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

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

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

An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System

Date Added
August 24th, 2021
PRO Number
Pro00112813
Researcher
Daniel Steinberg

List of Studies


Keywords
Heart, Surgery
Summary

This study is examining the use, safety and performance of an investigational, meaning not approved for commercial use or sale by the US Food and Drug Administration (FDA) device called Transcatheter Mitral Valve Replacement (TMVR). The TMVR is a device used to treat mitral valve disease in patients with heart failure (weakened heart muscle). The device is placed by a non surgical approach using a delivery catheter (hollow tube) placed in your blood vessel at the top of your leg and directed up to your heart. This five year study will include a screening process to determine you meet eligibility criteria. If you qualify you will then be seen for a baseline visit, undergo the procedure to place the device, day after procedure, at hospital discharge, 1,3,6, 12 months, then yearly for up to 5 years. Study related testing includes physical exams, medication review, 6 minute hall walk test, questionnaires, blood work, CT scans, electrocardiogram or ECG (recording of your heart's electrical activity) and echocardiogram (ultrasound test of your heart).

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

Cochlear implant expectations

Date Added
August 21st, 2021
PRO Number
Pro00113247
Researcher
Theodore McRackan

List of Studies


Keywords
Ears, Hearing, Surgery
Summary

The study will include 9 key informant interviews discussing how patients developed their impression of the benefit of an implant and how patients prefer expectation data be relayed. No video recordings will be performed during interviews. Interview notes or audio recordings will be taken and uploaded into a password protected network server. The results of interviews will mainly be descriptive. To test the plasticity of preoperative patient expectations and the impact of the CI evaluation the CIQOL expectations form will be administered prior to CI evaluation, directly after the CI evaluation, and prior to surgery for all patients who are undergoing cochlear implantation and meet inclusion/exclusion criteria and agree to participate. The decisional conflict scale will also be administered directly after the CI evaluation and prior to surgery for the above patient group. The 9 patients who undergo key informant interviews will also be part of the larger study group of 200 patients and have the same surveys administered and be subject to the same inclusion/exclusion criteria. The group of patients will also be asked about how they prefer expectation and QOL data to be relayed. All survey data will be collected in a secure RedCap database. Patients expectations at the three preoperative timepoints will be compared using paired T-tests. Data regarding how patients develop expectations and how they prefer expectation data to be presented to them will be mainly qualitative and discussed in terms of the most common themes from patient surveys and interviews. When exploring how patients prefer expectations and QOL data to be relayed we intend to include numbered clinical vignettes relaying differing levels of hearing capability. We will compare relaying information through vignettes to more conventional outcome measures such as speech recognition and QOL scores to determine which is the more effective means of communication.

Institution
MUSC
Recruitment Contact
David Aamodt
843-876-7069
aamodt@musc.edu

Fibrotic Mechanisms in Systemic Sclerosis

Date Added
August 17th, 2021
PRO Number
Pro00111928
Researcher
Deanna Baker Frost

List of Studies


Keywords
Autoimmune disease, Skin
Summary

We plan to obtain skin biopsies from patients with systemic sclerosis and healthy donors to grow cells from biopsies. With those cells, we will use them in experiments to see why the cells from systemic sclerosis patients have more fibrosis compared to patients without systemic sclerosis.

Institution
MUSC
Recruitment Contact
Deanna Baker Frost
8437928461
bakerde@musc.edu



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