Novel Application of Skills for Psychological Recovery Following Recent Sexual Assault

Date Added
December 22nd, 2022
PRO Number
Pro00122958
Researcher
Alyssa Rheingold

List of Studies


Keywords
Mental Health
Summary

The purpose of the study is to evaluate the preliminary acceptability and mental health outcomes associated with engagement in Skills for Psychological Recovery (SPR) and satisfaction with SPR among people who have experienced a sexual assault. The present study will conduct focus groups/interviews and surveys with providers of SPR and victim advocates at rape advocacy centers to understand perceptions of SPR and early interventions in rape advocacy center settings and determine adaptations needed to adapt SPR for the needs of survivors of recent sexual assault. The present study will also assess mental health outcomes on screening data collected as part of clinical care among people receiving SPR as part of clinical care via telehealth at Tri-County SPEAKS, Pathways to Healing, or National Crime Victims Research and Treatment Center and conducted one-time interviews and survey with survivors to get feedback on SPR for recent sexual assault.

Institution
MUSC
Recruitment Contact
Anna Foster
843-471-0302
fostanne@musc.edu

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, 52-WEEK PLACEBOCONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NON SEGMENTAL VITILIGO

Date Added
March 2nd, 2023
PRO Number
Pro00126424
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

Ritlecitinib (PF 06651600) is an investigational drug (referred to as "study drug" from here on) and is being developed as possible study treatment for participants with non segmental vitiligo (both active and stable vitiligo). The study drug will be compared with a placebo to find out if the study drug is better than the placebo for the study treatment of vitiligo. The duration of this study is a maximum of 60 weeks. There will be an initial screening period of 30 days where the study doctor will determine eligibility. If eligible, participants will be randomly assigned to receive the study drug or a placebo during a 52 week study treatment period. At the end of the treatment period, participants will enter a 4 week Follow Up Period.

Institution
MUSC
Recruitment Contact
Tiffany Vereen
843-792-6882
vereent@musc.edu

A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing the Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects with Moderate to Severe Atopic Dermatitis (Level-Up)

Date Added
March 22nd, 2023
PRO Number
Pro00125074
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Pediatrics, Skin
Summary

This is a global, Phase 3b/4, randomized, open-label, efficacy assessor-blinded, multi-center study that will evaluate upadacitinib compared with dupilumab, as monotherapy, in adolescents and adult subjects who have inadequate response to systemic therapy. The study will consist of a 35-day Screening Period; Period 1, a 16-week randomized, open-label, efficacy assessor blinded treatment period for all subjects, and a 30-day or 12-week follow-up visit for subjects on upadacitinib and dupilumab respectively, who will not enter the Period 2; Period 2, a 16-week open-label, efficacy assessor blinded extension period for those subjects with a < EASI 75 response at Week 16 (total duration 32 weeks) and a 30-day follow-up visit.

Institution
MUSC
Recruitment Contact
Mikayla DiDonato
8438762281
didonato@musc.edu

A multicenter randomized controlled trial to establish the impact of MeMed BV® on management of patients with suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("BV: JUPITER" TRIAL)

Date Added
March 29th, 2023
PRO Number
Pro00126966
Researcher
Gary Headden

List of Studies


Keywords
Pulmonary
Summary

1) You will be asked to provide a blood sample; up to two tubes for a total of up to 10mL (less than 2 teaspoons).
2) Samples will be processed and tested on the MeMed BV device.
3) You will be asked about your medical history, medications, and current illness, as well as demographic information (i.e. date of birth) and a contact phone number.
4) If eligible, it will be decided by chance, using a computer, if you will be put into one of two arms: the MeMed BV arm or the control arm. You have an equal chance of being placed in each group. You cannot choose your study group.
a. The MeMed BV arm: your clinician will receive the BV result, this will include a recommendation regarding antibiotic treatment
b. The control arm: your clinician will not receive the MeMed BV results and will treat you according to standard of care.
5) You will be contacted by a member of the study team at 28 (+/- 3) days after the day of consent to complete a short questionnaire regarding your current illness

Institution
MUSC
Recruitment Contact
Robert Houck
18436931860
houckr@musc.edu

A multicenter randomized controlled trial to establish the impact of MeMed BV® on management of patients with suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("BV: JUPITER" TRIAL)

Date Added
March 29th, 2023
PRO Number
Pro00126966
Researcher
Gary Headden

List of Studies


Keywords
Pulmonary
Summary

1) You will be asked to provide a blood sample; up to two tubes for a total of up to 10mL (less than 2 teaspoons).
2) Samples will be processed and tested on the MeMed BV device.
3) You will be asked about your medical history, medications, and current illness, as well as demographic information (i.e. date of birth) and a contact phone number.
4) If eligible, it will be decided by chance, using a computer, if you will be put into one of two arms: the MeMed BV arm or the control arm. You have an equal chance of being placed in each group. You cannot choose your study group.
a. The MeMed BV arm: your clinician will receive the BV result, this will include a recommendation regarding antibiotic treatment
b. The control arm: your clinician will not receive the MeMed BV results and will treat you according to standard of care.
5) You will be contacted by a member of the study team at 28 (+/- 3) days after the day of consent to complete a short questionnaire regarding your current illness

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Robert Houck
18436931860
houckr@musc.edu

A Prospective, Single-arm, Multi-center, Open-label Trial Evaluating the Continuous Application of Prevena™ Therapy for up to 14 days

Date Added
April 20th, 2023
PRO Number
Pro00124286
Researcher
Thomas Curran

List of Studies


Keywords
Surgery
Summary

The purpose of this study is to demonstrate that the continuous use of negative pressure dressings for up to 14 days has similar benefits and risks to the continuous use for up to 7 days. The 3M study product being used in this study includes the PREVENA Plus Incision Management System with PREVENA Dressings (Peel & Place, Customizable and ARTHRO●FORM). The study product is considered investigational because it has not been approved by the FDA for continuous use for up to 14 days. It is currently approved for use for up to 7 days.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
(843) 792-8896
(843) 792-8896

Targeting the Shared Substrates of Alcohol Misuse and Cognitive Impairment: Accelerated rTMS for Older Adults with Alcohol Use Disorder

Date Added
May 2nd, 2023
PRO Number
Pro00127570
Researcher
Lisa McTeague

List of Studies


Keywords
Alcohol, Brain, Psychiatry, Substance Use
Summary

Alcohol misuse is a risk factor for early onset cognitive impairment, contributing to 10% of early onset dementia, with risk corresponding to consumption. Additionally, continued drinking risks worsening cognitive decline and dementia progression, while worsening cognitive impairment contributes to drinking escalation. Repetitive transcranial magnetic stimulation (rTMS) has been shown to improve cognition in Alzheimer's Disease and Related Dimentias (ADRD) and separately reduce heavy drinking in alcohol use disorder. Our objective is to optimize rTMS for simultaneous mitigation of both drinking and cognitive dysfunction in older adults.

Institution
MUSC
Recruitment Contact
Charleston Alcohol Research Center
843-792-1222
alcoholstudy@musc.edu

Brightline-1: A Phase II/III, randomized, open-label, multi-center study of BI 907828 compared to doxorubicin as first line treatment of patients with advanced dedifferentiated liposarcoma

Date Added
May 9th, 2023
PRO Number
Pro00126917
Researcher
Daniel Reuben

List of Studies


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

The primary trial objective is to see if the study drug called BI 907828 may help people with dedifferentiated liposarcoma (DDLPS) and is better than the approved drug, doxorubicin.
Additional trial goals are to find an optimal dose of BI 907828
and to determine whether BI 907828 improves the response
rate, duration of response, overall survival, disease control rate, the tolerability and if the study drug has a positive impact on the quality of life, compared to doxorubicin.

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

A Multi-Center, Phase 3, Randomized Trial of Matched Unrelated Donor (MUD) versus HLAHaploidentical Related (Haplo) Myeloablative Hematopoietic Cell Transplantation for Children, Adolescents, and Young Adults (AYA) with Acute Leukemia or Myelodysplastic Syndrome (MDS)

Date Added
May 16th, 2023
PRO Number
Pro00128723
Researcher
Michelle Hudspeth

List of Studies


Keywords
Adolescents, Cancer/Leukemia
Summary

This study is for patients with acute leukemia or myelodysplastic syndrome (MDS). This study is being done to help understand whether a haplo related donor or a MUD HCT for people with acute leukemia or MDS is better or if there is no difference at all.

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

A Randomized Phase II Study Comparing Inotuzumab plus Chemotherapy versus Standard Chemotherapy in Older Adults with Philadelphia-Chromosome Negative B-Cell Acute Lymphoblastic Leukemia (ALL)

Date Added
May 18th, 2023
PRO Number
Pro00128781
Researcher
Alexander Coltoff

List of Studies

Keywords
Cancer, Cancer/Leukemia
Summary

This trial will enroll patients 50 years and older with acute lymphoblastic leukemia (ALL). Patients above age 50 years are not eligible for intensive chemotherapy regimens and have been shown to have worse outcomes than adolescents and young adults treated with the same chemotherapy. For instance, the 5-year survival for patients aged 55-65 years treated on an international ALL trial was 21% compared to 38% for younger patients. Similarly, the 5-year survival for patients treated at MD Anderson Cancer Center with the hyper-CVAD regimen was 30% for patients aged 40-59 years compared to 51% for those less then age 40 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
(843)792-9371
hcc-clinical-trials@musc.edu



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