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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: NCT05205863 Recruiting - Healthy Volunteers Clinical Trials

Dose-Response in PD and Safety of Cofact Under VKA Anticoagulation

Start date: November 26, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a randomized, open label, placebo-controlled, parallel design, single center, prospective study. Subjects will receive treatment with VKA. Subjects who reach the targeted INR, will receive single dose of Cofact. Multiple coagulation laboratory tests will be evaluated over a period of 15 days

NCT ID: NCT05205824 Recruiting - Stroke Clinical Trials

Validation IMU and EMG Algorithms in Stroke Patients

Start date: December 22, 2021
Phase: N/A
Study type: Interventional

The objective is to validate the algorithms for movement analysis that were developed previously in healthy participants, in a small study with stroke patients. Stroke subjects will be measured while performing tasks like walking, sitting and standing while wearing light-weight inertial measurements units (IMUs) incorporating 3D accelerometers, 3D gyroscopes and surface electromyography. During the measurements subjects will be recorded on video that serves as ground truth when validating the implemented algorithms for movement analysis. A face blurring program will be used for all video footage.

NCT ID: NCT05204238 Recruiting - Heart Failure Clinical Trials

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

Start date: September 1, 2020
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: NCT05201937 Not yet recruiting - Healthy Clinical Trials

A Study of JNJ-64281802 in Healthy Adult Participants

Start date: February 16, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-64281802 in healthy participants when administered in different multiple dose regimens and as different dose strengths.

NCT ID: NCT05200988 Not yet recruiting - Bladder Cancer Clinical Trials

Checkpoint Inhibition and Chemoradiotherapy as Bladder Sparing Treatment in UC

Start date: January 10, 2022
Phase: Phase 2
Study type: Interventional

This is a single-armed, multicenter, non-blinded phase 2 study to assess efficacy of induction ipilimumab + nivolumab followed by chemoradiation to spare the bladder in urothelial bladder cancer.

NCT ID: NCT05200975 Not yet recruiting - Clinical trials for Infection, Bacterial

Target Attainment of Cefuroxim

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

SUMMARY Rationale: Optimal antibiotic dosing in patients with bacterial infections is of high importance. Underdosing can lead to treatment failure and can promote emergence of antimicrobial resistance, while overdosing may lead to (harmful) side effects. The antibiotic cefuroxime is a second-generation cephalosporin and is frequently used in hospitalized patients. Cefuroxime exhibits, like other cephalosporins, time-dependent killing. The pharmacodynamic target can therefore be best described as the percentage of the dosing interval that the serum concentration remains above the minimum inhibitory concentration (MIC) of the bacteria (T>MIC). Attaining the pharmacokinetic-pharmacodynamic (PK-PD) target of 50%T>MIC is associated with antimicrobial therapeutic efficacy of cefuroxime. Because cefuroxime is almost exclusively excreted through the kidneys, dose reduction of cefuroxime for patients with renal impairment (eGFR<30ml/min/1.73m2) is standard of care. No prospective evidence exists that currently guideline-recommended cefuroxime dosing regimens result in at least 50%T>MIC in adult patients on general wards, especially not in patients with renal impairment receiving a reduced dose of cefuroxime. Objective: To investigate whether the PK-PD target of cefuroxime (50%T>MIC) is attained in the first 24 hours of treatment in adult patients on general wards with adequate and impaired renal function receiving regular and reduced doses of cefuroxime. Study design: Observational, prospective single center cohort study Study population: Adult patients (age ≥ 18 years) on general wards of Noordwest Ziekenhuisgroep (NWZ) receiving cefuroxime as part of standard care. Intervention: Three venapunctures within a period of 72 hours, containing a maximum of 18ml of venous blood in total. Main study parameters: Percentage of patients attaining the cefuroxime PK-PD target of 50%T>MIC. This will be investigated for patients with adequate renal function receiving a regular cefuroxime dose and impaired renal function receiving a guideline recommended reduced dose. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Risks imposed by participation are considered negligible. Three venapunctures, obtaining a maximum of 18 ml venous blood are not expected to cause AEs or SAEs. Participation itself does not bring any benefit as cefuroxime treatment is part of standard care, but the group related benefit could be significant. With the results of this study, current recommended cefuroxime dosing regimens are prospectively validated or an advice to reconsider current guidelines will be obtained.

NCT ID: NCT05200936 Recruiting - ADHD Clinical Trials

Safety and Efficacy of Low Dose MM-120 for ADHD Proof of Concept Trial

Start date: December 17, 2021
Phase: Phase 2
Study type: Interventional

This study measures the safety and efficacy of repeated low dose MM-120 as treatment for ADHD in adults: a multi-center, randomized, double-blind, placebo-controlled

NCT ID: NCT05200351 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

Equine-assisted Therapy for Therapy-resistant Adolescents With Autism Spectrum Disorders, a Replicated AB-design

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

The purpose of this study is to assess the (cost)effectivity of Equine assisted Therapy in adolescents with Autism Spectrum disorders.

NCT ID: NCT05200338 Recruiting - Sickle Cell Disease Clinical Trials

Preservation and Transfer of HBV Immunity After Allogeneic HSCT for SCD.

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

We hypothesize, that sickle cell disease (SCD) patients ending with mixed mononuclear chimerism after non-myeloablative HSCT with alemtuzumab/TBI conditioning will preserve their immune response to vaccinations administered prior to the transplantation and will therefore not need to be revaccinated. Furthermore, we hypothesize, that SCD patients after haploidentical HSCT can benefit from adoptive transfer of immunity from their donors. To test the first hypothesis, we will vaccinate patients undergoing the alemtuzumab/TBI HSCT with a hepatitis B virus (HBV) vaccine before the transplant. To test the second hypothesis, we will vaccinate haploidentical and matched related donors prior to stem cell donation against HBV. Neither the patient nor the donor may previously have been immunized against HBV in all cohorts. Post-transplantation, we will be able to evaluate whether SCD patients preserve their pre-transplant immune response in the post-transplantation period. Furthermore, we will determine whether donors transfer their immunity to HSCT recipients with SCD disease.