) is to learn about the microcirculatory regulation of the lower extremity under orthostatic stress with and without RIC - Remote Ischemic Preconditioning in healthy participants. The main question it aims to answer are: Do the beneficial effects of RIC withstand orthostatic stress? / Does RIC benefit lower extremity microcirculation in ortho-statically stressed subjects? Is there a relationship/correlation between the variables of microcirculation and hemodynamics in the context of RIC and orthostatic loading?

NCT ID: NCT05974189 Active, not recruiting - Clinical trials for Chronic Heart Failure With Reduced Ejection Fraction

The VERIFY Study: An Observational Study Called VERIFY to Learn More About the Use of Vericiguat in People With Chronic Heart Failure With Reduced Ejection Fraction

Start date: July 11, 2023
Phase:
Study type: Observational

This is an observational study in which the health data of people with chronic heart failure with reduced ejection fraction (HFrEF) are collected using administrative claims data. In observational studies, only observations are made and participants do not receive any advice or changes to healthcare. Chronic HFrEF is a longterm condition that occurs when the heart is weak and cannot pump enough blood to the rest of the body with each heartbeat. This leads to a reduced supply of oxygen which the body requires to function properly. The common symptoms include breathlessness, weakness, fatigue, and swelling in the ankles and legs. If left untreated, heart failure can lead to other serious health problems, including damage to other organs, which may result in hospital stays and even death. Vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC), which relaxes the blood vessels and allows more blood to flow through. As a result, the heart is able to pump better. Vericiguat was approved for the treatment of HFrEF based on the results of a study called VICTORIA. The VICTORIA study showed that vericiguat helps in lowering the chances of death or hospitalization due to heart failure. There is limited information available about the use of vericiguat for the treatment of HFrEF under realworld conditions. The main purpose of this study is to collect information about the characteristics of people with HFrEF, who are on vericiguat in addition to at least one standard treatment. Researchers will collect information about participants' basic characteristics, including their age, gender, other health conditions they may have, and the medicines they may be taking. The data will come from administrative claims data for people in the United States of America who were diagnosed with HFrEF between January 2020 and June 2022. In this study, only available data from routine care is collected. No visits or tests are required as part of this study.

NCT ID: NCT05952622 Active, not recruiting - Clinical trials for Proximal Humerus Fracture

Outcome After Plate Osteosynthesis of Proximal Humerus Fractures Using Continous Passive Motioning Therapy

Start date: April 1, 2018
Phase: N/A
Study type: Interventional

Patients suffering from a proximal humerus fracture treated with plate osteosynthesis will receive either regular aftercare (physiotherapy) or aftercare assisted with continous passive motion (physiotherapy + CPM). Change in functional and patient-reported outcome (PROM) over time will be evaluated and compared.

NCT ID: NCT05938387 Active, not recruiting - Glioblastoma Clinical Trials

Safety and Tolerability of CVGBM in Adults With Newly Diagnosed MGMT-Unmethylated Glioblastoma or Astrocytoma

Start date: May 9, 2023
Phase: Phase 1
Study type: Interventional

This study is an open-label, first-in-human, dose-escalation study of CV09050101 mRNA vaccine (CVGBM) in patients with newly diagnosed "MGMT-unmethylated" Glioblastoma (GBM). Patients with isocitrate dehydrogenase (IDH)-wildtype astrocytoma with a molecular signature of "unmethylated" GBM are also eligible. After surgical resection and completion of radiotherapy for GBM with or without chemotherapy, patients will receive CVGBM i.e. as monotherapy after radiotherapy with or without chemotherapy. The study consists of a dose-escalation part (Part A) which completes enrollment in February 2024 and a dose-expansion part (Part B) which is anticipated to begin enrolling in June/July 2024. Patients will receive a total of 7 administrations of CVGBM on Days 1, 8, 15, 29, 43, 57, and 71. At the discretion of the Investigator in alignment with the Sponsor's medical monitor the vaccinations may continue beyond Day 71 every 6 weeks until one year after the first CVGBM vaccination or upon disease progression or undue toxicity.

NCT ID: NCT05927415 Active, not recruiting - Renal Impairment Clinical Trials

A Study to Test How Kidney Problems Influence the Blood Concentrations of Efgartigimod

Start date: July 17, 2023
Phase: Phase 1
Study type: Interventional

A study to test how kidney problems influence the blood concentrations of efgartigimod