The impact of cannabis and tobacco/nicotine product co-use in young adults: Prospective cessation evaluation and substitution

Date Added
September 15th, 2023
PRO Number
Pro00131124
Researcher
Erin McClure

List of Studies


Keywords
Smoking, Substance Use
Summary

The goal of this project is to better understand the relationship between tobacco/nicotine and cannabis using behavioral economics during a tobacco/nicotine quit attempt. All participants will receive tobacco/nicotine cessation treatment (smoking and/or vaping treatment) for 12 weeks. To qualify, participants must be between the ages of 18-25 and use tobacco products (smoke cigarettes and/or vape nicotine) and use cannabis (in any form). Participants do not need to be interested in quitting cannabis/marijuana to qualify. This study is being conducted by the Medical University of South Carolina. All procedures are conducted remotely and there is no in-person visits are needed.

Institution
MUSC
Recruitment Contact
Emma Mandel
843-792-4097 or 843-830-0165
smokingstudy@musc.edu

A Randomized, Double-blind, Multi-center, Phase III Study of AK112 or Placebo Combined with Pemetrexed and Carboplatin in Patients with EGFRmutant Locally Advanced or Metastatic Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment

Date Added
September 13th, 2023
PRO Number
Pro00130566
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

The study is for patients who have been diagnosed with non-squamous non-small cell lung cancer (NSCLC). The investigational drug in this study is ivonescimab (AK112). The study drug is an antibody, it blocks two proteins in the body that help cancer cells live, grow and spread. The study drug will be given in addition to pemetrexed and carboplatin. There are two groups that a participant may be assigned to, which group a subject is assigned on will be determined by type of cancer treatments that they have previously received. Treatment Group A will receive the study drug along with pemetrexed and carboplatin. Treatment Group B will receive placebo along with pemetrexed and carboplatin. The drugs will be given via an infusion. There is a 50% chance of being assigned to either group. Participation in the study will last about 36 months. The study consist of a screening visit, treatment visits, and a safety follow up visit.

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

A Phase 3, Multi-center, Randomized, Double-blind Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy

Date Added
September 12th, 2023
PRO Number
Pro00131432
Researcher
Jessica Atkins

List of Studies

Keywords
Cardiovascular, Heart
Summary

This study is for patients with obstructive hypertrophic cardiomyopathy (oHCM). oHCM is a condition where the heart muscle becomes abnormally thickened, which can sometimes block the blood flow out of the heart and results in the heart muscle working harder to pump blood to the body.

The study is done to compare the side effects and effectiveness of an investigational (not yet approved by the Food and Drug Administration (FDA)) medication with the beta-blocker metoprolol succinate in participants with oHCM. The study medication is known as Aficamten and is a tablet taken by mouth. This is a randomized study (participants will be assigned by chance to the study medication Aficamten and placebo or metoprolol succinate and placebo). A placebo looks just like the study medication but has no active ingredient in it. The medications will be administered in the form of a pill. This study will take about 9 months and include about 11 visits to the study site. Study related procedures include blood work, echocardiograms (ultrasound test of the heart), electrocardiogram (recording of heart's electrical activity), exercise testing, physical exams, questionnaires and optional genetic testing. Risks associated with this study include shortness of breath, nausea, diarrhea, headaches and dizziness.

Institution
MUSC
Recruitment Contact
Kavin Panneerselvam
843-792-0464
panneeer@musc.edu

A Phase 1 Multicenter Dose Escalation and Dose Expansion Study of Antibody-Drug Conjugate MYTX-011 in Subjects with Non-Small Cell Lung Cancer

Date Added
September 12th, 2023
PRO Number
Pro00128530
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

The purpose of this research is to determine the safety and tolerability, the best dose for future development, as well as antitumor activity of a new antibody drug conjugate (ADC) called MYTX-011. MYTX-011 is a new drug, being studied in humans for the first time for treatment of advanced non-small cell lung cancer. The study team is investigating this drug to help treat lung cancers that are resistant to standard medications. This drug targets a protein called cMET on the cancer cell. MYTX-011 will attach to the cMET and release chemotherapy into the cancer cell.

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

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Baricitinib in Children from 6 Years to Less than 18 Years of Age with Alopecia Areata

Date Added
September 11th, 2023
PRO Number
Pro00126611
Researcher
Lara Wine Lee

List of Studies


Keywords
Pediatrics, Skin
Summary

This is a Phase 3, placebo-controlled, randomized, double-blind research study evaluating the efficacy, safety, and PK of baricitinib in children from 6 years to less than 18 years of age with severe alopecia areata. The study is divided into 4 periods: a 5-week screening period, a 36-week double-blind treatment period, an approximately 2-year long-term extension period, and a 4-week posttreatment follow-up period. If the subject meets all eligibility criteria they will be randomized to receive either baricitinib high dose, baricitinib low dose, or placebo for 36 weeks. Participants will then be transitioned into the long-term extension treatment period. Subjects will attend 18 clinic visits for up to 145 weeks.

Institution
MUSC
Recruitment Contact
Madeline Richmond
8437921436
richmoma@musc.edu

Improving Psychosocial Functioning among Veterans with Social Anxiety: A Pilot Evaluation of Self-Monitoring Intervention to Reduce Safety Behaviors

Date Added
September 5th, 2023
PRO Number
Pro00129894
Researcher
Anouk Grubaugh

List of Studies


Keywords
Anxiety
Summary

Social anxiety, which broadly consists of fears related to being negatively evaluated and avoidance of social situations, is highly prevalent among Veterans. Social anxiety is associated with significant deficits in social and occupational functioning. This study aims to evaluate a brief text-based intervention for decreasing social anxiety related safety behaviors among Veterans attempting to re-integrate into the workforce. Findings from this study will examine the efficacy of the text based intervention with aims at improving functional outcomes and quality of life among Veterans. Additional data from participating Veterans will provide valuable feedback on the intervention and assist in future refinement.

Institution
MUSC
Recruitment Contact
Sarah Szafranski
843-301-9917
sarah.szafranski@va.gov

Clinical Feasibility of Low Intensity Focused Ultrasound Pulsation for the Treatment of Treatment Resistant Major Depressive Disorder

Date Added
September 5th, 2023
PRO Number
Pro00128763
Researcher
Charles Palmer

List of Studies

Keywords
Depression, Mental Health, Psychiatry
Summary

The purpose of this pilot study is to evaluate safety and efficacy of a novel treatment, low intensity focused ultrasound pulsation (LIFUP) for treatment resistant depression (TRD). The initial visit will involve consent and an MRI scan, followed by two more treatment visits over the course of one week. During the first treatment day, participants will receive either focused ultrasound or sham stimulation. On the second treatment day, all participants will receive focused ultrasound. Response and potential side effects will be monitored pre- and post- each treatment along with one week and one month follow-up assessments. Follow-up assessments will also involve an MRI scan.

Institution
MUSC
Recruitment Contact
Charles Palmer
843-697-9989
palmecha@musc.edu

Health Education Approach to Lung Screening (HEALS)

Date Added
August 29th, 2023
PRO Number
Pro00130682
Researcher
Marvella Ford

List of Studies


Keywords
Cancer, Lung, Minorities
Summary

The Southeastern Consortium for Lung Cancer Health Equity (SC3), led by Dr. Robert A. Winn, assembles an outstanding interdisciplinary team of translational researchers positioned in the heart of the historical and current tobacco-producing region within the southeast. Collectively, SC3's investigative team has unparalleled experience in lung cancer screening, translational research in lung cancer health disparities, community outreach and engagement, and recruiting and retaining racial and ethnic minorities and individuals from other medically underserved groups using evidence-based strategies. As NCI-designated cancer centers, all three centers report high enrollment of underserved minorities onto interventional trials and are committed to reducing the substantial disparities found in lung cancer outcomes in their collective Black/African American and rural communities.

Institution
MUSC
Recruitment Contact
Ellen Gomez
8438762428
gomezel@musc.edu

A placebo-controlled trial to evaluate the efficacy and safety of spesolimab in the treatment of patients with Netherton syndrome

Date Added
August 28th, 2023
PRO Number
Pro00128405
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is a multi-center, randomized, double-blind, placebo-controlled, phase II/III study to evaluate the efficacy and safety of spesolimab compared to placebo in the treatment of Netherton syndrome. This study will last up to 72 weeks with 16 clinic visits. Eligible patients will be randomized 2:1 to receive either spesolimab i.v. loading doses at Week 0 plus spesolimab subcutaneous doses every 4 weeks, or to receive placebo i.v. loading dose at Week 0 plus placebo subcutaneous doses every 4 weeks. At Week 20, all patients will enter the open label period to receive spesolimab subcutaneous dose every 4 weeks up to Week 52. There will be a safety follow up visit 16 weeks after the last dose.

Institution
MUSC
Recruitment Contact
Mikayla DiDonato
843-876-2281
didonato@musc.edu

A 52-Week Open-Label Extension Study of Pimavanserin in Children and Adolescents with Irritability Associated with Autism Spectrum Disorder (ASD)

Date Added
August 28th, 2023
PRO Number
Pro00127713
Researcher
McLeod Gwynette

List of Studies


Keywords
Autism
Summary

Pimavanserin is an antipsychotic may have some beneficial effects on core autism symptoms and co-morbid conditions such as irritability, anxiety, sleep disorders, mood instability due to epilepsy, etc.). These potential benefits stem from pimavanserin's impact on the serotonin system in the body. This study will investigate pimavanserin in the treatment of irritability, core autism symptoms, and co-morbid conditions in children ages 6-17 years old.

Institution
MUSC
Recruitment Contact
McLeod Gwynette
843-792-4113
gwynette@musc.edu



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