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NCT ID: NCT06359301 Recruiting - Hip, Osteoarthritis Clinical Trials

H-34 DELTA Revision Cup

Start date: September 14, 2021
Phase:
Study type: Observational

THis study is aimed to provide a clinical and radiographic evaluation of 49 suitable subjects who underwent a total hip arthroplasty with DELTA Revision acetabular cup.

NCT ID: NCT06357572 Completed - Hemophilia A Clinical Trials

Real-life Clinical FEIBA Samples Measured Using the Version A of the HemA EnzySystem

Start date: March 26, 2024
Phase:
Study type: Observational

The goal of this observational study is to assess if the version A of the HemA EnzySystem, a novel portable coagulation testing platform, can be used in patients with hemophilia A treated with Factor VIII Bypassing Agent (FEIBA). The main question[s] it aims to answer are: - Can the version A of the HemA EnzySystem can record thrombin generation within a time frame of 60 min in fresh whole blood samples of patients with hemophilia A treated with FEIBA? - Are the TGA results of the version A of the HemA EnzySystem in agreement with the TGA results obtained with conventional methods in fresh non frozen plasma? Participants are asked to fill in a questionnaire regarding their general health and hemophilia treatment. Subsequently, blood will be drawn from the patients before, and at 30, 120, and 240 minutes after FEIBA administration. Whole blood is immediately tested using the Version A HemA EnzySystem, and plasma is generated for testing with the Ceveron s100 (Technoclone). Leftover samples are frozen for later additional coagulation testing.

NCT ID: NCT06357533 Not yet recruiting - Clinical trials for Non-Small Cell Lung Cancer

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

TROPION-Lung10
Start date: April 26, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.

NCT ID: NCT06357364 Recruiting - Procrastination Clinical Trials

Neural Changes Following Cognitive Behavior Therapy for Procrastination

Start date: April 8, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to compare the efficacy of and the neural changes following two cognitive behavior therapy (CBT) protocols for procrastination with a wait-list control group. The interventions will be delivered online in group settings. Both protocols include identical psychoeducation and cognitive modules aiming at identification and modification of dysfunctional automatic thoughts related to procrastination but will differ in the behavioral modules. The behavioral module in the first protocol is focused on timely beginning and realistic planning. The second protocol implements working time restriction. The wait-list control group will receive one of the CBT protocols after a waiting period that will last as long as the CBT intervention and the assessments performed directly after treatment. It is assumed that the interventions will be superior to the wait-list control. Primary (procrastination) and secondary (depression and anxiety) measures will be collected prior to and after the interventions (or waiting period in the wait-list group) and after 6 months in the two active condition groups. Additionally, neuroimaging measurements will be conducted before and after the interventions (or waiting period in the wait-list group). Approximately half of the participants will undergo functional Magnetic Resonance Imaging (fMRI), and another half will undergo electroencephalography (EEG). Both methods are aimed at exploring neural correlates of the expected improvements in participants' self-regulation abilities.

NCT ID: NCT06356129 Not yet recruiting - Clinical trials for Large B-cell Lymphoma

Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma

GOLSEEK-1
Start date: June 24, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness and safety of golcadomide in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphoma (LBCL).

NCT ID: NCT06350123 Not yet recruiting - Clinical trials for Chronic Kidney Disease

Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease.

MIRO-CKD
Start date: May 6, 2024
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the efficacy, safety and tolerability of balcinrenone/dapagliflozin compared with dapagliflozin alone on patients with chronic kidney disease (CKD) and albuminuria. This study will evaluate the effect of the balcinrenone/dapagliflozin on urinary albumin-to-creatinine ratio (UACR), compared with dapagliflozin in patients with CKD. This is a dose-finding study aiming to identify an optimal dose of balcinrenone/dapagliflozin for a future Phase III study in patients with CKD.

NCT ID: NCT06346392 Recruiting - Gastric Cancer Clinical Trials

AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2

Start date: March 4, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to measure the efficacy and safety of AZD0901 compared to Investigator's choice of therapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2.

NCT ID: NCT06345612 Recruiting - Type 1 Diabetes Clinical Trials

Impact of Eccentric Training in Hypoxia With Creatine on Metabolic Control and VO2max in Patients With Type 1 Diabetes

Start date: November 15, 2023
Phase: N/A
Study type: Interventional

Exercise plays an important role in treatment of diabetes. In recent years exercise training in normobaric hypoxia is used in training programs for athletes and in rehabilitation and also commercially. The aim of the study is to assess the impact of eccentric training conducted in conditions of normobaric hypoxia or normoxia and creatine supplementation on metabolic control: profile and stability of glucose concentration, HbA1c value, hypoglycemia and insulin demand, as well as the level of muscle strength, VO2max and anthropometric parameters

NCT ID: NCT06345235 Recruiting - Clinical trials for Transthyretin Amyloidosis

New Biomarkers and Plasma Prothrombotic Potential in Cardiac Transthyretin Amyloidosis

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

The development of cardiac amyloidosis is caused by the deposition of misfolded, insoluble proteins in the extracellular matrix of tissues. An important element of the clinical picture of the disease is the increased risk of thromboembolic complications, independent of the occurrence of atrial fibrillation, and the presence of intracardiac thrombi. The pathomechanism may be related to an increase in filling pressure or amyloid infiltration leading to myocardial damage and endothelial dysfunction, which may activate the prothrombotic inflammatory cascade, resulting in increased thrombogenic potential. Currently, there is limited published data on the potential role of new heart failure biomarkers in the assessment of ATTR cardiomyopathy, particularly in the assessment of asymptomatic carriers of pathogenic TTR variants. Moreover, there are few literature reports on the direct assessment of the coagulation system in this group of patients, and the pathomechanism of the increased thromboembolic risk is unexplored. Purpose of the study: To assess the diagnostic value of biomarkers related to heart failure (growth differentiation factor-15 (GDF15), soluble suppression of tumorigenicity-2 (ST2), galectin-3), amyloidosis ( TTR, tissue inhibitor of metalloproteinase-1 (TIMP-1), matrix metalloproteinase-9 (MMP-9, matrix metalloproteinase-9), neurofilament light chain (NfL)) and the generation potential thrombin as a marker of the prothrombotic state in the course of ATTR. Methods: This prospective, single-center study will include consecutive patients diagnosed with ATTR cardiomyopathy (GROUP 1, n=30), asymptomatic carriers of pathogenic TTR variants (GROUP 2, n=30), and a matched control group of healthy volunteers (GROUP 3 , n=20). Material for research was collected and secured from all study participants. After giving informed consent, all patients will be tested using the ELISA method from peripheral blood (enzyme-linked immunosorbent assay) GDF15, ST2, TTR, TIMP-1, MMP-9, galectin-3, NfL. The values of these biomarkers will be compared in subgroups and correlated with clinical data, laboratory test results, echocardiography including analysis of left ventricular global strain (GLS), and scintigraphy. Additionally, the prothrombotic potential of plasma will be tested in both groups of patients using the calibrated automatic thrombogram (CAT) method, in accordance with the protocol previously used in the laboratory Expected results: The project will provide information on the value of biomarkers in the assessment of ATTR cardiomyopathy, especially in the assessment of asymptomatic carriers of pathogenic TTR variants, which may translate into the creation of a diagnostic algorithm for early identification of the development of the disease. Moreover, it will allow us to determine whether patients with cardiac ATTR are characterized by a prothrombotic state, which has not yet been described in the literature and may have potential clinical implications.

NCT ID: NCT06344481 Recruiting - Cartilage Injury Clinical Trials

The Hyalex First-in-Human Study

Start date: March 7, 2024
Phase: Phase 1
Study type: Interventional

The Hyalex First-in-Human Study is a prospective, multicenter, open-label, single-arm, 2-phase, first-in-human study to evaluate the safety and technical performance of the HYALEX Knee Cartilage System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment.