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NCT ID: NCT06087835 Recruiting - Clinical trials for Chronic Kidney Disease With High Proteinuria

Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin in Participants With Chronic Kidney Disease and High Proteinuria (ZENITH High Proteinuria)

Start date: November 7, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomised, multicentre, double-blinded study to evaluate efficacy, safety and tolerability of treatment with zibotentan/dapagliflozin and dapagliflozin alone in participants with chronic kidney disease (CKD) and high proteinuria.

NCT ID: NCT06087809 Completed - Clinical trials for Community-acquired Pneumonia

Improving Short Course Treatment for Common Pediatric Infections

Start date: February 15, 2023
Phase: N/A
Study type: Interventional

Randomized quality improvement trial to improve the proportion of cases of community-acquired pneumonia (CAP) treated with no more than 5 days of antibiotics the proportion of cases of skin and soft tissue infections (SSTI) treated with no more than 7 days of antibiotics by primary care clinicians (PCC) within the Pediatric Physicians' Organization at Children's (PPOC), a state-wide pediatric primary care network. Interventions include education and feedback; clinical decision support (CDS) delivered at the point of care; and the combination of the two.

NCT ID: NCT06087653 Recruiting - Multiple Myeloma Clinical Trials

Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Lenalidomide in Multiple Myeloma (MM)

Start date: October 2, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Primary Objective • Assess the safety and tolerability of low-dose lenalidomide administered by continuous subcutaneous (SC) infusion (STAR-LLD) in combination with dexamethasone and a proteasome inhibitor (PI). Secondary Objectives - To assess the immunologic activity of natural killer (NK) cells and T cells for innate and humoral immunity. - To establish the pharmacokinetic (PK) profile of STAR-LLD at a defined infusion rate targeting steady-state blood concentrations. - To determine pharmacodynamic (PD) changes with STAR-LLD in a panel of biomarkers associated with clinical response to lenalidomide. - Evaluate changes in efficacy indicators including objective response rate (ORR), progression-free survival (PFS), and duration of response (DOR). Exploratory Objective - To assess the impact of STAR-LLD on patient reported symptoms and outcomes. Primary Endpoints - The grade, frequency, and relationship of treatment-emergent adverse events (TEAEs) including adverse events of special interest (AESIs): (gastrointestinal [GI] toxicity, fatigue, hematologic toxicity, rash (non-infusion site). - The observation of dose-limiting toxicities (DLTs) of STAR-LLD during Cycle 1. Secondary Endpoints - Immune profiles, functional assays for NK cell activation and antigen specific T-cell activity. - Blood concentrations of lenalidomide at on Day 1 and at steady state. - Changes in biomarkers during treatment. - Rate of complete response, very good partial response (VGPR), partial response (PR), stable disease (SD), and progressive disease. - Determination of ORR, PFS, and DOR

NCT ID: NCT06087497 Recruiting - Atrial Fibrillation Clinical Trials

The Z Stitch Early Bed Rest Assessment Study

ZEBRA
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The goal of this study is to understand the effects of early mobilization after a Z stitch procedure in patients undergoing certain heart-related treatments. The investigators want to find out if allowing patients to move around sooner after their procedure can improve their satisfaction and potentially lead to earlier discharge from the hospital. Type of Study: Clinical Trial Participant Population/Health Conditions: Patients aged 18-99 undergoing specific heart procedures such as atrial fibrillation treatment, atrial flutter treatment, supraventricular tachycardia treatment, diagnostic electrophysiology studies, AV node ablation, or Watchman device placement. Main Questions: Does early mobilization (getting up and moving around sooner) after the Z stitch procedure improve patient satisfaction? Participants will be divided into two groups, and researchers will compare those who have one hour of bedrest with those who have four hours of bedrest after the Z stitch procedure. The investigators want to see if the shorter bedrest period leads to higher patient satisfaction.

NCT ID: NCT06087445 Recruiting - Clinical trials for Cervical Spinal Cord Injury

A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia

Start date: October 31, 2023
Phase: N/A
Study type: Interventional

The goal of this pilot clinical study is to investigate the NeuroLife EMG-FES Sleeve System, a closed-loop approach to functional electrical stimulation, in adults (n=12) with chronic (>12 months) tetraplegia due to spinal cord injury. Briefly, the NeuroLife EMG-FES System is a completely non-invasive system (surface electrodes only, no implantable components) worn on the forearm which has up to 160 electrodes that can record electromyography (EMG), or muscle activity, and also electrically stimulate (FES) muscles. The main questions this study aims to answer are: 1) What is the safety, feasibility, and early efficacy of the NeuroLife EMG-FES system on upper extremity outcomes in chronic SCI survivors with tetraplegia, and 2) Can EMG be used as a biomarker of recovery over time in chronic SCI participants undergoing rehabilitation? Participants will complete an intensive, task-oriented rehabilitation protocol using the NeuroLife EMG-FES System (3x/week x 12 weeks) in an outpatient setting. We will assess functional outcomes using standardized clinical measures of hand and arm function at six timepoints.

NCT ID: NCT06087406 Recruiting - Clinical trials for Rheumatoid Arthritis

A Phase 1b Study of Imvotamab in Moderate to Severe Rheumatoid Arthritis

Start date: September 13, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety and tolerability of imvotamab in patients with moderate to severe rheumatoid arthritis who have failed prior therapies. Participants will be given imvotamab or placebo through a vein (i.e., intravenously). A placebo is a look-alike substance that contains no active drug

NCT ID: NCT06087393 Recruiting - Brain Tumor Clinical Trials

CONVIVO Endomicroscopy

Start date: January 8, 2024
Phase: N/A
Study type: Interventional

Visualization of the tissue microstructure during neurosurgery using a non destructive handheld imaging technology producing a real time digital image ("optical biopsy") at cellular resolution is a novel method that holds great promise for optimization and improvement of the surgical treatment of brain pathologies, brain tumors in particular. The goal of this project is to investigate and assess the ease of use of the CONVIVO FDA cleared system in discriminating healthy and abnormal tissues during in vivo use on the brain during neurosurgery in 30 patients with a working diagnosis of intrinsic brain tumors.

NCT ID: NCT06087328 Recruiting - Smoking Cessation Clinical Trials

CAN-DOSE Study: Cessation With Augmented Nicotine for Dual Use Of Smoking and E-cigarettes

CAN-DOSE
Start date: December 5, 2023
Phase: Phase 2
Study type: Interventional

Many people smoke cigarettes and use e-cigarettes, and have a hard time stopping. Nicotine replacement therapy medications, such as nicotine patches and lozenges, have been shown to help people quit e-cigarette use. The purpose of the present study is to see how well nicotine patches and lozenges help people quit both smoking and vaping, and to determine if higher doses of the medication work best.

NCT ID: NCT06087276 Recruiting - Essential Tremor Clinical Trials

Essential 3 - Decentralized, Phase 3 Study Evaluating the Safety and Efficacy of Ulixacaltamide in Essential Tremor (ET)

Start date: November 2, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical study is to compare ulixacaltamide and placebo treatment in essential tremor. The main question it aims to answer is: • Is ulixacaltamide a safe and efficacious treatment for patients with essential tremor? Participants will be asked to participate in one of two clinical studies where they will be treated with either ulixacaltamide or placebo for a period of up to 12 weeks. After the controlled study completion, they will be eligible to participate in a long-term, open-label safety study and be treated with ulixacaltamide.