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NCT ID: NCT05206357 Not yet recruiting - Clinical trials for Indolent 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: May 9, 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 Not yet recruiting - Systemic Sclerosis Clinical Trials

Rheopheresis for Raynaud's and Digital Ulcers in Systemic Sclerosis

RHEACT
Start date: January 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 Not yet 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: January 14, 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: NCT05203822 Not yet recruiting - Healthy Clinical Trials

Tepotinib Drug-Drug Interaction Study With Itraconazole in Healthy Participants

Start date: January 11, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the effect of multiple doses of itraconazole on singledose tepotinib pharmacokinetics in healthy participants. Study details include: Study Duration: up to 48 days Treatment Duration: single dose of tepotinib on Days 1 and 12, 11 days of treatment with itraconazole (Days 8 to 18) Visit Frequency: residence in the Clinical Research Unit from Days -1 to 4 and Days 11 to 15, ambulatory daily visits from Days 5 to 10 and 16 to 20

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: NCT05202262 Not yet 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

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.

NCT ID: NCT05200715 Recruiting - Uveitis Clinical Trials

AutoInflammatory Disease Alliance Registry (AIDA)

AIDA
Start date: August 6, 2020
Phase:
Study type: Observational [Patient Registry]

Autoinflammatory diseases (AID) are clinical entities characterized by recurrent inflammatory attacks in absence of infection, neoplasm or deregulation of the adaptive immune system. Among them, hereditary periodic syndromes, also known as monogenic AID, represent the prototype of this disease group, caused by mutations in genes involved in the regulation of innate immunity, inflammation and cell death. Based on recent experimental acquisitions in the field of monogenic AID, several immunologic disorders have been reclassified as polygenic/multifactorial AID, sharing pathogenetic and clinical features with hereditary periodic fevers. This has paved the way to new treatment targets for patients suffering from rare diseases of unknown origin, including Behçet's disease, Still disease, Schnitzler's disease, PFAPA (periodic fever, aphthous stomatitis, pharyngitis and cervical adenitis) syndrome, chronic recurrent multifocal osteomyelitis (CRMO), non-infectious uveitis and scleritis. Gathering information on such rare conditions is made difficult by the small number of patients, along with the difficulty of obtaining an accurate diagnosis in non-specialized clinical settings. In this context, the AIDA project promotes international collaboration among clinical centres to develop a permanent registry aimed at collecting demographic, genetic, clinical and therapeutic data of patients affected by monogenic and polygenic AID, in order to expand the current knowledge of these rare conditions.

NCT ID: NCT05199493 Recruiting - Cardiac Surgery Clinical Trials

Reducing Acute Kidney Injury Occurence by Administering Angiotensin II

AIDED
Start date: December 27, 2021
Phase: Phase 3
Study type: Interventional

The aim of this study is to evaluate whether adding angiotensin II to the standard of care is superior compared to the standard of care alone with respect to kidney damage (personalized approach) after cardiac surgery.