A Phase 2, double-blind, placebo-controlled, parallel-group study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and potential efficacy of multiple doses of ONO-2808 in patients with Multiple System Atrophy (MSA)

Date Added
June 11th, 2024
PRO Number
Pro00135088
Researcher
Gonzalo Revuelta

List of Studies


Keywords
Parkinsons
Summary

The purpose of this clinical trial is to evaluate the safety and effectiveness of ONO-2808 in patients with Multiple System Atrophy with cerebellar variant (MSA-C)and Multiple System Atrophy with parkinsonian variant (MSA-P).MSA is a rare, rapidly progressing, fatal, adult-onset neurodegenerative disorder of the central and autonomic nervous systems that is characterized clinically by a variable combination of parkinsonism, cerebellar impairment, and autonomic and motor dysfunctions ONO-2808 is an investigational drug meaning that its safety, effects, and how it works are still being studied. This is a randomized (assigned by chance), placebo-controlled study, which means that some participants will receive a fake treatment (placebo) while others get the real treatment. The placebo treatment looks like the ONO-2808 medications but doesn't contain any active ingredient. The medication is in pill form and will be administered orally. This research is also double-blind, meaning that neither the participants nor the researcher will know which treatment they will be receiving. If participants choose to take part in the study they will be asked to attend up to 16 visits and the study will take up to 34 weeks. During the study, participants will be asked to go through a screening period (up to 6 weeks). The purpose of this screening period is to make sure study participants meet all the study criteria. If participants meet all study criteria, they may be asked to volunteer for the double-blind treatments. The duration of the double-blind treatment is 24 weeks which consists of 14 visits, some visits will be done at the study center/ hospital and the remaining visits will be done by a nurse from IQVIA's Research Nurse and Phlebotomy Solutions (RNPS) at participants' home. During visits, participants should anticipate tests including electrocardiograms (ECGs), vitals measurements (including temperature, blood pressure, and heart rate), and a physical/neurological examination. Some of the risks include nausea, vomiting, abdominal pain, loss of appetite, dark urine, yellow eyes, and persistent fatigue.

Institution
MUSC
Recruitment Contact
Magdaline Volcy
843-792-1022
Volcy@musc.edu

A Phase 1b/2a Study To Evaluate The Safety Of CMTX-101 In Combination With Inhaled Tobramycin In People With Cystic Fibrosis Chronically Infected With Pseudomonas aeruginosa

Date Added
June 10th, 2024
PRO Number
Pro00137048
Researcher
Patrick Flume

List of Studies


Keywords
Cystic Fibrosis
Summary

This is a double-blind, randomized, placebo-controlled study of CMTX-101 in pwCF who are 18 years of age or older and chronically infected with P. aeruginosa. This study will evaluate the safety and tolerability, PK, immunogenicity, reduction of pulmonary P. aeruginosa burden, and exploratory endpoints of CMTX-101 in up to 41 participants. This study has 2 parts.

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

Phase 3 Double-blind Multicenter Randomized Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1

Date Added
June 5th, 2024
PRO Number
Pro00136188
Researcher
Eric Meissner

List of Studies


Keywords
HIV / AIDS
Summary

This study is for adults with HIV who are currently being treated with Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide [B/F/TAF]). The purpose of the research is to compare the effectiveness of B/F/TAF and the investigational once-daily medication Bictegravir/Lenacapavir (BIC/LEN). Participants will either continue taking B/F/TAF or switch to BIC/LEN for at least 48 weeks. The study will also look at the long-term effectiveness of BIC/LEN. Participants will be given the option of participating in an open-label phase of the study (where both the provider and participant know which drug they are on) where all participants receive BIC/LEN.

Institution
MUSC
Recruitment Contact
Jamila Williams
(843) 792-1088
keithja@musc.edu

Development of At-Home Transcutaneous Auricular Vagus Nerve Stimulation for Post-Stroke Rehabilitation

Date Added
June 4th, 2024
PRO Number
Pro00137256
Researcher
Bashar Badran

List of Studies


Keywords
Stroke Recovery
Summary

Early evidence suggests the benefits of post-stroke motor rehabilitation may be enhanced by applying electrical stimulation to the ear. This study aims to test the new approach of pairing ear stimulation with motor rehabilitation in the home setting in stroke survivors with upper limb motor function deficits.

Institution
MUSC
Recruitment Contact
Brenna Baker-Vogel
843-792-9502
bakebren@musc.edu

Investigate the anti-pain effect of taVNS in patients with chronic post-stroke upper extremity pain

Date Added
June 4th, 2024
PRO Number
Pro00137146
Researcher
Xiaolong Peng

List of Studies


Keywords
Pain, Stroke
Summary

The purpose of this study is to explore whether a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) can change the way you perceive pain. We will recruit up to 20 participants with chronic post-stroke upper extremity pain. The goal is to determine if there is a pain reduction after ear stimulation.

Institution
MUSC
Recruitment Contact
Brenna Baker-Vogel
843-792-3950
bakebren@musc.edu

A prospective trial of varenicline and incentives for e-cigarette cessation in adults who co-use cannabis

Date Added
June 4th, 2024
PRO Number
Pro00136601
Researcher
Erin McClure

List of Studies


Keywords
Smoking, Substance Use
Summary

The purpose of this study is to better understand tobacco outcomes using a commonly prescribed stop smoking medication (varenicline) and financial incentives for adults who also use cannabis. Varenicline is not FDA approved for e-cigarette cessation, but is FDA approved for cigarette cessation. We are also interested in how cannabis/marijuana and tobacco interact during a tobacco quit attempt. All participants will receive e-cigarette cessation treatment for 12 weeks. To qualify, participants must be between the ages of 18-40 and use both tobacco and cannabis. Participants do not need to be interested in quitting cannabis to qualify. This study is being conducted at two sites: the Medical University of South Carolina in Charleston, SC and Behavioral Health Services in Pickens, SC.

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

NRG-CC011: Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors: A Multi-Center Randomized Double-Blinded Controlled Trial

Date Added
June 4th, 2024
PRO Number
Pro00136484
Researcher
Abirami Sivapiragasam

List of Studies

Keywords
Cancer, Cancer/Breast, Drug Studies
Summary

This study is for patients that are breast cancer survivors suffering from cancer-related cognitive impairment. This study is being done to determine if breast cancer survivors suffering from cancer-related cognitive impairment have improvement in concentrating, learning new things, remembering, and making decisions by receiving computerized cognitive training. Patients can expect to be in the study 6 months.

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

Advanced Wireless Augmented Reality-Enhanced Exposure Therapy for Posttraumatic Stress Disorder

Date Added
June 4th, 2024
PRO Number
Pro00135785
Researcher
Ronald Acierno

List of Studies

Keywords
Anxiety, Mental Health, Military, Stress Disorders
Summary

The purpose of this study is to get feedback on an existing augmented reality (AR) software developed by researchers at Wayne State University (phase I) and then use the refined software, along with Prolonged Exposure (PE) therapy to treat Veterans and military personnel with posttraumatic stress disorder (PTSD).

AR involves wearing goggles through which you can see the real world, however virtual objects can be added to the environment (for example, like in the popular phone game Pokemon Go).

The technology was originally designed to help first responders, specifically police and firefighters, to overcome their avoidance of normal life situations caused by their trauma experience and PTSD. This includes a crowded party, a grocery store, a police roll call room and a fire station. This technology is now being expanded to include other common scenarios that military personnel and Veterans with PTSD may avoid.

This study will occur in 2 phases. Phase 1 will focus on getting feedback on the AR program from people who have completed PE therapy before to refine the technology. In phase 2, 40 Veterans and military personnel will be randomly selected to receive PTSD therapy + the refined AR technology or PE therapy alone.

This study is open to Veterans and active duty military personnel. All study activities will take place at the Ralph H. Johnson VA Health Care System and surrounding community-based outpatient clinics. This study is not open to civilians/non military personnel at this time.

Institution
MUSC
Recruitment Contact
Stephanie Hart
843-789-6519
zeigls@musc.edu

A Randomized Phase III Trial of Chemo-Immunotherapy vs Immunotherapy Alone for the Vulnerable older adult with Advanced Non-Small Cell Lung Cancer: The ACHIEVE Study

Date Added
June 3rd, 2024
PRO Number
Pro00137085
Researcher
Christopher Rangel

List of Studies

Keywords
Cancer, Cancer/Lung
Summary

Imagine you're flipping through a medical journal and stumble upon a study about lung cancer treatment. This study is not just any ordinary research; it's focused on a group often overlooked in clinical trials: older adults. The researchers are curious about how well a new treatment, called immunotherapy, works for these older folks who might have other health issues besides cancer. They've noticed that most studies tend to include younger, healthier people, so they want to see if the same treatments work as well for Grandma and Grandpa. They found that immunotherapy, which boosts the body's immune system to fight cancer, can be a game-changer for older adults with lung cancer. But here's the twist: they're not sure if it's always the best option, especially for those with a certain type of lung cancer marker. So, they're calling for more studies to figure out the best treatment plan for older adults with different levels of this marker. It's like a puzzle they're trying to solve to make sure Grandma and Grandpa get the best care possible.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinicaltrials@musc.edu

A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy With Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) Plus VINO-CPO Maintenance in Patients With High Risk Rhabdomyosarcoma (HR-RMS)

Date Added
May 29th, 2024
PRO Number
Pro00136652
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Cancer, Cancer/Sarcoma, Children's Health, Drug Studies, Men's Health, Pediatrics, Women's Health
Summary

This study is for patient that have been diagnosed with rhabdomyosarcoma (RMS). The investigational drug in this study is vinorelbine, vincristine, dactinomycin, and cyclophosphamide (together called VINO-AC with vincristine). The purpose of this study is to compare the effects, good and/or bad, vinorelbine has on people with high risk RMS. Also, to find out if adding maintenance therapy will help get rid of the cancer and/or lower the chance that the cancer comes back. Participants can expect to be in this study for 12 months and will include chemotherapy, radiation and possibly surgery.

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



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