A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Effectiveness of Arthrex Products used for Knee Sports Medicine Repair and Reconstruction

Date Added
October 15th, 2024
PRO Number
Pro00132834
Researcher
Harris Slone

List of Studies


Keywords
Joint
Summary

The study is for subjects that are undergoing knee surgery to repair and reconstruct the ligaments and tendons in the knee. Data will be collected to evaluate the continued safety and effectiveness of the screws and anchors that are used during the surgery to do the repair and reconstruction of the ligaments and tendons in the knee. There are six visits over a two-year time period that will be conducted during your standard of care visits with the doctor. During those visits outcome data will be collected via questionnaires. The study is designed to collect real world data from the general population on products that are cleared for sale in the U.S.

Institution
MUSC
Recruitment Contact
Jenna Williams
843-876-0111
wiljenna@musc.edu

A Phase 3, Open-label, Efficacy-Assessor-Blinded Study, Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Children from 2 to Less than 12 Years of Age with Moderate to Severe Atopic Dermatitis (START UP)

Date Added
October 9th, 2024
PRO Number
Pro00138750
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This study is being conducted at approximately 150 research centers worldwide and is expected to enroll approximately 675 pediatric subjects in total with moderately to severely AD. This study will have 2 cohorts, a Randomized Cohort, and a Dupilumab-Inadequate Responder / Dupilumab Medically Inadvisable Cohort. The study comprises a 35-day Screening Period; a 16-week, open-label, efficacy assessor blinded study treatment period for the subjects in the randomized cohort; an open-label period up to Week 160 for subjects in the upadacitinib study treatment arms across both cohorts (Randomized Cohort and Dupi-IR/Dupilumab Medically Inadvisable Cohort); an open label period up to Week 52 for subjects in the dupilumab arm; and a 30-day Follow up Visit/call after the last dose is administered for upadacitinib or dupilumab.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-9784
rowle@musc.edu

A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of FT218 in the Treatment of Idiopathic Hypersomnia (IH)

Date Added
October 9th, 2024
PRO Number
Pro00138642
Researcher
Thomas Uhde

List of Studies


Keywords
Sleep Disorders
Summary

This is a study to learn more about the use of a study medicine for the treatment of Idiopathic Hypersomnia (IH). The total duration of the study is approximately 3 1/2 months. Men and women between the ages of 18-75, with a primary diagnosis of IH, may be eligible.

Institution
MUSC
Recruitment Contact
Jelissa Suarez
843-876-9262
suarezj@musc.edu

NRG-CC012CD: MANAGING SYMPTOMS AND PSYCHOLOGICAL DISTRESS DURING ORAL ANTI-CANCER TREATMENT (SYMON)

Date Added
October 8th, 2024
PRO Number
Pro00139474
Researcher
Evan Graboyes

List of Studies


Keywords
Cancer, Drug Studies
Summary

This study will determine if people on oral anti-cancer treatment who have these symptoms monitoring calls plus other support will have less severe symptoms and less visits to the hospital, emergency room or urgent care compared to only symptom monitoring calls. The patients are expected to participate in this study for a minimum of 12 weeks. During the trial patients will receive a telephone call to monitor symptoms.

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

A Phase III, Randomized, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared with Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients with Heart Failure and Impaired Kidney Function

Date Added
October 8th, 2024
PRO Number
Pro00138745
Researcher
Vishal Rao

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart, Kidney
Summary

We are doing this study to learn more about how effective, safe and tolerable an experimental drug called balcinrenone is when used in combination with dapagliflozin for treating patients with heart failure and impaired kidney function and also to better understand the studied disease and associated health problems. Dapagliflozin is an approved drug to treat patients with heart failure, chronic kidney disease and type 2 diabetes mellitus.

Institution
MUSC
Recruitment Contact
Lauren Wakefield
843-876-5049
wakefila@musc.edu

Adapting and Piloting the Managing Emotions to Reduce Alcohol-Facilitated Aggression (MERA-A) Intervention among Veterans

Date Added
October 1st, 2024
PRO Number
Pro00139264
Researcher
Julianne Flanagan

List of Studies


Keywords
Alcohol
Summary

Rates of heavy episodic drinking (HED) among military veterans are almost double that of the general population. Veterans also experience more serious negative health consequences of HED, including high-risk behaviors such as aggression. Research shows there is a link between HED and aggression. However, no programs exist to reduce alcohol-related aggression among veterans. The purpose of this study is to examine the feasibility and acceptability of adapting a current therapy - Managing Emotions to Reduce Aggression (MERA) - to include alcohol-focused Motivational Interviewing plus Feedback (MIF). We will use a brief, four session protocol that includes an hour of talk therapy, plus completion of surveys at each of the four sessions.

Institution
MUSC
Recruitment Contact
Stacey Sellers
843-792-5807
sellersst@musc.edu

Strategy for Improving Stroke Treatment Response

Date Added
September 26th, 2024
PRO Number
Pro00136289
Researcher
Christine Holmstedt

List of Studies


Keywords
Stroke
Summary

The research is being done to determine if an investigational drug called "TS23" is safe and effective for the treatment of patients with an ischemic stroke that do not meet the criteria for standard treatments to remove the clot. The best dose of TS23 for these patients is unknown. Prior studies have shown that TS23 works without increasing safety concerns.

Institution
MUSC
Recruitment Contact
Caitlan LeMatty
843 792 8606
lemattyc@musc.edu

The Development of Patient-Centered Clinical AFO prescription Guidelines to Optimize Post-Stroke Function and Quality of Life

Date Added
September 25th, 2024
PRO Number
Pro00138736
Researcher
Steven Kautz

List of Studies


Keywords
Stroke Recovery
Summary

The goal of this study is to get the highest possible quality of life restuls for individuals suffering lower-limb impairment after suffering a stroke. This will be done by examining three different modern carbon fiber ankle-foot orthosis (AFO) options targeting the rehabilitation of individuals post-stroke. The study seeks to achieve the best AFO prescription that maximizes the mobility and satisfaction of the particpant.

Institution
MUSC
Recruitment Contact
Kelly Krajeck
843-792-9329
krajeck@musc.edu

Randomized Phase 2 Study of Nivolumab and Ipilimumab With or Without Cabozantinib in Patients With Advanced Nasopharyngeal Carcinoma That Have Progressed After Platinum Treatment and Immunotherapy

Date Added
September 23rd, 2024
PRO Number
Pro00138505
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Head & Neck, Men's Health, Women's Health
Summary

This study is designed to learn more about how nivolumab and ipilimumab, with or without cabozantinib effects the growth and spreading of head and neck cancer. If decided to take part in this study, participants will go through a screening period, treatment period, and follow-up period. During the screening period following signing of consent form participants will be evaluated for screening criteria and determined if they qualify for the study. During treatment period participants will be randomly assigned to either receive the combination of two immunotherapy drugs, nivolumab and ipilimumab for up to 2 years, or the two immunotherapy drugs with an additional targeted drug, cabozantinib, for up to 2 years unless your cancer gets worse or the side effects of the treatment become too severe. In the follow up period the side effects will be observed by the study team every 3 to 4 months for 2 years after treatment. The most common risks and discomforts expected in this study are diarrhea, nausea, vomiting, tiredness, weight loss, loss of appetite, changes in taste or voice, redness, pain or peeling of palms and soles, and high blood pressure which may cause blurred vision. There may not a benefit from joining the study. The head and neck cancer may improve while on this study but it may not, and it may even get worse. It will also help inform how well this combination treatment works at curing this type of cancer. The study results may be used to help others in the future.

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

Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness.

Date Added
September 23rd, 2024
PRO Number
Pro00136394
Researcher
Mark Miller

List of Studies

Keywords
Bone, Children's Health, Surgery
Summary

The primary objective of this study is to demonstrate the safety and effective use of Stryker's PEEK Customized Implants in patients receiving craniofacial (head and facial) surgery. Other objectives include using a CT scan to assist surgeons with providing a solution to complex and simple reconstruction challenges and reducing them to a single or two-stage procedure, thereby minimizing the overall surgery time and limiting the number of surgeries. Patient questionnaires and health information will be used during the study to demonstrate the safety and effectiveness of the implants. We will be enrolling ages 4 - 75 years old.

Institution
MUSC
Recruitment Contact
Monicagail Reyes
843-792-7333
reyesmo@musc.edu



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