Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation

Date Added
September 28th, 2021
PRO Number
Pro00115401
Researcher
Kimberly Green

List of Studies

Keywords
Cancer, Cancer/Myeloma
Summary

This study is for patients that have been diagnosed with multiple myeloma. The usual approach for patients with newly diagnosed multiple myeloma who are not in a study, is lenalidomide and dexamethasone in combination with bortezomib or daratumumab. This approach is approved by the Food and Drug Administration (FDA). The purpose of this study is to see if patients who have a small amount of cancer left after initial treatment (called minimal residual disease (MRD)), could benefit from adding a new drug to the usual treatment. The study approach, using a combination of four drugs, is investigational and not approved by the FDA. Patients can expect to be on this study for up to 2 years. Patients will then be followed by their doctor for up to 15 years after completion of the study or until disease progression..

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 3/4, Prospective, Randomized, Active Treatment Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract

Date Added
September 28th, 2021
PRO Number
Pro00114633
Researcher
Marion Wilson

List of Studies


Keywords
Vision/ Eye
Summary

The purpose of this study is to test the safety of an investigational drug product, IBI-10090 (DEXYCU), in children to treat eye inflammation (redness) caused by cataract surgery. DEXYCU was approved by the FDA in February 2018 for use in adults, however; has not yet been approved for use in children. The active ingredient in DEXYCU is dexamethasone. Instead of being an eye drop containing dexamethasone, DEXYCU remains in the eye as a tiny droplet and slowly releases dexamethasone over a period of approximately two to three weeks. After that time the droplet is absorbed by the body. Subjects 0 to 3 years of age who are undergoing cataract surgery will be eligible for this study. The study starts at screening visit which is 3-29 days before surgery. Any study-related procedures will be performed only after obtaining informed consent. Child will be in the study for about 90 days after signing informed consent. Enrollment in this study requires a total of 8 visits. If child is eligible he/she will be randomly assigned (like the flip of a coin) to either study group DEXYCU or control group, prednisolone acetate. Child will have study visits 1 day following cataract surgery, and then at approximately 1 week, 2 weeks, 4 weeks, 6 weeks and 3 months after surgery. All visits are standard of care visits for all cataract surgery patients except 2 weeks and 6 weeks after surgery visits.

Institution
MUSC
Recruitment Contact
Carol Bradham
843-792-2338
bradhamc@muscs.edu

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis

Date Added
September 20th, 2021
PRO Number
Pro00113230
Researcher
Rachana Krishna

List of Studies


Keywords
Interstitial Lung Disease (ILD)
Summary

This is a Phase 3, randomized, double-blind, placebo-controlled, efficacy and safety study of subjects with IPF treated with inhaled treprostinil over a 52-week period. This study is investigating whether a drug called inhaled treprostinil (brand name Tyvaso®) works to help people with IPF improve their lung function tests. The purpose of this research study is to see how well inhaled treprostinil works in participants with IPF and to gather information on how safe it is. This study will look at changes in your breathing tests, also called lung function tests. About 396 people will participate in this study from about 100 medical centers. Your participation in this study is voluntary and will last approximately 58 weeks. This time includes a Screening Period that could last up to approximately 6 weeks plus a 52-week Treatment Period.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Evaluation of the safety and efficacy of the reSept ASD Occluder to treat patients with clinically significant secundum atrial septal defect (ASCENT ASD STUDY)

Date Added
September 17th, 2021
PRO Number
Pro00111553
Researcher
John Rhodes

List of Studies


Keywords
Cardiovascular
Summary

Transcatheter closure of secundum ASD using a permanent implant is considered the standard of care for treatment of clinically significant ASD. Over the past twenty years, devices have evolved such that safety and effectiveness are equal or superior to surgical techniques while reducing the economic and psychological costs of care. Industry sources estimate that, globally, over half a million patients have received a septal occluder to treat atrial level shunts.

A key remaining drawback to all such devices is that they are permanent implants placed in a typically young population. Unlike surgical suture, which resorbs over time, all currently available septal occlusion implants are constructed with a metal framework that incorporates some amount of fabric-based material.

The reSept ASD Occluder is unique in that the framework of the implant is comprised of a bioresorbable material (PLGA) and is intended for use in patients with a clinically significant secundum ASD, who, in the judgment of their physician, require closure of the ASD and in whom a transcatheter approach is deemed appropriate.

Institution
MUSC
Recruitment Contact
Megan Bickford
843-876-3394
bickfome@musc.edu

A 52-week, open-label, single arm study to investigate the efficacy and safety of mepolizumab SC in participants aged 6 to 17 years with hypereosinophilic syndrome.

Date Added
September 8th, 2021
PRO Number
Pro00113422
Researcher
Kelli Williams

List of Studies


Keywords
Adolescents, Allergy, Pediatrics
Summary

The purpose of this study is to see if taking mepolizumab is safe and effective in treating Hypereosinophilic syndrome (HES) in children and adolescent patients ages 6 to 17 years who are receiving standard of care (SoC) therapy. Mepolizumab is administered through a subcutaneous injection (shot). Participation in the study will last for about 64 weeks approximately (1 year and 3 months).

Institution
MUSC
Recruitment Contact
Natalie Naylon
843-792-5824
naylon@musc.edu

Cranial-nerve non-invasive neuromodulation and dynamic balance in chronic stroke survivors

Date Added
September 7th, 2021
PRO Number
Pro00113565
Researcher
Steven Kautz

List of Studies


Keywords
Rehabilitation Studies, Stroke Recovery
Summary

Portable Neuromodulation Stimulator (PoNS) is non-invasive stimulation device placed on the tongue to stimulate those brain regions understood to be important for maintaining balance. This research study aims to collect evidence that PoNS therapy along with balance training and breathing exercises improves walking stability post-stroke.

Institution
MUSC
Recruitment Contact
Shraddha Srivastava
843-792-6165
srivasts@musc.edu

Can increasing motor evoked potential size improve upper extremity motor function in individuals with incomplete spinal cord injury?

Date Added
September 7th, 2021
PRO Number
Pro00113108
Researcher
Blair Dellenbach

List of Studies

Keywords
Central Nervous System, Nervous System, Rehabilitation Studies, Spinal Cord
Summary

The purpose of this study is to examine the relationship between common clinical assessments and measurements of the function of brain-spinal cord-muscle connections. For examining brain-to-muscle pathways, we use a transcranial magnetic stimulator. This stimulator produces a magnetic field for a very short period of time and indirectly stimulates brain cells with little or no discomfort. We hope that the results of this training study will help us in developing therapy strategies for individuals, better understanding clinical assessments, and understanding treatments that aim to improve function recovery in people with SCI.

There are 2 aims for this study. The purpose of the first is to examine the relationship between assessments commonly used in therapy and doctor's offices (clinical assessments) and measurements of the function of brain-spinal cord- muscle connections. This will require 2 visits, and each visit will last approximately 2 hours.

The purpose of the second aim is to examine the effects of training on brain-spinal cord-muscle response. This will require 30 visits, and each visit will last approximately 1.5 hours.

Institution
MUSC
Recruitment Contact
Blair Dellenbach
843-792-6313
stecb@musc.edu

MINDS Imaging Ancillary Study

Date Added
September 1st, 2021
PRO Number
Pro00111435
Researcher
John Rhodes

List of Studies


Keywords
Heart
Summary

Adults with Cognitive Heart Disease (ACHD) now outnumber children with CHD. ACHD patients can demonstrate some neurocognitive deficits which may reduce their quality of life. The goal of this research is to determine if the mind's ability to resist damage of the brain can impact the development and neurocognitive outcomes in ACHD patients.

Institution
MUSC
Recruitment Contact
Terry Headley
843-792-4629
headleyt@musc.edu

A PHASE III CLINICAL TRIAL EVALUATING DEESCALATION OF BREAST RADIATION FOR CONSERVATIVE TREATMENT OF STAGE I, HORMONE SENSITIVE, HER2-NEGATIVE, ONCOTYPE RECURRENCE SCORE ≤ 18 BREAST CANCER

Date Added
August 29th, 2021
PRO Number
Pro00113932
Researcher
Harriet Eldredge-Hindy

List of Studies

Keywords
Cancer/Breast
Summary

This study is for men and women with breast cancer. The purpose of this study is to compare the usual treatment of breast radiation and hormonal drugs after lumpectomy to using hormonal drugs alone.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)

Date Added
August 26th, 2021
PRO Number
Pro00111341
Researcher
Cynthia Dodds

List of Studies


Keywords
Brain, Infant, Movement Disorders, Pediatrics, Physical Therapy, Rehabilitation Studies, Stroke, Stroke Recovery
Summary

Constraint-induced movement therapy (CIMT) is the most efficacious treatment for children with hemiparesis from a perinatal arterial stroke but instead, weekly low-dose OT and/or PT is typical. The aims of this study are to compare 2 high doses of treatment to usual care in helping infants improve skills on the hemiplegic hand/arm and to improve bimanual activities. In addition, the association with gross motor, language and cognition will be explored.

Institution
MUSC
Recruitment Contact
Patricia Coker-Bolt
843-792-7491
cokerpc@musc.edu



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