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NCT ID: NCT04663646 Recruiting - Clinical trials for Perceptual Disorders

Optokinetic Stimulation for Hemineglect

Start date: January 10, 2023
Phase: N/A
Study type: Interventional

Hemineglect is a sequel to stroke, which appears more frequently when the injury occurs in the right cerebral hemisphere. Hemineglect refers to those patients who do not pay attention to their left side, presenting movement disorders that do not allow them to participate spontaneously in their activities of daily life. There are different methodologies for the treatment of hemineglect. Among them, we find optokinetic stimulation (OKS), which consists of creating an illusory movement to the left to center the patient's frame of reference and thus, make them pay more attention to their left side. In recent years, the effect that this therapy has on motor movement disorders has begun to be explored, although the parameters for its correct application still seem to be unclear. For this reason, our aim is to describe the effect that the OKS has on balance, posture, spatial representation and conscience, and movement disorders in hemineglect. Patients with hemineglect will undergo OKS to see its influence on the recovery of this sequel of stroke.

NCT ID: NCT04663347 Recruiting - Follicular Lymphoma Clinical Trials

Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

EPCORE™ NHL-2
Start date: November 3, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this trial is to measure the safety and effectiveness of epcoritamab (EPKINLY™), either by itself or together with other therapies, when treating subjects with B-cell non-Hodgkin Lymphoma (B-NHL). The aim of the first part of the trial is to identify the most appropriate dose of epcoritamab, and the aim of the second part of the trial is to assess the selected epcoritamab dose in a larger group of participants with B-NHL. All participants in this trial will receive either epcoritamab alone, or epcoritamab combined with another standard treatment regimen, with a total of 10 different treatment arms being studied. Trial details include: - The total trial duration will be up to 6 years. - The treatment duration for each participant depends upon which arm of treatment they are assigned to receive, but will be no more than 3 years. - The visit frequency for each participant depends upon which arm of treatment they are assigned to receive, but will be weekly to start for all participants, then will decrease to either: every 2 weeks, or every 3 weeks, or every 4 weeks, or every 8 weeks. - All participants will receive active drug; no one will be given placebo. Participants who receive treatment with epcoritamab will have it injected right under the skin. Participants will receive a different regimen of epcoritamab depending upon which arm of treatment they are assigned. Participants who receive standard treatments will have IV infusions and/or oral administration of those treatments. Participants will receive a different standard treatment regimen depending upon which arm of treatment they are assigned. Arm 9 (follicular lymphoma (FL)) is still open for enrolment of new patients, while the other arms have closed their recruitment.

NCT ID: NCT04662489 Recruiting - Clinical trials for Persistent Atrial Fibrillation

Radial Ablation for the Control of Persistent Atrial Fibrillation

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

The protocol aims to evaluate the efficacy of the radial ablation technique of the maintenance mechanisms in persistent atrial fibrillation compared to the isolation of the pulmonary veins evaluating the atrial fibrillation burden during one year follow-up.

NCT ID: NCT04662190 Recruiting - Clinical trials for Surgical Procedure, Unspecified

Evaluation of the Efficacy and Safety of 3D Printing for Orbital Surgery.

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

This is a multicentric, randomized, single-blinded clinical trial to evaluate the efficacy and safety of 3D printing for the planification and simulation of orbital decompression surgery for thyroid-associated orbitopathy.

NCT ID: NCT04662047 Recruiting - Clinical trials for Community-acquired Pneumonia

The Impact of Air Pollution on the Consumption of Antimicrobials in the General Population

ONAIR
Start date: January 1, 2021
Phase:
Study type: Observational

Objectives: To test the hypothesis that certain levels of air pollution may lead to increases in 1) antimicrobial consumption in the general population and 2) the presence of antibiotic resistance genes. Methods: The project will consist of two sub-studies: 1. A time series analysis of the association between daily antimicrobial consumption and air pollution in the 11 largest cities in Catalonia (2006-2022). Outcome variable: daily consumption of antimicrobials. Independent variables: air pollution and confounding variables. The analysis will use generalized additive models: through a random effects meta-analysis, the concentration-response estimates for each city will be added together to calculate the overall estimates. 2. Descriptive observational study of the relationship between the concentration of resistance genes and antimicrobial consumption in the Barcelona area (2021-2023). Outcome variable: concentration of antibiotic resistance genes. Independent variables: defined daily dose of antimicrobials per 1000 inhabitants-day. Descriptive analysis of the concentration and diversity of antibiotic resistance genes according to air quality monitoring station (urban vs. hospital environment), month, and correlation with antimicrobial consumption.

NCT ID: NCT04662034 Recruiting - Clinical trials for Systolic Left Ventricular Dysfunction

Performance and Safety of the Cardiac Microcurrent Therapy System

C-MIC-II
Start date: February 5, 2021
Phase: N/A
Study type: Interventional

Patients with idiopathic dilative cardiomyopathy who have systolic left ventricular dysfunction (NYHA III - IV) despite adequate therapy according treatment guidelines of heart failure and who have a baseline left ventricular ejection fraction of ≥25% and ≤35 will receive a C-MIC System and microcurrent therapy after device implantation with optimal medical management. At the end of the study after 6 months, the C-MIC System will be turned off. The control group will receive optimal medical management without device implantation.

NCT ID: NCT04661527 Recruiting - Clinical trials for COVID-19 Drug Treatment

Sarilumab Treatment In cytoKinE Storm Caused by Infection With COVID-19

STRIKESARS
Start date: April 22, 2020
Phase: Phase 2
Study type: Interventional

Phase II, one-arm, open label, multicentric study, to evaluate treatment of severe COVID-19 with sarilumab prior to entry into the intensive care unit (ICU).

NCT ID: NCT04660461 Recruiting - Clinical trials for Grönblad-Stranberg Disease (Pseudoxanthoma Elasticum)

Response to Oral Lansoprazole of Inorganic Pyrophosphate Levels in Patients With Grönblad-Stranberg Disease (Pseudoxanthoma Elasticum)

FIMPXE2016-01
Start date: February 4, 2020
Phase: Phase 4
Study type: Interventional

Protocol code and version: FIM-PXE-2016-01 Version 1.4 Trial title: "Response to oral lansoprazole of inorganic pyrophosphate levels in patients with Grönblad- Stranberg disease (Pseudoxanthoma Elasticum)" Trial design: Double-blind, placebo-controlled, randomised, two-stage crossover clinical trial, with each patient serving as their own control and reducing the number of patients to confirm our hypothesis. Principal Investigator: Dr. Pedro Valdivielso Felices Participating centres Virgen de la Victoria's Universitary Hospital in Malaga and Virgen de la Macarena's Universitary Hospital in Seville. Duration of the trial: 12 months Expected start date: December 2019 Objectives: Principal:To verify the changes in plasma PPi, and the main molecules that regulate it (NPP1-3, TNAP) after oral administration of lansoprazole in patients diagnosed with PXE. Description of treatment: Selection:20 patients who meet all the criteria for inclusion and none for exclusion. Randomisation and 1st stage: Patients will receive lansoprazole 30mg/day or their placebo for 8 weeks. Wash-out: After 8 weeks, all treatment will be suspended for 15 days. 2nd stage (crossed): Treatment is crossed, each patient serves as his or her own control. Evaluation variables: 1. Date of Birth 2. Sex. 3. Physical examination (anthropometry and vital signs) 4. Date of first symptom. 5. Date of final diagnosis 6. Ocular affectation (orange peel skin, complete striae angioides, lucentis, corrected visual acuity, cataracts, intraocular pressure, fundus (vascular flow, optic nerve drusen, retinal atrophy, neovascular membranes, macular thickness, colloid thickness). 7. Skin affectation (yellowish papules or plaques on the side of the neck or other areas of flexure and lax skin). 8. Vascular affectation (intermittent claudication clinic, angina and/or episode of acute myocardial infarction and/or non-embolic ischemic stroke, surgical or percutaneous revascularisation, cardiac murmur,10.) 9. History of renal lithiasis, arterial hypertension, diabetes mellitus, treatments, smoking and dyslipidemia. 10. Specific biochemical variables: Inorganic pyrophosphate (IPP) NPP1 and NPP2.3: activity and mass concentration of the enzyme Non-specific tissue alkaline phosphatase (NTAP) and PHA. Osteocalcin: To check possible side effects on bone metabolism. 5'-Nucleotidas General analytical parameters (haemoglobin, haematocrit, MVC, MHC, platelets, neutrophils, prothrombin activity, TPTA, thrombin time, ferritin, PCR, glycaemia, urea, creatinine, cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, uric acid, calcium, phosphorus, alkaline phosphatase, PTH). By means of routine clinical laboratory techniques. Number of patients: TOTAL : 20 patients(Competitive recruitment)

NCT ID: NCT04660344 Recruiting - Clinical trials for Muscle-invasive Bladder Cancer

A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy

IMvigor011
Start date: May 3, 2021
Phase: Phase 3
Study type: Interventional

This is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with placebo in participants with MIBC who are ctDNA positive and are at high risk for recurrence following cystectomy.

NCT ID: NCT04660214 Recruiting - Endoscopy Clinical Trials

Minimally Invasive Endoscopic Treatment of Zenker's Diverticulum Comparing LigaSureTM vs SB-Knife.

Start date: June 28, 2021
Phase: N/A
Study type: Interventional

The main purpose of this trial is to evaluate two devices used in the treatment of Zenker Diverticulum using flexible endoscopy (LigaSure and SB-knife). Analyze the technical success, clinical success, relapses, complications, and the mean procedure time with each device prospectively in order to transfer objective and uniform results to routine clinical practice.