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NCT ID: NCT04848818 Recruiting - Fracture Wrist Clinical Trials

Comparative Trial of Operative Treatment of Distal Pediatric Forearm Fractures With Biodegradable Nails and K-wires

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

The study is designed as a multicenter trial for the treatment of distal pediatric forearm fractures (=severely displaced distal metaphyseal forearm fractures) with a PLGA-based biodegradable intramedullary implant in children. The primary objective of the trial is to evaluate clinical outcome between Activa IM-Nail™ and K-wire in this indication. The secondary objective is to evaluate potential differences of potential complications in the operative method with either a biodegradable intramedullary PLGA-implant or with conventional K-wires. K-wire osteosynthesis will be made according to the conventional surgical technique by three paediatric trauma centers. Intramedullary PLGA implantation will be made by the Péterfy Hospital. The surgical indication will be the same in all groups, and follow-up will follow standard protocols. In the further clinical course, the patients in the study group treated with PLGA implants spare a subsequent operation for implant removal after 4-8 weeks. The results of different surgeries will be compared based on several criteria.

NCT ID: NCT04846543 Recruiting - Forearm Fracture Clinical Trials

Bioresorbable Intramedullary Nailing of Forearm Fractures

BRINFF
Start date: March 1, 2021
Phase: N/A
Study type: Interventional

The Activa IM-Nail™ is used in the fixation of forearm fractures with cast to achieve a level of reduction and stabilisation that is appropriate to the age of the child. The post-market clinical follow-up study will be performed to identify the residual risk related to re-fracture and to determine its impact to the risk/benefit ratio of Activa IM-Nail™.

NCT ID: NCT04844866 Recruiting - Clinical trials for Diffuse Large B-cell Lymphoma

Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients

DALY 2-EU
Start date: August 18, 2021
Phase: Phase 2
Study type: Interventional

This is a pivotal Phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in participants with relapsed/refractory diffuse large B-cell lymphoma, who are not eligible for high-dose chemotherapy and autologous stem cell transplantation.

NCT ID: NCT04825743 Recruiting - Clinical trials for ST-elevation Myocardial Infarction (STEMI)

A Phase 3 Study of Zalunfiban in Subjects With ST-elevation MI

CELEBRATE
Start date: April 24, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase 3 prospective, blinded, randomized, placebo controlled, international multicenter study. Subjects with STEMI will be enrolled in the ambulance if they meet all eligibility criteria. These subjects will be evaluated by (para)medics who transport the subjects to the participating hospitals in Europe and North America. Hospitals and ambulance services with experience in ambulance studies will be selected. Each subject will receive a single subcutaneous injection containing either zalunfiban Dose 1 (0.110 mg/kg) or zalunfiban Dose 2 (0.130 mg/kg) or placebo

NCT ID: NCT04824794 Recruiting - Clinical trials for Acute Myeloid Leukemia (AML)

GEN3014 Safety Trial in Relapsed or Refractory Hematologic Malignancies

Start date: March 9, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The drug that will be investigated in the study is an antibody, GEN3014. Since this is the first study of GEN3014 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN3014 dose to be tested in a larger group of participants and assess preliminary clinical activity of GEN3014. GEN3014 will be studied in relapsed or refractory multiple myeloma (also known as RRMM) and other blood cancers. The study consists of 3 parts: 1. The Dose Escalation will test increasing doses of GEN3014 to find a safe dose level to be tested in the other two parts. 2. Expansion Part A will further test the GEN3014 dose determined from the Dose Escalation Part. 3. Expansion Part B will compare intravenous (IV) GEN3014 with the subcutaneous (SC) daratumumab in ex-US countries. Participants will receive either GEN3014 or daratumumab; none will be given placebo. The study duration will be different for the individual participants. Overall, the study may be ongoing up to 5 years after the last participant's first treatment.

NCT ID: NCT04821310 Recruiting - Esophagitis Clinical Trials

Protonix Treatment of Maintenance of Healing in Pediatric Participants Aged 1-11 Years and 12-17 Years

Start date: January 13, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to explore the outcomes, tolerability and safety of 2 different doses of oral pantoprazole (full healing dose, half healing dose), assigned based upon weight, for the maintenance of healing of erosive esophagitis in pediatric participants aged 1 to 17 years with endoscopically-confirmed, healed erosive esophagitis.

NCT ID: NCT04819464 Recruiting - Healthy Clinical Trials

A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of Cenerimod

Start date: August 19, 2021
Phase: Phase 1
Study type: Interventional

This is a prospective, open-label, single-dose, phase 1 study, to assess the effect of mild and moderate hepatic impairment on the pharmacokinetics of cenerimod (ACT-334441).

NCT ID: NCT04800913 Recruiting - Atrial Fibrillation Clinical Trials

The Role of Multimodality Imaging in Left Atrial Appendage Closure

MILAAC
Start date: November 8, 2021
Phase: N/A
Study type: Interventional

The aim of the present prospective, randomized single-centre study is to examine the success rate, safety, overall preoperative and operative burden and long-time outcome of percutaneous left atrial appendage closure procedures after unimodal and multimodal preprocedural imaging. According to the investigators' primary hypothesis, simple, unimodal preprocedural imaging does not increase procedural burden of LAAC (total radiation dose, procedure time, fluoroscopy time, contrast amount). The investigators assume, that the success rate and safety of LAAC procedures is not reduced using unimodal preoperative imaging. Regarding to postoperative imaging, the investigators aim to compare the sensitivity of different imaging techniques in detecting postoperative complications. We assume, that multimodal imaging technique increases the accuracy and sensitivity of the detection of postoperative complications (PDL, device thrombi).

NCT ID: NCT04797780 Recruiting - Clinical trials for Myelodysplastic Syndromes

Tamibarotene Plus Azacitidine in Participants With Newly Diagnosed RARA-positive Higher-Risk Myelodysplastic Syndrome

Start date: February 8, 2021
Phase: Phase 3
Study type: Interventional

This study compares the efficacy of Tamibarotene in combination with azacitidine to azacitidine in combination with placebo in participants who are Retinoic Acid Receptor Alpha (RARA) positive, and newly diagnosed with higher-risk myelodysplastic syndrome (HR-MDS), and who have not received treatment for this diagnosis. The primary goal of the study is to compare the complete remission rate between the two treatment arms.

NCT ID: NCT04792255 Recruiting - Clinical trials for Carotid Artery Diseases

Digital Variance Angiography for Contrast Media Dose Reduction in Carotid Artery Stenting

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Digital Variance Angiography (DVA) is a new tool in medical imaging with a proven image quality reserve (1, 2). Previous studies have demonstrated the quality reserve of DVA in angiographic studies (1, 2), which allowed us to reduce contrast media use by 50% in carotid artery angiographic studies without affecting the image quality (3). CAS is an alternative treatment option for carotid artery revascularization in selected patient groups. Similar to most of the minimally invasive endovascular interventions, CAS also carries the risk of contrast-induced acute kidney injury, which is considered to be an independent predictor of 30-day major adverse events (4). The aim of this study is to apply DVA in patients undergoing carotid artery stenting (CAS) and utilize this technique to reduce contrast dose during the interventions, without affecting the intraprocedural radiation dose and the clinical outcome of the procedures. Investigators believe that the reduction in contrast media use and the associated image quality with the technique of DVA imaging can be incorporated into the everyday clinical practice, and will play an important role in improving the rate of contrast-induced acute kidney injury.