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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: NCT05206162 Completed - Clinical trials for Cortical Excitability

TMS-EEG as a Tool to Study the Neuromodulatory Effects of Theta Burst Stimulation

Start date: August 2, 2017
Phase: N/A
Study type: Interventional

To assess the effect of continuous (cTBS) and intermittent theta burst stimulation (iTBS) stimulation on motor cortex excitability using TMS-EEG. Based on prior literature, we hypothesized that N100 amplitude would be differently modulated by these two modalities.

NCT ID: NCT05206110 Not yet recruiting - Surgery Clinical Trials

Low Dose Versus Normal Dose Ketorolac for Postoperative Pain After Prostatectomy and Hysterectomy

Start date: February 14, 2022
Phase: N/A
Study type: Interventional

A monocenter, prospective, double-blind, randomized controlled non-inferiority trial will be designed to investigate if ketorolac 10 mg is as effective for pain relief as the standard dose of 30 mg in patients undergoing robot assisted radical prostatectomy (RARP) or hysterectomy by laparoscopic assisted vaginal hysterectomy (LAVH) or total laparoscopic hysterectomy (TLH). It is hypothesised that the postoperative pain score at rest at 8 hours after surgery when receiving ketolorac 10 mg is non-inferior to the pain score at rest when receiving ketolorac 30mg.

NCT ID: NCT05204810 Not yet recruiting - Hemodialysis Clinical Trials

Optimisation of Anticoagulation in Patients on Nocturnal Hemodialysis

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

To avoid clotting during extracorporeal treatment, an anticoagulant is added to the circuit, resulting in an increased risk for bleeding complications. In addition, there is evidence that a substantial number of fibers can become blocked before this is reflected in routinely observed parameters, or in termination of the dialysis session. In standard hemodialysis of 4 hours, the anticoagulant is administered at the beginning of dialysis. For nocturnal hemodialysis, there is no hard evidence whether anticoagulation should be administered only at the dialysis start or with an extra dosing halfway the dialysis session. The aim of this randomized cross-over study is to objectively quantify the number of patent fibers after nocturnal dialysis in two different settings: anticoagulation only at the dialysis start, and anticoagulation divided over two time points, i.e. dialysis start and halfway dialysis.

NCT ID: NCT05204732 Not yet recruiting - Gender Dysphoria Clinical Trials

Acoustic and Perceptual Effects of Intonation Training in Gender Diverse People

Start date: January 2022
Phase: N/A
Study type: Interventional

The aim of this project is to investigate the short- and the longer-term effect of intonation training on vocal characteristics, listener perceptions and patient related outcome measures (PROMS) in gender diverse people using a randomized sham-controlled trial.

NCT ID: NCT05204316 Enrolling by invitation - Headache Disorders Clinical Trials

NLP Headache Speech (NLPH-SPEECH): a Cross-sectional Study on Natural Language Processing Analysing Spoken Monologues by Headache Patients

NLPH SPEECH
Start date: January 13, 2022
Phase: N/A
Study type: Interventional

The research collects spoken descriptions of headache disorders by participants with headache disorders. The speech recordings are analyzed by natural language processing (NLP) tools to analyse linguistic properties of the texts and to obtain insight into the potential of NLP machine learning models for the recognition of headache syndromes of the participants.

NCT ID: NCT05204238 Recruiting - Heart Failure Clinical Trials

Follow Up of acuTe Heart failUre: a pRospective Echocardiographic and Clinical Study (FUTURE)

FUTURE-HIT
Start date: September 1, 2020
Phase:
Study type: Observational

Acute heart failure (AHF) is defined as rapid onset or rapid worsening of typical signs and symptoms of heart failure (HF) according to the 2016 European Society of Cardiology Guidelines. AHF is the first cause of hospitalization in people over 65 in Western countries, accounting for more than 1 million hospitalizations per year in the USA. This disease has many repercussions not only in terms of mortality and morbidity, but also in terms of resources and infrastructures necessary for these patients' treatment, which constitutes a high economic burden for the national health care system. Even with growing knowledge and means, nowadays, the prognosis of AHF is still poor and there are no proven therapies that lead to long-term benefits in terms of reduced mortality. A better management of the acute phase of decompensation, including the definition of effective diagnostic-therapeutic workup and the use of innovative drugs, could improve the course of the disease, with positive effects on the patient (gain in survival and reduction of admissions), but also on the community (containment of the overall health costs). In recent years, numerous scores have been outlined in various AHF settings, considering only a small number of parameters. Several prognostic models have been developed suggesting how difficult it is to evaluate the AHF patients' prognosis. All this effort towards the development of so numerous prognostic models is justified by the fact that, despite the evolution of treatments, the risk of re-hospitalization and of both intrahospital mortality and after discharge remains high. Several studies have investigated potential prognostic factors that could help evaluating the risk of cardiovascular events, but now there is no accurate and complete prognostic score, particularly for AHF patients. Therefore, to date there are no accurate scores or determinants of short- and medium-term prognosis that allow to improve the management of these patients. This will be an observational, prospective, multicentric, international, non-commercial (non-profit) study. The primary endpoint will be to evaluate the best parameters, among clinical, laboratory and echocardiographic variables assessed within 24 hours from the hospital admission and before discharge, that are able to predict rehospitalization for HF and cardiovascular death at 3 and 6 months, in patients admitted to the cardiology department for acute exacerbation of chronic HF or de novo AHF.

NCT ID: NCT05202678 Recruiting - Osteoporosis Clinical Trials

Local Osteo-Enhancement Procedure (LOEP) in the Proximal Femur of Women With Osteoporosis

RECONFIRM
Start date: July 5, 2021
Phase: N/A
Study type: Interventional

The research will be conducted as a prospective, post-market, multi-center study within Europe. The maximum number of subjects to be treated is 150 across up to 20 sites. This will be a non-randomized and open-label study. The study will collect procedural, short- and long-term data on the safety and clinical performance of AGN1 LOEP in the post-market setting in European countries where AGN1 LOEP is commercially available. AGN1 is intended to form new bone in voids in the proximal femur of women with osteoporosis.

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: NCT05199987 Not yet recruiting - Clinical trials for Severe Chronic Obstructive Pulmonary Disease

Breathing Control Exercises in Patients With Chronic Obstructive Pulmonary Disease.

Start date: January 31, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to test whether breathing control exercises embedded in occupational therapy sessions have an impact on quality of life and dyspnea in patients with chronic obstructive pulmonary disease (COPD).