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NCT ID: NCT05949827 Active, not recruiting - Critical Care Clinical Trials

Healing Light Algorithms for Nurses in the ICU

ENGAGE-ICU
Start date: June 1, 2023
Phase:
Study type: Observational

The purpose of this study is to investigate the impact of a newly installed device administering a Light Scheduling Algorithm with high circadian effective irradiances to mechanically ventilated patients on the perceived stress among nursing care specialists. The investigators will further evaluate the impact on commitment to the workplace, meaning of work, and empathy.

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

NCT ID: NCT05921903 Active, not recruiting - Clinical trials for Respiratory Syncytial Virus Infections

A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant and Are at an Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease and Compared to Healthy Adults 50 Years of Age and Above

RSV OA=ADJ-023
Start date: July 28, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of the RSVPreF3 OA investigational vaccine in an immunocompromised (lung and renal transplant recipients) population and assess whether a second dose of the vaccine increases the immune response.

NCT ID: NCT05917509 Active, not recruiting - HIV Infections Clinical Trials

A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy

VOLITION
Start date: July 6, 2023
Phase: Phase 3
Study type: Interventional

This is a multicentre study carried out in participants living with human immunodeficiency virus type 1 (HIV-1) who have not previously been treated with any antiretroviral therapies. The study will investigate two 2-drug regimens for the treatment of HIV-1: a fixed-dose combination oral tablet of dolutegravir/lamivudine (DTG/3TC) and cabotegravir plus rilpivirine long-acting agents (CAB + RPV LA). All participants will initially receive DTG/3TC once daily, and once virologic suppression is attained (plasma HIV-1 <50 c/mL), participants will be offered a choice to switch to CAB + RPV LA or to continue taking oral DTG/3TC. This study will provide important data on the efficacy, safety, implementation effectiveness, and patient-reported outcomes of these two regimens in a study where participants have the option to choose between them based on individual preference. The aim of the study is to evaluate the antiviral effectiveness at 11 months after switching to CAB+RPV LA following initial virologic suppression on DTG/3TC and to provide data on how long it takes participants to suppress their viral load on DTG/3TC.

NCT ID: NCT05916365 Active, not recruiting - Atopic Dermatitis Clinical Trials

Long-term Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participant With Moderate-to-Severe Atopic Dermatitis

ADlong
Start date: May 23, 2023
Phase: Phase 3
Study type: Interventional

The main purpose of the study is to assess the long-term tolerability and effectiveness of lebrikizumab in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD). Participants who complete the last assessment visit in ADjoin (Week 100) will be offered the opportunity to enroll in this extension study.

NCT ID: NCT05914259 Active, not recruiting - Clinical trials for Chronic Kidney Disease

An Observational Study to Learn More How Chronic Kidney Disease Gradually Changes Over Time in Adults Using Electronic Healthcare Records (CKD Natural History Study)

CKD-NH
Start date: May 31, 2023
Phase:
Study type: Observational

This is an observational study in which the health data of people with chronic kidney disease are studied using electronic healthcare records. In observational studies, only observations are made without participants receiving any advice or any changes to healthcare. Chronic kidney disease (CKD) is a condition in which the kidney's ability to work properly gradually decreases over time. This causes a buildup of waste in the body and can lead to loss of kidney function over the long term. CKD is divided into different stages based on how well the kidneys are filtering the blood. CKD is known to increase the risk of developing serious health problems such as serious heart problems, irreversible damage to kidneys requiring either dialysis or a kidney transplant (end stage kidney disease, ESKD), and early death. However, there is limited information available about how often heart problems occur in people with different stages of CKD, and how a history of heart problems might affect future risks for CKD patients. The purpose of this study is to collect more information on how CKD changes over time for people at different CKD stages and how it affects their heart and kidneys. The main information that researchers will collect in this study: changes in kidney function (worsening or improvement). Other information that researchers will collect: patient characteristics for each stage of CKD, the length of time for serious heart-related conditions to occur, the length of time it takes for CKD to progress to kidney failure, the length of time for occurrence of deaths due to any causes, and the length of time it takes for serious heart-related conditions and kidney failure to occur. This study will include CKD patients above 18 years of age. Researchers will review electronic healthcare records to identify CKD patients in two ways: using disease codes for CKD and using lab results which show abnormal kidney function. The data will come from participants' information stored in an electronic healthcare records database called Merative Explorys database Electronic Medical Record (EMR) in the United States of America. The research will cover the period from January 2010 up to December 2019. Researchers will track individual patients' data and will follow them for a maximum of 5 years or until they experience certain events like changes to their CKD stage, kidney failure, serious heart-related conditions, or death. In this study, only available data from routine care is analyzed. No visits or tests are required.

NCT ID: NCT05911360 Active, not recruiting - HIV Infections Clinical Trials

A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF

EYEWITNESS
Start date: July 7, 2023
Phase: Phase 3
Study type: Interventional

The study aims at evaluating the maintenance of virologic suppression of dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC) at Week 48 post-switch from bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in participants living with Human Immunodeficiency Virus Type 1 (HIV-1) who are of at least 50 years of age and above.

NCT ID: NCT05911009 Active, not recruiting - Long Covid Clinical Trials

To Investigate Efficacy, Pharmacodynamics, and Safety of BC 007 in Participants With Long COVID

BLOC
Start date: June 16, 2023
Phase: Phase 2
Study type: Interventional

This study is an interventional, randomized, multinational, multicenter, double-blind, phase 2 study with a follow-up period of circa 12 months. The intension of this clinical trial is to investigate the long-term sequelae (named Long COVID syndrome; post COVID or PASC) of an infection with Corona Virus Type 2 that has resulted in a condition known as Severe Acute Respiratory Syndrome Corona Virus Type 2 (SARS-CoV-2). The purpose of this study is to evaluate the efficacy and safety of BC 007 as a treatment for long-lasting COVID-symptoms in patients who were neither intubated nor supported with extracorporeal blood oxygenation (ECMO) during their acute COVID-19 infection. The study drug acts by neutralizing functional autoantibodies directed against G-protein coupled receptors (GPCRs). Neutralization of the autoantibodies is expected to induce a beneficial effect on symptoms typically seen in patients with long COVID syndrome. Functional autoantibodies are proteins belonging to the class of G-type immunoglobulins that can be synthesized by activation of the immune system and can induce various pathogenic activities by binding to one of the extracellular loops of G-proteins (GPCR-AAB). The study consists of a screening phase of up to 35 days, treatment (two administrations by intravenous infusion at two-week intervals either with the study drug (BC 007) or with placebo (NaCl 0.9%), with an initial follow-up period of 15 days after each administration and an extended follow-up period of 330 days. Patients are required to visit the study center for follow-up visits at specified intervals. For the entire study duration of 395 days from screening to the end of the study, 11 site visits are planned.

NCT ID: NCT05906628 Active, not recruiting - Hand Eczema Clinical Trials

Topical Ruxolitinib Evaluation in Chronic Hand Eczema

Start date: July 31, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adult participants with diagnosis of chronic hand eczema (CHE) and moderate to severe disease activity (Investigator's Global Assessement (IGA) of CHE score 3 or 4).