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NCT ID: NCT05206981 Recruiting - Traumatic Fracture Clinical Trials

Device Global Registry for the IlluminOss Bone Stabilization System

Start date: June 11, 2021
Phase:
Study type: Observational [Patient Registry]

This is a multi-center, observational patient registry. The primary objective of the study is to collect safety and performance data on the IlluminOss Device when used to provide stabilization and alignment for the treatment of traumatic or impending and pathologic fractures.

NCT ID: NCT05206773 Recruiting - Fabry Disease Clinical Trials

A Study to Evaluate the Effect of Venglustat Tablets on Neuropathic and Abdominal Pain in Male and Female Participants ≥16 Years of Age With Fabry Disease

PERIDOT
Start date: March 11, 2022
Phase: Phase 3
Study type: Interventional

This is a 12-month, parallel treatment, Phase 3, double-blind, randomized, placebo controlled study to evaluate the effect of venglustat on neuropathic and abdominal pain symptoms of Fabry disease in participants ≥16 years of age with Fabry disease who are treatment-naïve or untreated for at least 6 months. - Study visits will take place approximately every 3 months. - The double-blind period will be followed by an open-label extension (OLE) during which participants who have completed the double-blind period will be treated with venglustat for up to an additional 12 months.

NCT ID: NCT05206357 Recruiting - Clinical trials for Non-hodgkin Lymphoma

Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab

Start date: October 4, 2022
Phase: Phase 1
Study type: Interventional

The most common types of mature B-cell lymphomas (MBLs) in children are Burkitt lymphoma (BL) and diffuse large B-cell lymphoma (DLBCL). Initial treatment cures 90% - 95% of children with these malignancies, leaving a very small population of relapsed/refractory disease with a poor prognosis. The purpose of this study is to assess the safety and tolerability of epcoritamab in pediatric participants with relapsed/refractory aggressive mature B-cell neoplasms and young adult participants with Burkitt's or Burkitt-like lymphoma/leukemia. Adverse events and change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of relapsed/refractory aggressive mature B-cell neoplasms. Participants will receive subcutaneous (SC) of epcoritamab. Approximately 15 pediatric participants with a diagnosis of relapsed/refractory aggressive mature B-cell neoplasms and and young adult participants, ages of 18-25, with a diagnosis of Burkitt's or Burkitt-like lymphoma/leukemia will be enrolled at 50 sites globally. Participants will receive subcutaneous epcoritamab in 28-day cycles. Participants will be followed for a minimum of 3 years after enrollment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

NCT ID: NCT05204784 Recruiting - Systemic Sclerosis Clinical Trials

Rheopheresis for Raynaud's and Digital Ulcers in Systemic Sclerosis

RHEACT
Start date: February 28, 2022
Phase: N/A
Study type: Interventional

In this feasibility study, we aim to explore therapeutic Rheopheresis (RheoP) as a novel treatment option for SSc-associated Raynaud's phenomenon and/or digital ulcers and compare it to the standard of care treatment (intravenous iloprost. RheoP has been used for RP/DU with some success in observational studies, nevertheless, the optimal treatment modality, duration, or frequency of RheoP (and PEX in general) in SSc has not been established as of yet.

NCT ID: NCT05204212 Recruiting - Clinical trials for Non-valvular Atrial Fibrillation (NVAF): Paroxysmal, Persistent, Permanent

Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic KIDNEY Disease

LAA-KIDNEY
Start date: March 28, 2022
Phase: N/A
Study type: Interventional

In the proposed event driven trial, LAA closure devices will be compared in a 1:1 randomization to best medical care in AF patients at high risk of stroke and bleeding with ESKD. The trial will allow the use of the CE marked and clinically used LAA device Amplatzer Cardiac Plug and/or Amulet and all approved medical therapies in AF patients with ESKD including vitamin-K antagonists (VKA), NOACs as well as antiplatelet agents or no anticoagulation in excessive bleeding risk.

NCT ID: NCT05203536 Recruiting - Clinical trials for Acute Hypoxemic Respiratory Failure

Respiratory Mechanics Assessment During Assisted Mechanical Ventilation

ICEBERG
Start date: September 1, 2021
Phase:
Study type: Observational

To verify the association between respiratory system mechanical properties (ΔP, ΔPL,dyn, Pmus, Pplat and CRS and CL,dyn) assessed during assisted modes of ventilation (as average over the first three days since enrollment) and ICU mortality.

NCT ID: NCT05203172 Recruiting - Solid Tumors Clinical Trials

The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials

Start date: July 5, 2022
Phase: Phase 4
Study type: Interventional

The purpose of this clinical trial (called the FLOTILLA study) is to give continued access to the study medicines, as well as safety follow-up, for participants in prior clinical trials of encorafenib and/or binimetinib. All participants who took part in earlier encorafenib and/or binimetinib studies may participate the FLOTILLA study if they are still benefiting from the use of the study medicines. This will be determined by the study doctor. People may not participate in the FLOTILLA study if they have not enrolled in a prior study of encorafenib or binimetinib. Participants that had enrolled but had stopped receiving the study treatment in a prior study cannot enrolled in this study. Participants in the FLOTILLA study will receive encorafenib and/or binimetinib at the same dose and frequency as in their prior study, for up to about 5 years.

NCT ID: NCT05202262 Recruiting - Asthma Clinical Trials

A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants With Inadequately Controlled Asthma (VATHOS)

VATHOS
Start date: January 12, 2022
Phase: Phase 3
Study type: Interventional

This is a 24 week study to evaluate the efficacy and safety of budesonide and formoterol fumarate metered dose inhaler in adults and adolescents with inadequately controlled asthma.

NCT ID: NCT05202015 Recruiting - Clinical trials for Hepatocellular Carcinoma

Non-invasive MRI Subclassification of Heptocellular Carcinoma - HepCaSt-Study

HepCaSt
Start date: January 1, 2022
Phase:
Study type: Observational

Non-invasive MRI subclassification of Heptocellular Carcinoma - HepCaSt-Study

NCT ID: NCT05200754 Recruiting - Clinical trials for SARS-CoV-2 Infection

Trial With or Without Infusion of SARS-CoV-2 Antibody Containing Plasma in High-Risk Patients With COVID-19

RECOVER
Start date: September 3, 2020
Phase: Phase 2
Study type: Interventional

The study RECOVER is a randomized, open-label, multicenter phase II trial, designed to assess the clinical outcome of SARS-CoV-2 disease in high-risk patients (group 1 to group 4) following treatment with anti-SARS-CoV-2 convalescent/vaccine-boosted plasma or standard of care.