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NCT ID: NCT05339087 Recruiting - Systemic Sclerosis Clinical Trials

Efficacy and Safety of Riociguat in Incipient Pulmonary Vascular Disease as an Indicator for Early PAH

ESRA
Start date: October 24, 2022
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, multicenter, multinational study investigating the effect of riociguat (MK-4836) in patients with early pulmonary vascular disease.

NCT ID: NCT05339009 Recruiting - Clinical trials for Chronic Kidney Disease 5D

Bio-ADM as a Biomarker of Refilling in Chronic Hemodialysis Patient

REFILBIOADM
Start date: April 1, 2022
Phase:
Study type: Observational

Aim of this study is to evaluate in a population of chronic kidney disease patients on dialysis (Stage 5D) the predictive value of bio-adrenomedullin (bio-ADM) level on vascular refilling rate.

NCT ID: NCT05338970 Active, not recruiting - Clinical trials for Nonsquamous Non-small Cell Lung Cancer

HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy

Start date: July 8, 2022
Phase: Phase 3
Study type: Interventional

Disease progression is typical for patients with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC). Standard platinum-based chemotherapy offers limited efficacy and an unfavorable safety profile.There is an urgent need for more effective and tolerable therapies for patients with EGFRm NSCLC who have exhausted available targeted therapies. Clinical evidence suggest that patritumab deruxtecan constitutes a promising investigational therapy for patients with EGFRm NSCLC.

NCT ID: NCT05338892 Completed - Clinical trials for Diffuse Large B-Cell Lymphoma

Real-World Clinical Outcomes in Adult Patients Who Initiate Systemic Treatment for Relapsed/Refractory Diffuse Large B-Cell Lymphoma

ORCHID
Start date: June 22, 2022
Phase:
Study type: Observational

Primary Objective: To evaluate objective response rate (ORR) in adult patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL) who receive systemic treatment after at least 2 prior systemic therapies in the real-world setting according to Lugano classification of malignant lymphoma (Cheson, 2014) and as assessed by independent central review Secondary Objectives: To evaluate the following outcomes in adult patients with r/r DLBCL who are treated with currently available therapies in the real-world setting: 1. ORR according to Lugano classification and as assessed by treating physician evaluation 2. Complete Response (CR) rate according to Lugano classification and as assessed by: - Independent central review, and - Treating physician evaluation 3. Progression Free Survival (PFS) according to Lugano classification and as assessed by: - Independent central review, and - Treating physician evaluation 4. Overall Survival (OS) 5. Duration of response (DOR) according to Lugano classification and as assessed by - Independent central review and - Treating physician evaluation 6. Disease control rate (DCR) according to Lugano classification and as assessed by: - Independent central reviewed - Treating physician evaluation 7. Time to next treatment (TTNT)

NCT ID: NCT05338879 Completed - Clinical trials for Relapsed/Refractory Follicular Lymphoma

Real-World Clinical Outcomes in Adult Patients Who Initiate Systemic Treatment for Relapsed or Refractory Follicular Lymphoma

FLORA
Start date: June 22, 2022
Phase:
Study type: Observational

Primary Objective: To evaluate objective response rate (ORR) in adult patients with relapsed/refractory follicular lymphoma (r/r FL) grade 1-3a who are treated with currently available therapies in the real-world setting according to Lugano classification (Cheson, 2014) of malignant lymphoma and as assessed by independent central review. Secondary Objectives: To evaluate the following outcomes in adult patients with r/r FL grade 1-3a who are treated with currently available systemic therapies in the real-world setting: 1. Objective response rate (ORR) according to the Lugano classification and as assessed by treating physician evaluation 2. Complete response (CR) rate according to the Lugano classification and as assessed by: - Independent central review, and - Treating physician evaluation 3. Progression-free survival (PFS) according to the Lugano classification and as assessed by: - Independent central review, and - Treating physician evaluation 4. Overall survival (OS) 5. Duration of response (DOR) according to the Lugano classification and as assessed by: - Independent central review, and - Treating physician evaluation 6. Disease control rate (DCR) according to the Lugano classification and as assessed by: - Independent central review, and - Treating physician evaluation 7. Time to next treatment (TTNT) 8. Histological transformation (HT)

NCT ID: NCT05338775 Recruiting - Clinical trials for Relapsed/ Refractory Multiple Myeloma

A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma

TRIMM-3
Start date: May 25, 2022
Phase: Phase 1
Study type: Interventional

The purpose of the study is to identify the safe dose(s) of a PD-1 inhibitor in combination with talquetamab or teclistamab, and to characterize the safety and tolerability of talquetamab or teclistamab when administered in combination with a PD-1 inhibitor.

NCT ID: NCT05338359 Recruiting - Sepsis Syndrome Clinical Trials

Metrology to Enable Rapid and Accurate Clinical Measurements in Acute Management of Sepsis

SEPTIMET
Start date: January 25, 2022
Phase:
Study type: Observational

Sepsis is a life-threatening condition that arises when a dysregulated response to infection results in multi-organ dysfunction or failure. This can affect any organ, resulting in a diverse clinical presentation. Sepsis affects more than 3.4 million Europeans a year with 700,000 deaths from the condition and an additional one third of survivors dying through complications in the year following a sepsis event. To date, biomarkers that are used to predict bacterial infection (such as CRP or lactate) are used in combination and with other clinical symptoms due to the fact that they are non-specific for sepsis. The use of such biomarkers frequently varies between hospitals or even physicians. Biomarkers such as procalcitonin (PCT) have been reported as useful for differentiating between infectious and non-infectious causes of systemic inflammatory response syndrome. Yet calibration of PCT assays is problematic due to the absence of higher order method or international standard. External quality assessment (EQA) programs have highlighted poor comparability. This protocol is part of the international SEPTIMET project. The Emergency Department (ED) of the Pitié-Salpêtrière hospital takes part of the project with specific objectives in order to establish a large cohort of patients at very early stage sepsis (defined by Systemic Inflammatory Response Syndrome -SIRS - due to bacterial infection or the first symptoms of sepsis before septic shock, patients consulting in the first hours of the history of the disease at the emergency department) with the idea of spotting the condition before it manifests as a more serious presentation. This will measure the clinical criteria and putative biomarkers as patients progress to more serious presentation. Moreover, an expected biobank of >200 samples will be generated to provide material for the Laboratoire National de Métrologie et d'essais (LNE) in charge of analytical studies.

NCT ID: NCT05338190 Recruiting - Clinical trials for Primary Immune Thrombocytopenia (ITP)

Efficacy and Safety of Subcutaneous Belimumab or Placebo in Addition of Rituximab in Persistent or Chronic Immune Thrombocytopenia

RITUX-PLUS 2
Start date: November 14, 2022
Phase: Phase 3
Study type: Interventional

Primary immune thrombocytopenia (ITP) is an autoimmune disease mainly mediated by autoreactive B cells and the presence of pathogenic anti-platelet auto-antibodies that enhance platelet destruction and impair platelet production. There are approximately 4,000 newly diagnosed ITP cases each year in France. For patients with a platelet count of less than 30x109/L and/or bleeding symptoms, corticosteroids alone or in combination with intravenous immunoglobulin (IVIg) is the standard first-line treatment. However, approximately two-thirds of adult patients responding to this first-line treatment relapse within days or weeks after corticosteroids withdrawal and overall, the course of the disease is chronic in about 70% of the cases. The anti-CD20 monoclonal antibody rituximab is commonly used off-label as a second-line therapy in many European countries including France for adults with persistent (i.e., disease duration of more than 3 months) or chronic (disease duration of more than 12 months) ITP. Rituximab leads to an overall response rate of only 40 % at 1 year but 29.5% of lasting (5 years and more) response The investigators have shown that the absence of response to rituximab in ITP could be explained by the settlement and expansion of long-lived autoreactive plasma cells in the spleen made possible by the high amount of BAFF. Belimumab is a fully humanized anti-BAFF/Blys monoclonal Ab licensed for SLE. Based on the preliminary results of a phase 2 open prospective pilot study performed in our center combining rituximab with i.v belimumab seems highly promising We hypothesized that combining subcutaneous belimumab weekly over a 24 weeks period (Arm A) with rituximab is superior to rituximab and subcutaneous placebo weekly over 24 weeks period (Arm B) to achieve an overall response at W52. The study design will be a prospective randomized, double-blind, multicenter (international), superiority phase III clinical study

NCT ID: NCT05337995 Completed - Clinical trials for Chronic Low-back Pain

Locomotion Strategies of Low Back Pain Patients

Start date: March 1, 2022
Phase:
Study type: Observational

The biomechanical parameters studied in non-specific chronic low back pain patients in a locomotion task have so far focused on straight line walking. Although locomotion is primarily an automated action composed of repetitive patterns allowing movement from one place to another, walkers must respond to the environmental demands.These modifications show a flexible and adaptive approach to the constraints of the environment. In this study, we are particularly interested in a task of passage through a horizontal opening, similar to a doorway, which is a standardized task that has shown its interest in the study of perceptual-motor co-ordinations. In particular, it allows to consider anthropometric and functional abilities of individuals, reflecting their action capacities.

NCT ID: NCT05337436 Recruiting - Clinical trials for Chronic Kidney Diseases

Ionized Magnesium Balance During Hemodialysis Session

MAGNESIR
Start date: April 1, 2022
Phase:
Study type: Observational

Aim of this study is to evaluate in a population of chronic kidney disease patients on dialysis (Stage 5D) the balance of total and ionized magnesium according to different types of dialysate used in clinical practice (acetate + Mg 0.50 or 0.75 mM vs citrate + Mg 0.50 ou 0.75 mM)