Integrated Treatment for Opioid Use Disorder and Posttraumatic Stress Disorder

Date Added
October 8th, 2021
PRO Number
Pro00114390
Researcher
Tanya Saraiya

List of Studies

Keywords
Psychiatry
Summary

We are seeking participants who have used or currently use opioids, are between the ages of 18-65, and a have experienced a traumatic event. A traumatic event is something incredibly frightening, such as physical assault, domestic violence, or sexual assault. We will interview participants for their preferences in treatment for 60-90 minutes. Interviews are confidential. Participants will be compensated $25 for their time.

Institution
MUSC
Recruitment Contact
Tanya Saraiya
8438762374
saraiya@musc.edu

An investigation of reward brain circuitry structure and function in individuals with co-occurring alcohol use disorder and bipolar disorder and their unaffected offspring

Date Added
October 5th, 2021
PRO Number
Pro00114068
Researcher
Will Mellick

List of Studies


Keywords
Adolescents, Alcohol, Brain, Depression, Mental Health, Substance Use
Summary

The purpose of this two-visit brain imaging (magnetic resonance imaging, MRI) study is to identify brain targets for improving treatment and preventative interventions for individuals at risk for co-occurring bipolar disorder and alcohol use disorder. The preliminary visit for a parent and his/her biological child will include completion of clinical interviews, surveys, and labwork to determine study eligibility. If they are considered eligible for the study, brain imaging visits will occur within 1-2 weeks at which a 1-hour MRI will be completed along with additional clinical interviews, surveys, and labwork. Brief follow-up phone call interviews will be completed with participants every 3 months for 1 year. Study participation is confidential and compensated.

Institution
MUSC
Recruitment Contact
Sara Hix
(843) 792-7500
hixs@musc.edu

Registry of Recruitment-Ready Research Participants for Alzheimer's Disease-Related Clinical Trials

Date Added
October 5th, 2021
PRO Number
Pro00112875
Researcher
Jacobo Mintzer

List of Studies


Keywords
Alzheimers
Summary

The purpose of the Alzheimer's Disease Registry Study (ADRS) is to (1) create a registry that will continue to provide study-ready subjects who meet research diagnostic criteria for the different stages of AD and who have been evaluated using research instruments that allow for their participation in clinical trial research, (2) provide a platform to allow for continual follow-up with registry participants to allow for their participation in clinical trial research at different stages of the disease process, and (3) to incorporate a population of veterans and minorities suffering from AD, a population that is not proportionally represented in clinical trial research, into the registry.

By collecting data pertaining to medical history, current medication details, family history, vital signs, and memory/thinking symptom concerns and evaluating a subject's ability to perform certain tasks, such as memory and thinking tests, questions about their daily activities, and social functioning; researchers are able to determine a research subject's potential eligibility in a clinical trial research protocol.

A registry with such information would enable researchers to effectively and efficiently identify potentially eligible research subjects for the program's evolving portfolio of Alzheimer's disease-related clinical trials.

Institution
MUSC
Recruitment Contact
Allison Lapp
843-608-1950, ext 1109
allisonlapp@lcvresearch.org

An Open-Label, Tolerability and Efficacy Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents with 22q11.2 Deletion Syndrome

Date Added
October 1st, 2021
PRO Number
Pro00114473
Researcher
Caroline Buchanan

List of Studies

Keywords
Genetics
Summary

The Drug Product ZYN002 is a transdermal CBD gel. CBD is the primary non-euphoric cannabinoid contained in the Cannabis sativa L. plant. The CBD contained within ZYN002 is a pharmaceutically produced Active Pharmaceutical Ingredient (API) that is chemically identical to the CBD present in Cannabis. ZYN002 is currently being evaluated in clinical trials in children and adolescents with Fragile X Syndrome (FXS), autism spectrum disorder, 22q11.2 deletion syndrome, and developmental and epileptic encephalopathies. The present protocol for ZYN2-CL-031 (INSPIRE) is designed to evaluate the safety and tolerability of ZYN002 in the treatment of 11q11.2 Deletion Syndrome. Enrolled participants will be treated for a 1-14 week period and then further evaluated for continuation. Those eligible will be able to continue in the open-label study for an additional 24 weeks of treatment.

Institution
Self Regional
Recruitment Contact
Sarah English
18646726912
senglish@ggc.org

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
Hamza Hashmi

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 III Randomized Trial of Eribulin (NSC #707389) with or without Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 Therapy

Date Added
September 17th, 2021
PRO Number
Pro00114367
Researcher
Theodore Gourdin

List of Studies


Keywords
Cancer/Genitourinary, Urinary
Summary

This study is for patients with urothelial bladder cancer that has spread to other parts of the body. The purpose is to see if patients can live longer if they are treated with a new drug alone, a new drug in combination with one of the usual chemotherapy drugs or the usual chemotherapy drugs by themselves.

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

A Randomized, Active-Controlled, Efficacy Assessor-Blinded Study to Evaluate Pharmacokinetics, Safety and Efficacy of Risankizumab in Patients from 6 to Less than 18 Years of Age with Moderate to Severe Plaque Psoriasis

Date Added
September 14th, 2021
PRO Number
Pro00111592
Researcher
Colleen Cotton

List of Studies

Keywords
Children's Health, Drug Studies, Pediatrics, Skin
Summary

The purpose of this study is to test and compare the effects of investigational drug risankizumab to the active control, ustekinumab, on pediatric plaque psoriasis. Subjects that meet all eligibility criteria will be randomized 2:1 to receive 150 mg dose of risankizumab and 45mg or 90 mg dose of ustekinumab - both drug dosages are determined by weight. At Week 16, subjects receiving ustekinumab or are unresponsive to risankizumab, will be switched to or continue to receive 150 mg risankizumab every 12 weeks. Subjects that are responsive to risankizumab at Week 16, will be re-randomized 1:1 to continue risankizumab or withdrawal from the study drug. Subjects randomized to withdrawal will receive no study drug until a flare occurs, after which they will enter a 16-week re-treatment period.

Institution
MUSC
Recruitment Contact
Alyson Winter
8438763209
wintera@musc.edu

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Comparing the Efficacy and Safety of Tirzepatide versus Placebo in Patients with Heart Failure with Preserved Ejection Fraction and Obesity

Date Added
September 14th, 2021
PRO Number
Pro00111178
Researcher
Sheldon Litwin

List of Studies


Keywords
Heart, Obesity
Summary

The purpose of this research study is to evaluate the safety and effectiveness of tirzepatide compared to placebo (an inactive substance) in the treatment of individuals with Heart Failure with Preserved Ejection Fraction (HFpEF) and obesity.

Participants will undergo a screening visit where they will have a physical exam to asses health and blood will be drawn. If the blood tests show that a participant qualifies to continue, then they will be randomly assigned to either tirzepatide or placebo. Each participant will have a 50:50 chance of being on tirzepatide (like the flip of a coin.) Both tirzepatide and placebo will be supplied as a single dose in an injectable pen device. Subjects will inject the study drug under the skin (or subcutaneous) once a week with the injectable pen. Participation will last at least 52 weeks and may last up to 120 weeks.

Tirzepatide has been proven to provide significant body weight loss and improvement of fat and sugar metabolism in patients with type 2 diabetes. Body weight percent reduction in this study is estimated to be 15% to 16%.

Institution
MUSC
Recruitment Contact
Jacques Johnson
843-792-5873
johnjacq@musc.edu

Optimizing Prolonged Treatment in Myeloma Using MRD Assessment (OPTIMUM)

Date Added
September 9th, 2021
PRO Number
Pro00114332
Researcher
Hamza Hashmi

List of Studies

Keywords
Cancer
Summary

This study is for patients that have been diagnosed with multiple myeloma. The study drugs are Ixazomib and lenalidomide. The purpose of this study is to compare using lenalidomide and ixazomib to using lenalidomide and placebo. Participants will be on this study until disease progression or unacceptable toxicity.

Institution
MUSC
Recruitment Contact
Barbara Roe
843-652-1607
broe@tidelandshealth.org

A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS

Date Added
September 8th, 2021
PRO Number
Pro00114065
Researcher
Timothy Whelan

List of Studies


Keywords
Lung, Pulmonary
Summary

The purpose of this study is to compare the effects, good or bad, of PRM-151 versus placebo on patients with IPF during a 52-week period.. This study is testing an experimental drug called recombinant human pentraxin-2 (rhPTX-2; also known as PRM-151 or RO7490677). About 658 people will take part in this study.

Institution
MUSC
Recruitment Contact
Allison Patterson
(843) 792-5168
patteall@musc.edu



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