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NCT ID: NCT05382286 Recruiting - Clinical trials for Triple Negative Breast Cancer

Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

ASCENT-04
Start date: July 25, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).

NCT ID: NCT05371444 Completed - Stroke Clinical Trials

Control of Degrees of Freedom Post-stroke for the Recovery of the Upper Limb

DoF_UL_S
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

The study's methodology will be a single-blind, multicenter, parallel-group randomized controlled trial (RCT). The sample consists of stroke patients (supratentorial ischemic and hemorrhagic stroke of anterior territory) between 18 and 80 years of age, separated into 2 groups of 20 participants. The experimental group called "controlled DoF", the control group 1 called "non controlled DoF". The "controlled DoF" group will use an exoskeleton that will restrict the movement of the trunk and upper limb to release only the joint to work in the plane of interest. The "non-controlled DoF" group will receive the same therapy time as the previous group but without any restriction of joint movements. The training will be functional with multiarticular and combined planes tasks. All groups receive the conventional rehabilitation of the health center (ideally 45 minutes 1 per day). Using motion sensors, clinical scales, and electroencephalography (EEG), the data will be obtained pre-intervention, post-intervention, and in a follow-up at 3 and 6 months.

NCT ID: NCT05360446 Recruiting - Clinical trials for Coronary Artery Disease

Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events

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

CKJX839D12303 is a research study to determine if the study treatment, called inclisiran, in comparison to placebo taken in addition to statin medication can effectively reduce the total amount of plaque formed in the heart's vessels as measured by coronary computed tomography angiography (CCTA) from baseline to month 24. This study is being conducted in eligible participants with a diagnosis of non-obstructive coronary artery disease (NOCAD), where the coronary arteries are blocked less than 50%, and with no previous cardiovascular events.

NCT ID: NCT05359731 Completed - Analgesia Clinical Trials

Pharmacokinetic Analysis of Bupivacaine in the Presence and Absence of Perineural Dexamethasone in Axillary Blockade

Start date: June 28, 2022
Phase: Phase 4
Study type: Interventional

The investigators will conduct a prospective, randomized, double-blinded study using an axillary brachial plexus block in patients undergoing elective surgery of the distal forearm and hand to characterize and describe the pharmacokinetics of bupivacaine associated with perineural dexamethasone. The pharmacokinetic analysis will be performed by measuring bupivacaine plasma levels at different time intervals after the blockade (15, 30, 45, 60, and 90 minutes), allowing comparison between 2 different groups: Bupivacaine (B) and Bupivacaine-dexamethasone (BD). Thus, the hypothesis is that plasma levels of bupivacaine during the first 90 minutes after a blockade are lower in the presence of perineural dexamethasone, suggesting a decrease, at least initially, in systemic absorption from the injection site.

NCT ID: NCT05353777 Completed - Clinical trials for Bariatric Surgery Candidate

Clinical Evaluation of the Levita Robotic Platform

Start date: May 15, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and feasibility of the Levita Robotic Platform (LRP) used with the Levita Magnetic Surgical System (MSS)

NCT ID: NCT05352919 Enrolling by invitation - Clinical trials for Systemic Lupus Erythematosus (SLE)

A Study to Evaluate the Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adults With Active Systemic Lupus Erythematosus

EMERALD
Start date: June 10, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the long-term safety and tolerability of litifilimab in participants with active systemic lupus erythematosus (SLE). The secondary objectives of this study are to evaluate the long-term effect of litifilimab on disease activity in participants with SLE, to evaluate the long-term effect of litifilimab in participants with SLE in maintaining low disease activity, to evaluate the effect of litifilimab in participants with active SLE in preventing irreversible organ damage, to assess long-term use of oral corticosteroid (OCS) with participants receiving litifilimab treatment, to assess the impact of litifilimab on participant-reported Health-Related Quality-of-Life Questionnaire (HRQoL), symptoms, and impacts of SLE, to evaluate long-term effect of litifilimab on laboratory parameters, and to evaluate immunogenicity of litifilimab.

NCT ID: NCT05352672 Recruiting - Melanoma Clinical Trials

Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

Start date: July 14, 2022
Phase: Phase 3
Study type: Interventional

This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called REGN2810, also known as cemiplimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on patients with a type of skin cancer known as melanoma. The aims of the study are to see how effective the combination of fianlimab and cemiplimab are in treating the melanoma skin cancer, in comparison with a medication, pembrolizumab, approved for the treatment of melanoma skin cancer in adults, and to observe any similarities, or differences, in how the study drugs work in adolescent participants compared with adult participants. The study is looking at several other research questions, including: - What side effects may happen from receiving the study drugs - How much study drug is in the blood at different times - Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections. - How administering the study drugs might improve quality of life

NCT ID: NCT05350072 Active, not recruiting - Sjogren Syndrome Clinical Trials

Two-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome

NEPTUNUS-1
Start date: July 28, 2022
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, placebo controlled, 2-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-1)

NCT ID: NCT05349214 Recruiting - Sjogren Syndrome Clinical Trials

Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome

NEPTUNUS-2
Start date: August 4, 2022
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-2)

NCT ID: NCT05348733 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

A Study Called FINE-REAL to Learn More About the Use of the Drug Finerenone in a Routine Medical Care Setting

Start date: June 13, 2022
Phase:
Study type: Observational

This is an observational study in people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who will be receiving finerenone. Kidneys filter extra water and waste out of the blood and make urine. CKD is a long-term, progressive, decrease in the kidneys' ability to filter the blood properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough, resulting in high blood sugar levels that can cause damage to the kidneys. As a result, CKD can occur as a complication of T2D. Finerenone works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone reduces the risk of kidney disease progressively getting worse. Finerenone is available and approved for doctors to prescribe to people with CKD and T2D. Since it has only recently become available for these patients, there is a need for more information about the use of finerenone in the real-world setting. The main purpose of the study is to learn more about treatment patterns in people with CKD and T2D who just started or will start finerenone treatment as decided and prescribed by their doctor as part of their routine medical care. To answer this question, the researchers will collect data on: - Clinical characteristics (e.g., history of CKD and T2D, blood pressure, heart health) of the participants - Reasons for starting finerenone - Reasons for stopping finerenone early - How long participants have been taking finerenone (planned by their doctor compared to actual time it was taken) - Dosing of finerenone - Other medications used while taking finerenone The researchers will also collect data on medical problems (called adverse events) that the participants may have during the study. All adverse events are collected, even if they might not be related to the study treatment. Hyperkalemia, a medical term used to describe a potassium level in the blood that is higher than normal, is of special interest when finerenone is combined with some medications commonly taken to control blood pressure. Researchers want to know how often higher potassium levels occur, and when it leads to: - Stopping finerenone treatment too early - Dialysis (a medical procedure to filter the blood of extra water and waste) - Care in a hospital All data will come from medical records or from interviews study doctors will have with the participants during visits that take place during routine medical care. Participants in the US will be invited to provide voluntary blood and urine samples that could be analyzed later to better understand possible changes in protein or nucleic acid levels over time. Each participant will be in the study for 12 months. This time participating in the study may be shorter if their finerenone treatment is stopped early or the study comes to an end as planned in September 2027.