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NCT ID: NCT05580315 Recruiting - Clinical trials for Discoid Meniscus of Knee

EPOS Discoid Meniscus (DiMe) Project

DiMe
Start date: September 8, 2022
Phase:
Study type: Observational

The aims of this Discoid Meniscus (DiMe) project are to analyze DM tears characteristics in the pediatric European population to describe current treatment options in symptomatic DM, and to evaluate clinical outcomes. To reach these objectives, a prospective database including symptomatic DM and variables associated with DM characteristics, type of tears, treatment, imaging, and clinical follow-up will be implemented. Data collection platform will provide future studies to understand the best treatment option for skeletally immature patient with symptomatic DM according to their history and lesion characteristics.

NCT ID: NCT05578976 Recruiting - Clinical trials for Diffuse Large B-Cell Lymphoma

A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

EPCORE DLBCL-2
Start date: February 8, 2023
Phase: Phase 3
Study type: Interventional

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) or R-CHOP in adult participants globally with diffuse large b-cell lymphoma (DLBCL). Change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in groups called treatment arms. Participants will receive epcoritamab combined with R-CHOP, followed by epcoritamab or R-CHOP followed by rituximab will be explored. Approximately 900 adult participants with with newly diagnosed DLBCL will be enrolled in the study in approximately 315 sites in globally. In the Arm 1, participants will receive subcutaneous epcoritamab combined with intravenous and oral R-CHOP followed by subcutaneous epcoritamab in 21-day cycles. In the Arm 2, participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles. 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: NCT05572515 Recruiting - Clinical trials for Relapsed or Refractory Multiple Myeloma

A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma

MajesTEC-9
Start date: March 29, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd.

NCT ID: NCT05565378 Recruiting - Clinical trials for Lung Cancer, Non-Small Cell

A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer

Start date: October 14, 2022
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PDy) of novel immunotherapy combinations compared with immunotherapy monotherapy in participants with Programmed death ligand-1 (PD L-1) high (Tumor cells [TC]/ Tumor proportion score [TPS] ≥ 50%), previously untreated, unresectable, locally advanced or metastatic NSCLC. Drug name mentioned as Belrestotug, GSK4428859A, and EOS884448 are all interchangeable for the same compound. In the rest of the document, the drug will be referred to as Belrestotug.

NCT ID: NCT05564793 Recruiting - Clinical trials for Heart Failure With Reduced Ejection Fraction

Improving CRT Outcome With Non-Invasive Cardiac Mapping

ICONIC-M
Start date: December 20, 2023
Phase: N/A
Study type: Interventional

The ICONIC-M study is a multicenter randomized controlled study to assess patient response to CRT comparing ECGI map guided left ventricular lead placement with empirical lead placement. The hypothesis of the investigation is to demonstrate that CRT LV lead implantation guided by a map obtained with the Amycard 01C System and showing LV Latest Electrical Activated Site (LEAS) in combination with a CT cardiac venogram improves CRT outcome. An improved CRT outcome is defined as a ≥30% increase in LVESVi reduction compared to empiric CRT LV lead implantation. The sample size will be 136 in the Control arm and 194 in the Active arm. A total of 330 subjects. The study follows an adaptive design, in where one interim analysis at 70% enrollment will be performed. The sponsor may stop enrollment when either one of the following conditions apply: - Statistical significant difference between groups in the primary endpoint has been reached confirming a difference in reduction of the LVESVi of ≥30% in the Active arm compared to the Control arm - There is no trend or reason to believe statistical significance will be reached with a higher sample size. Statistical significance (primary endpoint) is reached at interim (70%) or at total (100%) of enrollment with a significance value P lower than 0.025.

NCT ID: NCT05562466 Recruiting - Asthma Clinical Trials

A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate/Mometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma

Start date: May 11, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the superiority in terms of efficacy and evaluate the safety of QMF149 (indacaterol (acetate) / mometasone (furoate)) compared to budesonide in children from 6 to less than 12 years of age with asthma. - The study duration will be up to 37 weeks including an investigational treatment duration of 12 weeks and a comparator treatment duration of 12 weeks. - The visit frequency will be 3 weeks for screening, run-in and wash-out period, 6 weeks interval for visits during each treatment period, 30 days for safety follow-up.

NCT ID: NCT05556096 Recruiting - Clinical trials for Generalized Myasthenia Gravis

Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis

Start date: November 21, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of ALXN1720 for the treatment of generalized MG (gMG) in adults with autoantibodies against acetylcholine receptor (AChR).

NCT ID: NCT05552521 Recruiting - Septic Shock Clinical Trials

Diastolic Dysfunction in Septic Shock and Cardiomyopathy Genetic Variants

SepticHeartG
Start date: September 20, 2022
Phase:
Study type: Observational

Sepsis is a life-threatening infection with increasing incidence, and its spectrum of disease can involve cardiac dysfunction, which further adds to mortality. Although cardiac involvement in sepsis has been classically attributed to systolic dysfunction, diastolic dysfunction is increasingly diagnosed due to new echocardiographic techniques and the conceptual evolution of diastolic dysfunction. Combining systolic and diastolic dysfunction assessment could lead to a better diagnosis of septic cardiac dysfunction. Furthermore, earlier forms of septic cardiac dysfunction could be more promptly recognized by measuring novel and less used parameters of diastolic dysfunction. We hypothesize that left atrium (LA) strain and isovolumetric relaxation time (IVRT) derived intervals could be new and earlier predictors of diastolic dysfunction in septic patients with a potential impact on clinical presentation and prognosis and that rare genetic variation associated with inherited cardiomyopathies could underline the risk and severity of sepsis-related myocardial dysfunction with potential impact on diagnosis and prognosis.

NCT ID: NCT05552326 Recruiting - Clinical trials for Severe Hypertriglyceridemia

A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

Start date: August 31, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

NCT ID: NCT05552222 Recruiting - Multiple Myeloma Clinical Trials

A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma

MajesTEC-7
Start date: October 25, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).