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NCT ID: NCT04128072 Recruiting - Clinical trials for Stage IB-IIB Cutaneous T-Cell Lymphoma

Anti-CCR4 Monoclonal Antibody (Mogamulizumab) and Total Skin Electron Beam Therapy (TSEB) in Patients With Stage IB-IIB Cutaneous T-Cell Lymphoma

MOGAT
Start date: March 7, 2023
Phase: Phase 2
Study type: Interventional

Cutaneous T-Cell Lymphoma (CTCL) has a chronic, relapsing course with patients undergoing multiple, consecutive therapies. Treatment aims at the clearance of skin disease, minimization of recurrence, prevention of disease progression and preservation of quality of life. The treatment of CTCL is primarily determined by the disease extent. Prolonged complete remissions have been obtained with skin-directed therapies in early stage Mycosis fungoides (MF) (IA-IIA), whereas advanced stages CTCL (IIB-IVB) are often refractory to treatment and, thus, have an unfavorable prognosis. Currently, there is no standard treatment option for CTCL, especially for advanced stages, and the optimal treatment sequence is still debated with a large variability in the therapeutic approach across countries. Patients with advanced-stage disease or refractory cutaneous CTCL should be treated with systemic therapies and, whenever possible, should be offered to participate in clinical trials. Currently, there is a urgent call for new treatments in CTCL with higher response rate and prolonged time to progression; In this study, we propose a very innovative treatment schedule in which mogamulizumab is used before Total Skin Electron Beam therapy (TSEB) for systemic disease control and as a maintenance treatment after skin-directed therapy. We hypothesize that our regimen will show a more manageable toxicity profile than a combination treatment and allow for a long-term mogamulizumab administration.

NCT ID: NCT04126200 Recruiting - Multiple Myeloma Clinical Trials

Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

DREAMM5
Start date: October 7, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

B-cell maturation antigen (BCMA) is a target present on tumor cells in participants with multiple myeloma. Belantamab mafodotin (GSK2857916); is an antibody-drug conjugate (ADC) containing humanized anti-BCMA monoclonal antibody (mAb). This is a phase I/II, randomized, open-label, platform study designed to evaluate the effects of belantamab mafodotin in combination with other anti-cancer drugs in participants with relapsed/refractory multiple myeloma. The Platform design incorporates a single master protocol, where multiple treatment combinations, as sub-studies, will be evaluated simultaneously.

NCT ID: NCT04119050 Recruiting - Clinical trials for Warm Autoimmune Hemolytic Anemia

Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia

ENERGY
Start date: August 15, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).

NCT ID: NCT04108546 Recruiting - Back Pain Clinical Trials

Massage and Electroacupuncture in Chronic Lumbar Pain

Start date: February 1, 2020
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate and compare in patients with chronic back pain two therapeutic interventions: a) the combination of massage and electroacupuncture; and b) the application of epidural analgesia in pain, functioning-incompetence, quality of life and mood.

NCT ID: NCT04098536 Recruiting - Atherosclerosis Clinical Trials

Acute Exposure to Diesel: Prolong Effects on Inflammation and Vasculature

DEVA
Start date: January 1, 2015
Phase: N/A
Study type: Interventional

Cross-over double-blind study. Healthy subjects will be exposed to diesel exhaust fumes and/or filtered air during a 2-hour session. Several parameters will be assesed i.e. endothelial function will be assessed with flow mediated dilation (FMD) techniques, arterial stiffness with pulse wave velocity (PWV) and reflected waves with augmentation index (AIx). C reactive protein (CRP), fibrinogen, protein C levels and protein S activity will be also measured. Heart rate variability and standard deviation of normal to normal intervals R-R intervals (SDNN) will be used to assess sympathetic activity. Measurements were assessed before, 2 and 24 hours after diesel exposure.

NCT ID: NCT04094818 Recruiting - Sepsis Clinical Trials

HostDx Sepsis in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections and Suspected Sepsis

SEPSIS-SHIELD
Start date: February 28, 2020
Phase:
Study type: Observational

This study will analyze gene expression and other laboratory data from biological samples collected from participants with suspected respiratory, urinary, intra-abdominal, and/or skin & soft tissue infections; or suspected sepsis of any cause.

NCT ID: NCT04092309 Recruiting - Clinical trials for Hematopoietic Stem Cell Transplantation

Effect of Angiotensin Converting Enzyme and Sacubitril Valsartan in Patients After Bone Marrow Transplantation

Start date: September 20, 2019
Phase: N/A
Study type: Interventional

The purpose of the present study is to investigate the effect of ACE inhibitors and the sacubitril-valsartan complex in bone marrow transplant patients by assessing cardiovascular and endothelial parameters in order to search for a potent protective role.

NCT ID: NCT04090021 Recruiting - Clinical trials for Helicobacter Pylori Infection

Genotypic Resistance-guided Versus Empirical Therapy for H. Pylori Eradication.

Start date: September 1, 2019
Phase: Phase 4
Study type: Interventional

This study aims to investigate the efficacy of a 7-day genotypic resistance-guided triple therapy, compared with empirical concomitant therapy, for first-line eradication of H. pylori.

NCT ID: NCT04073420 Recruiting - Clinical trials for Valve Disease, Heart

Medtronic Cardiac Surgery PMCF Registry

Start date: December 2, 2019
Phase:
Study type: Observational [Patient Registry]

This registry is being conducted to support ongoing post-market surveillance activities.

NCT ID: NCT04064359 Recruiting - Solid Tumor Clinical Trials

Safety and Preliminary Efficacy of OBT076 in Recurrent/Metastatic CD205+ Solid Tumors

Start date: July 25, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate OBT076, which is a drug that combines an antibody with an anti-cancer drug. This class of drugs are called Antibody-Drug Conjugates (ADC). Antibodies are normally produced in the human body by the immune system to fight infections but can be designed to target cancer cells and deliver an anti-cancer drug. OBT076 is composed of an antibody that targets the CD205 protein on cancer cells and delivers an anti-cancer drug which can kill them. OBT076 is an "Investigational Drug", which means that it is still being studied and has not yet been approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) or any other regulatory authorities to be prescribed by doctors for the treatment of metastatic or recurrent solid tumors. The use of OBT076 in this study is investigational. This is a Phase I research study designed to look at several dose levels of the study drug to find the highest dose level that is safe and well-tolerated (does not cause unacceptable side effects), and to examine the effects of the study drug in a small group of research participants. The study will also look at the effectiveness of OBT076 as an anti-cancer therapy. Once the optimal dose is determined and safety is assessed, additional research participants will be treated at the optimal dose level to further evaluate safety and effectiveness.