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NCT ID: NCT06064929 Recruiting - Lupus Nephritis Clinical Trials

A Study of Felzartamab in Participants With Lupus Nephritis

Start date: November 1, 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to evaluate the safety and tolerability of felzartamab plus standard of care in participants with refractory Lupus Nephritis (LN).

NCT ID: NCT06064916 Recruiting - Pseudophakia Clinical Trials

Visual Outcomes and Patient Satisfaction With Vivity IOL in Post Refractive Patients

Start date: July 25, 2023
Phase:
Study type: Observational [Patient Registry]

This is a non-interventional, prospective, observational study of the outcomes for post myopic refractive surgery patients following successful, uncomplicated cataract surgery with bilateral implantation of the Vivity IOL (DAT***/CCWET*). Patients will be assessed for monocular and binocular distance, intermediate, and near vision.

NCT ID: NCT06064890 Recruiting - Clinical trials for Frontotemporal Dementia

A Study to Evaluate the Safety and Effect of AVB-101, a Gene Therapy Product, in Subjects With a Genetic Sub-type of Frontotemporal Dementia (FTD-GRN)

ASPIRE-FTD
Start date: August 30, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical study is to learn about an investigational gene therapy product called AVB-101, which is designed to treat a disease called Frontotemporal Dementia with Progranulin Mutations (FTD-GRN). FTD-GRN is an early-onset form of dementia, a progressive brain disorder that affects behavior, language and movement. These symptoms result from below normal levels of a protein called progranulin (PGRN) in the brain, which leads to the death of nerve cells (neurons), affecting the brain's ability to function. The main questions that the study aims to answer are: 1. Is a one-time treatment with AVB-101 safe for patients with FTD-GRN? 2. Does a one-time treatment with AVB-101 restore PGRN levels to at least normal levels? 3. Could AVB-101 work as a treatment to slow down or stop progression of FTD-GRN? In this study there is no placebo (a dummy pill or treatment used for comparison purposes), so all participants will receive a one-time treatment of AVB-101 delivered directly to the brain, with follow-up assessments for 5 years.

NCT ID: NCT06064877 Recruiting - Clinical trials for Recurrent Head and Neck Squamous Cell Carcinoma

A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma

FIERCE-HN
Start date: January 11, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of ficlatuzumab plus cetuximab compared to placebo plus cetuximab in participants with recurrent/metastatic (R/M) HPV-negative Head and Neck Cancer. The primary hypothesis is that ficlatuzumab combined with cetuximab is superior to cetuximab alone in terms of progression-free survival and/or overall survival.

NCT ID: NCT06064851 Recruiting - Clinical trials for Heavy Menstrual Bleeding

Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Von Willebrand Disease Patients

HMB/VWD
Start date: October 27, 2023
Phase: N/A
Study type: Interventional

The objectives of this study are to determine if transcutaneous auricular neurostimulation (tAN) can modulate hemostasis, improve perceived quality of life, and improve pain during the menstrual cycle of von Willebrand Disease (VWD) patients.

NCT ID: NCT06064695 Recruiting - Clinical trials for Generalized Myasthenia Gravis

Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Myasthenia Gravis

Start date: July 12, 2023
Phase: N/A
Study type: Interventional

During this pilot study, the investigators will examine the effects of whole-body electrical muscle stimulation exercise (WB-EMS Exercise) on neuromuscular junction (NMJ) transmission and fatigability in adults with Generalized Myasthenia Gravis (gMG). The investigators will also test whether a relationship exists between NMJ transmission dysfunction and fatigability in gMG, which has long been presumed but never directly assessed. Participants will undergo clinical and electrophysiologic testing before and after the WB-EMS Exercise intervention. The WB-EMS Exercise intervention will be delivered 2 times per week for 4 weeks. The hypotheses are (a) that the WB-EMS exercise will improve fatigability and NMJ transmission, and (b) that NMJ transmission dysfunction is related to fatigability.

NCT ID: NCT06064682 Recruiting - Osteosarcoma Clinical Trials

An Organoid-based Functional Precision Medicine Trial in Osteosarcoma

PREMOST
Start date: February 12, 2024
Phase:
Study type: Observational

The purpose of this study is to examine if we can predict sensitivity of osteosarcoma to different chemotherapy agents using tissue cultures in the laboratory. We know that different chemotherapy agents can be used in the treatment, but not every sarcoma responds to them equally. It is important to understand if testing of the tissue obtained during a routine biopsy or surgery may be useful in selecting appropriate treatments. In addition, additional testing of the tumor, including genetic testing, will help us to understand osteosarcoma better.

NCT ID: NCT06064656 Completed - Clinical trials for Fibrodysplasia Ossificans Progressiva (FOP)

A Non-Interventional Study of Clinical Characteristics and Mortality of US Patients With Fibrodysplasia Ossificans Progressiva (FOP)

Start date: June 29, 2023
Phase:
Study type: Observational

Primary Objective(s): - To describe the demographic characteristics of people living with FOP - To describe the prevalence of clinical characteristics of interest in people living with FOP - To describe the use of key medications in people living with FOP - To estimate the crude mortality rate among people with FOP

NCT ID: NCT06064617 Recruiting - Clinical trials for Accommodation Disorder

Accommodative Behaviors in Multifocal Contact Lenses

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

Soft multifocal contact lenses are used for a variety of reasons in patient care. Multifocal contact lenses are most often used to correct presbyopic vision by providing a range of clear vision at both distance and near. Multifocal contact lenses correct vision at different distances by introducing a power gradient over the eye. They are designed using center near or center distance designs. For center near designs, the near addition is place in the center of the lens, and the power becomes more negative in the periphery. Conversely, for center distance designs, the distance prescription is placed in the center, and the power of the lens becomes more positive in the periphery in order to provide the near addition. Center near and distance designs have varying advantages and disadvantages for presbyopic vision correction, so a fitter may choose a specific design based on a patient's individual visual needs. Generally, it is thought that center near designs provide the most accommodative relief and superior near vision because the near addition is centered in the pupil and able to allow maximum near correction, even with miotic pupil size changes associated with accommodation. Plus lenses, or add powers, in spectacles are often used in the management of accommodative and binocular vision disorders. An add power, or plus lens, relieves accommodative demand. There is conflicting evidence on whether the add power in soft multifocal contact lenses can be used to manage accommodative and binocular vision disorders. Some case reports demonstrate benefits of multifocal contact lenses in accommodative insufficiency and convergence excess but the evidence is not clear and many previous studies utilize lenses that are not readily used anymore. Studies show that soft multifocal contact lenses alter accommodation in participants who wear lenses, but most studies use enter-distance lens designs, which is the most commonly used lens for myopia management. Most studies that have evaluated accommodative ability and function while wearing soft multifocal contact lenses have examined center distance lenses. Because center distance lenses are used for myopia management, the interest has been to determine if children maintain normal accommodative function while wearing the lenses. Accommodative function while wearing center near lenses has likely not been studied often because these lens designs are used most in presbyopic populations who have no or waning accommodative ability and are using the lenses, specifically, to account for that accommodative inability.-Knowing how spectacle lenses with add powers effectively treat some binocular vision and accommodative disorders and understanding how center near multifocal contact lenses correct presbyopic vision, it is reasonable to hypothesize that center near multifocal contact lenses may provide a greater therapeutic effect for accommodative and binocular vision disorders than center near designs because the central portion of the lens is the addition power, unlike the center-distance lens designs. This study will aim to determine how accommodative function varies with center distance and center near multifocal contact lenses.

NCT ID: NCT06064604 Not yet recruiting - Stroke Clinical Trials

Clinical Efficacy of Exoskeleton Assistance for Individuals Post-Stroke

Start date: January 1, 2027
Phase: N/A
Study type: Interventional

An exoskeleton device is a robotic system designed to improve an individual's ability to move and perform tasks encountered in everyday situations. These devices consist of external rigid limb segments that assists humans through different body movements with the use of actuators. These devices are controlled by an onboard computer that determines the timing and magnitude of assistance deployed to the user. Exoskeleton controller performance is key to providing beneficial assistance that does not inhibit the user's movement. Preceding work will compare the benefit of personalized hip versus ankle joint exoskeleton assistance for improvement of post-stroke gait. It will combine exoskeleton technology with the user's movement feedback to improve wearable robotic assistance to an individual stroke survivor's gait pattern. For the clinical trial research covered under this protocol, the investigator will test various exoskeleton technologies with stroke survivors in real-world contexts, indoors and outdoors, and measure clinically meaningful outcomes and user perceptions regarding technology usability and adoption. The long-term goal is to deploy self-adaptive, adoptable exoskeletons for personalized assistance during community ambulation.